WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
(1999; 168 pages) [Spanish] View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related issues
Open this folder and view contents3. International Chemical Reference Substances and Infrared Reference Spectra
Open this folder and view contents4. Quality control - national laboratories
Open this folder and view contents5. Good manufacturing practices
Open this folder and view contents6. Quality systems and inspection
Open this folder and view contents7. Other quality assurance topics
Open this folder and view contents8. Nomenclature and terminology
Open this folder and view contents9. Legal aspects of pharmaceuticals
Open this folder and view contents10. Regulatory issues
Open this folder and view contents11. Training activities
View the document12. Pharmaceuticals contaminated with diethylene glycol
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1. List of available International Chemical Reference Substances1
View the documentAnnex 2. List of available International Infrared Reference Spectra1
Open this folder and view contentsAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
Open this folder and view contentsAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Open this folder and view contentsAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
Open this folder and view contentsAnnex 6. Guidelines for inspection of drug distribution channels
View the documentAnnex 7. Good pharmacy practice in community and hospital pharmacy settings
Close this folderAnnex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
View the documentIntroduction
View the documentDrafting national legislation: points for consideration
View the documentDefining the scope of the marketing authorization procedure for medicinal products
Close this folderExample of a legislative scheme for regulating medicinal products
View the documentGeneral considerations
View the documentPotential value of the scheme
Close this folderModel legislative text and commentary
View the documentPart A. Administration
View the documentPart B. Provisional registration/marketing authorization and inventory of medicinal products
View the documentPart C. Screening of products and issuance of product licences/authorizations
View the documentPart D. Other activities requiring authorization/licensing
View the documentPart E. General provisions
View the documentPart F. Interpretation
View the documentReferences
View the documentSelected bibliography
View the documentAppendix 1. Provisional legislative scheme for registration of pharmacy personnel
View the documentAppendix 2. Guidelines, documents and other regulatory instruments established by WHO to support drug regulatory authorities
Open this folder and view contentsAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover
 
Part F. Interpretation

22. The legislation should include an interpretation of terms which may be used in a special context. In the model text given here, terms which might need interpretation include:

"Appointed date" means the date specified under section 5.1 of the Law.

"Inventory" refers to the listing of provisionally registered/authorized medicinal products under section 5.2 of the Law.

"Medicinal product" means any medicine intended for human or veterinary use, presented in its finished dosage form or as a starting material for use in such dosage form, as defined in paragraph 5, p. 106 (see also p. 111).

"Minister" means the minister responsible for matters relating to medicinal products.

"Person" includes an individual as well as a body corporate, partnership or association of persons, and establishments such as hospital pharmacies, clinics, and health centres storing or distributing medicinal products.

"Provisionally authorized/registered" is used in relation to a medicinal product which has been listed in the inventory under section 5 of the Law and which has not been screened for purposes of a product licence/marketing authorization under sections 6 and 9 of the Law.

"Register" means the register of medicinal products for which a product licence/marketing authorization has been issued in terms of sections 6 and 9 of the Law or the register of persons, i.e. the pharmacist and pharmacy assistant.

"Sell" means to sell for cash or on credit or by way of exchange, whether by wholesale or retail; "sale" shall have a corresponding meaning.

The above are some of the more important terms used in the legislative scheme which need to be defined, but other terms may also require definition. The WHO text on Good manufacturing practices for pharmaceutical products (see Appendix 2) contains a number of definitions of terms such as "manufacture" which can be included, after adaptation if necessary, in the definition section.

 

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