Registration is the precondition for placing a product on the market. The registration process for human and veterinary medicinal products dates back to the 1965 European Community Medicines Directive, which laid down three basic criteria on which decisions regarding marketing authorisation are based. They are:

• safety
• quality
• efficacy

Over the past 40 years, requirements in terms of these three criteria have been updated continually in line with advances in scientific knowledge.

The process requires applicants to submit data supporting the safety, quality and efficacy of a product in a detailed Dossier, which is reviewed by an independent scientific committee working on behalf of the governmental agency. The scientific review examines all aspects of the product, and includes a detailed risk-benefit analysis. Only after passing this review and being declared safe, of high quality and efficacious, may a product be offered for sale.

The safety and efficacy of the product are monitored closely following its entry into the marketplace, under statutory post-marketing surveillance or Pharmacovigilance programmes. The quality is monitored via Good Manufacturing Practice inspections and sampling and testing programmes. The authorities have the right to restrict conditions of use or even withdraw a product from the market if they believe it poses any risk to consumers, users, animals or the environment.