WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 863 - Thirty-fourth Report
(1996; 200 pages) View the PDF document
Table of Contents
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related activities
View the document3. Simple test methodology
Open this folder and view contents4. Stability of dosage forms
Open this folder and view contents5. Good manufacturing practices for pharmaceutical products
Close this folder6. Legal and administrative aspects of the functioning of national drug regulatory authorities
View the document6.1. Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability
View the document6.2. The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
View the document6.3. Guiding principles for formulating national drug legislation
View the document6.4. Role of the pharmacist
View the document6.5. Model legislative provisions to update national legal texts to deal with counterfeit drugs
View the document6.6. Additional guidance
View the document6.7. Training activities
Open this folder and view contents7. Quality assurance in the supply system
View the document8. Terminology
View the documentAcknowledgements
View the documentReferences
Open this folder and view contentsAnnex 1 - Guidelines for the graphic representation of chemical formulae
View the documentAnnex 2 - List of available International Chemical Reference Substances1
View the documentAnnex 3 - List of available International Infrared Reference Spectra
Open this folder and view contentsAnnex 4 - General recommendations for the preparation and use of infrared spectra in pharmaceutical analysis
Open this folder and view contentsAnnex 5 - Guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms
Open this folder and view contentsAnnex 6 - Good manufacturing practices: guidelines on the validation of manufacturing processes
Open this folder and view contentsAnnex 7 - Good manufacturing practices: supplementary guidelines for the manufacture of investigational pharmaceutical products for clinical trials in humans
Open this folder and view contentsAnnex 8 - Good manufacturing practices: supplementary guidelines for the manufacture of herbal medicinal products1
Open this folder and view contentsAnnex 9 - Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability
Open this folder and view contentsAnnex 10 - Guidelines for implementation of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Open this folder and view contentsAnnex 11 - Guidelines for the assessment of herbal medicines1,2
Open this folder and view contentsAnnex 12 - Guidelines on import procedures for pharmaceutical products
View the documentBack Cover
 

6.3. Guiding principles for formulating national drug legislation

The Committee considered two draft texts providing guidance in the form of a model legislative scheme and a draft law for adaptation by small national drug regulatory authorities on the regulation of pharmacists and pharmacies. It concluded that such guidance would be of immediate value to the many countries still in the process of establishing drug regulatory and legislative systems. While other countries might also profit from such a framework, the Committee pointed out that authorities should always be cautious about changing systems and procedures that work effectively. The introductory notes to the two documents should be expanded so as to explain more clearly for whom the advice was intended and how it could be adapted to national needs. The Committee therefore recommended that work on such texts should be continued, and suggested that the drafts might be published in one of the WHO periodicals so as to widen the consultative procedure and be made available in several languages.

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Last updated: May 3, 2013