Sampling and testing programmes

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Every year the European Medicines Agency identifies a group of Centrally Authorised Products (CAPs) that will be submitted to the sampling and testing exercise.

The main objectives of the sampling and testing are:

  • to supervise the quality of medicinal products placed on the market
  • to check compliance of the medicinal product placed on the market with its authorised specifications;

In a wider sense this may include:

  • to monitor the quality of the finished products in all parts of the distribution chain throughout the authorised shelf-life
  • to ensure that the control methods are satisfactory
  • to investigate suspected quality defects of CAPs - when requested
  • to assist in testing of counterfeits of CAPs - when requested.

Previously products were selected for testing usually three years after the product had been granted a marketing authorisation. This approach has gradually been replaced by a risk-based approach. Typically 40-45 products are tested per year. The list of products is submitted for adoption to the the CHMP (Committee for Medicinal Products for Human Use) and CVMP (Committee for Medicinal Products for Veterinary Use).

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.

Send all queries regarding this content to: samptest@ema.europa.eu.

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