- Todos > Medicine Access and Rational Use > Controlled Medicines
- Todos > Quality and Safety: Medicines > Quality Assurance
- Todos > Quality and Safety: Medicines > Regulatory Support
- Palabras clave > controlled substances
- Palabras clave > customs
- Palabras clave > drug and narcotics control
- Palabras clave > import/export authorization
- Palabras clave > importation - regulation
- Palabras clave > importation and port-clearing process
- Palabras clave > international commerce
- Palabras clave > National Medicines Regulatory Authority (NMRA)
- Palabras clave > psychotropic substance
- Palabras clave > WHO certification scheme
(2014; 10 pages)
Public health considerations demand that pharmaceutical products should not be treated in the same way as ordinary commodities. Their manufacture and subsequent handling within the distribution chain, both nationally and internationally, must conform to prescribed standards and be rigorously controlled. These precautions serve to assure the quality of authentic products, and to prevent the infiltration of illicit products into the supply system.
Within the context of its revised drug strategy, adopted in 1986 by the Thirty-ninth World Health Assembly in resolution WHA39.27, WHO developed "Guiding principles for small national drug regulatory authorities" which established a regulatory approach in line with the resources available within a small national regulatory authority, and were intended to assure not only the quality, but also the safety and efficacy, of pharmaceutical products distributed under its aegis.
The principles emphasize the need for the effective use of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce. This constitutes a formal agreement between participating Member States to provide information on any product under consideration for export, notably on its registration status in the country of origin and whether or not the manufacturer complies with WHO's guidelines on good manufacturing practices (GMP) for pharmaceutical products.
Pharmaceutical products containing substances controlled under the international conventions have long been subjected to rigorous border controls. Some of these controls, and particularly those designed to prevent the diversion and illicit interchange of products during transit, are relevant to all pharmaceutical products, and are therefore included in these guidelines.