Conditions for Provision of Packaging/Labelling Services for Drugs under Foreign Ownership (GUIDE-0067)

(May 1^st, 2004)

Contact: Drugs GMP Inspection Unit
Tel: (613) 957-1492
Fax: (613) 952-9805
E-Mail: GMP_questions_BPF@hc-sc.gc.ca

Cover Letter

Health Products and Food Branch Inspectorate
Holland Cross, Tower "A", 2^nd Floor
11 Holland Avenue
Address Locator # 3002C
OTTAWA, Ontario
K1A 0K9

April 23, 2004

04-104725-188

To: Associations

I am pleased to inform you that the document entitled "Conditions for Provision of Packaging/Labelling Services for Drugs under Foreign Ownership" is now available on the Compliance and Enforcement website at the following address:

This document has been developed by the Inspectorate and is intended to clarify specific requirements to be met by a Canadian establishment seeking to bring into Canada a shipment of a drug solely to provide contract packaging/labelling services in relation to that drug that is then re-exported to the foreign manufacturer who retains ownership of the drug during such a transaction. Drugs imported outside the scope of this document should meet all applicable requirements under the Food and Drugs Act and Regulations.

Inquiries about this document can be addressed to Ms. France Dansereau, Manager, Drug GMP Inspection Unit, by telephone at (613) 957-1492, by fax at (613) 952-9805, or by email at GMP_questions_BPF@hc-sc.gc.ca.

Original signed by
Diana Dowthwaite (for)

Jean Lambert
Director General

Cover Page

Health Products and Food Branch Inspectorate
Guide-0067 Conditions for Provision of Packaging/Labelling Services for Drugs under Foreign Ownership

• Supersedes:
  New document
• Date issued:
  May 1^st, 2004
• Date of implementation:
  July 1^st, 2004

Ce document est aussi disponible en français.

Table of Contents

• 1.0 Purpose
• 2.0 Background
• 3.0 Scope
• 4.0 Requirements
• 5.0 Period of Retention of Records
• GMP Committee Members
• Health Products and Food Branch Inspectorate Operational Centres
• Annex / Annexe : Notification Form / Formulaire de notification

1.0 Purpose

This document clarifies the specific requirements to be met by a Canadian packager / labeller in possession of an Establishment Licence that brings a drug into Canada solely to provide contract packaging/labelling services for that drug, which is then returned to the same fabricator from whom the product was received and who retains ownership of the drug throughout the transaction.

Such drugs:

• are not sold in Canada.
• do not have a DIN
• are not represented as Canadian products
• are not sold by the Canadian establishment providing the packaging/labelling service.

If the conditions set forth are met, the Inspectorate will have a degree of confidence to the effect that the drugs received are not imported for sale in Canada in contravention of the Food and Drug Regulations (FDR) but rather are being packaged and returned to the fabricator. The Inspectorate may ask for further evidence that the drugs to be packaged are returned to the fabricator.

2.0 Background

Under section A.01.040 of the FDR, all drugs in dosage form that are imported into Canada for the purpose of sale must comply with the requirements of the Food and Drugs Act (FDA) and Regulations, regardless of whether the drug is to be sold to Canadian or to foreign customers. However, it has been recognized that an establishment may wish to import a commercial shipment of a drug that has not been authorized for sale in Canada solely for the purpose of providing a contract packaging/labelling service to a foreign establishment that retains ownership of the drug. Therefore certain conditions must be met in order to ensure that such drugs are not sold by the Canadian establishment and are returned to the foreign fabricator that owns the drug. It should be understood that no Certificate of Pharmaceutical Product (CPP) will be issued for these drugs.

In response to questions from industry pertaining to the requirements that must be met in order for drugs to enter into Canada, the Inspectorate developed a "Guidance document on the commercial importation and exportation of drugs in dosage forms under the Food and Drugs Act". Further information is available in this guidance document.

