Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees (GUI-0002)

Our Mandate:
To manage and deliver a national compliance and enforcement program for blood and donor semen; cells, tissues and organs; drugs (human and veterinary); medical devices and natural health products, collaborating with and across, all regions.

Supersedes: December 21, 2012

Date issued: April 1, 2013

Date of implementation: April 1, 2013

Disclaimer

This document does not constitute part of the Food and Drugs Act (Act) or its associated Regulations and in the event of any inconsistency or conflict between that Act or Regulations and this document, the Act or the Regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the Regulations and the applicable administrative policies.

Table of contents

1.0 Purpose

This guidance document is intended to give explanation of Part C, Division 1A of the  Food and Drug Regulations (FDR) as it pertains to drug establishment licensing. This document describes the responsibilities of persons involved in all licensable activities, what a Drug Establishment Licence (DEL) is, when it is required, who is required to hold a licence, and the activities it covers.

In addition, Section 10 of this guidance is intended to help applicants for DEL and Dealer's Licences to understand their payment obligations under the three sets of regulations which set out the regulatory requirements for fees for (1) DEL, (2) DEL in respect of veterinary drugs only, (3) Dealer's Licences, and (4) Dealer's Licences in respect of veterinary drugs only. The three sets of regulations are as follows:

2.0 Background

A DEL is required for any person in Canada engaged in any of the six licensable activities with respect to drugs in dosage form and bulk intermediates of Schedule C (radiopharmaceutical) and Schedule D (biological) drugs. The six licensable activities are: fabricate, package/label, test, import, distribute and wholesale.

Drug establishments are inspected by the Inspectorate Program to assess whether a person is performing licensable activities in compliance with the requirements of Part C, Divisions 2 to 4 of the FDR pertaining to Good Manufacturing Practices (GMP). A DEL will only be issued once the Inspectorate has assessed the applicant as being in compliance with these requirements.

Foreign sites whose drugs are to be imported by Canadian importers also fall under the scope of drug establishment licensing. These sites are inspected or evaluated according to the FDR pertaining to GMP compliance. A foreign site will only be listed on a foreign site annex to a DEL, once it has been assessed as being in compliance with these requirements.

3.0 Scope

This guidance document applies to all persons subject to the Establishment Licensing requirements of the Food and Drugs Act and FDR set out in Part C, Division 1A. Exemptions to these requirements are described in Section 7.0 of this document.

The Application Form and Instructions is a separate document found on the Health Canada website.

4.0 Glossary of Terms with Explanatory Notes

The interpretation section of FDR Part C, Division 1A, C.01A.001, provides definitions of the terms necessary for the application of the DEL regulatory framework set out in Divisions 1A, 2, 3 and 4 of the FDR. It should also be noted that other definitions currently in the (FDA) also apply to all Divisions of the FDR. To facilitate greater understanding of the Division 1A requirements, the terms in this document are not restricted to those listed in the interpretation section of Part C, Division 1A and include terms not in the regulations.

Alternate Sample Retention (ASR):
means of complying with FDR C.02.025(1). These drug specific requests are submitted annually by an importer or distributor to the Inspectorate and should be included with an application, amendment, notification or renewal. If the application criteria are met, then an ASR annex may accompany the DEL.
Alternate Sample Retention (ASR) Site Annex:
listing of sample retention sites that have been assessed against GMPs. This annex is a part of the DEL.
Antimicrobial Agent:
means a drug that is capable of destroying pathogenic micro-organisms and that is labelled as being for use in the disinfection of environmental surfaces or medical devices, as defined in the Medical Devices Regulations, that (a) are not invasive devices as defined in those Regulations; and (b) are intended to come into contact with intact skin only. ( FDR C.01A.001)
Note: Changes to the Food and Drug Regulations pertaining to DELs took place in 2004. Certain antimicrobial agents have been exempted from the requirements of Division 1A (Establishment Licences of Part C of the Food and Drug Regulations). However, all other pertinent requirements of the Food and Drugs Act and Food and Drug Regulations apply.

The following drugs are still subject to Division 1A (Establishment Licences):

  1. antimicrobial agents used for contact lenses which are required to be sterile,
  2. chemosterilants and high level antimicrobial agents used to sterilize invasive devices or devices used for circulation and reintroduction of a body fluid, and
  3. any other antimicrobial agents used for devices to be introduced in a body cavity or that come in contact with a body fluid.
Biological:
a drug that is listed in Schedule D to the Act that is in dosage form, or a drug that is a bulk process intermediate that can be used in the preparation of a drug listed in Schedule D to the Food and Drugs Act.
Note: This category applies to Human Drugs only. Veterinary Biologicals are regulated by the Veterinary Biologics Section ( VBS) of the Animal Health Directorate, Canadian Food Inspection Agency ( CFIA).
Bulk Process Intermediate:
any intermediate form of a Schedule C or D drug ( e.g., final bulk intermediate, bulk material, bulk concentrate, or drug substance) which must undergo further processing before it becomes a final product. They are usually characterized by a holding time, storage conditions and the application of in-process tests.
Certificate of Compliance ( CoC):
a certificate issued by a Regulatory Authority attesting to the GMP compliance of a recognized building in that country. In Canada, the CoC is issued by the Inspectorate.
Category IV drug:
a non-sterile, OTC drug for which a DIN is issued based on compliance with Category IV monograph.
Note: For more details regarding category IV monographs, please consult the Therapeutic Products Directorate's guidance documents.)
Class Monograph:
a document prepared by the Department of Health that lists the types and strengths of medicinal ingredients that may be contained in drugs of a specified class; and sets out labelling and other requirements that apply to those drugs( FDR C.01A.001)
Clinical Trial:
an investigation in respect of a drug for use in humans that involves human subjects and that is intended to discover or verify the clinical, pharmacological or pharmacodynamic effects of the drug, identify any adverse events in respect of the drug, study the absorption, distribution, metabolism and excretion of the drug, or ascertain the safety or efficacy of the drug. ( FDRC.05.001)
Note: Clinical trial drugs for human use are exempt from the requirements of Division 1A, in accordance with FDR C.01A.002(1): any activity with respect to a drug that is used only for the purposes of clinical testing in accordance with FDR C.05.006(1) or FDR C.08.005 . (See also Section 7.0 of this document).
Controlled Drug:
A controlled drug means a substance included in Schedule I, II, III, IV or V of the Controlled Drugs and Substances Act.
Dilute Drug Premix:
A drug for veterinary use that results from mixing a drug premix with a feed as defined in Section 2 of the Feeds Act, to such a level that at least 10 kg of the resulting mixture is required to medicate one tonne of complete feed, as defined in Section 2 of the Feeds Regulations, 1983, with the lowest approved dosage level of the drug. (Section C.01A.001 of the Food and Drug Regulations).
Distributor:
"manufacturer" or "distributor" means a person, including an association or partnership, who under their own name, or under a trade-, design or word mark, trade name or other name, word or mark controlled by them, sells a food or drug; ( FDR A.01.010)
Distribute:
means to sell a drug where the person is:
(a) a distributor of a drug listed in Schedule C or D to the Act or in Schedule F to these Regulations , a controlled drug as defined in subsection G.01.001 (1) or a narcotic as defined in the Narcotic Control Regulations who does not hold the drug identification number for the drug or narcotic; and
(b) a distributor of a drug for which that distributor holds the drug identification number ( FDR C.01A.003)

Distributors of OTC products do not require a DEL if they are not the DIN owner.
Dosage Form Class:
means a tablet, capsule, solution, suspension, aerosol, powder, suppository, medical gas or drug premix, or any other dosage form class designated by the Minister. ( FDR C.01A.001)
Note: This definition applies to Division 1A, 2, 3 and 4 of the Food and Drug Regulations.
Drug:
"A drug in dosage form, or a drug that is a bulk process intermediate that can be used in the preparation of a drug listed in Schedule C to the Act or in Schedule D to the Act that is of biological origin. It does not include a dilute drug premix, a medicated feed as defined in section 2 of the Feeds Regulations, 1983, a drug that is used only for the purposes of an experimental study in accordance with a certificate issued under section C.08.015 or a drug listed in Schedule H to the Act" ( FDR C.01A.001(2))

Note: This definition applies to Division 1A and 2 of the Food and Drug Regulations. The existing wording of Division 3 and Division 4 defines the drugs to which those Divisions apply, which is based on Schedule C and D respectively. The definition ensures that the Division 2 GMP requirements extend to both finished drugs and to bulk process intermediates of Schedule C and D Drugs. This definition of drug excludes from the application of Division 1A and 2 (i) dilute drug premixes; (ii) medicated feeds; (iii) drugs used for the purposes of an experimental study; and (iv) restricted drugs. However, this does not exclude these drugs from any relevant provision of the Food and Drug Regulations.
Drug Establishment:
a building in Canada in which any of the six licensable activities: fabricate, package/label, test, import, distribute, and wholesale of biologicals, vaccines, blood and blood components, pharmaceuticals and radiopharmaceuticals are being conducted.
Drug Establishment Licence ( DEL):
a licence issued to a person in Canada to conduct licensable activities in a building which has been inspected and assessed as being in compliance with the requirements of Divisions 2 to 4 of the Food and Drug Regulations.
Drug Identification Number ( DIN):
A Drug Identification Number ( DIN) is a computer-generated eight digit number assigned by Health Canada to a drug product prior to being marketed in Canada. It uniquely identifies all drug products sold in a dosage form in Canada and is located on the label of prescription and over-the-counter drug products that have been evaluated and authorized for sale in Canada.
A DIN uniquely identifies the following product characteristics: manufacturer; product name; active ingredient(s); strength(s) of active ingredient(s); pharmaceutical form; route of administration.
Note: a DIN is assigned to each drug product approved under the Food and Drugs Act and Regulations (except for Schedule C drugs).
Drug Premix:
"a drug for veterinary use to which a Drug Identification Number has been assigned, where the directions on its label specify that it is to be mixed with feed as defined in section 2 of the Feeds Act." ( FDR C.01A.001)
Ethical Drug:
a drug that in accordance with Federal Legislation does not require a prescription, but that is generally prescribed by a medical practitioner, e.g. nitroglycerine.
Note: As ethical drugs are not listed in any Schedule to the FDA or FDR they do not require a DEL for the activity of wholesale.
Fabricate:
"to prepare and preserve a drug for the purposes of sale" ( FDR C.01A.001)
Note: this definition applies to Division 1A, 2, 3 and 4 of the Food and Drug Regulations.
Foreign Site:
a building outside of Canada that conducts the following licensable activities: fabricate, package/label or test and is listed on the foreign site annex of a DEL.
Foreign Site Annex:
a listing of foreign sites on a DEL that have been assessed by the HPFBI as meeting the FDR under Division 2-4 and given a compliant rating.
Note: Please note that a person cannot import any drugs nor sell any existing stock that has been fabricated, packaged/labelled or tested at a foreign site that does not appear on their DEL.
Import:
"to import into Canada a drug for the purpose of sale." ( FDR C.01A.001)
Note: The person that is responsible for the sale of the drug in Canada must hold a DEL as an importer.

Part C, Division 1 of the Food and Drug Regulations has been expanded to more clearly identify the importer. Importers of Schedule C and D drugs are no longer exempt from the labelling requirements described in C.01.004.

