This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the whole series, please click here.

As medicinal products are not permitted to be placed on a market until the marketing authorisation (“MA”) for that market is obtained, the procedural aspects of applying for and obtaining MAs are a material hurdle to obtaining market access and making products available to patients.

As part of the European Commission’s proposed revisions to the pharmaceutical legislative framework, announced on 26 April 2023, changes have been suggested to the MA application procedure to improve timely and equitable access to medicines and security of supply, to promote innovation, to make medicines more environmentally sustainable and to address antimicrobial resistance, pursuant to the European Commission’s stated main objectives in its Press Release.

What are the current procedures?

Under the current Directive 2001/83/EC on the Community code relating to medicinal products for human use (“Directive”) and Regulation (EC) No 726/2004 (“Regulation”) laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, there are generally two types of MAs:

• centralised (obtained via the centralised procedure); and
• national (which may be obtained via the decentralised, mutual recognition or purely national procedures).

Under the centralised authorisation procedure, which is compulsory for certain medicines (including those containing a new active substance to treat HIV, cancer, diabetes, neurodegenerative disease etc), a single MA application is made to the European Medicines Authority (“EMA”). The EMA makes a recommendation to the European Commission about whether a MA should be granted, and the European Commission makes a legally binding decision based on the EMA’s recommendation. The centralised MA that is granted by the European Commission is then valid in all EU Member States as well as the European Economic Area countries (Iceland, Liechtenstein and Norway). For more detail about the calendar for the assessment process, see the EMA’s From laboratory to patient: the journey of a medicine assessed by EMA.

Under the decentralised authorisation procedure, an application is made in several Member States and the applicant nominates a “Reference Member State” that is responsible for leading the administrative procedure and each of the other Member States to which the applicant would like its product to be authorised (known as a “Concerned Member State”). Once the MA application is validated and assessed through the decentralised procedure, the national competent authority of each Member State involved adopts a national decision, issuing the national MAs where the applicant is successful.  

Applications that are made under the national authorisation procedure are specific to each EU Member State, although some Member States may adopt mutual recognition of MAs granted in other Member States.

What are the proposed changes?

The proposed revision of the pharmaceutical legislation consists of repealing and replacing both the Directive and Regulation; however, the general principles of the centralised procedural would be maintained.

Proposed changes to the centralised procedure for obtaining an MA include the following:

• The scope of medicines that are required to go through the centralised procedure will be extended to antimicrobial medicinal products and products seeking paediatric use.^[1]
• The timeframes for completing various phases of the MA application process will be reduced. Notably, the deadline for the CHMP to assess the MA application and issue its opinion as part of the centralised procedure will be reduced from 210 to 180 “active” days from receipt of a valid application.^[2] Member States will likewise be required to ensure the procedure for granting a MA under the national procedure is completed within a maximum of 180 days from receipt of a valid application.^[3]
• The circumstances in which the European Commission may authorise duplicate MA applications as part of the centralised procedure will be limited to where one of the medicinal product’s “indications or pharmaceutical forms is protected by a patent or a supplementary protection certificate in one or more Member States” (but the initial or duplicate MA must be withdrawn once the IP right expires) or “for reasons of co-marketing with a different undertaking not belonging to the same group as the marketing authorisation holder of the medicinal product”.^[4]
• There will be greater scope for centralised MAs to be granted under exceptional circumstances for a new therapeutic indication for an existing MA, and conditional MAs where there is an unmet medical need or with post-authorisation study requirements (such as, safety, efficacy and environmental risk assessment studies).^[5]
• Instead of a 5-year duration, a centralised MA (not granted under exceptional circumstances or conditionally) will be valid for an unlimited period with the possibility for the Commission to decide to limit the validity to 5 years where there are safety concerns.^[6]
• Temporary emergency marketing authorisations will be available during public health emergencies to enable faster availability of the medicinal product.^[7]
• MA applications will be required to be submitted electronically under both the centralised and national procedures,^[8] consistent with objective for wider use of electronic processes to reduce administrative burden.
• Additional information will need to be provided with the MA application, whether under the centralised or national procedure, including an environmental risk assessment (see our article on the strengthened environmental risk assessment requirements) and an antimicrobial stewardship plan (for applications concerning an antimicrobial medicinal product – see our article on the proposals to fight against antimicrobial resistance), lack of which could result in the refusal of the application. There are also specific requirements for Paediatric Use MAs (see our coverage of the proposed reform for paediatric medicines here).^[9]
• An active substance master file for a chemical active substance of a medicinal product, or additional quality master file for an active substance other than a chemical active substance, will be introduced as options for submission in place of providing all the relevant data each time an assessment is made. The objective is to provide for a single assessment of the active substance by issuing a certificate, thus minimising duplication of processes.^[10]
• Centralised MA holders will have obligations to monitor and prevent shortages in the availability and supply of medicinal products; e.g., by keeping a shortage prevention plan in place (see our article on the proposed reforms relating to the prevention of shortages of medicinal products).^[11]

We will continue to monitor the proposed revisions closely for changes as the European Commission’s proposals progress through the EU legislative process.

[1] Article 3(1) and Annex I 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”).

[2] Article 6(6) Proposed Regulation.

[3] 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”).

[4] Article 25 Proposed Regulation.

[5] Articles 18-20 Proposed Regulation.

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

[7] Section 3 Proposed Regulation.

[8] Article 5(3) Proposed Regulation; article 6(1) Proposed Directive.

[9] Article 6(2) and Annex I Proposed Directive.

[10] Articles 25-26 Proposed Directive.

[11] Article 117 Proposed Regulation.