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 the European Commission (Centralised Procedure).

Marketing authorisations are granted nationally by the Medicines Authority in accordance with the Medicines Act, 2003 and the Medicines (Marketing Authorisation) Regulations.  Marketing Authorisations are granted by the European Commission in accordance with Regulation 726/2004.

Currently the three main types of procedures recognised for the granting of a marketing authorisation and to place a product on the market in Malta are:

·         National Procedures (Regulation 4(1) and 4(2) of Medicines (Marketing Authorisation)      Regulations

·         European Procedures (Mutual Recognition (MRP) and Decentralised (DCP) Procedures)

·         Centralised Procedure (List and detailed information on products authorised)

Information on Parallel Importation of medicinal products can be found in the section on Parallel Importation.

National Procedures

Marketing Authorisation procedure in accordance 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 for new products to be placed on the market in Malta,   a national application can be submitted to the Medicines Authority.  National Marketing Authorisation applications are required for products that are not already registered in any country in the EU/EEA.

The list of products with a national marketing authorisation in Malta is available and the respective approved Summaries of Product Characteristics (SmPC) and Package Leaflets (PL) can also be accessed for each product by using the search link on this page.

Guidelines and Application forms

General information on marketing authorisations and application forms are available in Chapter 1 of Volume 2A – Marketing Authorisation, of the Notice to Applicants on the European Commission website.

Authorisation in line with regulation 4(2) of the Medicines (Marketing Authorisation) Regulations, in accordance with article 126(a) of Directive 2001/83/EC - 21/10/09

In the absence of a marketing authorisation for a medicinal product, the Licensing Authority may authorise the placing of that medicinal product on the market in Malta, provided that the said product is authorised in another Member State (EU/EEA country).  An authorisation is thus granted in accordance with Regulation 4(2) of the Medicines (Marketing Authorisation) Regulations, under the Medicines Act, 2003. A link to the legislation page (Maltese Legislation) of the Medicines Authority’s website can be found here. 

This authorisation procedure is being applied mainly to cover the public health need created by the lack of applications for marketing authorisations for products which were on the derogation list and for products which were authorised in the period between the publication of the derogation list and the date of accession.  It is strongly recommended that Malta is now included with the other concerned member states in the Mutual Recognition and in the Decentralised procedures.   

It is to be stressed that this procedure should in no way be considered as an easy way of circumventing the current procedures stipulated by the EU legislation or as a ‘fast-track’ procedure.  The Mutual Recognition Procedure and the Decentralised Procedure have to be used for the products that are being authorised in the EU/EEA.  Malta should be included as a Concerned Member State in these procedures.  Applications for products for which the marketing authorisation is withdrawn by the Marketing Authorisation holder (other than for safety reasons) and subsequently received through the ‘article 126(a)’ route, may not be considered.  

Those product authorisations granted in accordance with article 126a for which a repeat use MR procedure has in the meantime (since date of authorisation) been carried out, and Malta was not included as Concerned Member State, will not be renewed.

Applications in accordance with article 126a received for products for which a MRP procedure (first or second wave) or a DC procedure have been started from 1 August 2010 where Malta was not included as Concerned Member State, will not be accepted by the Medicines Authority.

From 1 August 2010, applications in accordance with article 126a which should be submitted as line extensions to products having a marketing authorisation may not be accepted and applicants will be directed submit these applications as national line extensions.

Guidelines and Application forms

Details regarding the procedure involved and guidance on filling in the application forms can be found in the Guidelines [Guidelines for the placing of medicinal products on the market in Malta through an application for an Authorisation in line with regulation 4(2) of the Medicines (Marketing Authorisation) Regulations, in accordance with article 126(a) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004]. 

In order to apply for this authorisation, the proposed product authorisation holder must submit to the Medicines Authority all necessary documentation, including the Application Form [Application Form: Authorisation in line with regulation 4(2) of the Medicines (Marketing Authorisation) Regulations, in accordance with article 126(a) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004] and its annexes, as well as fees [Legal Notice 315 of  2006: Medicines Authority (Fees) Regulations, 2006; and Legal Notice 427 of 2007) for fees in Euros] and the declaration of access.  

After notification by the Medicines Authority of the issue of an authorisation for a medicinal product, the Authorisation holder must notify the Medicines Authority of any variations to the authorised product, which have been approved in the Member State (EU/EEA country of source) that will affect the product information (that is the SmPC and/or package leaflet and/or immediate and/or outer labelling and packaging). The Variations Notification Form [Variations Notification Form for an Authorisation in line with regulation 4(2) of the Medicines (Marketing Authorisation) Regulations, in accordance with article 126(a) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004], needs to be submitted before the product having these changes is placed on the market in Malta.

