Good distribution practice
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain.
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 during COVID-19 pandemicGuidance is available for marketing authorisation holders, manufacturers and importers of human medicines on adaptations to the regulatory framework to address challenges of the COVID-19 pandemic, including with GDP certificates and inspections: In this context, GDP certificates for EEA distributors and wholesalers are automatically extended until the end of 2023. This does not waive distributors' and wholesalers' obligations to comply with GDP standards. National competent authorities may launch inspections (including distant assessment) at any time if required. On-site inspections will resume as soon as COVID-19 restrictions are lifted. The guidance was agreed by the GMP/GDP Inspectors Working Group coordinated by EMA, the European Commission, the European medicines regulatory network and endorsed by the EU Executive Steering Group on Shortages of Medicines Caused by Major Events. It is updated as the pandemic develops. For more information, see: |
On this page
- Agency role
- Legal framework and guidelines
- Wholesale distribution authorisation
- EudraGMDP database
- GMP/GDP Inspectors Working Group
- Compilation of Union procedures
Agency role
The Agency's work involves harmonisation of GDP activities at an EU level, including:
- 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 2001/82/EC 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:
- Guidelines on GDP of medicinal products for human use
- Guidelines on principles of GDP for active substances for medicinal products for human use
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).
GMP/GDP Inspectors Working Group
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:
EMA published the Word version of some of the templates for the convenience of inspectorates:
