Sampling and testing of centrally authorised products. Annual report 2003

Article 57 of the Council Regulation 726/2004 gives to the European Medicines Agency (EMEA) the responsibility to co-ordinate 'the supervision, under practical conditions of use, of medicinal products which have been authorised within the Community'. As part of this responsibility, the EMEA implements, every year, a post-authorisation sampling and testing programme, aimed at monitoring the quality of the Centrally Authorised Products (CAPs) available on the European market. The first annual report to be published on the outcome of the sampling and testing programme is for products submitted for testing in 2003 and it will be continued in subsequent years.

European Medicines Agency: Inspection: Sampling and testing http://www.emea.europa.eu/Inspections/Samptest.html

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