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
Close this folder1. General considerations
View the document1.1 The scope of drug control
View the document1.2 Basic responsibilities
View the document1.3 Licensing functions
View the document1.4 Product licences
View the document1.5 Manufacturers’ and distributors’ licences
View the document1.6 New drug assessments
View the document1.7 Authorization of clinical trials
View the document1.8 Terms of reference of the regulatory authority
View the document1.9 Powers of enforcement
View the document1.10 Technical competence
View the document1.11 Advisory bodies
View the document1.12 Independence of operation
Open this folder and view contents2. Administrative aspects of the licensing process
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
1.3 Licensing functions

These objectives can be accomplished effectively only if a mandatory system of licensing products, manufacturers, importing agents, and distributors is in place.

A small authority has strictly limited capacity to undertake these tasks. For the assurances it requires in relation to imported pharmaceutical products and drug substances, it is vitally dependent on authoritative, reliable, and independent information generated in the exporting country. This information is most effectively obtained through the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce.

Before a formal licensing system can become operative, it is necessary:

(a) to adopt a precise definition of a drug product and of the various categories of licence-holders;

(b) to determine the content and format of licences, both for products and for licence-holders;

(c) to detail the criteria on which licence applications will be assessed; and

(d) to provide guidance to interested parties on the content and format of licence applications, and on the circumstances in which an application for renewal, extension or variation of a licence will be required.

The definition of a drug product is commonly contingent upon the claims that are made for it. Ideally, controls need to be applied to any product that is offered for sale for administration to human beings for treating, preventing and diagnosing disease, for anaesthesia, for contraception, and for otherwise altering normal physiological functions.1 In practice, exemptions may need to be granted to various specific categories of products in order to address priorities effectively. It might be decided as an interim measure, for example, to require licences only for products listed in a national formulary. Ultimately, however, control needs to be extended not only to all products moving in the major distribution channels, but to those formulated in pharmacies and hospital dispensaries, to herbal preparations, and to other traditional medicines entering into local commerce.

1 Veterinary products administered to food-producing animals may also fall into this category; see the revised WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce (WHO Technical Report Series, No. 790, 1990, Annex 5).

Analogous priorities may also need to be accorded to the registration of licence-holders, although the ultimate objective should be to embrace all manufacturers, importing agents, wholesalers involved in repackaging, pharmacies, and hospital dispensaries in a system that imposes upon them relevant statutory obligations.

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