Reply To: EU GMP Audit

#6266
Pharma Digests
Pharma Expert

    In the European Union (EU), there are two main routes for authorising medicines: a centralised route and a national route.

    Under the centralised authorisation procedure, pharmaceutical companies submit a single marketing authorisation application to EMA.

    This allows the marketing-authorisation holder to market the medicine and make it available to patients and healthcare professionals throughout the EU on the basis of a single marketing authorisation.

    EMA’s Committee for Medicinal products for Human Use (CHMP) or Committee for Medicinal products
    for Veterinary Use (CVMP) carry out a scientific assessment of the application and give a recommendation on whether the medicine should be marketed or not.

    Once granted by the European Commission, the centralised marketing authorisation is valid in all EU Member States as well as in the EEA countries Iceland, Liechtenstein and Norway.

    If a company wishes to request marketing authorisation in several EU Member States for a medicine that is outside the scope of the centralised procedure, it may use one of the following routes:
    – the mutual-recognition procedure, whereby a marketing authorisation granted in one Member State can be recognised in other EU countries;
    – the decentralised procedure, whereby a medicine that has not yet been authorised in the EU can be simultaneously authorised in several EU Member States.