- Tous > Medicine Access and Rational Use > Controlled Medicines
- Tous > Quality and Safety: Medicines > Quality Assurance
- Tous > Quality and Safety: Medicines > Regulatory Support
- Mots-clés > controlled substances
- Mots-clés > customs
- Mots-clés > drug and narcotics control
- Mots-clés > import/export authorization
- Mots-clés > importation - regulation
- Mots-clés > importation and port-clearing process
- Mots-clés > international commerce
- Mots-clés > National Medicines Regulatory Authority (NMRA)
- Mots-clés > psychotropic substance
- Mots-clés > WHO certification scheme
(2019; 13 pages)
This document is a revision of the 1996 publication: Guidelines on import procedures for pharmaceutical products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations, thirty-fourth report. Geneva: World Health Organization; 1996: Annex 12 (WHO Technical Report Series, No. 863; http://apps.who.int/medicinedocs/ documents/s21962en/s21962en.pdf).
These guidelines, which stem from the above considerations, were first developed in 1996 in consultation with NRAs, the pharmaceutical industry, the World Customs Organization and the United Nations International Drug Control Programme. Following the recommendation of the 52nd Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP), these guidelines were reviewed, adding critical and contemporary topics, such as: the e-commerce/internet-mediated distribution and the alert systems mechanism that should be in place between entry ports/ NRAs/WHO, in case of unregistered, unlicensed, substandard and falsified medical products. Lastly, the glossary was revised and cross-references were added to other established WHO guidance documents.
These guidelines are directed to all parties involved in the importation of medical products, including NRAs, competent trade ministries, customs authorities, port authorities and importing agents.
They are intended to promote efficiency in applying relevant regulations, to simplify the checking and handling of medical products for import and, inter alia, to provide a basis for collaboration between the various interested parties.
They are applicable to medical products destined for use within the country of import and are intended to be adopted into prevailing national procedures and legal requirements.