The authorisation will be valid for five (5) years. The Medicines Authority would need to be notified of the intention for renewal (if applicable) at least 3 months prior to the end of validity of the authorisation by submission of  the Renewal Form [Renewal Form for an Authorisation in line with regulation 4(2) of the Medicines (Marketing Authorisation) Regulations, in accordance with article 126(a) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004]. The licence will not be renewed unless a Renewal Application Form is submitted.  If during the 5-year period the product has been granted a marketing authorisation, the Authorisation in line with regulation 4(2) of the Medicines (Marketing Authorisation) Regulations, will not be renewed. 

A List of Authorisations in line with regulation 4(2) of the Medicines (Marketing Authorisation) Regulations, [in accordance with article 126(a) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004], can be found on the Medicines Authority’s website. 

European Procedures

In cases where a national authorisation is required for a product that is already registered in another member state of the EEA the Mutual Recognition procedure has to be used.   Where a product is not already authorised, both the Mutual Recognition and the Decentralised procedures may be used for obtaining a Marketing Authorisation for Malta. 

Guidelines and Application forms

More detailed information on the Mutual Recognition and Decentralised Procedures and all documentation and templates can be found in the CMDh section of the Heads of Medicines Agencies website.

Details on documentation to be supplied can be found in  Volume 2A of Chapter 2 of the Notice to Applicants – Mutual Recognition and application forms can be downloaded from Chapter 1 of Volume 2A – Marketing Authorisation of the European Commission website. 

Malta as Reference Member State in the Decentralised Procedure

Since 2007 the Medicines Authority is accepting applications as Reference Member State in the Decentralised Procedure. 

Until further notice, the applications considered will be those for solid oral dosage forms and oral solutions in accordance with article 10 of Directive 2001/83/EC, as amended. 

To be able to consider such applications, some information is requested to enable the Medicines Authority to assess whether to accept the submission of an application for a Marketing Authorisation or not.  The Request Form on the CMDh website should be filled in and sent to the Medicines Authority at least 6 months before the proposed submission date.  The requests should be sent by e-mail directly to the CMDh (MRP/DCP) contact point with a copy to the e-mail address prelicensing.mru@gov.mt.   

The slots for the 20 procedures planned for 2010 are all booked. A few procedures are on the waiting list should slots become available in case of cancellation by the applicants. 

Currently the Medicines Authority is filling in slots for 2011 - 2012. Please send in the pre-submission forms in due time for consideration, at least six months before proposed submission date.  Once you are given a slot, you are requested to inform the Medicines Authority immediately should you not be able for any reason to submit in the agreed timeline.  The Medicines Authority should be informed in good time about any problems encountered that may lead to postponement or cancellation of the slot that is granted.

Information and guidance documents on the decentralised procedure can be found on the CMDh website.

Public assessment reports of products authorised with procedures where Malta is RMS are being made available on http://www.medicinesauthority.gov.mt/par.htm

Centralised Procedure

In order to obtain a community authorisation, through the Centralised procedure a marketing authorisation application must be submitted to the European Medicines Agency (EMA).  Products authorised by the Centralised system (Centrally Authorised Products) can be automatically marketed in Malta, as their marketing authorisation is valid in all EU/EEA countries.  A list of these products and more information on these products can be found on the EMA website.

Guidelines and Application forms

More detailed information and application forms on the Centralised Procedure can be found in EudraLex - Volume 2 - Pharmaceutical Legislation Notice to applicants and regulatory guidelines medicinal products for human use.

More information can also be accessed on the EMA website.

Marketing Authorisations lists, forms and publications:

List of Marketing Authorisations Issued ¹ - 28/07/2010

List of Authorisations in line with regulation 4(2) of the Medicines (Marketing Authorisation) Regulations, in accordance with article 126(a) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 ¹ - Latest Update (28/07/2010)

List of authorised products withdrawn by the Marketing Authorisation Holder - 17/06/2010

List of Parallel Import Licences ¹ - 28/07/2010

Application for Transfer of MAH for an Authorised Product - 7/4/09

Application for MAH Transfer during Authorisation Procedure - 7/4/09

Application for notification in line with article 61(3) of Directive 2001/83/EC, as amended

Form for the withdrawal of a product authorisation or licence - 23/7/09

MAH Authorisation for Contact Person - 8/1/10

Guideline on the implementation of the “Sunset Clause” – Cessation of a Marketing Authorisation if a product is not placed on the market in Malta 

European Procedures

Requirements for electronic submissions – 10/5/10 NEW!

¹ Disclaimer: The information contained in this list and in the SmPCs and package leaflets is for general information purposes only and thus the information in the list and the published product information should not be used officially as a substitute for the Marketing Authorisation legal documents held by the Marketing Authorisation Holders