  1. No person shall import a drug in dosage form into Canada for the purpose of sale unless they have in Canada a person who is responsible for the sale of the drug.
  2. No person who imports a drug in dosage form into Canada shall sell any lot or batch of the drug unless the name of the person who imports it, and the address of the principal place of business in Canada of the person responsible for its sale, appears on the inner and outer labels of the drug.
Inspection:
On-site monitoring and assessment against the applicable requirements of the FDA and its associated Regulations. Inspections are routinely conducted on a predetermined cycle or as required to assess compliance.
Inspection Rating:
A compliance rating given based on an inspection against Good Manufacturing Practices ( GMP) which includes FDR Part C, Division 2 and the GMP Guidelines. A GMP inspection rating consists of one out of two possible designations:

  • C: At the time of the inspection, the regulated party has demonstrated that the activities it conducts are in compliance with the Food and Drugs Act and its associated Regulations;

  • NC: At the time of the inspection, the regulated party has not demonstrated that the activities it conducts are in compliance with the Food and Drugs Act and its associated Regulations;
Label:
Includes any legend, word, or mark attached to, included in, belonging to, or accompanying any food, drug, cosmetic, device, or package (Section 2 of the Act). As described in package/label, the action of labelling refers to affixing the inner or outer label to the drug."(C.01A.001)
Note: The action of labelling refers to affixing the inner or outer label to the drug.
Licensable Activity:
The six licensable activities are: fabricate, package/label, test, import, distribute and wholesale.
Marketing Authorization:
A legal document issued by Health Canada, authorizing the sale of a drug or a device based on the health and safety requirements of the Food and Drug Act and its associated Regulations. The marketing authorization may be in the form of a Notice of Compliance ( NOC), Drug Identification Number ( DIN).
Medical Gas:
"Any gas or mixture of gases manufactured, sold or represented for use as a drug" ( FDR C.02.002)
Note: A medical gas with a DIN is considered a drug in dosage form.
Minister:
The Minister of Health is responsible for the administration of the Food and Drugs Act.
Mutual Recognition Agreement ( MRA) Country:
A country that is a signatory to a mutual recognition agreement with Canada that provides for the establishment of mutual recognition of compliance certification for Good Manufacturing Practices for drugs. ( FDR C.01A.001)
Natural Health Product:
is a substance set out in Schedule 1 or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine that is manufactured, sold or represented for use in

  1. the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
  2. restoring or correcting organic functions in humans; or
  3. modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.
However, a natural health product does not include a substance set out in Schedule 2 of the Natural Health Products Regulations. any combination of substances that includes a substance set out in Schedule 2 or a homeopathic medicine or a traditional medicine that is or includes a substance set out in Schedule 2
Over-the-Counter ( OTC):
a non-prescription drug which still requires a market authorization.
Note: OTC drugs are not considered pharmaceuticals as per the FDA or FDR therefore they do not require a DEL for the activity of wholesale.
Package/Label:
"to put a drug in its immediate container or to affix the inner or outer label to the drug" ( FDR C.01A.001)
Note: This definition applies to Division 1A, 2, 3 and 4 of the Food and Drug Regulations and refers to the activity. Packaging material is defined in Division 2. The application section of the Establishment Licensing regulations however, states that Divisions 1A to 4 do not apply to a person whose activity is limited to affixing a label to a previously labelled container ( e.g. a re-labeller). In order for this to apply, this requires that the integrity of the inner package is not compromised and that the new label does not contain label requirements of FDR C.01.004 and FDR C.01.005.

The assembly of promotional packages and/or displays of already packaged/labelled drugs is not a licensable activity.
Pharmaceutical:
"a drug other than a drug listed in Schedule C or D to the Act". ( FDR C.01A.001) This definition applies to Division 1A, 2, 3 and 4 of the Food and Drug Regulations.
Pharmacist:
means an individual who ( a) is registered or otherwise authorized under the laws of a province or territory to practice pharmacy; and ( b) is practicing pharmacy in that province or territory.
Practitioner:
A person authorized by the law of a province of Canada to treat patients with any drug listed or described in Schedule F to the Regulations. ( FDR C.01.001)
Prescription:
means an order given by a practitioner directing that a stated amount of any drug or mixture of drugs specified therein be dispensed for the person named in the order ( FDR C.01.001)
Radiopharmaceutical:
A drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons. ( FDR C.03.201) These drugs are listed in Schedule C to the Food and Drugs Act.
Re-packaging/Re-Labelling:
Replacement of packaging or labelling of previously packaged and labelled products.
Note: If the new label contains information required by the FDR C.01.004 and FDR C.01.005 (inner and outer label), this would be considered part of the licensable activity package/label. An example would be applying a new label with a different expiry date or DIN.

Re-labelling is exempt from the requirements of Establishment Licensing only if the integrity of the inner label is not compromised. An example would be the addition of information not defined in the FDR to a container that already has a proper label.
Retail Sale:
the sale of goods to the public for use or consumption rather than for resale.
Regulatory Authority:
means a government agency or other entity in an MRA country that has a legal right to control the use or sale of drugs within that country and that may take enforcement action to ensure that drugs marketed within its jurisdiction comply with legal requirements. ( FDR C.01A.001)
Sell:
includes offer for sale, expose for sale, have in possession for sale, and distribute, regardless of whether the distribution is made for consideration (even if there is no exchange of money) (Section 2 of the FDA)
Note: If a drug is sold from a person at a location in Canada to a person at a location either inside or outside of Canada, this activity is considered a sale in Canada.
Site:
this term was repealed from Division 1A of the Food and Drug Regulations and does not apply to establishment licences.
Site means:
  1. a building specified in an establishment licence and located more than one kilometre from any other building specified in the licence; or
  2. more than one building specified in an establishment licence, all of which are located within one kilometre of each other

Note: The definition of site still exists under the Establishment Licensing Fees. The definition of site applies for fees for veterinary drugs.
Sterile:
Free from viable microorganisms
Sterile Dosage Form:
A dosage form which has been fabricated and packaged/labelled according to GMP requirements specified in the Food and Drug Regulations ( FDR C.02.029)
Test:
To perform the test, including any examinations, evaluations, and assessments, as specified in the Division 2 of the Food and Drug Regulations
Note: Every building that performs tests requires a DEL. If the testing is done outside of Canada, then this building should be listed on a DEL holder's foreign site annex and must be GMP compliant.

FDR C.02.009 sets out raw material testing requirements. FDR C.01A.004 prohibits such testing except in accordance with a DEL; unless the person performing the test holds an EL as a fabricator, packager/labeller, a distributor and DIN holder, or an importer.

Any company that performs tests required under Division 2 must have a GMP compliance rating established by the Health Products and Food Branch ( HPFB) Inspectorate and have, or be listed on, an Establishment License ( EL). These tests include, but are not limited to, the testing of an active pharmaceutical ingredient ( API) as a raw material to be used in the fabrication of a dosage form as described in C.02.009 of the Food and Drug Regulations.
Vaccine:
A preparation of a weakened or killed pathogen, such as a bacterium or virus, or of a portion of the pathogen's structure that upon administration stimulates antibody production or cellular immunity against the pathogen but is incapable of causing severe infection. These are listed in Schedule D to the FDA.
Warehouse:
Any location used by an establishment to store drug(s). ( FDR C.01.A.005 (g))
Note: See Note in Section 8.0 of this document.
Whole Blood and its Components:
Blood and Blood Derivatives, human plasma collected by plasmapheresis, plasma. These are listed in Schedule D to the FDA.
Wholesale:
means to sell any of the following drugs, other than at retail sale, where the seller's name does not appear on the label of the drugs:

  1. a drug listed in Schedule C or D to the Act or in Schedule F to these Regulations or a controlled drug as defined in subsection G.01.001(1); or,
  2. a narcotic as defined in Narcotic Control Regulations.

Note: Wholesaling does not apply to OTC & non-scheduled drugs, thus is not a licensable activity and a DEL is not required. (C.01A.001).

5.0 Acronyms

ASR
Alternate Sample Retention Site
CoC
Certificate of Compliance
DEL
Drug Establishment Licence
DIN
Drug Identification Number
EL
Establishment Licence
ELBIU
Establishment Licensing, Billing and Invoicing Unit
FDA
Food and Drugs Act
FDR
Food and Drug Regulations
GMP
Good Manufacturing Practices
HECSB
Healthy Environments and Consumer Safety Branch
HPFB
Health Products and Food Branch
MRA
Mutual Recognition Agreement
OTC
Over-The-Counter
TPD
Therapeutic Products Directorate
VDD
Veterinary Drugs Directorate

6.0 Requirements of the Establishment Licence Regulations

Regulation

FDR C.01A.004.

  • (1) Subject to subsection (2), no person shall, except in accordance with an establishment licence;
    • (a) fabricate, package/label, distribute as set out in section C.01A.003, import or wholesale a drug; or
    • (b) perform the tests, including examinations, required under Division 2.
  • (2) A person does not require an establishment licence to perform tests under Division 2 if the person holds an establishment licence as a fabricator, a packager/labeller, a distributor referred to in paragraph C.01A.003(b) or an importer.
  • (3) No person shall carry on an activity referred to in subsection (1) in respect of a narcotic as defined in the Narcotic Control Regulations or a controlled drug as defined in subsection G.01.001(1) unless the person holds a licence for that narcotic or drug under the Narcotic Control Regulations or Part G of these Regulations, as the case may be.

Interpretation

FDR C.01A.004(1) refers to the activities which require a licence.
FDR C.01A.004(2) states that a person does not require a DEL to perform tests under Division 2 if the person holds a DEL as a fabricator, a packager/labeller, a distributor or importer.

Although not required, fabricators and packagers/labellers who do their own testing will only have the activity of testing listed on the DEL upon request of the DEL holder.

FDR C.01A.004(3) discusses licensable activities for narcotics or drugs listed in Part G of the FDR. If a licensable activity is in respect of a narcotic or a drug listed in Part G of the FDR, the person must hold a licence for that narcotic or drug under the Narcotic Control Regulations or Part G of the FDR in addition to the DEL.

Note: A Narcotic licence is issued by the Office of the Controlled Substances, Healthy Environments and Consumer Safety Branch (HECSB). (See Appendix D)

Responsibility

It is the responsibility of the regulated party (the person performing the activities) to be aware of the requirement to obtain and maintain a DEL and/or a Narcotic Licence perform the licensable activities.

7.0 Exemptions to the Requirements of the Establishment Licence Regulations

Regulation

FDR C.01A.002.

  • (1) This Division does not apply to:
    • (a) wholesaling a drug premix;
    • (b) importing or compounding, pursuant to a prescription, a drug that is not commercially available in Canada by one of the following persons, namely,
      • (i) a pharmacist
      • (ii) a practitioner; and
      • (iii) a person who compounds a drug under the supervision of a practitioner;
    • (c) any activity with respect to a drug that is used only for the purposes of clinical testing in accordance with subsection C.05.006(1) or section C.08.0;
    • (d) fabricating, packaging/labelling, testing as required under Division 2, distributing as a distributer referred to in section C.01A.003, wholesaling or importing any of the following drugs for which prescriptions are not required and that are for human use in dosage form and not represented as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states set out in Schedule A to the Act, namely;
      • (i) homeopathic drugs;
      • (ii) drugs that meet the requirements of a class monograph entitled "Vitamin Supplements", "Mineral Supplements", "Dietary Vitamin Supplements" or "Dietary Mineral Supplements", as the case may be; and
      • (iii) drugs that;
        • (A) contain a plant, mineral or animal substance in respect of which therapeutic activity or disease prevention activity is claimed, including traditional herbal medicines, traditional Chinese medicines, ayurvedic (East Indian) medicines and traditional aboriginal (North American) medicines; and
        • (B) the medical use of which is based solely on historical and ethnological evidence from references relating to a medical system other than one based on conventional scientific standards; and,
    • (e) fabricating, packaging/labelling, testing, distributing, and importing of antimicrobial agents.
  • (2) This Division and Divisions 2 to 4 do not apply to the affixing of a label to a previously labelled container.

