Compliance with GDP ensures that:
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.
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 GDP 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 GDP certificate is needed.
Any questions about GDP certificates and their validity should be addressed to the competent authority that issued the certificate.
For more information, see:
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).
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 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.
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:
Rapid alert notification of a quality defect / recallFollow-up and non-urgent information for quality defects