UPDATED: What Are The Initial Steps in Applying for a Marketing Authorisation?

Editor’s Note:  The original version of this article was our most read article of 2017. Because regulatory professionals need access to the most up to date and relevant information, we have updated the article and extended it to take into consideration a number of developments.

We have also provided a number of links to the relevant authorities, organisations and pieces of legislation to assist you.

Eudralex Volume 2A was updated to Revision 9 in November 2018.  Volume 2A of Procedures for Marketing Authorisation from the European Commission Health & Consumers Directorate – General states that a medicinal product may only be placed on the market in the European Economic Area (EEA) when a marketing authorisation has been issued by the competent authority of a Member State for its own territory (national authorisation) or when an authorisation has been granted in accordance with Regulation (EC) No 726/2004 for the entire Union (this is known as a Union authorisation). The marketing authorisation holder must be established within the EEA.

A marketing authorisation outlines the terms under which the marketing of a medicinal product is authorised in the European Union. A marketing authorisation is composed of:

(i) a decision granting the marketing authorisation issued by the relevant authority;


(ii) a technical dossier with the data submitted by the applicant in accordance with Articles 8(3) to 11 of Directive 2001/83/EC and Annex I thereto, Articles 6(2) and 31(2) of Regulation (EC) No 726/2004, or Article 7 of Regulation (EC) No 1394/2007.

Marketing Authorisation Initial Steps in Applying for a MAH

Competent Authorities

The competent authorities of the Member States are responsible for granting marketing authorisations for medicinal products which are placed on their markets, except for medicinal products which are authorised under the above referenced Regulation (EC) No 726/2004.

In order to obtain a national marketing authorisation, an application must be submitted to the competent authority of a member state. In cases where national authorisations are requested for the same medicinal product in more than one Member State and the MA holder has received a marketing authorisation (MA) in a Member State, the applicant/MAH must submit an application in the Member States concerned using the procedure of mutual recognition. The Member States concerned should then recognise the marketing authorisation already granted by the reference Member State and authorise the marketing of the product in their national territory.

If a marketing authorisation has not already been granted in the Union, the applicant may avail of a decentralised procedure and submit an application in all the Member States where it intends to obtain a marketing authorisation at the same time, and choose one of them as the Reference Member State (the RMS). Based on the assessment report prepared by the reference Member State and any comments made by the concerned Member State, marketing authorisation should be granted in accordance with the decision taken by the reference Member State and concerned Member State in this decentralised procedure.

The marketing authorisation must contain the summary of product characteristics (SMPC) according to Article 11 of Directive 2001/83/EC and the labelling and package leaflet according to Article 54,55,59 and 63.

Duration of a Marketing Authorisation

A marketing authorisation granted in the Union has an initial duration of five years (as per Articles 14(1) of Regulation (EC) No 726/2004 and 24(1) of Directive 2001/83/EC). After these five years, the marketing authorisation may be renewed on the basis of a re-evaluation of the risk-benefit balance. The marketing authorisation holder must provide the EMA (the European Medicines Agency) or the national competent authority with a consolidated version of the file in respect of quality, safety and efficacy, including all variations introduced since the marketing authorisation was granted, at least nine months before the MA ceases to be valid (Articles 14(2) of Regulation (EC) No 726/2004 and 24(2) of Directive 2001/83/EC). Once renewed, the MA is valid for an unlimited period unless the Commission or the national competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal (Articles 14(3) of Regulation (EC) No 726/2004 and 24(3) of Directive 2001/83/EC).

As noted above, we will look at Union authorisations on the blog at a later stage.  We will also delve further into the issue of MA’s in further updates.

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