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 B. Provisional registration/marketing authorization and inventory of medicinal products

5.1 The drug regulatory authority shall, by order published in the gazette [variant: or through other means of notification], require manufacturers, importers and exporters of medicinal products to notify the drug regulatory authority of such particulars as are specified in the order concerning the medicinal products which such manufacturers, importers, or exporters wish to continue to manufacture, import, export or sell after such date (hereafter referred to as the appointed date) as is specified in the order.

5.2 Medicinal products for which a notification has been received by the drug regulatory authority on or before the appointed date shall be listed in the provisionally authorized/registered medicinal products inventory (hereafter referred to as the inventory), and until granted a product licence/marketing authorization or ordered by the drug regulatory authority (or board) not to be manufactured, imported, exported or sold, such products shall have the status of provisionally authorized/registered medicinal products.

5.3 After the appointed date no person shall import, manufacture, export or sell a medicinal product not listed in the inventory without the prior written permission of the drug regulatory authority unless a product authorization/licence has been granted in respect of such product under section 6 of this Law.

5.4 The inventory, the format of which may be laid down in regulations, shall be made available for inspection at such place and at such times as specified by the drug regulatory authority in an order published in the gazette or one or more newspapers as may be specified in the regulations.

5.5 The inventory shall be revised accordingly as and when provisionally authorized/registered products listed therein have been granted a product authorization/licence under section 6.1, or the drug regulatory authority has ordered under section 6.3 that any such provisionally authorized/registered medicinal product should not be manufactured, imported, exported or sold from such date as is specified in the order.

This section provides for a system of provisional authorization/registration for medicinal products which are being manufactured, imported, exported or sold from a specific date, and which will be continued to be manufactured, imported, exported or sold even after that date (appointed date).

 

Medicinal products which are notified on or before the appointed date will be listed in a provisionally authorized/registered medicinal products inventory. The scheme envisages this inventory as well as a register. The latter is for medicinal products which have been granted a product licence/marketing authorization. The procedure for screening provisionally authorized/registered products, as well as new applications for other medicinal products, is contained in section 6.

For a provisionally authorized/registered medicinal product, the drug regulatory authority may decide one of two things: either to grant a product licence/marketing authorization, or to phase out or ban its manufacture, import, sale or export. In either event, the product will be deleted from the inventory. If a product licence/marketing authorization is granted, it will be entered in the register of medicinal products for which a product licence/marketing authorization has been granted (see section 9).

At some point - depending on the pace at which the screening process can proceed - the inventory will cease to exist, as all products which had the provisionally authorized/registered status would have been screened and either granted a product licence/marketing authorization or eliminated from the market.

Section 14 makes it an offence to manufacture, import, sell or export a product unless it has a marketing authorization or is deemed to be provisionally authorized/registered.

A renewal process will be established at regular intervals for those products which show satisfactory performance in the market and comply with regulations.

 

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