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.
Lien permanent pour cette publication :
publications.gc.ca/pub?id=9.885272&sl=1
| Ministère/Organisme | Canada. Health Canada, issuing body. |
|---|---|
| Titre | Guidance on the application for a certificate of a pharmaceutical product and good manufacturing practice certificate (GUI-0024). |
| Variante du titre | Guidance on the application for a certificate of a pharmaceutical product (GUI-0024) v14 |
| Type de publication | Monographie |
| Langue | [Anglais] |
| Autres langues publiées | [Français] |
| Format | Électronique |
| Document électronique | |
| 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). |
| Information sur la publication | Ottawa, ON : Health Canada = Santé Canada, 2020. ©2020 |
| Description | 1 online resource (25 pages) |
| ISBN | 9780660342986 |
| Numéro de catalogue |
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| Descripteurs | Drugs -- Certification -- Canada. |
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