This content applies to human and veterinary medicines.
Any manufacturer of medicines intended for the EU market must comply with EU good manufacturing practice (GMP) no matter where in the world they are located.
GMP requires that medicines:
EMA, the European Commission and the Heads of Medicines Agencies (HMA) have phased out the extraordinary regulatory flexibilities for medicines that applied during the COVID-19 pandemic. These flexibilities helped address regulatory and supply challenges arising from the pandemic.
This follows the end of the COVID-19 public health emergency, in line with the World Health Organisation's (WHO) declaration from May 2023.
The GMP / GDP Inspectors Working Group extended the validity of GMP certificates as a temporary regulatory flexibility in 2021. The working group prolonged this extension until the end of 2024. From 2025, this extension no longer applies.
When making this decision, the working group took into account that national competent authorities (NCAs) had resumed regular on-site inspections. It also considered that NCAs are using other methods to gather compliance information, such as distant assessments and inspections that international partners carry out. These methods enabled decisions on certificate validity. They also helped reduce inspection backlogs, which are expected to be resolved in 2025.
NCAs will decide on a case-by-case basis whether any additional extension to a GMP certificate is needed.
Any questions about GMP certificates and their validity should be addressed to the competent authority that issued the certificate.
For more information, see:
The Agency has a coordinating role for GMP inspections of manufacturing sites for medicines whose marketing authorisation in the EU is submitted through the centralised procedure or as part of a referral procedure.
The Agency also plays a key role in coordinating and harmonising GMP activities at an EU level. It is involved in:
Marketing authorisation holders and applicants need to use EMA's IRIS system to communicate with EMA on GMP inspections requested by the Agency’s scientific committees.
Using IRIS for GMP inspections improves efficiency by harmonising and automating processes and re-using master data held by EMA. It also simplifies retrieving and reporting data.
More information on the use of EMA's IRIS system:
These legal instruments lay down the principles and guidelines of GMP in the EU:
The EU GMP guidelines provide interpretation of these principles and guidelines, supplemented by a series of annexes that modify or augment the detailed guidelines for certain types of product, or provide more specific guidance on a particular topic.
The GMP / Good Distribution Practice (GDP) Inspectors Working Group provides additional interpretation of the EU GMP guidelines in the form of questions and answers (Q&As).
Annex 1: Manufacture of Sterile Medicinal Products was revised in August 2022. It comes into operation on 25 August 2023 except for point 8.123 which is postponed until 25 August 2024.
Manufacturers and importers located in the European Economic Area (EEA) must hold an authorisation issued by the national competent authority of the Member State where they carry out these activities.
They must comply with EU GMP to obtain a manufacturing or import authorisation. They can ensure that they meet all their legal obligations by following the EU GMP guidelines.
Importers are responsible to ensure that the third country manufacturer they are importing from comply with GMP.
Marketing authorisation applicants are responsible to ensure that the proposed manufacturing sites included in the marketing authorisation application comply with GMP. For more information, see section 5.2 Inspections of the Pre-authorisation guidance.
Manufacturers of active substances intended for the manufacture of human medicines for the EU market must register with the national competent authority of the Member State where they are located.
Active substance manufacturers must comply with GMP. In addition, the manufacturer of the finished product is obliged to ensure that the active substances they use have been manufactured in compliance with GMP.
Importers of active substances intended for the EU market are also required to register. In addition, each consignment needs to be accompanied by a confirmation by the competent authority of the country where it is produced that it conforms to GMP standards equivalent to those in the EU, unless a waiver applies.
In the EU, national competent authorities are responsible for inspecting manufacturing sites located within their own territories.
Manufacturing sites outside the EU are inspected by the national competent authority of the Member State where the EU importer is located, unless a mutual recognition agreement (MRA) is in place between the EU and the country concerned. If an MRA applies, the authorities mutually rely on each other's inspections.
If products are imported directly into more than one Member State from a manufacturing site outside the EU, there may be more than one national competent authority responsible for inspecting it. EMA facilitates cooperation between the authorities concerned in supervising the site.
EU competent authorities plan routine inspections following a risk-based approach, or if there is suspicion of non-compliance.
EudraGMDP is a publicly accessible EU database which contains manufacturing and import authorisations, registration of active substance manufacturers, GMP certificates and non-compliance statements.
After inspecting a manufacturing site, EU competent authorities issue a GMP certificate or a non-compliance statement, which is entered in the EudraGMDP database.
EMA chairs and provides the secretariat for the GMP/GDP Inspectors Working Group of senior inspectors appointed by all the EEA competent authorities. It meets at EMA four times a year.
The European Commission and observers from EU accession countries, mutual recognition partner authorities, the European Directorate for the Quality of Medicines and HealthCare and the World Health Organization also attend the working group's meetings.
The group provides a forum for harmonisation and discussion of common issues, such as:
EMA maintains a compilation of GMP and good distribution practice (GDP) inspection-related procedures and forms agreed by all Member States. This facilitates cooperation between EU Member States and supports harmonisation and exchange of inspection-related information.
It covers the basis for national procedures that form part of the national inspectorates' quality systems:
For products derived from blood or blood plasma, EMA is responsible for coordinating inspections of the blood establishments in which collection, testing, processing, storage and distribution is carried out under the PMF certification procedure.
For more information on the PMF certification procedure, see Plasma master files.
EMA is responsible for coordinating inspections of vaccine antigen manufacturing sites under the VAMF certification procedure.
For more information on the VAMF certification procedure, see Vaccine antigens.
The EU has signed mutual recognition agreements on GMP inspections with regulatory authorities outside the EU. This allows EU authorities and their counterparts to: