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Home / Activities / Registration / National Procedures / National Marketing Authorisations

National Marketing Authorisations

 

Marketing Authorisation procedure in line with regulation 4 (1) of the Medicines (Marketing Authorisation) Regulations, in accordance with articles 8 and 10 of Directive 2001/83/EC

In order to obtain Marketing Authorisations (MA) for new products to be placed on the market in Malta, a national application should be submitted to the Medicines Authority.  National Marketing Authorisation applications are required for products that are not already registered in any country in the European Union (EU)/European Economic Area (EEA). This procedure should only be used to market the product in Malta (and not in any other Member State) or as the basis for a future mutual-recognition application to other Member States with Malta as Reference Member State.

Guidelines and Application forms

General information on the regulatory requirments for applying for marketing authorisations can be found in Volume 2A, Chapter 1 (Marketing Authorisation) of the Notice to Applicants and application forms can be downloaded from Volume 2B of the Notice to Applicants of the European Commission website. 

Should you require more information please contact us on licensing.medicinesauthority@gov.mt.

To book a slot for the procedure, please fill in the pre-submission form and send to the mailbox licensing.medicinesauthority@gov.mt.

 

Paged edited: 15 March 2020