Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Open this folder and view contentsIntroduction
Close this folder1. National drug regulation
Close this folderGuiding principles for small national drug regulatory authorities1,2
Open this folder and view contents1. General considerations
Close this folder2. Administrative aspects of the licensing process
View the document2.1 Provisional registration of existing medicinal products
View the document2.2 Screening of provisionally registered products
View the document2.3 New product licences
View the document2.4 Renewal and variation of licences
Open this folder and view contents3. Technical aspects of the licensing process
Open this folder and view contents2. Product assessment and registration
Open this folder and view contents3. Distribution
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Open this folder and view contents6. Laboratory services
Open this folder and view contents7. International trade in pharmaceuticals
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover
2.1 Provisional registration of existing medicinal products

Before any system of control can become effective, it is necessary to identify and catalogue all products already sold or otherwise supplied on the domestic market, in both the public and the private sectors, that qualify for control. To this end, all manufacturers and importing agencies must be given reasonable notice through official gazettes, the trade press and other media of their obligation to notify the authority by a specific date of all medicinal products that they currently distribute within the jurisdiction of the authority and that they intend to continue to supply after a duly appointed day, on which licensing requirements enter into operation. After the appointed day no medicinal product may lawfully be distributed or supplied unless its existence has been notified to the authority, and no new product may be introduced until a request for a product licence has been granted by the authority.

Effective administration of the provisional registration procedure is dependent upon:

(a) prior identification of all interested manufacturers and importers;

(b) a precise definition of a notifiable medicinal product based primarily on the labelled claims and the indications for use;

(c) the issuance of guidelines on the procedure to be followed.

Each notified product must be identified by name (either brand or generic), the names and full addresses of the manufacturer and importing agent, a description of the dosage form, its composition - including active and inactive ingredients (using international nonproprietary names where appropriate) - the therapeutic class, the indications, a copy of all labelling, including any package insert, and a copy of any relevant certificates and warranties relating to the product or its components.

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