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 D. Other activities requiring authorization/licensing

13.1 On or after such date as is specified in a notice published in the gazette or in any official publication as may be specified in the regulation, a person carrying on a business of manufacturing, importing, exporting, compounding, storing, dispensing, selling, supplying or otherwise distributing medicinal products must possess a valid authorization/licence in order to carry out that activity.

13.2 The licensing authority shall maintain a register of pharmacies. An application for registration of pharmacy premises under this section must be made in accordance with regulations issued by the minister.

13.3 The particulars to be furnished by applicants for an authorization/licence, their qualifications and suitability, and the terms, requirements and conditions under which such authorizations/licences may be granted, shall be specified by the drug regulatory authority in regulations made under the Law.

13.4 Any person aggrieved by a decision of the drug regulatory authority may appeal, within two weeks of the notification of the decision of the drug regulatory authority, to the minister/authority.

13.5 On receipt of an appeal the minister/authority may decide whether or not the drug regulatory authority should be directed to rescind, suspend, vary, modify, reconfirm or reconsider the order in respect of which the appeal has been lodged.

Parts B and C were concerned with medicinal products, whereas Part D deals with individuals, companies, firms, hospital clinics or dispensaries, pharmacies, etc., who need a licence/authorization to engage in various activities.

 

There is a right of appeal to the minister/authority against any decision of the drug regulatory authority. Provision for administrative relief in the first instance is important, as litigation generally tends to be protracted, costly and inconvenient for all parties concerned.

 

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