Medicinal products marketed in Malta must have a Marketing Authorisation (MA) to be placed on the market, granted by the Medicines Authority (through national, Mutual Recognition or Decentralised Procedures) or by the European Commission (Community registrations granted through the Centralised Procedure).
Marketing authorisations are granted nationally by the Medicines Authority in accordance with the Medicines Act, 2003 (Chapter 458 of the Laws of Malta) and the Medicines (Marketing Authorisation) Regulations (Subsidiary Legislation 458.34). Marketing Authorisations are granted by the European Commission in accordance with Regulation 726/2004.
Currently the three main types of registration procedures recognised for the granting of an authorisation to place a product on the market in Malta are:
Information on Parallel Importation of medicinal products can be found in the section on Parallel Importation.
Information on the re-labelling and/or repackaging of products for placing on the market in Malta is found in the General Guidelines on the Repackaging of medicinal products for human use.
Details of all the medicinal products for human use authorised to be placed on the market in Malta together with the product information are available on the Medicines Database. From the database you can also download the lists of medicinal products authorised nationally or centrally.
In spite of all the efforts made to deliver this information, we cannot exclude inadvertent errors or omissions; therefore you can use this page exclusively for information purposes only. This information has no validity for legal effects and the Medicines Authority is not responsible for any unauthorised or illegal use of the information supplied. The information contained in this list and in the summaries of product characteristics and package leaflets, is for general information purposes only; this information may be updated several times and therefore there could be differences between the version of the information shown here and other information in the public domain. While every effort is made to ensure the accuracy of the information, it is not possible to guarantee that it is complete, accurate and up-to-date. We will investigate immediately any errors which are brought to our attention.
For a list of recent product reclassifications of legal status (i.e. change in prescription status), please visit here.
Public assessment reports of products authorised in the EU through the mutual recognition or decentralised procedures are available here.
A list of products authorised through the centralised procedure and more information on these products can be found on the EMA website.
Details of source countries of article 126(a) and parallel import licenses and details of batch release sites of medicinal products with a marketing authorisation are available here.
Updated: 6 April 2020