Compliance: marketing authorisation

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Marketing authorisation holders are responsible for ensuring that they and any parties working for them comply with all relevant standards set out in European Union (EU) legislation and guidelines. Compliance with these standards ensures the reliability and integrity of the data that support the authorisation of medicines and their quality, safety and effectiveness once on the market.

The European Medicines Agency (EMA) is responsible for harmonising these standards at EU level. It also coordinates inspections to verify that medicine developers comply with them.  

The Agency's scientific committees may request that samples of medicines are analysed in an official laboratory as part of the approval process.

United Kingdom’s (UK) withdrawal from the EU

EMA has published important information to help users of the centralised procedure prepare for the expected consequences of 'Brexit', including their obligations related to establishment within the European Economic Area (EEA). For more information, see UK’s withdrawal from the EU.

In this section

In other sections

Marketing authorisation holders should also consider the regulatory information in the sections below:


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