Ema backdating Free webcamporn live
For more information on the VAMF certification procedure, see Vaccine antigens.
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.
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.
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.
The Agency also plays a key role in coordinating and harmonising GMP activities at an EU level.
It is involved in: In addition Directive 2001/83/EC and Directive 2001/82/EC lay down related provisions.
Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes.
The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at European Union (EU) level.
If an MRA applies, the authorities mutually rely on each other's inspections.