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 |
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| Title | Guidance on the application for a certificate of a pharmaceutical product and good manufacturing practice certificate (GUI-0024). |
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| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Digital text |
| Electronic document | |
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| Publishing information |
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| Description | 1 online resource (25 pages) |
| ISBN | 9780660342986 |
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