G/TBT/N/CAN/417  
 
1 July 2014  
(14-3768)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: English/French  
 
  NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6 
 
1. Notifying Member: CANADA  
If applicable, name of local government involved (Article 3.2 and 7.2):    
2. Agency responsible: Health Canada 
Name and address (including telephon e and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above :  
Canadian Enquiry Point, Foreign Affairs, Trade and Development Canada 
111 Sussex Drive, Ottawa, Ontario, Canada, K1A 0G2  
Tel.:  +1 343 203 4273 Fax.: +1 613 943 0346 E-mail: enquirypoint@international.gc.ca  
3. Notified under Article 2.9.2 [ X ], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other:  
4. Products covered (HS or CCCN where applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): Drugs 
5. Title, number of pages and language(s) of the notified document: Regulations 
Amending the Food and Drug Regulations (Ret ention of Records - Miscellaneous Program)  
(4 pages, available in English and French).     
6. Description of content: Currently, the Food and Drug Regulations  (the Regulations) 
include a list of information that drug manufacturers must collect and maintain for 
inspection and auditing purposes, but there is no timeframe specified for this record-
keeping requirement. The information falls into  the following categories: records regarding 
clinical trials and animal testing; results of developmental chemistry investigations and stability testing; manufacturing records and batch analysis; reports of adverse drug 
reactions; and published scientific literature. 
The amendment sets a requirement for all manufacturers of new drugs to keep this 
information for at least seven years from the date the records were established. It is 
important to note that other provisions in the Regulations may place further record 
keeping requirements on the manufacture r, but seven years is the minimum.  
Some non-substantive changes have also been included to correct errors that were 
inadvertently introduced when previous amendments were made to the Food and Drugs 
Regulations . These changes are intended to further clarify the interpretation of the 
Regulations. 
7. Objective and rationale, including the nature of urgent problems where applicable: 
This regulatory amendment will address the i ssue identified by providing clarity regarding 
record retention requirements for manufacturers of new drugs.  G/TBT/N/CAN/417 
 
- 2 - 
 
  8. Relevant documents:  Canada Gazette , Part II, 4 June 2014, Pages 1484-1487 (available 
in English and French) 
9. Proposed date of adoption: 16 May 2014 
Proposed date of entry into force: 16 May 2014   
10. Final date for comments: Not applicable. Consultations were not conducted as the 
amendments are purely technical to address the recommendations of the Standing Joint Committee for the Scrutiny of Regulations, and will not impact on stakeholder interests 
11. Texts available from: Nati onal enquiry point [X] or address, telephone and fax 
numbers and email and website addresse s, if available, of other body:  The electronic 
version of the regulatory text can be downloaded at:  
http://canadagazette.gc. ca/rp-pr/p2/2014/ 2014-06-04/pdf/g2-14812.pdf#page=138 
http://canadagazette.gc.ca/rp-pr/p2/20 14/2014-06-04/html/sor-dors125-eng.php   
http://canadagazette.gc.ca/rp-pr/p2/20 14/2014-06-04/html/so r-dors125-fra.php