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New or revised Q&As are marked as 'New' or 'Rev.' with the relevant date.
If an issue is not resolved by the Q&As below, please send a question to the European Medicines Agency.
This proof of establishment should be included in annex 5.3 of the application form.
It should be emphasised that while the MAH may delegate certain activities to third parties, the MAH remains responsible for assuring all the obligations imposed on MAHs by the European legislation and by national law, as applicable.
To exercise the Union’s competences, the institutions may adopt regulations, directives, decisions, recommendations and opinions.Companies or firms formed in accordance with the law of a Member State and having their registered office, central administration or principal place of business within the EEA will be treated in the same way as natural persons who are nationals of Member States.An applicant should demonstrate that it is duly established in the EEA.The granting of a marketing authorisation by a competent authority does not discharge the holder from civil and criminal liability as provided for by European Union law. The MAH of a centralised marketing authorisation must be established within the European Economic Area (EEA; Norway, Iceland, Liechtenstein and the Member States of the European Union).In order to fulfil this requirement, the MAH must have a permanent legal structure that is formed in accordance with the law of an EEA Member State and allows the concerned holder to assume the duties and responsibilities as well as to perform the tasks laid down by Union law.