WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
(1999; 168 pages) [Spanish] Ver el documento en el formato PDF
Índice de contenido
Ver el documentoWHO Expert Committee on Specifications for Pharmaceutical Preparations
Ver el documento1. Introduction
Abrir esta carpeta y ver su contenido2. The international pharmacopoeia and related issues
Abrir esta carpeta y ver su contenido3. International Chemical Reference Substances and Infrared Reference Spectra
Abrir esta carpeta y ver su contenido4. Quality control - national laboratories
Abrir esta carpeta y ver su contenido5. Good manufacturing practices
Abrir esta carpeta y ver su contenido6. Quality systems and inspection
Abrir esta carpeta y ver su contenido7. Other quality assurance topics
Abrir esta carpeta y ver su contenido8. Nomenclature and terminology
Abrir esta carpeta y ver su contenido9. Legal aspects of pharmaceuticals
Abrir esta carpeta y ver su contenido10. Regulatory issues
Abrir esta carpeta y ver su contenido11. Training activities
Ver el documento12. Pharmaceuticals contaminated with diethylene glycol
Ver el documentoAcknowledgements
Ver el documentoReferences
Ver el documentoAnnex 1. List of available International Chemical Reference Substances1
Ver el documentoAnnex 2. List of available International Infrared Reference Spectra1
Abrir esta carpeta y ver su contenidoAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
Abrir esta carpeta y ver su contenidoAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Abrir esta carpeta y ver su contenidoAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
Abrir esta carpeta y ver su contenidoAnnex 6. Guidelines for inspection of drug distribution channels
Ver el documentoAnnex 7. Good pharmacy practice in community and hospital pharmacy settings
Cerrar esta carpetaAnnex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
Ver el documentoIntroduction
Ver el documentoDrafting national legislation: points for consideration
Ver el documentoDefining the scope of the marketing authorization procedure for medicinal products
Cerrar esta carpetaExample of a legislative scheme for regulating medicinal products
Ver el documentoGeneral considerations
Ver el documentoPotential value of the scheme
Cerrar esta carpetaModel legislative text and commentary
Ver el documentoPart A. Administration
Ver el documentoPart B. Provisional registration/marketing authorization and inventory of medicinal products
Ver el documentoPart C. Screening of products and issuance of product licences/authorizations
Ver el documentoPart D. Other activities requiring authorization/licensing
Ver el documentoPart E. General provisions
Ver el documentoPart F. Interpretation
Ver el documentoReferences
Ver el documentoSelected bibliography
Ver el documentoAppendix 1. Provisional legislative scheme for registration of pharmacy personnel
Ver el documentoAppendix 2. Guidelines, documents and other regulatory instruments established by WHO to support drug regulatory authorities
Abrir esta carpeta y ver su contenidoAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
Ver el documentoWorld Health Organization Technical Report Series
Ver el documentoSelected WHO Publications of Related Interest
Ver el documentoBack 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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Última actualización: le 3 mayo 2013