WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 863 - Thirty-fourth Report
(1996; 200 pages) View the PDF document
Table of Contents
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related activities
View the document3. Simple test methodology
Open this folder and view contents4. Stability of dosage forms
Open this folder and view contents5. Good manufacturing practices for pharmaceutical products
Open this folder and view contents6. Legal and administrative aspects of the functioning of national drug regulatory authorities
Open this folder and view contents7. Quality assurance in the supply system
View the document8. Terminology
View the documentAcknowledgements
View the documentReferences
Open this folder and view contentsAnnex 1 - Guidelines for the graphic representation of chemical formulae
View the documentAnnex 2 - List of available International Chemical Reference Substances1
View the documentAnnex 3 - List of available International Infrared Reference Spectra
Open this folder and view contentsAnnex 4 - General recommendations for the preparation and use of infrared spectra in pharmaceutical analysis
Open this folder and view contentsAnnex 5 - Guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms
Open this folder and view contentsAnnex 6 - Good manufacturing practices: guidelines on the validation of manufacturing processes
Open this folder and view contentsAnnex 7 - Good manufacturing practices: supplementary guidelines for the manufacture of investigational pharmaceutical products for clinical trials in humans
Open this folder and view contentsAnnex 8 - Good manufacturing practices: supplementary guidelines for the manufacture of herbal medicinal products1
Open this folder and view contentsAnnex 9 - Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability
Open this folder and view contentsAnnex 10 - Guidelines for implementation of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Open this folder and view contentsAnnex 11 - Guidelines for the assessment of herbal medicines1,2
Close this folderAnnex 12 - Guidelines on import procedures for pharmaceutical products
View the document1. Introductory notes
View the document2. Objectives and scope
View the document3. Legal responsibilities
View the document4. Legal basis of control
View the document5. Required documentation
View the document6. Implementation of controls
View the document7. Procedures applicable to pharmaceutical starting materials
View the document8. Storage facilities
View the document9. Training requirements
View the documentReferences
View the documentGlossary
View the documentAppendix - Special import controls for narcotic drugs and psychotropic substances1
View the documentBack Cover
 

Appendix - Special import controls for narcotic drugs and psychotropic substances1

1 "Narcotic drug" means any of the substances listed in Schedules I and II of the Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol, whether natural or synthetic; "psychotropic substance" means any substance, natural or synthetic, listed in Schedule I, II, III or IV of the Convention on Psychotropic Substances, 1971.


In accordance with the requirements of the international drug control treaties (i.e. the Single Convention on Narcotic Drugs, 1961, and that Convention as amended by the 1972 Protocol, and the Convention on Psychotropic Substances, 1971, referred to subsequently as the 1961 Convention and the 1971 Convention), each state must adopt national legislation and administrative regulations, and establish administrative structures to ensure the full implementation of the provisions of these treaties on its territory and cooperation with other states.

Most of the requirements specified in these guidelines on import procedures for pharmaceutical products also apply to the border control of narcotic drugs and psychotropic substances. In addition, detailed information on the control of international trade in narcotic drugs and psychotropic substances can be found in Article 31 of the 1961 Convention and Article 12 of the 1971 Convention respectively. The guidelines provided in this Appendix are intended to facilitate the operation of control at entry points, and can be expanded by taking into account the legislation and administrative regulations in force in each country.

The customs authorities and, if applicable, any other law enforcement authorities assigned to border control should cooperate closely with the competent authorities for the control of narcotic drugs and psychotropic substances designated by the government (subsequently referred to as the competent authorities). It should be noted that, while the competent authorities in some countries are different from the national drug regulatory authority, in others they may be one and the same.

The customs authorities, or any other competent law enforcement authorities, should be well trained and equipped (e.g. with drug identification kits) so that they can distinguish consignments of narcotic drugs and psychotropic substances from other pharmaceutical products. They should be provided with lists of narcotic drugs and psychotropic substances under international control, e.g. the "Yellow List" and "Green List" published by the International Narcotics Control Board, which include, inter alia, trade names of pharmaceutical products containing narcotic drugs and psychotropic substances. They may also make use of the Multilingual dictionary of narcotic drugs and psychotropic substances under international control (ST/NAR/1/REV.1) published by the United Nations (sales number E/F/S.93.XI.2). Furthermore, they should be provided with lists of narcotic drugs and psychotropic substances whose importation into the country has been prohibited.