Interpretation

Wholesaling a Drug Premix
Wholesaling a drug premix does not require a DEL.

Licensable Activities by a Practitioner or Pharmacist
Importing or compounding by a pharmacist, practitioner or person under the supervision of a practitioner is exempt from establishment licensing only if all three of the following criteria are met:

  • i) the activity is pursuant to a prescription
    • As defined in Division 1 of the FDR, prescriptions must be for a specific patient.
  • (ii) the activity is limited to importing or compounding, under the supervision of a practitioner.
    • FDR C.01A.002(1)(b)(iii) exempts the compounding of a drug pursuant to a prescription from the requirement for a DEL. The compounding of radiopharmaceuticals is included in this exemption.
  • (iii) the activity is related to a drug that is not commercially available in Canada
    • The purpose of this exemption is to allow patients to have access to drugs which are not commercially available in Canada. It cannot be used for drugs which are authorized for use in Canada (having received a Notice of Compliance)

Note: If any of the three criteria above are not met, a practitioner or pharmacist will require a DEL to conduct licensable activities.

Activities Associated With Clinical Tests (Trials)
Clinical trial drugs for human use are exempt from the requirements of Division 1A, in accordance with FDR C.01A.002(1)(c). However, drugs which have a DIN and/or NOC and are used in a clinical trial are subject to the requirements of Division 1A. These clinical trials are often referred to Phase IV clinical trials.

Natural Health Products (NHPs)
Effective January 1, 2006 all establishments that conduct licensable activities with natural health products are no longer issued a DEL. Foreign sites which fabricate, package/label or test only NHPs will also no longer be included in the foreign site annex of a DEL. All NHP companies must hold an NHP site licence to manufacture, import, label or package NHPs for sale in Canada.

Antimicrobial Agents
Fabricating, packaging/labelling, testing, distributing, and importing of certain antimicrobial agents does not require a DEL. However, all other pertinent requirements of the FDA and FDR apply. Please refer to GUI-0049 to determine if your antimicrobial agent requires a DEL.

The following drugs are still subject to Division 1A (Establishment Licences):

  1. antimicrobial agents used for contact lenses which are required to be sterile;
  2. chemosterilants and high level antimicrobial agents used to sterilize invasive devices or devices used for circulation and reintroduction of a body fluid; and,
  3. any other antimicrobial agents used for devices to be introduced in a body cavity or that come in contact with a body fluid.

Activities Associated With Affixing a Label to a Previously Labelled Container
Division 1A requirements do not apply if the drug is in a container that has previously been labelled as required by the FDR sections C.01.004 and C.01.005 (inner and outer label).

Note: The assembly of promotional packages and/or displays of already packaged/labelled drugs is not a licensable activity.

If the new label contains information required by the FDR sections C.01.004 and C.01.005 (inner and outer label), this would then be considered licensable.

8.0 Application for a Drug Establishment Licence

Regulation

FDR C.01A.005

Subject to section C.01A.006, a person who wishes to apply for an establishment licence shall submit an application to the Minister, in a form established by the Minister which contains the following information:

  • (a) the applicant's name, address and telephone number, and their facsimile number and  electronic mail address, if any;
  • (b) the name and telephone number, and the facsimile number and electronic mail address, if any, of a person to contact in case of an emergency;
  • (c) each activity set out in Table I to section C.01A.008 for which the licence is requested;
  • (d) each category of drugs set out in Table II to section C.01A.008 for which the licence is requested;
  • (e) each dosage form class in respect of which the applicant proposes to carry out a licensed activity, and whether it will be in a sterile dosage form;
  • (f) whether the applicant proposes to carry out a licensed activity in respect of a drug that is a bulk process intermediate;
  • (g) the address of each building in Canada in which the applicant proposes to fabricate, package/label, test as required under Division 2 or store drugs, specifying for each building which of those activities and for which category of drugs and, for each category;
    • (i) the dosage form classes, and whether any drugs will be in a sterile dosage form; and,
    • (ii) whether any drugs will be bulk process intermediates.
  • (h) the address of each building in Canada at which records will be maintained;
  • (i) whether any building referred to in paragraphs (g) and (h) is a dwelling-house;
  • (j) the drug identification number, if any, or a name that clearly identifies the drug:
    • (i) for each narcotic as defined in the Narcotic Control Regulations or each controlled drug as defined in subsection G.01.001(1) for which the licence is requested; and,
    • (ii) for each other drug within a category of drugs for which the licence is  requested, unless the licence is to perform tests required under Division 2, distribute as set out in paragraph C.01A.003(a), or wholesale.
  • (k) if any of the buildings referred to in paragraph (g) have been inspected under the Act or these Regulations, the date of the last inspection;
  • (l) evidence that the applicant's buildings, equipment and proposed practices and procedures meet the applicable requirements of Divisions 2 to 4;
  • (m) in the case of an importer of a drug that is fabricated, packaged/labelled or tested in an MRA country at a recognized building;
    • (i) the name and address of each fabricator, packager/labeller and tester of the drug and the address of each building at which the drug is fabricated, packaged/labelled or tested, specifying for each building the activities and the category of drug and;
      • (A) the dosage form class and whether the drug is in a sterile dosage form, and,
      • (B) whether the drug is a bulk process intermediate.
    • (ii) in respect of each activity done in an MRA country at a recognized building, the name of the regulatory authority that is designated under subsection C.01A.019(1) in respect of that activity for that drug and that has recognized that building as meeting its good manufacturing practices standards in respect of that activity for that drug; and;
    • (iii) in respect of any other activities,
      • (A) a certificate from a Canadian inspector indicating that the fabricator's, packager/labeller's or tester's buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4; or,
      • (B) other evidence establishing that the fabricator's, packager/labeller's or tester's buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4.
  • (n) in the case of any other importer, the name and address of each fabricator, packager/labeller and tester of the drugs proposed to be imported and the address of each building at which the drugs will be fabricated, packaged/labelled and tested, specifying for each building which of those activities and for which category of drugs and, for each category;
    • (i) the dosage form classes and whether any drugs will be in a sterile dosage form; and,
    • (ii) whether any drugs will be bulk process intermediates; and,
  • (o) in the case of an importer referred to in paragraph (n);
    • (i) a certificate from a Canadian inspector indicating that the fabricator's, packager/labeller's and tester's buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4; or,
    • (ii) other evidence establishing that the fabricator's, packager/labeller's and tester's buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4.

Interpretation
If a person wishes to conduct the licensable activities, they need to submit a DEL application.

Table 1: Licensable Activities and Interpretations
Licensable activities Interpretation
Fabricate Note: This definition applies to Division 1A, 2, 3 and 4 of the FDR
Package/Label Note: This activity also includes affixing a label to a previously labelled container to fulfill the regulatory requirements of Part C of the FDR.

Part C, Division 1A requirements do not apply if the drug is in a container that has previously been labelled as required by the FDR, sections FDR C.01.004 and FDR C.01.005 (inner and outer label).

The assembly of promotional packages and/or displays of already packaged/labelled drugs is not a licensable activity.
Test Note: Every building that performs tests requires a DEL. If the testing is done outside of Canada, then this building must be listed on a DEL holder's foreign site annex.

FDR C.02.009 sets out raw material testing requirements. FDR C.01A.004 prohibits such testing except in accordance with a DEL; unless the person performing the test holds an Establishment Licence (EL) as a fabricator, packager/labeller, a distributor and DIN holder, or an importer.

Any company that performs tests required under Division 2 must have a GMP compliance rating established by the HPFB Inspectorate and have, or be listed on, an EL. These tests include, but are not limited to, the testing of an active pharmaceutical ingredient (API) as a raw material to be used in the fabrication of a dosage form as described in C.02.009 of the FDR.
Import Note: All drugs being imported into Canada must be imported by a person holding a valid DEL. All foreign sites which fabricate, package/label and test the drugs are to be included on the foreign site annex of the importer's DEL.
Distribute Distributors of OTC products do not require a DEL if they are not the DIN owner
Wholesale Note: Wholesaling of OTC & non-scheduled drugs is not a licensable activity and thus a DEL is not required for this activity.

A person who wishes to apply for a DEL must submit an application in a form established by the Minister. This application form contains the information specified in FDR C.01A.005, Drug Establishment Licence Application: Form and Instructions.

Note: FDR C.01A.005(g) requires the applicant to provide the address of each building in Canada in which the applicant proposes to fabricate, package/label, test as required under Division 2 or store drugs. Storage of drugs is not a licensable activity, but each warehouse location used to store drugs should be identified to the Inspectorate. If the warehouse is only storing drugs, a DEL is not required under Division 1A. Please provide the warehouse locations in letter format.

Responsibility
It is the responsibility of the applicant to ensure the DEL application form is accurate and complete in accordance with the requirements of FDR C01A.005 before submitting it to the Establishment Licensing, Billing and Invoicing Unit (ELBIU). Incomplete application forms will delay the processing, scheduling of the GMP inspection and issuance of the licence. The applicant should be prepared for a GMP inspection before making the application. It is the responsibility of the applicant to ensure appropriate contracts are in place for all activities being contracted out to other companies.

9.0 Issuing a Drug Establishment Licence

Regulation

FDR C.01A.007

  • (1) The Minister may, on receipt of an application for an establishment licence or an amended establishment licence, require the submission of further details pertaining to the information contained in the application that are necessary to enable the Minister to process the application.
  • (2) When considering an application for an establishment licence or an amended establishment licence, the Minister may require that
    • (a) an inspection be made during normal business hours of any building referred to in paragraph C.01A.005(1)(g) or (h); and
    • (b) the applicant, if a fabricator, a packager/labeller, a person who performs tests required under Division 2, a distributor referred to in paragraph C.01A.003(b) or an importer, supply samples of any material to be used in the fabrication, packaging/labelling or testing of a drug.

Regulation

FDR C.01A.008

  • (1) Subject to section C.01A.010, the Minister shall, on receipt of the information and material required by sections C.01A.005 to C.01A.007, issue or amend an establishment licence.
  • (2) The establishment licence shall indicate;
    • (a) each activity that is authorized and the category of drugs for which each activity is authorized, as set out in the tables to this section, specifying for each activity and category whether sterile dosage forms are authorized;
    • (b) the address of each building in Canada at which a category of drugs is authorized to be fabricated, packaged/labelled, tested as required under Division 2 or stored, specifying for each building which of those activities and for which category of drugs, and whether sterile dosage forms of the category are authorized; and,
    • (c) in addition to the matters referred to in paragraphs (a) and (b), in the case of an importer;
      • (i) the name and address of each fabricator, packager/labeller and tester from whom the importer is authorized to obtain the drug for import; and,
      • (ii) the address of each building at which the drug is authorized to be fabricated, packaged/labelled or tested, specifying for each building the activities and the category of drugs that are authorized, and whether sterile dosage forms are authorized.
    • (d) [Repealed, SOR/2002-368, s. 5]
  • (3) The Minister may indicate in an establishment licence a period for which records shall be retained under Division 2 that, based on the safety profile of the drug or materials, is sufficient to ensure the health of the consumer.
  • (4) The Minister may, in addition to the requirements of subsection (2), set out in an establishment licence terms and conditions respecting
    • (a) the tests to be performed in respect of a drug, and the equipment to be used, to ensure that the drug is not unsafe for use; and
    • (b) any other matters necessary to prevent injury to the health of consumers, including conditions under which drugs are fabricated, packaged/labelled or tested.
Table 2: Items and Activities
Item Activities
1 Fabricate
2 Package/label
3 Perform the tests, including any examinations, required under Division 2
4 Distribute as set out in paragraph C.01A.003(a)
5 Distribute as set out in paragraph C.01A.003(b)
6 Import
7 Wholesale
Table 3: Items and Categories of Drugs
Item Categories of Drugs
1 Pharmaceuticals
2 Vaccines
3 Whole blood and its components
4 Drugs listed in Schedule D to the Act, other than vaccines or whole blood and its components
5 Drugs listed in Schedule C to the Act
6 Drugs listed in Schedule F to these Regulations, controlled drugs as defined in subsection G.01.001(1) and narcotics as defined in the Narcotic Control Regulations

Interpretation

FDR C.01A.008 specifies that a DEL shall be issued if all the information required in the application form is provided and that compliance with the FDR has been satisfied.

