Compliance

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All organisations involved in the development, marketing, manufacture and distribution of medicines are responsible for ensuring that they comply with all relevant standards set out in European Union (EU) legislation and guidelines on pharmaceuticals. The European Medicines Agency (EMA) is responsible for harmonising these standards at EU level. It also coordinates inspections to verify compliance.

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.

Compliance in the product lifecycle

Research and developmentMarketing authorisation applicationPost-authorisation
Good laboratory practice (GLP) 
Good clinical practice (GCP)
Good manufacturing practice (GMP)
 Pharmacovigilance inspections
 Sampling and testing
  Good distribution practice (GDP)
  Product defects and recalls


Inspections

Authorities in the EU regularly inspect sites of companies within and outside the EU involved in developing, manufacturing and distributing medicines intended for the EU market, to verify their compliance with the relevant standards.

These inspections ensure the reliability and integrity of the data that support the authorisation of medicines and their quality, safety and effectiveness once on the market.

An inspection may either be ‘for cause’, when it is triggered by a finding of possible non-compliance with relevant standards, or ‘routine’, when inspections are carried out as part of surveillance programme.

Inspections are conducted for authorised medicines and medicines that are currently being evaluated for authorisation.

Agency role

EMA coordinates inspections for human and veterinary medicines authorised under the centralised procedure or in the context of a referral, on request from the Agency's Committee for Medicinal Products for Human Use (CHMP) or Committee for Medicinal Products for Veterinary Use (CVMP).

EMA does not conduct inspections itself but requests that the inspection be carried out by national authorities in the EU Member States.

The Agency is the primary contact point for notifying suspected quality defects with any centrally authorised products, and is responsible for coordinating the investigation, evaluation and follow-up of such cases

EMA also operates a sampling and testing programme to verify the quality of centrally authorised medicines placed on the market and to check their compliance with their authorised specifications. 

In addition, EMA plays a key role is in coordinating and harmonising EU-wide activities, including:

  • developing and harmonising standards at EU level;
  • developing EU guidelines on inspections and related procedures;
  • preparing guidance through inspectors working groups;
  • coordinating advice on the interpretation of regulatory requirements.

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