(1999; 168 pages) [Spanish]
The primary prerequisite for any programme combating pharmaceutical counterfeiting is the existence of an established drug regulatory authority in the country, which complies with the "Guiding principles for small national drug regulatory authorities" (1). That implies the availability of at least the following:
• A legal framework. The legislation is also expected to cover criminal activity in relation to the manufacture, import, distribution, sale and dispensing of counterfeit pharmaceuticals. The act of counterfeiting should be an offence such that the inspector of drugs, the police and other investigating agencies are all able to take action. The law should also provide for deterrent punishments.
• A system requiring:
(a) licensing/authorization of manufacturers, importers, distributors, retailers, pharmacies;
(b) registration/marketing authorization of drugs;
(c) proper labelling.
• Adequate professional staff and resources within the drug regulatory authority.