FDR C.01A.005 states the applicant's buildings, equipment, proposed practices and procedures must meet the applicable requirements of Divisions 2 to 4. This is determined through an inspection performed by the Inspectorate. When an application is received by the ELBIU, the appropriate region will be advised so that an inspection can be scheduled.

A DEL will be issued once the inspection has shown that the applicant meets the requirements of FDR C.01A.005, which includes requirements under Divisions 2 to 4 of the FDR.

A DEL may be issued with Terms and Conditions.

Responsibility

The ELBIU will inform the applicable Regional Office of the new application. (Appendix D)

The Regional Office will schedule and perform the GMP inspection. Once the building is GMP compliant, the Regional Office will inform the ELBIU, who will proceed in issuing the DEL.

9.1 Amending a Drug Establishment Licence

Regulation

FDR C.01A.006

  • (1) A person who wishes to amend an establishment licence shall submit an application to the Minister, in a form established by the Minister that contains the applicable information specified in section C.01A.005.
  • (2) An establishment licence must be amended where the licensee proposes;
    • (a) to add an activity or category of drugs, as set out in the tables to section C.01A.008;
    • (b) in respect of a category of drugs and activity indicated in the licence, to authorize sterile dosage forms of the category;
    • (c) to add any building in Canada at which drugs are authorized to be fabricated, packaged/labelled, tested as required under Division 2 or stored, or to add, for an existing building, an authorization to fabricate, package/label, test or store a category of drugs, or sterile dosage forms of the category; and,
    • (d) in addition to the matters set out in paragraphs (a) to (c), in the case of an importer;
      • (i) to add a fabricator, packager/labeller or tester of a drug;
      • (ii) to amend the name or address of a fabricator, packager/labeller or tester indicated in the licence; and,
      • (iii) if the address of the buildings at which drugs are authorized to be fabricated, packaged/labelled or tested is indicated in the licence, to add additional buildings or, for an existing building, to add an authorization to fabricate, package/label or test a category of drugs, or sterile dosage forms of the category.

Interpretation

FDR C.01A.006 defines the changes which require an amendment to a licence.

Table 4: List of possible amendments to an EL
Example Amendment What is required from the Applicant?
New activity Completion of Drug Establishment Licence application form:

Part A and Part B - Section 1,2,3 & 4
New product category Completion of Drug Establishment Licence application form:

Part A and Part B - Section 1,2,3 & 4
New sterile dosage form where the existing licence does not indicate sterile dosage form in the category Completion of Drug Establishment Licence application form:

Part A and Part B - Section 1,2,3 & 4
New domestic building Completion of Drug Establishment Licence application form:

Part A and Part B - Section 1, 2, 3 & 4. Possibly 5 if new building denotes importation
New foreign site or an amendment to a foreign site name, address, activity or addition of sterile dosage form Completion of Drug Establishment Licence application form:

(Part A and Part B - Section 1,2,3 & 5)

Note: For amendments that indicate new sterile dosage forms a DIN or the statement indicating "DIN Pending" is required on the DEL application form.

As per the appropriate section of FDR C.01A.007(2) an amendment may require a GMP inspection. The decision to inspect is made by the Inspectors in the Regions.

Responsibility

It is the responsibility of the applicant to submit an amendment in a timely manner using Drug Establishment Licence Application: Form and Instructions.

The ELBIU will process the amendment and inform the appropriate Regions. Once the amendment is approved by the Regions, the ELBIU will issue the amended licence. In the case of new foreign sites, the GMP evidence is forwarded for review or a COC is requested from the MRA country, if required. Once the site is assigned a valid GMP compliance expiry date an amended foreign site annex will be issued.

9.2 Annual Review of a Drug Establishment Licence

Regulation

Effective April 1 2011, an establishment licence will no longer expire on December 31 of each year, as per the  Regulations. Application for annual review is due on April 1, of each year. Authorized foreign sites will continue to be assigned a GMP compliance expiry date which will appear on the foreign site annex of the licence. DELs issued with terms and conditions will continue to have a GMP compliance expiration date.

Interpretation

Beginning April 1, 2012, and each following year, EL holders will be required to submit a request for an annual review to maintain their licence. All licence holders will receive a notification prior to April 1 of each year. Any changes for the coming year must be indicated on the annual review application and returned to the ELBIU within the specified period indicated in the notification.

Failure to submit an annual review request will render the DEL invalid. Any activities performed after that date would be in contravention of the Regulations. In addition, if the licence is rendered invalid, the applicant must submit a new DEL application. Once the new application is found to meet all the regulatory requirements will a new licence be issued.

Responsibilities

A notification will be sent to licence holders by the ELBIU prior to April 1 of each year. It is the responsibility of the applicant to ensure all information in the application for annual review is accurate and to indicate any changes required.

9.3 Requirements of Notification, Refusal to Issue or Amend and Suspension Processes for Drug Establishment Licences

Regulation

FDR C.01A.013

Every person who holds an establishment licence shall notify the Minister in writing within 15 days after:

  • (a) there is any change to the information referred to in any of paragraphs C.01A.005 (a),(b),(e),(f),(h) and (i), and subparagraphs C.01A.005(g)(i) and (ii); or,
  • (b)an event occurs that results in their being in contravention of any of the applicable requirements of Divisions 2 to 4, where it may affect the quality, safety or efficacy of a drug fabricated, packaged/labelled, tested as required under Division 2 or stored by them.

Interpretation

A licence holder must notify the ELBIU in writing within 15 days of making any of the following changes:

  • (a) the applicant's name, address and telephone number, and their facsimile number and electronic mail address, if any;
  • (b) the name and telephone number, and the facsimile number and electronic mail address, if any, of a person to contact in case of an emergency;
  • (e) each dosage form class in respect of which the applicant proposes to carry out a licensed activity, and whether it will be in a sterile dosage form;
  • (f) whether the applicant proposes to carry out a licensed activity in respect of a drug that is a bulk process intermediate;
  • (g) the address of each building in Canada in which the applicant proposes to fabricate, package/label, test as required under Division 2 or store drugs, specifying for each building which of those activities and for which category of drugs and, for each category;
    • (i) the dosage form classes, and whether any drugs will be in a sterile dosage form;
    • and,
    • (ii) whether any drugs will be bulk process intermediates.
  • (h) the address of each building in Canada at which records will be maintained;
    • (i) whether any building referred to in paragraphs (g) and (h) is a dwelling-house.

Regulation

FDR C.01A.014.

  • (1) No licensee shall carry on a licensed activity in respect of any category of drugs if a change referred to in subsection (2) has occurred in respect of that category, unless:
    • (a) they have filed with the Minister a notice that contains sufficient information to enable the Minister to assess the safety of the drug, taking into account the change; and,
    • (b) the Minister has issued to them a letter indicating that the information will be reviewed and has not, within 90 days after issuing the letter, sent them a notice indicating that the change is not acceptable.
  • (2) Notification is required in respect of the following changes where they may affect whether a drug can be fabricated, packaged/labelled, tested or stored in accordance with the applicable requirements of Divisions 2 to 4:
    • (a) changes to the plans and specifications of a building where a drug is fabricated, packaged/labelled, tested or stored;
    • (b) changes to the equipment that is used in the fabrication, packaging/labelling or testing of a drug;
    • (c) changes to the practices or procedures; and,
    • (d) in the case of an importer, other than an importer of a drug that is fabricated, packaged/labelled or tested in an MRA country at a recognized building, any change referred to in paragraphs (a) to (c) that relates to the fabricator, packager/labeller or tester of the drug being imported.

Interpretation

Notifications for changes listed FDR C.01A.014 (2)(a)(b)(c) are submitted to the Regional Office responsible for the establishment (Appendix D).

Section FDR C.01A.014 (2)(d) specifies that an importer of a drug from a non-MRA country must notify the Inspectorate if a drug from a foreign site listed on their DEL is no longer fabricated, packaged/labelled, tested or stored in accordance with the applicable requirements of Divisions 2 to 4. Changes to a foreign site as described in FDR C.01A.014 (2)(d) should be submitted to the ELBIU (Appendix D).

Regulations

FDR C.01A.015

  • (1) An importer of a drug that is fabricated, packaged/labelled or tested in an MRA country at a recognized building shall immediately notify the Minister if the fabricator, packager/labeller or tester indicated in the importer's establishment licence no longer holds a valid permit, licence or other authorization issued by the regulatory authority that recognized that building.
  • (2) The Minister shall, on receiving a notification under subsection (1), amend the importer's establishment licence by removing the name and address of that fabricator, packager/labeller or tester.

Interpretation

This section specifies that an importer of a drug from an MRA country must notify the ELBIU immediately if a foreign building listed on their DEL is found to no longer hold a valid permit. This foreign building will be removed from the importer's DEL. The foreign building will also be removed if the Inspectorate learns, prior to being notified, that it no longer holds a valid permit.

Responsibility

It is the responsibility of the company to inform the ELBIU of any changes indicated in this section.

9.4 Refusal to Issue or Amend a Drug Establishment Licence

Regulation

FDR C.01A.010.

  • (1) The Minister may refuse to issue or amend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if
    • (a) the applicant has made a false or misleading statement in relation to the application for the licence; or
    • (b) the applicant has had an establishment licence suspended in respect of the matter.
  • (2) The Minister shall refuse to issue or amend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if the Minister has reasonable grounds to believe that issuing or amending an establishment licence in respect of the matter would constitute a risk to the health of the consumer.
  • (3) Where the Minister refuses to issue or amend an establishment licence, the Minister shall
    • (a) notify the applicant in writing of the reasons for the refusal; and
    • (b) give the applicant an opportunity to be heard.

Interpretation

The Minister has discretion to refuse to issue or amend a DEL under FDR C.01A.010(1) if conditions (a) or (b) are met. The Minister must refuse to issue or amend if the conditions under FDR C.01A.010(2) are met.

9.5 Licence Suspension

Regulation

FDR C.01A.016.

