Article 57 of the Council Regulation 726/2004 gives to the European Medicines Agency 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 European Medicines Agency implements every year a sampling and testing programme, aimed at supervising the quality of the Centrally Authorised Products (CAPs) available on the European market. The objectives and description of the programme have been recently revised.
In carrying out the above duty, the European Medicines Agency is supported by other institutional partners (EDQM, OMCL network, national authorities and inspection services and rapporteurs), and by the marketing authorisation holders; each of these plays an important role in the success of the programmes.
Testing of CAPs can also be carried out by national authorities as part of the national supervision of the product concerned.
A trial programme, involving a small number of products was carried out in 1998. Regular annual programmes have been implemented since. Information on the numbers of the products tested each year is available.
Annual reports on the outcome of the sampling and testing programme have been published starting with products submitted for testing in 2003. It is not foreseen to publish a report on the results prior to 2003, however the list of all centrally authorised products tested between 1998 and 2002 is available.
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Documents of interest
|Document(s)||Language||Status||First published||Last updated||Effective Date|
|Results of the sampling and testing programme for the year 2012||(English only)||18/12/2013|
|Results of the sampling and testing programme for the year 2011||(English only)||17/10/2012|
|Results of the sampling and testing programme for the year 2010||(English only)||27/10/2011|
|Results of the sampling and testing programme for the year 2009||(English only)||10/08/2010||14/12/2010|
|Ten years of sampling and testing of centrally authorised products: 1998-2007||(English only)||21/07/2008|
|Sampling and testing of centrally authorised products: Objectives and description of the programme||(English only)||06/01/2005|
|Sampling and testing of centrally authorised products: Development of risk based approach for the selection of products||(English only)||10/01/2008|
|Results of the sampling and testing programme for the year 2008||(English only)||01/03/2010|