Marketing Authorisation Holders MAHs

In the EU, a basic requirement for marketing authorisation holders (MAHs) is that they must have permanently and continuously at their disposal a nominated qualified person, with responsibility for pharmacovigilance. This person should have experience in all aspects of pharmacovigilance and, if not the holder of a medical or veterinary qualification, they should have access to such a person. The duties of the qualified person include ... 

They need assurance that the medicines they are offered fulfil these requirements and are supported by information that permits optimal use. The information about and the usage of medicines gets out of date, and there is an obligation on licence holders continually to review their licence with particular regard to safety. Marketing Authorisation Holders (MAH), i.e. pharmaceutical companies, can also change the efficacy claims to their licence, e.g. new indications, extension of age groups, or... 

Annex 16 of Volume 4 of the Good Manufacmring Practice Guidelines proposes that the ultimate responsibility for the performance of an authorised medicinal product over its lifetime its safety, quality and efficacy lies with the Marketing Authorisation Holder (MAH) [4]. 

The Marketing Authorisation Holder of a product has to have at his disposal a qualified person who is responsible for pharmacovigilance of that product [7]. The MAH is supported by expertise from Regulatory Affairs officers who are responsible for taking care of dossier documentation, including Quality, Toxicology and Clinical Sciences, and updates. 

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