  • (1) Subject to subsection (3), the Minister may suspend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if the Minister has reasonable grounds to believe that
    • (a) the licensee has contravened any provision of the Actor these Regulations; or
    • (b) the licensee has made a false or misleading statement in the application for the establishment licence.
  • (2) Before suspending an establishment licence, the Minister shall consider
    • (a) the licensee's history of compliance with the Act and these Regulations; and
    • (b) the risk that allowing the licence to continue in force would constitute for the health of the consumer.
  • (3) Subject to subsection C.01A.017(1), the Minister shall not suspend an establishment licence until
    • (a) an inspector has sent the licensee a written notice that sets out the reason for the proposed suspension, any corrective action required to be taken and the time within which it must be taken;
    • (b) if corrective action is required, the time set out in the notice has passed without the action having been taken; and
    • (c) the licensee has been given an opportunity to be heard in respect of the suspension.

Regulation

FDR C.01A.017.

  • (1) The Minister may suspend an establishment licence without giving the licensee an opportunity to be heard if it is necessary to do so to prevent injury to the health of the consumer, by giving the licensee a notice in writing that states the reason for the suspension.
  • (2) A licensee may request of the Minister, in writing, that the suspension be reconsidered.
  • (3) The Minister shall, within 45 days after the date of receiving the request, provide the licensee with the opportunity to be heard.

Regulation

FDR C.01A.018.

The Minister may reinstate an establishment licence after it has been suspended.

Interpretation

A licence may be suspended, as per the process described in FDR C.01A.016, FDR C.01A.017 and FDR C.01A.018 of the FDR.

10.0 Drug Establishment Licensing Fees

This section of the guidance applies to three sets of regulations which set out the regulatory requirements for fees for (1) DEL, (2) DEL in respect of veterinary drugs only, (3) Dealer's Licences, and (4) Dealer's Licences in respect of veterinary drugs only. The three sets of regulations are as follows:

  • Fees In Respect of Drugs and Medical Devices Regulations (Part 2, Division 2 and Part 2, Division 3);
  • Establishment Licensing Fees (Veterinary Drugs) Regulations;
  • Licensed Dealers for Controlled Drugs and Narcotics Fees (Veterinary Use) Regulations

The regulatory requirements concerning DEL fees can be found in Part 2, Division 2 of the Fees In Respect of Drugs and Medical Devices Regulations. The DEL fees set out in the regulations are to be increased annually by 2%, rounded upwards to the nearest dollar, beginning April 1, 2012.

Note that the dollar amounts used throughout this section are the fees applicable to licence applications submitted on or before March 31, 2014, and are included only for ease of reference. Please consult the regulations for a definitive statement of fees applicable.

10.1 Application

The regulatory requirements enumerated in Part 2, Division 2 of the regulations apply to applicants who submit a DEL application that is in respect of human drugs or human and veterinary drugs. The regulations do not apply to a drug that is a natural health product.

Part 2, Division 2 of the regulations does not apply to (1) any publicly funded health care facility or (2) any branch or agency of the Government of Canada or the government of a province. DEL applicants that fall within either of these two categories are not required to pay DEL fees.

10.2 Time of Payment

10.2.1 General Rule

The applicable fee is generally payable at the time the applicant submits (1) an application for a DEL or (2) an application for the annual review of a DEL or (3) an application for the amendment of a DEL.

An applicant who applies for a DEL, annual review, or amendment must include all applicable fees with the application to be sent to Health Canada. Applicants who do not include their payment or have submitted insufficient payment will accrue interest on the payable fees until the full payment is processed..

10.2.2 First Year of Activities

For an applicant who has not completed its first full calendar year of conducting activities under any DEL, the payment of the applicable DEL fee is deferred until the end of that first full calendar year. "Calendar year" means a period of twelve consecutive months commencing on January 1.

It is the responsibility of a licence applicant to submit payments on time; interest will be charged for all late payments. If it is discovered by Health Canada that an applicant does not qualify for payment deferral, all applicable fees are immediately payable with interest.

Applicants who qualify for payment deferral may also qualify for fee remission, as noted in 10.3

Please note: For how to submit payment please follow the following instructions: "How to Pay Fees," that can be found on the Health Canada website.

Payment of fees by credit card or in Canadian funds is strongly advised.

Example:
If an applicant who has never previously held a DEL is issued a DEL on any day in 2013, the payment of the fee is deferred until the final business day of December 2014.
Using the same scenario above, if an application for an amendment is submitted any time between the initial DEL application and the final business day of December 2014, the payment of the fee is deferred until the final business day of December 2014, as long as the DEL was issued or any day in 2013.

10.3 Remission

10.3.1 General Rule

If the applicable DEL fee calculated in accordance with the schedules to Part 2, Division 2 of the Fees In Respect of Drugs and Medical Devices Regulations is an amount that is greater than 1% of its actual gross revenue generated from activities conducted under a DEL during the previous calendar year, fee remission will be reviewed and considered. The amount remitted will equal the difference between the total applicable fees and the amount of 1% of the applicant's actual gross revenue.

If an applicant wishes to apply for fee remission, it must make this request by submitting a Drug Establishment Licence Calculation Chart, and a Certified Statement of Revenue signed by the individual responsible for the applicant's financial affairs that sets out the actual gross revenue along with the application (1) for a DEL or (2) for the annual review of a DEL or (3) for the amendment of a DEL. The statement can be a signed copy of the applicant's general ledger or signed copy of sales logs from the general ledger.

For administrative efficiency, the applicant should determine how much is owed after remission and submit that amount with the application.

Example:
In this example, the total fee payable by an applicant, according to the schedules set out in the regulation, is $16,075. The applicant's actual gross revenue equals $500,000. One percent of the applicant's gross revenue is therefore $5,000.
The amount of the remission would be calculated as follows:
Remission = $16,075 - $5,000
Total = $11,075
Therefore, the total payable amount by the applicant is $5,000 in this example.

10.3.2 Audited Sales Records

If, on the basis of any information available to Health Canada, the information that is supplied in support of a request for fee remission is deemed not adequate to determine the applicant's actual gross revenue, Health Canada may require the applicant to provide sales records that have been audited by a qualified independent auditor. The audited records are to be used for the purpose of determining the fee payable or the amount of the remission.

If the applicant does not submit audited sales records within 60 days after Health Canada makes an official request for such records, remission will be automatically denied. The full DEL fee will be payable with interest.

Note that any expense incurred in having sales records audited by an independent auditor rests with the applicant.

10.4 Fees

The sections below provide further explanation of the fees. The diagram shown below may help in understanding how the regulations operate.

Figure 1: Upstream / Downstream Activity Chart

Figure 1: Upstream / Downstream Activity Chart:

At the top of Figure 1: Upstream/Downstream Activity Chart is a box with the following text "Upstream/Downstream Activity Chart". On the left hand side of the image is an arrow that starts at the bottom of the image with the text "Downstream" and points up to the top of the image with the text "Upstream". There are a series of boxes that run from the upper left-hand corner of the image to the bottom right-hand corner which make up a six-step staircase. Starting at the top left, there is one blue box titled "Fabricator". The next step down has one grey box left-justified, followed by a pink box; both boxes in this step contain the title "Packager". The next step down has two grey boxes left-justified followed by a purple box; each box in this step contains the title "Importer/DIN Distributor". The next step down has three grey boxes left-justified followed by a red box; each box on this step contains the title "DIN Distributor". The next step down has white space the equivalent of four boxes followed by a green box containing the title "Wholesaler / type (a) Distributor". The bottom step has five grey boxes left-justified followed by a yellow box; each box in this step contains the title "Test".

Upstream/Downstream Activity Chart

Fees are charged for the examination of an application (1) for a DEL or (2) for the annual review of a DEL or (3) for the amendment of a DEL. The fee payable for the examination of a DEL in respect of a single building (or "establishment", the term used in some of the regulations when referring to the licence) is calculated based on the most 'upstream' activity that is to be conducted at that building. A licence for a higher-level, 'upstream' activity can include lower-level 'downstream' activities without additional fees payable. The sum of the payable fees for each building subject to an application is the full DEL fee.

10.4.1 Fabrication

The fee for each building, subject to a licence application, where the applicant proposes to conduct activities that include fabricating drugs is $16,075.

Where the applicant proposes to fabricate in respect of multiple categories of drugs, the fee is $4,027 for each additional category at each building fabricating multiple categories of drugs.

Where the applicant proposes to fabricate in respect of multiple dosage form classes, the fee is $8,043 for two classes at each building where there are two classes; the fee is $16,075 for three classes at each building where there are three classes; the fee is $20,102 for four classes at each building where there are four classes; the fee is $24,117 for five classes at each building where there are five classes; the fee is $28,133 for six classes at each building where there are six classes; the fee is $28,133 plus an additional $1,613 for each additional class at each building where there are 7 or more classes.

Where the applicant proposes to fabricate in respect of a sterile dosage form, the fee is $8,043 at each building fabricating in respect of a sterile dosage form.

The fee for each building, subject to a licence application, where the applicant proposes to conduct activities that include fabricating drugs and importing drugs from a fabricator outside Canada, the additional fees noted below apply. Note that, although no further fees apply in respect of the applicant's buildings, additional fees apply in respect of each foreign fabricator's buildings (Note: it is also referred to as a "foreign site").

Where the applicant proposes to conduct importing activities at a building where it is proposed to fabricate drugs, the fee is $1,613 for each foreign building used to fabricate drugs that are to be imported.

Where the applicant proposes to conduct importing activities of more than one dosage form at a building where it is proposed to fabricate drugs, the fee is $812 for each additional dosage form at each foreign building.

10.4.2 Package/Label

The fee for each building, that is subject to a licence application, where the applicant intends to conduct activities that include packaging/labelling drugs but not fabricating is $10,748.

The fees noted below may also apply to an application where the most upstream activity is packaging/labelling of drugs:

  • Where the applicant proposes to package/label in respect of multiple categories of drugs but not fabricate, the fee is $2,685 for each additional category at each building packaging/labelling multiple categories of drugs.
  • Where the applicant proposes to package/label in respect of multiple dosage form classes but not fabricate, the fee is $5,359 for two classes at each building where there are two classes; and, the fee is $8,043 for three or more classes at each building where there are three classes or more.

If the intended packaging / labelling building also imports drugs from foreign fabricators, there are additional payable fees in respect of each foreign fabricator's buildings (Note: it is also referred to as a "foreign site"). The bullets below explain the rules.

Where the applicant proposes to conduct importing activities at a building where it is proposed to package/label drugs but not fabricate, the fee is $1,613 for each foreign building used to fabricate drugs that are to be imported.

Where the applicant proposes to conduct importing activities of more than one dosage form at a building where it is proposed to package/label drugs but not fabricate, the fee is $812 for each additional dosage form at each foreign building.

10.4.3 Medical Gas (packaging at multiple buildings)

The rule in this section of the guidance applies only to applicants proposing to conduct activities other than fabrication in regard to drugs in the dosage form class of medical gas.

  • Where the applicant proposes to conduct packaging in the form of transfilling at multiple buildings but not fabricating, the fee is $10,748.
  • Where the applicant proposes to conduct packaging in the form of transfilling at multiple buildings but not fabricating, the payable fee for each activity downstream from packaging at each such building is calculated as if there were no proposal to package at that building, i.e., an additional fee will apply for importation, distribution or testing of medical gas at each building.

10.4.4 Importation

The fee for each building, that is subject to a licence application, where the applicant proposes to conduct activities that include importing drugs from a fabricator outside Canada (Note: it is also referred to as a "foreign site") but not fabricating or packaging/labelling is $6,701.

Where the applicant proposes to import in respect of multiple categories of drugs, the fee is $1,676 for each additional category at each building importing multiple categories of drugs.

