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
2.3 New product licences

No product that is first proposed for authorization after the appointed day (see section 2.1 above) should be accorded a product licence without first having been submitted to technical assessment. Such products may not necessarily contain a new active ingredient: they may constitute a new combination of two or more established substances or they may merely represent a new dosage strength, a new dosage form, or a generic version of a pre-existing, nominally equivalent licensed product. In no case should the requirement for assessment be waived. A rationale for the formulation of every new product should invariably be provided, but the extent of the required review will vary considerably according to circumstances. The normal procedure for the authorization of a product is accomplished in three stages:

(a) the application is received from the manufacturer and is checked and assessed for completeness by the authority’s technical staff;

(b) it is submitted to the competent standing committee for advice on whether or not to authorize marketing of the product;

(c) the formal administrative action to grant or refuse a licence and to settle its content is then taken by the authority.

The assessment of the product must be based primarily on its safety, quality, and efficacy, with regard to its intended use. In accordance with locally determined requirements, the assessment might also impinge upon comparative efficacy and/or safety and embrace economic factors, including price, cost-effectiveness, and other considerations determined by national policy.

For administrative convenience, the product licence should be as simple as possible. It should always describe the product by name, manufacturer and importing agent, identify the ingredients (preferably by their international nonproprietary names), and provide full details of the dosage form. It should also contain a serial number, the date of issuance of the licence, its date of expiry, and any special conditions to be observed. It is advisable to cite certain additional items in the licence for easy reference, such as shelf-life and sales category; but in other particulars it should refer to the information submitted by the licence-holder in the dated product application.

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