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

We consistently receive questions regarding the steps required when applying for a marketing authorisation (MA).  In this article we aim to provide a guide to assist companies applying for an MA

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

When Can A Pharmaceutical Product Be Placed On the Market?

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.

What Is A Marketing Authorisation?

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;

and

(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  (MA’s) 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 MA, 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 (MAH) 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 MA 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

An MA 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 MA may be renewed on the basis of a re-evaluation of the risk-benefit balance. The MAH 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).

We Can Help

If you would like more information about how we can help you with issues related to your MA, then please get in touch with us.  Simply complete the details below or call us on 00353 52 61 76 706.