Where the applicant proposes to import in respect of multiple dosage form classes, the fee is $3,351 for two classes at each building where there are two classes; and, the fee is $6,701 for three or more classes at each building where there are three classes or more.

Additional fees for each foreign fabricator's buildings (Note: it is also referred to as a "foreign site") apply as noted below.

A fee of $1,613 for each foreign building used to fabricate drugs that are to be imported.

A fee of $812 for each additional dosage form at each foreign building.

10.4.5 Distribution (DIN Distribution)

The fee for each building, subject to a licence application, where the applicant proposes to conduct activities that include distributing drugs as it is referred to in paragraph C.01A.003(b) of the FDR but not fabricating, packaging/labelling, or importing is $6,701.

10.4.5.1 Where the applicant proposes to distribute in respect of multiple categories of drugs, the fee is $1,676 for each additional category at each building importing multiple categories of drugs.

10.4.5.2 Where the applicant proposes to distribute in respect of multiple dosage form classes, the fee is $3,351 for two classes at each building where there are two classes; and, the fee is $6,701 for three or more classes at each building where there are three classes or more.

10.4.6 Wholesale (Wholesaler / Type A Distributor)

The fee for each building, subject to a licence application, where the applicant proposes to conduct activities that include wholesaling drugs or distributing drugs as it is referred to in paragraph C.01A.003(a) of the FDR, but not fabricating, packaging / labelling, importing, or distributing as it is referred to in paragraph C.01A.003(b) of the FDR, is $4,027.

10.4.7 Test

The fee for each building, subject to a licence application, where the applicant proposes to only conduct the testing activity is $2,685.

10.5 Drug Analysis

In addition to the fees referred to in 10.4.1 (fabrication), 10.4.2 (package/label), 10.4.3 (medical gas), 10.4.4 (importation), and 10.4.5 (distribution as referred to in paragraph C.01A.003(b) of the FDR), a drug analysis fee is payable at the highest fee set out below that corresponds to the appropriate drug described below.

Table 5: Drug Analysis Fee
Description Fee
Vaccines $26,791
Schedule D Drugs which are not vaccines or whole blood and its components $10,717
Drugs for Human Use listed in Schedule F to the Food and Drug Regulations or controlled drugs or narcotics $8,043
Drugs with DINs or GPS
(not included in any other item)
$4,027
Examples of the Applicable Drug Analysis Fee
  • (i) fabricator and DIN holder of ibuprofen tablets:
    item 4 ($4,027)
  • (ii) distributor and DIN holder of codeine tablets for human use:
    item 3 ($8,043)

There are types of products where the drug analysis component of the fee is $0. These products include the following:

  1. Radiopharmaceuticals
  2. Whole blood and its components
  3. Hemodialysis products
  4. Disinfectants which are not labelled as disinfectants of medical devices
  5. Sensitivity discs and sensitivity tablets
  6. Drugs that meet the requirements of a class monograph having one of the following titles:
    1. Acne Therapies
    2. Antidandruff Products
    3. Antiperspirants
    4. Antiseptic Skin Cleaners
    5. Athlete Foot Treatments
    6. Contact Lens Disinfectants
    7. Fluoride Containing Anti-Caries Products
    8. Medicated Skin Care Products
    9. Sunburn Protectants
    10. Throat Lozenges

10.6 Amendments

10.6.1 Sterile Dosage Forms

If the application to amend a DEL, where the DEL authorizes the holder to conduct one or more activities including fabricating drugs, seeks to authorize the holder to fabricate drugs in sterile dosage forms for the first time at a building, the fee payable is $8,043 at each additional building.

10.6.2 Activity

If an applicant seeks to amend a DEL by adding an activity that is upstream from the activity currently authorized at a building, the applicable fee as indicated in 10.4.1 (fabrication), 10.4.2 (package/label), 10.4.3 (medical gas), 10.4.4 (importation), 10.4.5 (distribution as referred to in paragraph C.01A.003(b) of the FDR), or 10.4.6 (wholesale) is payable. Refer to the appropriate section to determine the payable fee.

  • If the applicant seeks to amend a DEL by adding an activity that is downstream from the activities currently authorized at a building, there the basic fee of the additional activity is not payable.
  • If an applicant seeks to amend a DEL by adding a new building that is to conduct a regulated activity, the applicable fee as indicated in 10.4.1 (fabrication), 10.4.2 (package/label), 10.4.3 (medical gas), 10.4.4 (importation), 10.4.5 (distribution as referred to in paragraph C.01A.003(b) of the FDR), 10.4.6 (wholesale), or 10.4.7 (testing) is payable on the most upstream activity identified on the application form.
  • If an applicant seeks to amend a DEL by removing an existing authorized building that is currently conducting a regulated activity, there is no payable fee but the amendment is still required. Payment adjustment of the fees paid for the authorized building to be removed from the licence cannot be refunded.

10.6.3 Category of Drugs

If an applicant seeks to add an additional category of drug in respect of an activity conducted at a building that is already authorized by a DEL, the following may apply:

  • If the amendment seeks to authorize the holder to fabricate an additional category, the fee is $4,027 at each proposed building.
  • If the amendment seeks to authorize the holder to package/label an additional category, the fee is $2,685 at each proposed building.
  • If the amendment seeks to authorize the holder to import an additional category, the fee is $1,676 at each proposed building.
  • If the amendment seeks to authorize the holder to distribute (as a DIN Distributor) as referred to in paragraph C.01A.003(b) of the FDR an additional category, the fee is $1,676 at each proposed building.
  • If the amendment seeks to authorize the holder to distribute as referred to in paragraph C.01A.003(a) of the FDR or to wholesale (Wholesaler / Type A Distributor) an additional category, there is no fee applicable at each proposed building.
  • If the amendment seeks to authorize the holder to test an additional category, there is no applicable the fee is at each proposed building.

10.7 Dealer's Licence

The regulatory requirements concerning Dealer's Licence fees can be found in Part 2, Division 3 of the Fees In Respect of Drugs and Medical Devices Regulations. The Dealer's Licence fee set out in the regulations is to be increased annually by 2%, rounded upwards to the nearest dollar, beginning April 1, 2012.

Only two types of Dealer's Licences have a fee set: Dealer's Licences issued under section G.02.003.2 of the FDR, and section 9.2 of the Narcotic Control Regulations.

Note that any dollar amounts used in this section are the fees applicable to licence applications submitted on or before March 31, 2013, and are included only for ease of reference.Please consult the regulations for a definitive statement of fees applicable.

10.7.1 Application

The regulatory requirements enumerated in Part 2, Division 3 of the regulations apply to applicants who submit a Dealer's Licence application that is in respect of human drugs or human and veterinary drugs. The regulations do not apply to a drug that is a natural health product.

Part 2, Division 3 of the regulations does not apply (1) to any publicly funded health care facility or (2) any branch or agency of the Government of Canada or the government of a province or (3) any person or organization engaged only in scientific. Dealer's Licence applicants that fall within any of these three categories are not required to pay Dealer's Licence fees.

10.7.2 Time of Payment

10.7.2.1 General Rule

The applicable fee is payable at the time the applicant submits (1) an application for a Dealer's Licence or (2) an application for the renewal of a Dealer's Licence.

An applicant who applies for a Dealer's Licence or Dealer's Licence renewal must include the applicable fee with the application to be sent to Health Canada. Applications that do not include all applicable fees are considered incomplete, and interest will accrue on the payable fees until the full payment is processed.

10.7.2.2 First Year of Activities

For an applicant has not completed its first full calendar year of conducting activities under a Dealer's Licence, the payment of the Dealer's Licence fee is deferred until the end of that first full calendar year. "Calendar year" means a period of twelve consecutive months commencing on January 1.

It is the responsibility of the applicant to submit payments on time; interest will be charged for any late payment. If it is discovered by Health Canada that an applicant does not qualify for payment deferral, the applicable fee is immediately payable with interest. Applicants who do not include their payment or have submitted insufficient payment will accrue interest on the payable fees until the full payment is processed.

Applicants who qualify for payment deferral may also qualify for fee remission, as noted in 10.8.

Please note: For how to submit payment please follow the following instructions: "How to Pay Fees", that can be found on the Health Canada website.

Payment of fees by credit card or in Canadian funds is strongly advised.

If an applicant who has never previously held a Dealer's Licence - is issued a licence on any day in 2013, the payment of the fee is deferred until the final business day of December 2014.
Using the same scenario above, an application for an amendment is submitted any time between the initial DEL application and the final business day of December 2014, the payment of the fee is deferred until the final business day of December 2014, as long as the DEL was issued on any day in 2013.

10.8 Remission

10.8.1 Dealer's Licence Only

If the Dealer's Licence fee calculated in accordance with Part 2, Division 3 of the Fees In Respect of Drugs and Medical Devices Regulations is an amount that is greater than 1% of the applicant's actual gross revenue generated from activities conducted under a Dealer's Licence during the previous calendar year, fee remission will be reviewed, considered and granted. The amount remitted will equal the difference between the total applicable fees and the amount of 1% of gross revenue.

If an applicant wishes to apply for fee remission, it must make this request by submitting a Drug Establishment Licence Calculation Chart, and a Certified Statement of Revenue signed by the individual responsible for the applicant's financial affairs that sets out the actual gross revenue along with the application for a Dealer's Licence. The statement can be a signed copy of the applicant's general ledger or a signed copy of the sales logs from the general ledger.

For administrative efficiency, the applicant should determine how much is owed after remission and submit that amount with the application.

Example:
In this example, the total fee payable by an applicant, according to the schedules set out in the regulation, is $4,694. The applicant's actual gross revenue equals $200,000. One percent of the applicant's gross revenue is therefore $2,000.
The amount of the remission would be calculated as follows:
Remission = $4,694 - $2,000
Total = $2,694
Therefore, the total payable amount by the applicant is $2,000, in this example.

10.8.2 Dealer's Licence and Drug Establishment Licence

Where an applicant submits an application for both a Dealer's Licence and a DEL, the remission is reviewed, considered and granted where the Dealer's Licence fee and the applicable DEL fees are together greater than 1% of the applicant's actual gross revenue from activities conducted under its DEL and Dealer's Licence during the previous calendar year.

The above rule only applies if the following conditions are also met:

The applicant cannot have already received a remission for the Dealer's Licence only (refer to 10.8.1) or the DEL only (refer to 10.8); the Dealer's licence and the Establishment licence were issued for the same holder and are related to the same activities conducted at the same premises, and, the applicant makes this request by submitting a Drug Establishment Licence Calculation Chart, and a Certified Statement of Revenue signed by the individual responsible for the applicant's financial affairs that sets out the actual gross revenue along with the application for a Dealer's Licence refer to 10.8.1).

Example:
In this example, according to the regulation, the total fee payable by an applicant is $16,075 for a DEL and $4,694 for a Dealer's Licence. The applicant's actual gross revenue equals $600,000. One percent of the applicant's gross revenue is therefore $6,000.
The amount of the remission would be calculated as follows:
Remission = ($16,075 + $4,694) - $6,000
Total = $14,769
Therefore, the total payable amount by the applicant is $6,000 in this example.

10.8.3 Audited Sales Records

If, on the basis of any information available to Health Canada, the information that is supplied in support of a request for fee remission is deemed not adequate to determine the applicant's actual gross revenue, Health Canada may require the applicant to provide sales records that have been audited by a qualified independent auditor. The audited records are to be used for the purpose of determining the fee payable or the amount of the remission.

