ARCHIVED - New Presentation of Official Documents Requiring Sign of Authenticity - Paper and Seal

(April 8^th, 2004)

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

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

April 8, 2004

04-106538-390

To: Associations / Stakeholders, International Partners

I am pleased to inform you that as of April 1^st 2004, the Inspectorate has introduced a change for their official documents requiring a sign of authenticity. Both the paper and the seal now have special security features. Notably, the seals have a fluorescent watermark and indicate in large fonts the year of issuance. These seals indicating a page number in sequential order are affixed on each page therefore numbering each one.

Additional changes to Certificate of Pharmaceutical Products (CPP) issued for sites and not products has also been made to respond to stakeholder's requests.

The CPP and the Certificate of Compliance (CoC) are the first documents issued using these new seals. In 2005, these seals will also be used on the Establishment Licences (EL).

Please also note that a new guidance document on the application for CPP is being developed and will be available soon on the Inspectorate website. You will be notified when the new guidance document becomes available.

Inquiries about this issue can be adressed to Ms. France Dansereau at the Compliance and Enforcement Coordination Division, by telephone at (613) 957-1492, by fax at (613) 952-9805, or by e-mail at GMP_Questions_BPF@hc-sc.gc.ca.

Original signed by
Diana Dowthwaite (for)

Jean Lambert
Director General