Market Authorisation Holders

Market Authorisation Holders (MAHs) who market medicinal products in Malta that are in scope of the Delegated Regulation 2016/161 need to be onboarded with the Malta Medicines Verification Organisation (MaMVO).

For the purposes of registration with MaMVO, the terms “Market Authorisations” and “Authorisations” are considered inclusive of all marketed Centrally Authorised Products, all marketed products subject of Parallel Distribution Notices held by the European Medicines Agency, National Marketing Authorisations, Parallel Import Licences, and Article 126a Authorisations, and the terms “Market Authorisation Holders (MAH)” and “Authorisation Holders (AH)” are considered inclusive of any and all holders of any such authorisations to market medicinal products in Malta.

Onboarding

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