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 C. Screening of products and issuance of product licences/authorizations

6.1 In accordance with the national drug policy and the country's health-care needs, and in relation to considerations of product quality, safety and efficacy, the drug regulatory authority shall decide whether a provisionally authorized/registered product, or a product which is not listed in the inventory but for which an application for its manufacture, import, export or sale has been filed after the appointed date, should be granted a product licence/marketing authorization.

6.2 The drug regulatory authority may at any time call upon any manufacturer, importer or exporter to furnish such information as is required in order to enable a provisionally authorized/registered product, or a product proposed for manufacture, import or export after the appointed date, to be evaluated and assessed.

6.3 The drug regulatory authority may at any time, after scientific evaluation, determine that an authorized/registered product should not be eligible for a product authorization/licence and that such product should not be manufactured, imported, sold or exported, either with immediate effect or from such date as is specified in an order made by the drug regulatory authority.

6.4 Upon an order made under subsection 6.1 or 6.3 taking effect, the inventory shall be accordingly revised with respect to the entry for the relevant product.

This section deals with the factors to be taken into account in screening medicinal products (either those which are provisionally authorized/registered or for which a new application has been made for manufacture, import, export or sale) and the procedures to be followed in granting a product licence/marketing authorization.


7. Any manufacturer, importer or exporter who fails, without valid reason, to furnish such particulars within the stipulated time-limit, or within an extended time-limit as may have been granted by the drug regulatory authority, shall not be entitled to manufacture, import, sell or export the medicinal product from such date as is specified by the drug regulatory authority in a communication addressed to the manufacturer, importer or exporter.

This section addresses the situation where a manufacturer, importer or exporter has not submitted the particulars and data necessary for the product to be screened.


8. In determining whether a product licence/marketing authorization should be granted or not, the drug regulatory authority shall consult the medicinal products advisory committee, relevant authorities and health professionals, and may take into account regulatory information from other countries and relevant international organizations.

This section addresses the consultative process that must take place when products are being screened.


The drug regulatory authority may wish to consider how a particular medicinal product has been regulated in other countries. Product licences/marketing authorizations may be subject to various terms and conditions relating to:


- manufacture
- import
- export
- marketing
- distribution
- prescription
- use
- labelling
- packaging
- pricing
- advertising/promotion or
- conditions of sale.


The legislative scheme assumes that drug regulatory authorities in small countries should make the maximum use of regulatory information available in the public domain. Such information is available through a number of sources such as the WHO Certification Scheme on the Quality of Pharmaceuticals Moving in International Commerce (the WHO Certification Scheme); the authorities of countries with advanced drug regulatory systems; the World Health Organization; and drug-related commercial as well as non-commercial publications (e.g. national formularies; drug compendia; medical journals).


Appendix 2 describes the various publications and services that have been developed specifically to support drug regulatory authorities.


9. The drug regulatory authority shall maintain a register of medicinal products for which marketing authorizations have been issued and shall make the register, or extracts from it, available 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.

This section provides for a register to be maintained of medicinal products for which product licences/marketing authorizations have been granted. This register will eventually replace the inventory as all provisionally authorized/registered products are screened.


10. Regulations made under this Law shall specify the terms, conditions, and validity of product licences/marketing authorizations, the format of the register, and the particulars to be furnished to obtain a product licence/marketing authorization for provisionally approved/authorized products or for products not listed in the inventory, and other requirements, including the payment of fees, for applications for a product licence/marketing authorization.

This section provides for regulations to be made on matters relating to licences/marketing authorizations and the register. The use of modern technology such as computers facilitates the compilation, updating and printing of the inventory and the register. WHO has developed a model package for computer-assisted drug registration which can be adapted to develop such inventories or registers and even to the issuing of licences/marketing authorizations (see Appendix 2).


11.1 The drug regulatory authority may revoke or suspend the marketing authorization for importation, manufacture, sale or exportation of a medicinal product if it appears or there is reason to suspect that the conditions for the licence are no longer being fulfilled.

11.2 The drug regulatory authority may vary the provisions of the marketing authorization provided it is satisfied that such a variation does not adversely affect the safety, quality or efficacy of the medicinal product.

11.3 The order of the drug regulatory authority may specify how the order is to take effect, particularly with regard to recalling the product from the market and the procedures, if any, for notifying health professionals and the public.

11.4 An applicant (licence/marketing authorization holder) shall not deviate from the particulars submitted in the drug registration dossier unless authorized by the drug regulatory authority. A formulation or other error pertaining to a medicine shall be immediately reported to the drug regulatory authority. An adverse drug event reported to a licence/marketing authorization holder shall be conveyed to the drug regulatory authority by the licence holder within three days of the initial report.

This section empowers the regulatory authority to take prompt action to withdraw a product from the market when such a course of action is warranted by public health considerations.


12.1 Any manufacturer, importer or exporter who is aggrieved by an order made by the drug regulatory authority (see sections 11.1-11.4) may appeal to the minister/authority, in writing, within two weeks from the date of the order.

12.2 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 against which the appeal has been lodged.

This section provides for administrative relief, prior to institution of action in a court of law in accordance with the country's legal and judicial system. Provision for administrative relief in the first instance is important, as litigation is generally protracted, costly and inconvenient to all parties concerned.


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