Marketing authorisation (MA)

Initial MA

In accordance with relevant EU legislations, as transposed into Luxembourg legislation, no medicinal product may be placed on the market without prior authorisation. If a pharmaceutical company wishes to obtain an MA, it must file an application with the competent authority(ies). The application must include the results of analyses conducted on the medicinal product and research and development reports: industrial development (quality), pre-clinical trials, clinical trials, scientific literature, etc.

Once the application has been submitted to competent authority(ies) – in eCTD format –, it will then be evaluated, and an opinion issued on the balance benefits and risks. If the opinion is positive, the competent authority will deliver an MA.

An MA may be granted at European level or national level. Marketing authorisation applications may be filed using one of the following procedures:

  • The Centralised Procedure (CP): the MA is granted by the European Commission following a positive opinion from the European Medicines Agency (EMA). The MA is granted for all EU Member States (+ Norway, Iceland and Lichtenstein), and published here. This procedure is mandatory for innovative products, such as anti-cancer drugs.
  • The Decentralised Procedure (DCP): an initial MA is granted for the EU Member States chosen by the applicant.
  • The Mutual Recognition Procedure (MRP): if an initial MA has already been granted in an EU Member State, the applicant may decide to register the medicinal product in other EU Member States of their choice, based on the dossier that has already been assessed.

    When an MA is granted through the MRP and DCP procedures, the assessment is shared between the Member States.

  • The National Procedure: the MA is granted by a National Medicines Agency, and is only valid in that country. This procedure is only possible if an MA has not yet been granted in any other EU country.

After the initial MA: the life cycle of the medicinal product

Variations

If changes are made to the initial marketing authorisation, variations must be submitted to competent authority(ies).

Definitions of the different types of variations are provided in Commission Regulation (EC) No 1234/2008 of 24 November 2008 (as amended) concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products.

New amendment to Regulation 1234/2008, applicable from 1 January 2025 

The amendment to the regulation introduces important changes regarding the submission of variations and the applicable procedures, and entered into force on 1 January 2025:

  • Type IA: Super-grouping: Type IA variations may be submitted for several MAs held by the same MA holder in a process known as 'super grouping'. Please refer to Chapter 6 of the CMDh Best Practice Guides for details of the applicable variations (Pdf).
  • Type IA: Annual Update: Notifications by an MA holder for several Type IA variations for a single MA must be submitted as a single notification in an 'Annual Update' within no more than 12 months after the implementation of the first Type IA variation in the annual update, and no earlier than 9 months after the implementation of the first Type IA variation in the annual update. Please refer to Chapter 6 of the CMDh Best Practice Guides for further details (Pdf).
  • Mandatory worksharing: An MA holder must submit the same Type IB or Type II variation, or the same group of variations (including one or several Type IB or Type II variations) affecting more than one MA from the same holder, in a single application as part of a worksharing procedure. Please refer to Chapter 7 of the CMDh Best Practice Guides for further details (Pdf).
    Note: When choosing the RMS for worksharing, please bear in mind that Luxembourg's resources are currently limited.
    Note 2: Mandatory worksharing also applies to Luxembourg's national procedures. Please update your procedures as quickly as possible.

For more information on variation-related procedures that are applicable in Luxembourg, please see:

eAF

Since 29 September 2025, the EMA strongly recommends the use of electronic application forms (eAF) online via the PLM portal for MRP/DCP/NP human variations.

For more information, please consult the PLM portal.

Submitting an eCTD baseline sequence

For MAs granted through a national procedure, if the eCTD application is not up to date, or if the dossier has never been submitted in eCTD format, the dossier should be updated without delay to bring it into compliance with regulatory requirements. A consolidated application in eCTD format can be submitted – instead of submitting all of the variations individually – after sending a request to the Division of Pharmacy and Medicines (Division de la pharmacie et des médicaments - DPM) (maa.hum@ms.etat.lu).

Please download the harmonisation group's guidance on submitting a baseline sequence (Pdf, 866 Kb).

Renewal 

An MA is generally delivered for a limited period of time. Before the MA expires, the marketing authorisation holder must submit a renewal of the MA, either immediately or 6 months in advance.

Withdrawal 

Lastly, if the MA holder wishes to withdraw their MA, they can submit a MA withdrawal request, either immediately or 6 months in advance. For medicinal products that are already on the market, a cessation-of-marketing notification must be submitted in accordance with the procedures described on the Unavailability/Marketing Status page before requesting the withdrawal of the MA (except in exceptional cases).

Procedures in Luxembourg & Point of Contact

In Luxembourg, the Minister of Health is responsible for granting MAs based on opinions issued by the expert commission ('Committee of Experts'). The Division of Pharmacy and Medicines of the Health Directorate is responsible for the regulatory approval of application dossiers, and for registrations in the national medicinal products database.

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