As from 9th February 2019, MAHs who market medicinal products in Malta that are in scope of the Delegated Regulation are required to certify that all packs released to the Maltese market carry the necessary safety features such as unique identifiers and anti-tamper devices.
Such authorisation holders need to be registered with MaMVO and pay the relevant fees.
Kindly note that for the purposes of registration with the Malta Medicines Verification Organisation, the terms Market Authorisations and Authorisations are considered inclusive of all marketed Centrally Authorised Products, national Marketing Authorisation, 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.
Contribution Fees are applicable to the holders of any authorisation to place a medicinal product for human use bearing the safety features as per Delegated Regulation (EU) 2016/161 on the Maltese market.
The contributions have to be calculated per Marketing Authorisation Holder (MAH) companies who bring medicines on the Maltese market, taking into consideration the number of Marketing Authorisations (MA) covered by each MAH.