Switching a medicinal ingredient from prescription to non-prescription status draft guidance document: Contact information and glossary
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20. Contact information
If applicants have any questions regarding switches, they should contact Health Canada.
20.1 Rx to NPD switches
Please contact NNHPD by email: nnhpd.consultation-dpsnso@hc-sc.gc.ca
20.2 Rx to NHP switches
Relative to the NDS or SNDS portion of the switch process, please contact the relevant review bureau in TPD. The description and contact information for the various bureaus can be found in Appendix 2 of the guidance document “Management of Drug Submissions and Applications”.
Relative to the PLA part of the switch process, which occurs after a successful NDS or SNDS, please contact NNHPD by email: nnhpd.consultation-dpsnso@hc-sc.gc.ca
Appendix A: Glossary
Acronyms
- DEL
- Drug Establishment Licence
- DIN
- Drug Identification Number
- DNF
- Drug Notification Form
- EMA
- European Medicines Agency
- FDR
- Food and Drug Regulations
- GMP
- Good Manufacturing Practices
- MDR
- Medical Device Regulations
- NDS
- New Drug Submission
- NHP
- Natural Health Product
- NHPR
- Natural Health Products Regulations
- NHPID
- Natural Health Products Ingredients Database
- NNHPD
- Natural and Non-prescription Health Products Directorate
- NOC
- Notice of Compliance
- NOD
- Notice of Deficiency
- NOD-W
- NOD-Withdrawal
- NON
- Notice of Non-compliance
- NON-W
- NON-Withdrawal
- NPD
- Non-prescription Drug
- NPN
- Natural Product Number
- PBRER
- Periodic Benefit-Risk Evaluation Report
- PDL
- Prescription Drug List
- PLA
- Product Licence Application
- PSUR
- Periodic Safety Update Report
- Rx
- Prescription
- SL
- Site Licence
- SNDS
- Supplement to a New Drug Submission
- TPD
- Therapeutic Products Directorate
- US FDA
- Food and Drug Administration of the United States of America
Terms
Note that all the definitions that follow are for the purposes of this guidance document and the use of these terms may differ in other Health Canada documents.
- Abuse
- refers to the use of a product for purposes other than for which it was prescribed; for example, using it for its reinforcing properties.
- Addiction
- refers to the problematic use of a drug resulting in harm. These harms can range from mild (being late for work), to severe (losing a job or home) and are accompanied by impaired control over drug use; compulsive drug-seeking behaviour; continued use despite harms; and cravings.
- Applicant
- refers to the applicant or sponsor who is initiating the request for an Rx to NPD or Rx to NHP switch.
- Canadian Drug Facts Table
- refers to a table on the outer label of NPDs that is required to display specific information, per section C.01.004.02 (1) of the FDR. The purpose of the Canadian Drug Facts Table is to display the information in a standardized, easy-to-read format in order to enhance the safe and effective use of NPDs.
- Combination Product
- refers to a therapeutic product that combines a drug component and a device component (which by themselves would be classified as a drug or a device), such that the distinctive nature of the drug component and device component is integrated in a singular product.
- Conditions
- refers to diseases, conditions, disorders, abnormal physical states or their symptoms (for the purposes of simplifying the text of this guidance document).
- Conditions of Use
-
include elements such as
- the use, indication or purpose of a health product;
- the dosage form;
- the route of administration;
- the dose (including sub-population, amount, dosage unit, frequency and directions for use);
- the duration of use, if any; and
- the risk information including precautions, warnings, contraindications, or known adverse reactions associated with the use of the product or its medicinal ingredients.
- Dependence
- refers to a difficulty discontinuing drug use due to unpleasant physical and/or psychological withdrawal effects.
- Drug
- refers to natural health products, pharmaceuticals and biologics.
- Market Experience
- is knowledge gained about an authorized product once it is being sold.
- Medicinal Ingredient(s)
- refers to the substance(s) in the product that contributes to the product’s therapeutic effect (synonym: active ingredient(s)).
- Near Miss
- is an event that could have resulted in unwanted consequences, but did not, either by chance or through timely intervention.
- Non-prescription status
- refers to the default status of products that are not prescription drugs (i.e. products with prescription status). For example, NHPs and NPDs both have non-prescription status.
- Psychoactive Effects
- are effects of a substance or mixture of substances on the central nervous system that results in temporary changes in cognition, perception, mood and consciousness, which can in turn lead to temporary changes in behaviour. Examples of these include, but are not limited to, dizziness, calmness, stimulation, anxiety, irritability, cognitive impairment, hallucinations, drowsiness and euphoria.
- Practitioner
- refers to people who are entitled to treat patients with prescription drugs according to provincial/territorial laws and are practicing their profession in that province/territory. Two common examples are doctors and dentists.
- Problematic Use
- is intentionally taking a medication or drug substance to get high or to alter one’s mood. The most common types of prescription drugs that can lead to problematic use include opioids, benzodiazepines and stimulants. Problematic substance use over time is linked to drug dependence, drug tolerance and substance use disorder (addiction).
- Serious Adverse Reaction
- is a noxious and unintended response to a drug that occurs at any dose and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death.
- Switch Submission
- for Rx to NPD switches, this refers to the NDS or SNDS in which a switch is requested; for Rx to NHP switches, this refers to the NDS and PLA, or the SNDS and PLA, in which the switch is requested.
- Switch
- refers to a change of status from prescription status to non-prescription status.
- Tolerance
- refers to the need to take progressively higher doses of a drug substance in order to achieve the same desired effect.
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