3.0 Scope

This document applies to commercial shipments of unapproved drugs in dosage form that are brought into Canada solely for the purpose of providing a packaging/labelling service to the foreign fabricator that owns the drug.

Drugs imported outside the scope of this document should meet all applicable requirements under the FDA and Regulations.

This document does not apply to the following:

• drugs imported for personal use
• active pharmaceutical ingredients
• samples of drugs to be tested by a Canadian laboratory
• drugs to be sold in Canada
• drugs represented as Canadian products, such as those bearing a Canadian name, logo, address, or any other Canadian symbol.

4.0 Requirements

Drugs may be brought into Canada by a licenced Packager / Labeller for the purpose of providing packaging/labelling services to a foreign fabricator that retains ownership of the drug under the following conditions:

4.1 Ten (10) days prior to each shipment to Canada a notice (see attached annex) is sent by the Canadian contract packager/labeller to Health Canada specifying the following:

• the name of the drug and the quantity that is to be received by the contract packager/labeller
• the lot number of the drug to be received
• the name and address of the foreign owner of the drug
• the name and address of Canadian contract packager/labeller
• the date and port of entry into Canada
• the anticipated date of return of the drug to the foreign owner in the same country of origin.

4.2 Ten (10) days following completion of each packaging/labelling order and the return of the drug to the foreign owner a notice (see attached annex) is sent to Health Canada specifying the following:

• confirmation of the return of the packaged/labelled drug and any bulk unpackaged drug to the same fabricator in the same country from whom it was received
• the quantity returned
• brief description of packaging format(s) returned to owner and copies of labels and any other printed packaging components used to package/label the drug.

4.3 The following information is maintained on the premises of the Canadian contract packager/labeller and will be subject to review at the time of inspection:

• a written and signed contract that specifies the services to be provided and states that the drug remains under the ownership of the foreign establishment and that it is to be returned to the same owner from which it is received
• evidence that the foreign regulatory authority has authorized the packaging/labelling activity in Canada
• copies of labels and any other printed packaging components used to package/label the drug
• packaging/labelling batch documents for all services provided
• evidence that all quantities of the drug received have been returned to the foreign owner.

4.3.1 The following information must be sent to the Health Products and Food Branch Inspectorate, Drug GMP Inspection Unit, in Ottawa:

• evidence that the foreign establishment that owns the drug is in compliance with applicable GMP requirements. Evidence acceptable is described in the document "Conditions for acceptance of foreign inspection reports for listing foreign sites on Canadian Establishment licence".

4.4 The information required under 4.1 and 4.2 must be sent to the operational centre of the Health Products and Food Branch Inspectorate located in the region of the contract packager/labeller. Please consult the attached list of Operational Centres. Acknowledgement of receipt of the notification will not be issued by the Operational Centre but this information may be verified at any time by an inspector.

4.5 A copy of the information required under 4.1 must also be included with the shipment when it is brought into Canada.

5.0 Period of Retention of Records

Records required by Section 4.0 of this document must be kept for a period of 1 year after the expiration date on the label of the drug or 4 years after the finished packaged product is returned to its owner if no such date is indicated on the label.

