This content applies to human and veterinary medicines.

Any manufacturer of medicines intended for the EU market, no matter where in the world it is located, must comply with GMP.

GMP requires that medicines:

  • are of consistent high quality;
  • are appropriate for their intended use;
  • meet the requirements of the marketing authorisation or clinical trial authorisation.

Regulatory expectations and GMP certificates following the-COVID-19 public health emergency

EMA, the European Commission and Heads of Medicines Agencies (HMA) have phased out the extraordinary regulatory flexibilities for medicines put in place during the COVID-19 pandemic to help address regulatory and supply challenges arising from the pandemic.

This follows the end of the COVID-19 public health emergency declared by WHO in May 2023.

On-site GMP and GDP inspections have restarted after being postponed or carried out remotely during the pandemic.

However, a considerable number of postponed inspections still need to be carried out.

The validity of GMP and GDP certificates was extended until the end of 2023. The GMP/GDP Inspectors Working Group has decided to continue the extension of the validity date until 2024 or the conclusion of the next on-site inspection, whichever comes first, except where clarifying remarks in the document state otherwise. 

Meanwhile, competent authorities will perform risk-based supervision of sites, either by on-site inspections or distant assessments, and based on the outcome may continue to issue, withdraw or restrict GMP and GDP certificates, as appropriate.

The inspections will be prioritised based on risk, so that the highest priority manufacturers, such as manufacturers of sterile product and biological products, and wholesale distributors are inspected first. In addition, inspections will be prioritised depending on the date of the last inspection.

Questions about the validity date of a GMP or GDP certificate should be addressed to the competent authority that issued the certificate. 

It is incumbent upon manufacturers, importers and distributors to continue complying with GMP and GDP as appropriate. 

Supervisory authorities will remain vigilant to ensure the quality of medicines that are made available to patients in the EEA.

Inspections (including distant assessments) may be carried out at any time. In case of serious non-compliance, appropriate regulatory actions will be triggered.

The guidance was agreed by the GMP/GDP Inspectors Working Group coordinated by EMA. It will be updated when there is additional information available.

EMA role

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:

  • coordinating the preparation of new and revised guidance on GMP;
  • ensuring common interpretation of EU GMP requirements and related technical issues;
  • developing EU-wide procedures on GMP inspections and related activities;
  • facilitating cooperation between Member States for inspections of manufacturers in third countries.

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:

Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA

IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants

Legal framework and guidance

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.

Manufacturing authorisation

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.

Registration of manufacturers of active substances

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.

Responsibility for inspections

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 database

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.

GMP/GDP Inspectors Working Group

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:

  • updates or amendments to the EU GMP guidelines;
  • the compilation of Union procedures;
  • harmonised interpretation of GMP and related requirements.

Compilation of Union procedures

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:

    Compilation of Union procedures on inspections and exchange of information

    EMA published the Word and PDF versions of some of the templates for the convenience of inspectorates

    Important

    The forms and templates should be downloaded and saved first before being completed, using for example “Save target as” function. To report any technical issues with the form, please use the EMA Service Desk portal.

    Revision of template for serious GMP non-compliance

    EMA's GMP/GDP Inspectors Working Group is discussing actions required after an inspection concludes that a manufacturing site does not comply with GMP, specifically where this can lead to a shortage of critical medicines. EMA has held a public consultation on an updated template for GMP non-compliance statement in 2018:

    Inspections for pharmaceutical starting materials

    Plasma master file (PMF) inspections

    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.

    Vaccine antigen master file (VAMF) inspections

    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.

    Mutual recognition agreements

    The EU has signed mutual recognition agreements on GMP inspections with regulatory authorities outside the EU. This allows EU authorities and their counterparts to:

    • rely on each other's GMP inspections;
    • waive batch testing of products on entry into their territories;
    • share information on inspections and quality defects.
    • The scope of each agreement differs.

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