Guidance on the application for a certificate of a pharmaceutical product and good manufacturing practice certificate (GUI-0024).: H139-14/2020E-PDF
"This guidance document clarifies the requirements to be met for the issuance of a Certificate of a Pharmaceutical Product (CPP) or a Certificate of Good Manufacturing Practices (GMP) and describes the procedure for their request. A CPP is issued for human drugs (pharmaceutical, biological and radiopharmaceutical) as well as for veterinary drugs (food producing animals and non-food producing animals). Since the Food and Drugs Act and Regulations apply also to veterinary pharmaceuticals intended for non-food producing animals, they must be fabricated according to GMP requirements and consequently, Health Canada chooses to issue CPPs for these pharmaceutical products. Products falling under the Natural Health Products (NHP) framework are excluded from the scope of this document"--Page 4.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.885272&sl=0
| Department/Agency | Canada. Health Canada, issuing body. |
|---|---|
| Title | Guidance on the application for a certificate of a pharmaceutical product and good manufacturing practice certificate (GUI-0024). |
| Variant title | Guidance on the application for a certificate of a pharmaceutical product (GUI-0024) v14 |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Electronic |
| Electronic document | |
| Note(s) | Issued also in French under title: Guide sur la façon de présenter une demande de certificat de produit pharmaceutique et certificat de bonnes pratiques de fabrication (GUI-0024). "April 01, 2020." "Pub.: 190622." Issued also in HTML format. Includes bibliographical references (page 14). |
| Publishing information | Ottawa, ON : Health Canada = Santé Canada, 2020. ©2020 |
| Description | 1 online resource (25 pages) |
| ISBN | 9780660342986 |
| Catalogue number |
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| Subject terms | Drugs -- Certification -- Canada. |
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