GMP Committee Members

• France Dansereau, Chair
  Manager, Drug GMP Inspection Unit, HPFBI^{Footnote 1}
  Ottawa, ON
• Kim Dayman-Rutkus
  Director, Policy and Strategic Planning Division, HPFBI
  Ottawa, ON
• Richard Ferland
  MRA officer, HPFBI
  Longueuil, QC
• Francisco Fernandes
  Compliance Specialist, Ontario & Nunavut Operational Centre, HPFBI
  Toronto, ON
• Taras Gedz
  Acting Manager, Product Quality Division, BPS^{Footnote 2}
  Ottawa, ON
• Denis Girard
  Scientific Assessment Advisor, VDD^{Footnote 3}
  Ottawa, ON
• Raymond Giroux
  Drug Specialist, Quebec Operational Centre, HPFBI
  Longueuil, QC
• Paul Gustafson
  Compliance Officer, Manitoba and Saskatchewan Operational Centre, HPFBI
  Winnipeg, MB
• Grazyna Kujath
  Compliance Officer, Atlantic Operational Centre, HPFBI
  Halifax, NS
• Stephen McCaul
  MRA Officer, HPFBI
  Toronto, ON
• Médic Ndayishimiye, Secretary
  Compliance Officer, HPFBI
  Ottawa, ON
• Willem Stevens
  Senior Biologist/Evaluator, BGTD^{Footnote 4}
  Ottawa, ON
• Stéphane Taillefer
  Compliance Specialist, HPFBI
  Ottawa, ON
• Sheila Welock
  Drug Specialist, Western Operational Centre, HPFBI
  Burnaby, BC

Health Products and Food Branch Inspectorate
Operational Centres

• Atlantic Operational Centre
  1505 Barrington Street, Suite 1625
  Halifax, Nova Scotia, B2J 3Y6
  Manager:
  T 902 426 5350
  F 902-426-6676
• Quebec Operational Centre
  1001 West St-Laurent Blvd.
  Longueuil, Québec, J4K 1C7
  Manager:
  T 450-646-1353
  F 450-928-4455
• Ontario and Nunavut Operational Centre
  2301 Midland Avenue
  Scarborough, Ontario, M1P 4R7
  Manager:
  T 416-973-1600
  F 416-973-1954
• Manitoba and Saskatchewan Operational Centre
  510 Lagimodière Blvd.
  Winnipeg, Manitoba, R2J 3Y1
  Manager:
  T 204-984-1341
  F 204-984-2155
• Western Operational Centre
  4595 Canada Way, 4^th Floor
  Burnaby, British Columbia, V5G 1J9
  Manager:
  T 604-666-3704
  F 604-666-3149
• Drug GMP Inspection Unit
  Graham Spry Building, 2^nd Floor
  250 Lanark Avenue, P.L. 2002B
  Ottawa, Ontario, K1A 0K9
  Manager:
  T 613-957-1492
  F 613-952-9805

Annex / Annexe : Notification Form / Formulaire de notification

Part 1/ Partie 1
Notification to Health Canada prior to shipment to Canada / Notification à Santé Canada avant l'envoi au Canada

• Contract packager-labeller - Emballeur/étiqueteur contractuel
  • Name / Nom :
  • Address / Adresse :
  • City / Ville, Province :
  • Postal Code / Code postal :
  • Telephone / Téléphone :
  • Fax :
• Drug to be packaged/labelled - Drogue à être emballée/étiquetée
  • Name (active ingredient) / Nom (ingrédient actif) :
  • Brand name / Nom de marque :
  • Quantity / Quantité :
  • Manufacture date / Date de fabrication
• Foreign fabricator - Manufacturier étranger
  • Name / Nom :
  • Address / Adresse :
  • City / Ville :
  • Country / Pays :
• Expected date of entry into Canada - Date prévue d'entrée au Canada
• Port of entry in Canada - Port d'entrée au Canada
• Expected date of return to the fabricator - Date prévue de retour au manufacturier étranger

Part 2/ Partie 2
Notification to Health Canada after the return of the drug to the foreign owner / Notification à Santé Canada après l'expédition de la drogue au propriétaire étranger

• Quantity packaged - Quantité emballée
• Type and format of packaging material - Type et format du matériel d'emballage
• Quantity of drug per packaging unit - Quantité de drogue / unité d'emballage
• Number of units packaged - Nombre d'unités emballées
• Quantity of packaged units returned to the fabricator - Nombre d'unités emballées retournées au manufacturier
• Date of return - Date de retour
• Transport Mode - Moyen de transport
• If discrepancies, please explain: - Si différence, svp expliquez
• Signature :