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EMA chairs and provides the secretariat for the GMP/GDP Inspectors Working Group of senior inspectors appointed by all the EEA competent authorities. The European Commission and observers from EU accession coutnries, mutual recognition partner authorities, the European Directorate for the Quality of Medicines and Health Care 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.

Importers are responsible to ensure that the third country manufacturer they are importing from comply with GMP.

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.

The Agency also plays a key role in coordinating and harmonising GMP activities at an EU level.


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