Compliance with GDP ensures that:

  • medicines in the supply chain are authorised in accordance with European Union (EU) legislation;
  • medicines are stored in the right conditions at all times, including during transportation;
  • contamination by or of other products is avoided;
  • an adequate turnover of stored medicines takes place;
  • the right products reach the right addressee within a satisfactory time period.

The distributor should also put in place a tracing system to enable finding faulty products and an effective recall procedure.

GDP also applies to the sourcing, storage and transportation of active pharmaceutical ingredients and other ingredients used in the production of the medicines.

Regulatory expectations and GDP 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.

Agency role

  • coordinating the preparation of new and revised guidance on GDP;
  • developing EU-wide procedures relating to GDP inspections.

Legal framework and guidance

Directives 2001/83/EC and with Regulation-2019/6-EN-EUR-Lex lay down the provisions for distribution of medicines in the EU.

In addition to the Directives mentioned above, two European Commission guidelines establish the requirements of GDP:

The Good manufacturing practice (GMP) / GDP Inspectors Working Group provides additional interpretation of the EU GMP and GDP guidelines in the form of questions and answers (Q&As).

Wholesale distribution authorisation

Anyone engaged in the activity of wholesale distribution of medicinal products in the EEA must hold a wholesale distribution authorisation issued by the national competent authority of the Member State where they carry out these activities. The same national authority is responsible for inspecting the wholesale distributor.

Wholesale distributors must comply with EU GDP to obtain a wholesale distribution authorisation. They can ensure that they meet all their legal obligations by following the GDP guidelines.

Manufacturing authorisation holders do not require a separate authorisation to distribute products that are already subject to a manufacturing authorisation.

Importers and distributors of active substances intended for the manufacture of medicines in the EEA are obliged to register with the relevant national competent authority and comply with the principles of GDP for active substances.

Parallel distributors also must comply with GDP. For more information, see Parallel distribution.

EudraGMDP database

EudraGMDP is a publicly accessible EU database containing all wholesale distribution authorisations and details of registered importers and distributors of active substances in the EEA.

After inspecting a wholesale distributer, EU competent authorities issue a GDP certificate or a non-compliance statement, which is entered in the EudraGMDP database.

EudraGMDP also contains information relating to good manufacturing practice (GMP).

EMA coordinates the GMP/GDP Inspectors Working Group of senior inspectors appointed by all EEA competent authorities. It meets at EMA four times a year.

The group provides a forum for harmonisation and discussion of common issues, such as updates or amendments to the EU GDP guidelines and the compilation of Union procedures.

Compilation of Union procedures

EMA maintains a compilation of GDP and GMP 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 how quality defects and non-compliance are handled and how GMP and GDP inspections are carried out and reported:

Compilation of Union procedures on inspections and exchange of information

EMA published the Word version of some of the templates for the convenience of inspectorates:

Rapid alert notification of a quality defect / recallFollow-up and non-urgent information for quality defects

 

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