If the applicant does not submit audited sales records within 60 days after Health Canada makes an official request for such records, remission will be automatically denied. The Dealer's Licence fee and DEL fees, if applicable (refer to 10.8.2), will be payable with interest.

Note that any expense incurred in having sales records audited by an independent auditor rests with the applicant.

10.8.4 Fees

The fee for the examination of an application (1) for a Dealer's Licence or (2) for the renewal of a Dealer's Licence is $4,694.

10.9 Drug Establishment Licence that is in respect of veterinary drugs only

The regulatory requirements concerning DEL fees for licences that are in respect of veterinary drugs only can be found in the Establishment Licensing Fees (Veterinary Drugs) Regulations.

Note that any dollar amounts used in this section are included only for ease of reference. Please consult the regulations for a definitive statement of fees applicable.

10.9.1 Application

The regulatory requirements enumerated in the regulations apply to applicants who are issued a DEL that is in respect of drugs for veterinary use only. The regulations do not apply to a drug that is a natural health product.

10.9.2 Time of Payment

10.9.2.1 Initial Application

The applicable fee is generally payable on the day on which the relevant DEL is issued. An invoice will be issued to the applicant indicating the amount owed. There is an exception that is noted in 10.10.1.

10.9.2.2 First Year of Activities - Payment Deferral

For an applicant who has not completed its first full calendar year of conducting activities under any DEL, the payment of the applicable DEL fee is deferred until 90 days after the end of that first full calendar year. "Calendar year" means a period of twelve consecutive months commencing on January 1.

Example:
An applicant issued its first DEL any time in 2013 would be required to pay the DEL fee for that first calendar year 90 days after the end of 2014.
10.9.2.3 Annual Licence Review

The applicable fee for the annual review of a DEL is payable on the day that the annual review application is submitted, unless the applicant has not completed its first calendar year of activities under the DEL. It is the responsibility of a licence applicant to submit payments on time, interest will charged for all late payments.

Please note: For how to submit payment please follow the following instructions: "How to Pay Fees," that can be found on the Health Canada website.

Payment of fees by credit card or in Canadian funds is strongly advised.

10.10 Remission

If an applicant's total payable fee is an amount that is greater than 1.5% of the applicant's actual gross revenue generated from activities conducted under a DEL during the previous calendar year, fee remission will be reviewed, considered and granted. The amount remitted will equal the difference between the total applicable fees and the amount of 1.5% of gross revenue.

If an applicant wishes to apply for fee remission, it must make this request by submitting a Drug Establishment Licence Calculation Chart, and a Certified Statement of Revenue signed by the individual responsible for the applicant's financial affairs that sets out the actual gross revenue along with the application (1) for a DEL or (2) for the annual review of a DEL or (3) for the amendment of a DEL. The statement can be a signed copy of the applicant's general ledger or sales logs from the general ledger.

Example:
In this example, the total fee payable by an applicant, according to the regulation, is $6,000. The applicant's actual gross revenue equals $100,000. Therefore 1.5 percent of the applicant's gross revenue is therefore $1,500.
The amount of the remission would be calculated as follows:
Remission = 6,000 - 1,500
Total = 4,500
Therefore, the total payable amount by the applicant is $1,500 in this example.

10.10.1 First Year of Activities - Statement

The applicant must provide Health Canada with a statement that sets out the actual gross revenue once the applicant has not completed its first calendar year of conducting activities under the licence, and the Certified Statement of Revenue must be provided within 90 days after the day on which that first calendar year ends.

10.10.2 Audited Sales Records

If, on the basis of any information available to Health Canada, the information that is supplied in support of a request for fee remission is deemed not adequate to determine the applicant's actual gross revenue, Health Canada may require the applicant to provide sales records that have been audited by a qualified independent auditor. The audited records are to be used for the purpose of determining the fee payable or the amount of the remission.

If the applicant does not submit audited sales records within 90 days after Health Canada makes an official request for such records, remission will be automatically denied. The DEL fee will be payable with interest.

Note that any expense incurred in having sales records audited by an independent auditor rests with the applicant.

10.11 Fees

The sections below provide further explanation of the fees. Please refer to Figure 1: Upstream / Downstream Activity Chart in section 10.4.

Fees are charged (1) for the issuance of a DEL or (2) for the annual review of a DEL or (3) for the amendment of a DEL or (4) for the reinstatement of a DEL. The fee payable for the issuance of a DEL in respect of a site (Note: refer to the definition of "site" in section 1 of the Establishment Licensing Fees (Veterinary Drugs) Regulations) is calculated based on the most 'upstream' activity that is to be conducted at that site. A licence for a higher-level, 'upstream' activity can include lower-level 'downstream' activities without additional fees payable. The sum of the payable fees for each site subject to an issued DEL is the full DEL fee.

10.11.1 Fabrication

The fee for each site, where the applicant is authorized to conduct activities that include fabricating drugs is $6,000.

  • Where the applicant is authorized to fabricate in respect of multiple categories of drugs, the fee is $1,500 for each additional category at each building fabricating multiple categories of drugs.
  • Where the applicant is authorized to fabricate in respect of multiple dosage form classes, the fee is $3,000 for two classes at each building where there are two classes; the fee is $6,000 for three classes at each building where there are three classes; the fee is $7,500 for four classes at each building where there are four classes; the fee is $9,000 for five classes at each building where there are five classes; the fee is $10,500 for six classes at each building where there are six classes; the fee is $10,500 plus an additional $600 for each additional class at each building where there are 7 or more classes.
  • Where the applicant is authorized to fabricate in respect of a sterile dosage form, the fee is $3,000 at each building fabricating in respect of a sterile dosage form.
  • The fee for each site, where the applicant is authorized to conduct activities that include fabricating drugs and importing drugs from a fabricator outside Canada, the additional fees noted below apply. Note that, although no further fees apply in respect of the applicant's site, additional fees apply in respect of each foreign fabricator's buildings. (Note: it is also referred to as a "foreign site").
  • Where the applicant is authorized to conduct importing activities at a site where it is proposed to fabricate drugs, the fee is $600 for each foreign building used to fabricate drugs that are to be imported.
  • Where the applicant is authorized to conduct importing activities of more than one dosage form at a site where it is proposed to fabricate drugs, the fee is $300 for each additional dosage form at each foreign building.

10.11.2 Package/Label

The fee for each site, where the applicant intends to conduct activities that include packaging/labelling drugs but not fabricating is $4,000.

  • Where the applicant is authorized to package/label in respect of multiple categories of drugs but not fabricate, the fee is $1,000 for each additional category at each site packaging/labelling multiple categories of drugs.
  • Where the applicant is authorized to package/label in respect of multiple dosage form classes but not fabricate, the fee is $2,000 for two classes at each site where there are two classes; and, the fee is $3,000 for three or more classes at each site where there are three classes or more.
  • If the intended packaging/labelling site also imports drugs from foreign fabricators, there are additional payable fees in respect of each foreign fabricator's buildings (Note: it is also referred to as a "foreign site). The bullets below explain the rules.
  • Where the applicant is authorized to conduct importing activities at a site where it is proposed to package/label drugs but not fabricate, the fee is $600 for each foreign building used to fabricate drugs that are to be imported.
  • Where the applicant is authorized to conduct importing activities of more than one dosage form at a site where it is proposed to package/label drugs but not fabricate, the fee is $300 for each additional dosage form at each foreign building.

10.11.3 Importation

The fee for each site, where the applicant is authorized to conduct activities that include importing drugs from a fabricator outside Canada (Note: it is also referred to as a "foreign site") but not fabricating or packaging/labelling is $2,500.

  • Where the applicant is authorized to import in respect of multiple categories of drugs, the fee is $625 for each additional category at each site importing multiple categories of drugs.
  • Where the applicant is authorized to import in respect of multiple dosage form classes, the fee is $1,250 for two classes at each site where there are two classes; and, the fee is $2,500 for three or more classes at each site where there are three classes or more.
  • Additional fees for each foreign fabricator's buildings apply as noted below.
  • A fee of $600 for each foreign building used to fabricate drugs that are to be imported.
  • A fee of $300 for each additional dosage form at each foreign building.

10.11.4 Distribution (DIN Distributor)

The fee for each site, where the applicant is authorized to conduct activities that include distributing drugs as it is referred to in paragraph C.01A.003(b) of the FDR but not fabricating, packaging/labelling, or importing is [$2,500] / [the basic fee for importing in Schedule 3].

  • Where the applicant is authorized to distribute in respect of multiple categories of drugs, the fee is $625 for each additional category at each site importing multiple categories of drugs.
  • Where the applicant is authorized to distribute in respect of multiple dosage form classes, the fee is $1,250 for two classes at each site where there are two classes; and, the fee is $2,500 for three or more classes at each site where there are three classes or more.

10.11.5 Wholesale (Wholesale / Type A Distributor)

The fee for each site, where the applicant is authorized to conduct activities that include wholesaling drugs or distributing drugs as it is referred to in paragraph C.01A.003(a) of the FDR but not fabricating, packaging/labelling, importing, or distributing as it is referred to in paragraph C.01A.003(b) of the Food and Drug Regulations is $1,500.

10.11.6 Test

The fee for each site, where the applicant is authorized to only conduct the testing activity is $1,000.

10.11.7 Drug Analysis

In addition to the fees referred to in 10.4.1 (fabrication), 10.4.2 (package/label), 10.4.4 (importation), 10.4.5 (distribution as referred to in paragraph C.01A.003(b) of the FDA), a drug analysis fee is payable at the highest fee set out below that corresponds to the appropriate drug described below.

Table 6: Drug Analysis Fee for Veterinary Use Only
Item Description Fee
4 Drugs for veterinary use $250

10.12 Amendments

10.12.1 Sterile Dosage Forms

If the application to amend a DEL, where the DEL authorizes the holder to conduct one or more activities including fabricating drugs, seeks to authorize the holder to fabricate drugs in sterile dosage forms for the first time at a site, the fee payable is $6,000 at each additional site.

10.12.2 Activity

If an applicant seeks to amend a DEL by adding an activity that is upstream from the activity currently authorized at a site, the applicable fee as indicated in 10.4.1 (fabrication), 104.2 (package/label), 10.4.4 (importation), and 10.4.5 (distribution as referred to in paragraph C.01A.003(b) of the FDR), or 10.4.6 (wholesale) is payable. Refer to the appropriate section to determine the payable fee.

  • If the applicant seeks to amend a DEL by adding an activity that is downstream from the activity currently authorized at a building, there the basic fee of the additional activity is not payable.
  • If an applicant seeks to amend a DEL by adding a new site that is to conduct a regulated activity, the applicable fee as indicated in 10.4.1 (fabrication), 10.4.2 (package/label), 10.4.4 (importation), 10.4.5 (distribution as referred to in paragraph C.01A.003(b) of the FDR), 10.4.6 (wholesale), or 10.4.7 (testing) is payable on the most upstream activity identified on the application form.
  • If an applicant seeks to amend a DEL by removing an existing authorized site that is currently conducting a regulated activity, there is no payable fee but the amendment is still required. Payment adjustment of the fees paid for the authorized building to be removed from the licence cannot be refunded.

