Compliance: post-authorisation

Marketing authorisation holders, manufacturers and distributors are responsible for ensuring that they comply with all relevant standards set out in European Union (EU) legislation and guidelines once the medicine is on the market, including good manufacturing practice (GMP), good distribution practice (GDP) and good pharmacovigilance practices (GVP).

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

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 this section

• Good distribution practice (GDP)
• Quality defects and recalls
• Falsified medicines: reporting obligations

In other sections

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

• Falsified medicines: overview
• Medicine shortages
• Good manufacturing practice (GMP)
• Good pharmacovigilance practices (GVP)
• Sampling and testing
• Parallel distribution
• Pharmacovigilance inspections