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 E. General provisions

14. It shall be an offence under this Law for any person to manufacture, import, sell or export a product after the appointed date unless such product at the time of manufacture, import, distribution or export has the status of a provisionally authorized/registered medicinal product under section 5.2 or has received a product licence/marketing authorization under section 6.

This section deals with the situation in which a product which is neither provisionally authorized/registered nor covered by a product licence/marketing authorization is manufactured, imported, distributed, sold or exported after the appointed date.


15. After such date as is specified under section 13.1 of the Law, it shall be an offence for any person to engage in any of the activities mentioned in that section, unless this person holds a valid authorization/licence granted by the drug regulatory authority or is otherwise legally entitled to engage in any such activity.

This section deals with the situation in which a person engages in an activity mentioned in section 13 without a licence or legal right (under another law).


16.1 No person shall manufacture, import, export, compound, store, sell, promote or distribute a medicinal product:

(a) that is unfit for use in humans or in animals;


(b) that is adulterated;

(c) that contains any natural or added deleterious substance which renders it injurious to health;

(d) that has been manufactured, prepared, preserved, packaged or stored for sale under insanitary and/or unfavourable conditions; or

(e) that has been labelled, packaged or promoted in a manner that is false, misleading, deceptive or likely to create an erroneous impression regarding its source, character, value, quality, composition, potency, merit or safety.


16.2 No person shall manufacture, import, export, distribute, sell, supply or use any counterfeit starting materials.

16.3 No person shall manufacture a medicinal product using any counterfeit starting materials or without taking reasonable measures to ensure that the starting materials used in the manufacture of such medicinal products are not counterfeit or of suspect quality.

16.4 No manufacturer, importer, exporter, distributor, pharmacist, health practitioner, health worker or other person shall manufacture, import, export, compound, prepare, promote, sell, supply, obtain, display, dispense or otherwise distribute, for a fee or by way of sample or gift, any medicinal product which is a counterfeit or known or suspected to be a counterfeit.

This section is of a general nature aimed at ensuring that only medicinal products which meet acceptable standards are marketed.


One potential problem area in implementing this provision is the lack of quality control facilities where products could be tested and verified in small developing countries. Through cooperative arrangements with neighbouring countries with good quality control facilities, however, it should be possible to have products tested there. Participation in the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce also provides an opportunity for quality defects to be investigated.


17. Where any standard is prescribed for any medicinal product, no person shall label, package, sell, offer for sale, distribute or promote any such medicinal product which does not conform to such standard in such a manner that makes it likely to be mistaken for the medicinal product for which the standard has been prescribed.

The applicable standards will have to be specified in the regulations.


18.1 The drug regulatory authority or any authorized officer shall have the power to visit and inspect any manufacturing plant, processing unit, business establishment, warehouse, office, or any premises used for or in connection with the manufacture, import, export, distribution, storage, sale, supply, dispensing or use of any medicinal product, to take samples of any medicinal product or of any substance, and to examine records or other documents relating to any medicinal product.

18.2 No person shall refuse to permit the drug regulatory authority or any authorized officer to enter and inspect or take samples or documents.

18.3 An inspector may at any reasonable time and on production of his or her certificate of authority enter any premises:

(a) for the purpose of ascertaining whether there is or has been any contravention of the legislation;


(b) generally, for the purpose of discharging his or her functions under the legislation.


18.4 An inspector may:

(a) inspect the premises, any article and any document for the purposes of the legislation;


(b) seize any substance, article or document which he or she has reasonable cause to believe to be a substance, article or document in which or by means of which an offence under the legislation is being or has been committed.


"Premises" for the purposes of this section includes any premises, ship, aircraft or vehicle. "Premises" does not include a private residence.


It will be useful to develop a plan of action, with appropriate checklists and guide, to enable authorized officers to conduct inspections.


19. Any person who contravenes or fails to comply with any provision of this Law or any regulation or any order made under this Law shall be guilty of an offence, and on conviction shall be liable to a fine between .......... and .............. or imprisonment for a term not exceeding ............. months/years, or both; in the case of a continuing offence, to a fine not exceeding ................... for every day or part of a day during which the offence has continued.

The minimum and maximum penalties (imprisonment and/or fine) must be determined in line with the penalties generally prescribed by other laws currently in force in the country.


The need for "deterrent penalties" must be carefully balanced against the risk of "overkill". Too high a penalty, particularly one entailing mandatory jail sentences, for instance, can lead to lax enforcement and will be counterproductive in the long run. On the other hand, products like medicinal products need to be manufactured and handled with great care; any deliberate or negligent departure from established standards and norms can result in otherwise avoidable mortality and morbidity. The ubiquitous problem of counterfeit drugs has reinforced the need for severe penalties for certain types of violations involving deliberate or fraudulent behaviour.


20. The provisions of this Law shall extend to all persons, in both the public and private sectors, engaged in manufacturing, importing, exporting, compounding, storing, distributing, promoting, selling or in any other way dealing with medicinal products.

In some countries express statutory provision is required in order for a law to apply to the state or to the public (government) sector. It is important that regulatory controls apply to all medicinal products, irrespective of who is responsible for their manufacture, import or export, distribution or sale.


21. Regulations shall be made for all or any of the matters for which the Law provides for regulations to be made and, in particular, for the following purposes:

(a) Prohibiting, limiting, restricting, or imposing conditions on, either generally or in relation to: (i) a particular medicinal product; (ii) the manufacture, import, export, compounding, dispensing, administration, sale or supply of medicinal products; (iii) printed packaging material, package leaflets and data sheets/product information, promotion to health professionals, advertising to the general public and conduct of marketing practices.


(b) Withdrawing medicinal products from sale or distribution.

(c) Prescribing the standards to be followed in the manufacture, storage, sale, supply, dispensing and distribution of medicinal products.

(d) Classifying medicinal products for purposes of regulating importation, manufacture, compounding, prescribing, dispensing, selling, storage and distribution.

(e) Regulating persons entitled to import, manufacture, compound, export, store, prescribe, dispense or sell medicinal products.

(f) Prescribing the terms, conditions, procedures and time-limit for the issuance of licences/authorizations under Parts C and D of the Law and the forms, fees, particulars and records necessary for applications for licensing and grounds for suspension, cancellation or withdrawal of licences/product authorizations.

(g) Regulating the composition and terms of reference of the medicinal products advisory committee and/or board of medicinal products,

(h) Granting exemptions from the requirement of a product licence/marketing authorization for imports of medicinal products required for a named patient or to meet a public health emergency.

(i) Designating laboratories and analysts for the purposes of conducting analyses and submitting reports.

(j) Regulating the licensing/authorizing and licensing/authorization renewal fees in order to support the drug regulatory functions.

(k) Prescribing any regulation in matters pertaining to this Law.

(l) Regulating clinical trials on medicinal products.

(m) Regulating drug donations.

(n) Regulating the obligation to report on drug adverse reactions.

(o) Regulating the obligation to report on product variations such as quality or manufacturing change.

There are a number of sections which provide for regulations to be made. This catalogue is in addition to the matters referred to in those sections.


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