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
2.4 Renewal and variation of licences

Licences should never be regarded as immutable. Ideally, they should be reviewed at, say, five-year intervals. However, many national authorities do not have the capacity to undertake this task, particularly for as long as they remain engaged in the initial review of provisionally licensed products. In these circumstances many products fall to review on an ad hoc basis. Sometimes this is inspired by recently generated concern regarding safety. More frequently, a product attracts attention because the licence-holder has altered the formulation in some way - by changing, for instance, the source of the starting materials, the nature of the excipients, the route of synthesis of an active ingredient, or the claims made in labelling and promotional material. The precise circumstances in which licence-holders are required to apply for variations in a product licence differ from country to country. These circumstances should be clearly defined in all product licence documents, including provisional licences.

Licence-holders should be required, in all circumstances, to inform regulatory authorities immediately of unanticipated adverse effects that could possibly be associated with a licensed product and that might call for restrictive licensing action or the withdrawal of the product licence.

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