Checks conducted during the border control of narcotic drugs and of psychotropic substances listed in Schedules I and II of the 1971 Convention should ensure that each consignment has been duly authorized by the competent authorities of the importing country. The competent authorities express their consent to each import by issuing an import certificate (for narcotic drugs) or an import authorization (for psychotropic substances). When presented with the original of this document, the competent authorities of the exporting country may issue an export authorization permitting the consignment containing narcotic drugs or psychotropic substances to leave the exporting country. In free ports and zones governments should exercise the same supervision and control as in other parts of their territory, provided, however, that they may apply more drastic measures if appropriate.

The competent authorities of the importing country may wish to inform the customs, or any other competent law enforcement authorities, of authorized imports of narcotic drugs and psychotropic substances before the entry of the consignment into the country.

In addition to the other documents referred to in section 5 of the guidelines, the customs authorities should require the importer or importer's agent to provide them with a copy of the respective import authorization (certificate) issued by the competent authorities of the importing country. This document should be compared with the export authorization issued by the competent authorities of the exporting country, a copy of which must accompany each consignment. The authenticity of these documents must be carefully checked. In case of doubt, the competent authorities should be consulted immediately.

Import and export authorizations (certificates) should contain the following information:

- the name of the narcotic drug or psychotropic substance (if available, the International Nonproprietary Name);

- the quantity to be imported/exported, expressed in terms of anhydrous base content;

- the pharmaceutical form and, if in the form of a preparation, the name of the preparation;

- the name and address of the importer and exporter;

- the period of validity of the authorization.


In addition, the export authorization should contain the number and date of the corresponding import authorization/certificate and the name of the competent authority of the importing country by whom it was issued.

The competent authorities of the importing country may wish to specify in the import authorization/certificate the entry point through which the importation must be effected.

During the visual and physical examination of the imported consignment, the quantity of narcotic drugs or psychotropic substances contained in it should be carefully checked. If the quantity exceeds the amount authorized, the consignment should be stopped by the customs and the matter brought to the attention of the competent authorities for the control of narcotic drugs and psychotropic substances in the importing country. If the quantity imported is the same as, or less than, the amount authorized, the quantity should be recorded on the copy of the export authorization accompanying the consignment and communicated to the competent authorities of the importing country.

All consignments containing psychotropic substances included in Schedule III of the 1971 Convention must be accompanied by a separate export declaration. This document should indicate the name and address of the exporter and importer, the name of the substance, the quantity and the pharmaceutical form in which the substance is exported, including, if applicable, the name of the preparation and the date of dispatch.

Pursuant to the recommendations contained in resolutions of the Economic and Social Council of the United Nations, many governments now require import authorizations not only for psychotropic substances in Schedules I and II but also for those in Schedules III and IV of the 1971 Convention. This strengthening of the control requirements has proved to be very useful in preventing attempts to divert psychotropic substances, such as stimulants, sedative-hypnotics and tranquillizers, into illicit traffic.

SELECTED WHO PUBLICATIONS OF RELATED INTEREST

The international pharmacopoeia, third edition.

Price (Sw.fr.)*

Volume 1: general methods of analysis. 1979 (223 pages)

24.-

Volume 2: quality specifications. 1981 (342 pages)

36.-

Volume 3: quality specifications. 1988 (407 pages)

64.-

Volume 4: tests, methods, and general requirements; quality specifications for pharmaceutical substances, excipients, and dosage forms. 1994 (358 pages)

85.-

   

Basic tests for pharmaceutical dosage forms.
1991 (v+129 pages)

24.-

   

Basic tests for pharmaceutical substances.
1986 (205 pages)

34.-

   

WHO Expert Committee on Specifications for Pharmaceutical Preparations.
Thirty-third report.
WHO Technical Report Series, No. 834, 1993 (v + 30 pages)

7.-

   

WHO Expert Committee on Specifications for Pharmaceutical Preparations.
Thirty-second report. WHO Technical Report Series, No. 823, 1992 (vi + 134 pages)

17.-

   

international nonproprietary names for pharmaceutical substances. Cumulative list No. 9.
1996 (xliii + 885 pages)

250.-

   

The use of essential drugs.
Sixth report of the WHO Expert Committee.
WHO Technical Report Series, No. 850, 1995 (iv+ 138 pages)

21.-

   

WHO Expert Committee on Biological Standardization.
Forty-fifth report.
WHO Technical Report Series, No. 858, 1995 (vi + 102 pages)

17.-

Further information on these and other WHO publications can be obtained from Distribution and Sales, World Health Organization, 1211 Geneva 27, Switzerland

*Prices in developing countries are 70% of those listed here.

 

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Last updated: May 3, 2013