Pharmaceuticals

Medicinal products can only placed on the domestic market if there is a valid marketing authorisation in respect of such products issued by the Medicines Authority in accordance with the Medicines Act (Chapter 458 of the Laws of Malta) and the Medicines (Marketing Authorisation) Regulations (Subsidiary Legislation 458.34) or by the European Commission in compliance with Regulation 726/2004.

Registration Procedures

Hence there are three types of registration procedures:

(i) National registration – as laid down in the Medicines Act (Chapter 458 of the Laws of Malta) and the Medicines (Marketing Authorisation) Regulations (Subsidiary Legislation 458.34);

(ii) European registration through the Mutual Recognition and Decentralised Procedures – In 2005 the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh) was set up. Every EU member state has a representative which is part of the CMDh. Such procedures have harmonised marketing authorisations issued within the EU, so that a marketing authorisation validly granted in a Member State will be mutually recognised in other Member States.

(iii) Parallel Importation – This occurs when a medicinal product which has already been granted marketing authorisation in Malta, is going to be imported into Malta from another EU Member State, which importer is not the same importer who was originally granted marketing authorisation in Malta. In such a scenario the importer would have to obtain a licence. The Medicine Authority’s official website (http://www.medicinesauthority.gov.mt/Medicinesdatabase) contains a Medicines Database which lists those medicinal products which have already obtained marketing authorisation in Malta together with information on such medicinal products.