. /.WORLD TRADE
ORGANIZATIONG/TBT/Notif.99/651
22 December 1999
(99-5535)
Committee on Technical Barriers to Trade
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   CANADA
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:   Department of Health
Agency or authority designated to handle comments regarding the notification shall be
indicated if different from above:   National Enquiry Point
3. Notified under Article 2.9.2 [  ], 2.10.1 [    ], 5.6.2 [ X], 5.7.1 [    ], other:           
4. Products covered (HS or CCCN where applicable, 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:   Proposed Amendment
to the Food and Drug Regulations (1068 – Es tablishment Licences and Good Manufacturing
Practices) (pages 3732-3741;  English and French)
6. Description of content:   In 1996, amendments to the Food and Drug Regulations created a
comprehensive establishment licensing framework for drugs.  This framework comprises
Division 1A, Establishment Licenses (EL) a nd Division 2, Good Manufacturing Practices
(GMP).  This amendment was intended to ensure that products are fabricated,
packaged/labeled, imported, stored, tested and distributed according to applicable GMP
requirements sufficient to safeguard the safety and quality of all drug products.
A multi-sectoral Mutual Recognition Agreement (MRA) was signed by Canada and several
other countries (European Community and Swit zerland).  Health Canada is involved in
two industrial sectors — medical devices and drugs.  The MRA in the drug sector is limited
to determining the equivalence of GMP standards applied to one or a series of
manufacturing processes and the compliance assessment methods by regulatory authorities.
A GMP compliance system includes the inspection of manufacturing sites and the issuanceof a compliance certificate for sites that satisfy the regulatory requirements.
The purpose of the Agreement is to establish mutual recognition of each party’s GMP
compliance certificate or equivalent document.  Recognition of another party’s compliance
certification will be limited to the manufacturing processes inspected by a designated
regulatory authority in an MRA country.  The GMP compliance certification will berecognized by the other party of the agreement without the requirement for additional proof
of GMP compliance at time of importation. Exemptions may apply to a distributor holding a
valid Drug Identification Number (DIN) or an importer where a drug is fabricated,
packaged/labeled or tested at a site that has been issued a certification of compliance by a
designated regulatory authority.G/TBT/Notif.99/651
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7. Objective and rationale, including the na ture of urgent problems where applicable:
Protection of human health and safety
8. Relevant documents:   Canada Gazette, Part I, 11 December 1999
9. Proposed date of adoption:  Not stated
Proposed date of entry into force:  1 April 2000
10. Final date for comments:   9 February 2000
11. Texts available from:  National enquiry point [ X] or address, e-mail and telefax
number of the other body: