This article is part of our series covering the proposed reforms to the EU pharmaceutical legislation. To view the entire series, click here.

As covered in our article from last year, as part of the EU Pharmaceutical Reform, proposals were made to revise marketing authorisation (“MA”) procedures in the EU. The European Parliament adopted its position at first reading, on 10 April 2024, of revised versions of the original two European Commission proposals:^[1]

• Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC (“Proposed Directive”); and
• Proposal for a Regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 (“Proposed Regulation”).

This article provides more information about the proposed changes that are relevant to EU MA procedures, including revisions since the original proposals in 2023.

MAs importantly determine whether medicinal products are permitted to be placed on the EU market. The different routes for obtaining a centralised MA or national MAs are broadly retained in that there are the centralised, decentralised, mutual recognition and purely national procedures. However, the Proposed Directive and Propose Regulation consists of changes to the scope of MAs, and process of obtaining and retaining them. The Proposed Directive also contains a new provision for the purely national MA procedure granted in a single Member State, governing aspects of the examination process, timeframe and applicable conditions under the procedure.^[2] 

Centralised procedure

As mentioned in our previous article, various changes were made to the centralised procedure, including the following: 

• Broader scope for centralised procedure – The reform would extend the scope of medicines required to go through the centralised procedure to antimicrobial medicinal products and products seeking paediatric use.^[3] 
• Shorter timelines – The reform reduces the deadline for the CHMP to assess the application from 210 to 180 days.^[4]
• Unlimited validity – The reform would create an unlimited validity period for a centralised MA (not granted under exceptional circumstances or conditionally) with the possibility for the Commission to decide to limit the validity to 5 years where there are safety concerns.^[5]
• Exceptional circumstances and conditional MAs – The reform would establish a greater scope for centralised MAs to be granted under exceptional circumstances for a new therapeutic indication for an existing MA, and for conditional MAs where there is an unmet medical need or with post-authorisation study requirements (such as, safety, efficacy and environmental risk assessment studies).^[6] However, the Revised Proposed Regulations create a consequence for not meeting certain post-authorisation requirements; i.e., suspension, revocation or variation of the MAs.^[7] There is also a new provision for the publication of the specific obligations and timelines for compliance for conditional MAs.^[8]

Decentralised and mutual recognition procedures

In addition to proposing changes to the centralised procedure, changes were proposed to the decentralised and mutual recognition procedures. 

• Ability for Member State to opt into the procedure – Notably, even if a Member State has not been identified by the MA applicant as a “Reference Member State” or “Concerned Member State”, the competent authority of a Member State may request to enter the decentralised or mutual recognition procedure for “justified public health reasons” (and it has 30 days from the applicant’s submission of the application to do so).^[9]
• Withdrawn applications due to deficiencies – For the decentralised procedure, if the Reference Member State concerns that the submitted data is not of sufficient quality or maturity for the completion of the examination of the MA application, the examination can be terminated. The applicant may be given a time limit to address the deficiencies, but if not addressed by the time limit, the application shall be considered as withdrawn.^[10]
• Shorter timelines – Currently under the decentralised and mutual recognition procedures, the Concerned Member States are to approve the assessment report prepared or updated by the Reference Member State within 90 days of receipt and adopt a decision in conformity with the approved assessment report within 30 days. The reform would shorten the timing for the Concerned Member States to approve the assessment report to within 60 days.^[11]
• Composition of Coordination Group – As is the case at present, the Coordination Group for Mutual Recognition and Decentralised Procedures examines questions relating to MAs in two or more Member States and concerning variations of these MAs. It also oversees any disagreement between Member States in the procedures and promotes the harmonisation of national MAs throughout the EU.^[12] However, the Revised Proposed Directive introduced a new requirement whereby the coordination is to be composed of one representative per Member State as well as one representative from patients’ organisations.
• Publication of MA documents – In addition to making the SmPC and packaging leaflet publicly available, the Revised Proposed Directive also requires that the antimicrobial stewardship and access plan (and other special information) be made publicly available.^[13]

What happens next?

The European Council will now review the Parliament’s position, which will become a legislative act if accepted or the proposal may return to the European Parliament if the Council decides to amend the position. To read more about the legislative process and for links to other articles on this series (which covers other topics, such as antimicrobial resistance, parallel imports and regulatory data and market protection rules), see this article.

[1] European Parliament legislative resolution of 10 April 2024 on the proposal for a directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC (COM(2023)0192 – C9-0143/2023 – 2023/0132(COD)) (“Revised Proposed Directive”); European Parliament legislative resolution of 10 April 2024 on the proposal for a regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 (COM(2023)0193 – C9-0144/2023 – 2023/0131(COD)) (“Revised Proposed Regulation”).

[2] Article 32 of Proposed Directive. 

[3] Article 3(1) and Annex I of the Proposed Regulation.

[4] Article 3(1) and Annex I of the Proposed Regulation.

[5] Article 17(1)-(2) Proposed Regulation.

[6] Articles 18-20 Proposed Regulation.

[7] Articles 18(2) and 19(7) of the Revised Proposed Regulation.

[8] Article 19(8a) of the Revised Proposed Regulation.

[9] Articles 34(3) and 36(4) of the Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC (“Proposed Directive”).

[10] Article 34(4) of Proposed Directive.

[11] Articles 34(6) and 36(6) of the Proposed Directive.

[12] Articles 38-39 of the Proposed Directive.

[13] Article 43 of Revised Proposed Directive.