10.12.3 Category of Drugs

If an applicant seeks to add a category of drug in respect of an activity conducted at a site that is already authorized by a DEL, the following may apply:

  • If the amendment seeks to authorize the holder to fabricate an additional category, the fee is $1,500 at each proposed site.
  • If the amendment seeks to authorize the holder to package/label an additional category, the fee is $1,000 at each proposed site.
  • If the amendment seeks to authorize the holder to import an additional category, the fee is $6,440 at each proposed site.
  • If the amendment seeks to authorize the DIN Distributor to distribute as referred to in paragraph C.01A.003(b) of the FDR an additional category, the fee is $625 at each proposed site.
  • If the amendment seeks to authorize the Wholesaler / Type A Distributor to distribute as referred to in paragraph C.01A.003(a) of the FDR or to wholesale an additional category, there is no fee at each proposed site.
  • If the amendment seeks to authorize the holder to test an additional category, there is no fee at each proposed site.

10.13 Reinstatement

If an applicant's DEL has been suspended and subsequently reinstated, the fee is payable at the time that a DEL is reinstated, so long as the applicant has not completed its first year of activities under the DEL. The fee applicable is based on the application received for acquired licence.

10.14 Dealer's Licence that is in respect of veterinary drugs only

The regulatory requirements concerning DEL fees for licences that are in respect of veterinary drugs only can be found in the Licensed Dealers for Controlled Drugs and Narcotics Fees (Veterinary Use) Regulations.

Only two types of Dealer's Licences have a fee set: Dealer's Licences issued under section G.02.003.2 of the Food and Drug Regulations, and section 9.2 of the Narcotic Control Regulations.

Note that any dollar amounts used in this section are included only for ease of reference.Please consult the regulations for a definitive statement of fees applicable.

10.15 Application

The regulatory requirements enumerated in the regulations apply to applicants who are issued a Dealer's Licence application that is in respect drugs for veterinary use only. The regulations do not apply to a drug that is a natural health product.

The regulations do not apply to (1) any branch or agency of the Government of Canada or of the government of a province or (2) any person or organization engaged only in scientific investigation or companies dealing solely with products subjected to the benzodiazepine and other targeted substances regulations. Dealer's Licence applicants that fall within any of these three categories are not required to pay Dealer's Licence fees.

10.16 Time of Payment

10.16.1 Initial Application

The applicable fee is generally payable on the day on which the relevant Dealer's Licence is issued. If the applicant has not completed their first calendar year of conducting activites under the licence, the licence for a Dealer licence is $875 for each site at which the licensed activities are to be conducted. An invoice will be issued to the applicant indicating the amount owed. There is an exception that is noted in 10.10.1.

Please note: For how to submit payment please follow the following instructions: "How to Pay Fees," (that can be found on the Health Canada website.

Payment of fees by credit card or in Canadian funds is strongly advised.

10.17 Dealer's Licence Only

If the applicant has not completed their first calendar year of conducting activities under the Dealer's licence, the applicant must provide the Certified Statement of Revenue within 90 days after the day on which that year ends in order to be eligible for a remission.

If an applicant's fee calculated in accordance with the Licensed Dealers for Controlled Drugs and Narcotics Fees (Veterinary Use) Regulations is an amount that is greater than 1.5% of its actual gross revenue generated from activities conducted under a Dealer's Licence during the previous calendar year, fee remission will be reviewed, considered and granted. The amount remitted will equal the difference between the total applicable fees and the amount of 1.5% of gross revenue.

If an applicant wishes to apply for fee remission, it must make this request by submitting a Calculation Chart, and a Certified Statement of Revenue signed by the individual responsible for the applicant's financial affairs that sets out the actual gross revenue along with the application (1) for a Dealer's Licence or (2) for the renewal of a Dealer's Licence. The statement can be a signed copy of the applicant's general ledger or a signed copy of the sales logs from the general ledger.

Example:
In this example, the total fee payable by an applicant, according to the regulation, is $1,750. The applicant's actual gross revenue equals $100,000. 1.5 percent of the applicant's gross revenue is therefore $1,500.
The amount of the remission would be calculated as follows:
Remission = $1,750 - $1,500
Total = $250
Therefore, the total payable amount by the applicant is $1,500 in this example.

10.17.1 Dealer's Licence and Drug Establishment Licence

Where an applicant submits an application for both a Dealer's Licence and a DEL that are both in respect of drugs for veterinary use only, the remission is granted where the Dealer's Licence fee and the applicable DEL fees are together greater than 1.5% of the applicant's actual gross revenue generated from the same activities conducted at the same premises during the previous calendar year.

The above rule only applies if the following conditions are also met:

  • the applicant cannot have already received a remission for the Dealer's Licence only (refer to 10.18.1) or the DEL only (refer to 10.10); and,
  • the applicant makes this request by submitting a Drug Establishment Licence Calculation Chart, and a Certified Statement of Revenue signed by the individual responsible for the applicant's financial affairs that sets out the actual gross revenue along with the application for a Dealer's Licence (refer to 10.18.1).

If the applicant has not completed their first calendar year of conducting activities either under the Dealers's licence, the applicant must provide the Certified Statement of Revenue within 90 days after the day on which that year ends in order to be eligible for a fee remission.

Example:
In this example, according to the regulation, the total fee payable by an applicant is $6,000 for a
DEL
and $1,750 for a Dealer's Licence. The applicant's actual gross revenue equals $400,000. 1.5 percent of the applicant's gross revenue is therefore $6,000.
The amount of the remission would be calculated as follows:
Remission = ($6,000 + $1,750) - $6,000
Total = $1,750
Therefore, the total payable amount by the applicant is $6,000 in this example.

10.17.2 First Year of Activities - Payment Deferral

If the applicant requests a fee remission in accordance with 10.18.1, the applicable fees are payable upon 90 days after the day on which the applicant's first calendar year conducting activities under the Dealer's Licence or Dealer's Licence and the DEL ends.

10.18 Audited Sales Records

If, on the basis of any information available to Health Canada, the information that is supplied in support of a request for fee remission is deemed not adequate to determine the applicant's actual gross revenue, Health Canada may require the applicant to provide sales records that have been audited by a qualified independent auditor. The audited records are to be used for the purpose of determining the fee payable or the amount of the remission.

If the applicant does not submit audited sales records within 90 days after Health Canada makes an official request for such records, remission will be automatically denied. The Dealer's Licence fee and DEL fee, if applicable will be payable with interest.

Note that any expense incurred in having sales records audited by an independent auditor rests with the applicant.

10.19 Fees

The fee for the (1) issuance of a Dealer's Licence or (2) for the renewal of a Dealer's Licence is $1,750 for each site (Note: refer to the definition of "site" in section 1 of the Licensed Dealers for Controlled Drugs and Narcotics Fees (Veterinary Use) Regulations).

Even where an applicant is issued a Dealer's Licence under section G.02.003.2 of the Food and Drug Regulations, and section 9.2 of the Narcotic Control Regulations, the maximum fee payable is $1,750.

10.20 Managing Disputes

To file a dispute regarding a fee that is subject to this guidance document, contact Health Canada at:

Establishment Licensing, Billing and Invoicing Unit
2nd Floor, Graham Spry Building,
250 Lanark Ave,
Address locator: 2002D
Ottawa, ON K1A 0K9
or
Fax: 613-957-6711
or
Email: ELIU_EFLE@hc-sc.gc.ca

Appendix A: Summary of Licensable Activities

Summary of Licensable Activities
Category on Drug Establishment Licence (Columns) Pharmaceutical Vaccine Blood Schedule D Schedule C 6Table 1 footnote 1

Table 1 footnotes

Table 1 footnote 1

A separate category on the licence "6" includes the wholesaling of drugs listed in Schedule F to the FDR, drugs listed in Schedule of Part G to the FDR, and narcotics as defined in section 2 of the Narcotic Control Act. The wholesale of pharmaceutical drugs listed in Schedule F is included

Return to table 1 footnote 1 referrer

Table 1 footnote 2

In accordance with C.01A.003(a), if the person does not own the DIN and is selling a non-scheduled drug, they are exempt from establishment licensing requirements

Return to table 1 footnote 2 referrer

X = Drug Establishment Licence required

Activity on Drug Establishment Licence (Rows) Schedule F Includes Human and Veterinary Drugs, Part & narcotics as defined in section 2 of the Narcotic Control Act Non-Scheduled Includes: OTC, Ethical or Drug Pre-mixes Schedule D Schedule D

Blood and Blood Components
Biologicals

Includes Bulk Process Intermediates

Human Drugs Only
Radiopharmaceuticals

Includes Bulk Process Intermediates
Schedule F, Part G & Narcotics Does not include: OTC, Ethical or Drug Pre-mixes
Fabricate X X X X X  
Package / Label X X X X X  
Test X X X X X  
Import X X X X X  
Distribute XTable 1 footnote 2 X X X X  
Wholesale   X X X X X

Appendix B: Dosage Form Classes

Please refer to the link below (Drug Product Database Online Query). Dosage forms and routes of administration will be periodically updated by the Therapeutic Products Directorate.

Appendix C: References

  1. Food and Drugs Act
  2. Food and Drug Regulations
  3. Compliance and Enforcement Policy (POL-0001)
  4. Good Manufacturing Practices (GMP) and Establishment Licensing Enforcement Directive (POL-0004)
  5. Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080)
  6. Good Manufacturing Practices (GMP) Guidelines - 2009 Edition, Version 2 (GUI-0001)
  7. Guidance Document Annex 3 to the Current Edition of the Good Manufacturing Practices (GMP) Guidelines - Schedule C Drugs (GUI-0026)
  8. Annex 2 to the Current Edition of the Good Manufacturing Practices Guidelines Schedule D Drugs for (Biological Drugs) (GUI-0027)
  9. Good Manufacturing Practices (GMP) for Schedule D Drugs, Part 2, Human Blood and Blood Components
  10. Annex 13 to the Current Edition of the Good Manufacturing Practices Guidelines Drugs Used in Clinical Trials (GUI-0036)
  11. Annex 1 to the Current Edition of the Good Manufacturing Practices Guidelines - Selected Category IV Monograph Drugs (GUI-0066)
  12. Good Manufacturing Practices (GMP) for Medical Gases (GUI-0031)
  13. Guidance Document Annex 4 to the Current Edition of the Good Manufacturing Practices Guidelines - Veterinary Drugs (GUI-0012)
  14. Drug Establishment Licence Application: Form and Instructions (FRM-0033)
  15. Guidance Document Alternate Sample Retention Site Guidelines (GUI-0014)
  16. Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051)
  17. Standard for the Fabrication, Control and Distribution of Antimicrobial Agents for Use on Environmental Surfaces and Certain Medical Devices Version 2 (GUI-0049)
  18. Renewal Documents
  19. Fees Regulations
  20. GMP Inspection Policy for Canadian Drug Establishments (POL-0011)

Other Useful Links

Appendix D: Health Products and Food Branch Inspectorate and other Health Canada Contacts

Health Products and Food Branch Inspectorate and Regions and Programs Bureau

  • Establishment Licensing, Billing and Invoicing Unit (ELBIU)
    Establishment Licensing Unit Manager
  • Drug Good Manufacturing Practices
    Inspection Unit
  • Drug Compliance Verification and
    Investigation Unit

Other Health Canada Contact

  • Submission Information and Policy Division (SIPD)
  • Natural Health Products Directorate (NHPD)
  • Office of Controlled Substances
    Licences and Permits Division
    • Tel: (613) 948-7796
      Fax: (613) 948-3585
  • Veterinary Drugs Directorate (VDD)

Appendix E: Summary of Document Changes

Summary of Document Changes
Document Version Section Change
December 21, 2012 Throughout Editorial improvements
10 Multiple updates for clarity on fee deferral and fee remission
April 1, 2013 Throughout Multiple updates to fees as of April 1, 2013
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