As an immediate action, EMA has released an updated template for GMP non-compliance statement for public consultation until : For products derived from blood or blood plasma, EMA is responsible for coordinating inspections of the blood establishments in which collection, testing, processing, storage and distribution is carried out under the PMF certification procedure.For more information on the PMF certification procedure, see Plasma master files.
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.
They must comply with EU GMP to obtain a manufacturing or import authorisation.
They can ensure that they meet all their legal obligations by following the EU GMP guidelines.
The EU has signed mutual recognition agreements on GMP inspections with regulatory authorities outside the EU.
ESA replaced Incapacity Benefit and Income Support (paid on the basis of incapacity for work) for new claimants on 27 October 2008.
Importers of active substances intended for the EU market are also required to register.
In addition, each consignment needs to be accompanied by a confirmation by the competent authority of the country where it is produced that it conforms to GMP standards equivalent to those in the EU, unless a waiver applies.
Active substance manufacturers must comply with GMP.
In addition, the manufacturer of the finished product is obliged to ensure that the active substances they use have been manufactured in compliance with GMP.
Jobcentre Plus will transfer existing Incapacity Benefit and Income Support claimants over to ESA by 2014.