EU Marketing Authorisation Application

You apply for an EU marketing authorisation for a human medicine by one of two routes. You can submit a single application to EMA under the centralised procedure, which leads to one Commission decision valid across the EU/EEA. Or you can apply to national competent authorities through the decentralised (DCP) or mutual recognition (MRP) procedure, or a purely national one. Your product decides the route: some medicines must go centralised, some may, and the rest go national.

Approach: I used EMA's guidance pages and the Commission's Notice to Applicants, Volume 2A, Chapter 1 (Rev. 11, July 2019). I couldn't read the consolidated texts of Directive 2001/83/EC and Regulation (EC) No 726/2004 this time, so the legal points below come from the Notice to Applicants. That document says it "is not legally binding" and that the Directive and Regulation prevail in case of doubt.

1. Pick the route

Centralised procedure: mandatory (EMA). The legal basis is the Annex to Reg. 726/2004. It covers:

• medicines made by biotechnology;
• advanced therapies;
• orphan medicines;
• new active substances for HIV/AIDS, cancer, diabetes, neurodegenerative diseases, immune dysfunctions and viral diseases.

Biosimilars made by one of the biotechnological processes in that Annex "must however be authorised via the centralised procedure" (NtA Ch.1 §3.1).

Centralised procedure: optional (Art. 3(2), Reg. 726/2004). It is open to:

• new active substances for other indications;
• products that are a significant therapeutic, scientific or technical innovation;
• products where a Union authorisation is in the interest of patients at Union level.

For these, "The applicant has to request confirmation that the product is eligible… and the EMA will decide." Generics of centrally authorised products can also use the centralised route. Under Art. 3(3) they may instead go national, DCP or MRP if conditions such as the same SmPC and the same name in all Member States are met (NtA §2.2, §3.1).

DCP: use this when the product has no authorisation anywhere in the EU yet.

• You submit to the reference Member State and the concerned Member States at the same time.
• You must assure the authorities that the dossier, SmPC, labelling and leaflet are identical in all of them. Prescription status and product names may differ.
• The outcome is a set of national authorisations (NtA §3.2.1).

MRP: use this when you already hold a national authorisation in one Member State. If you want the same product in other Member States, you "must submit an application in the Member States concerned using the procedure of mutual recognition" (NtA §2.1, §3.2.2).

You can't hold both kinds at once. Once a central authorisation exists, a national authorisation for the same product can only co-exist if its therapeutic indications are different (NtA §2.2).

According to EMA, most generics and non-prescription medicines are authorised at national level (EMA).

2. Choose the legal basis of the application

The legal basis is separate from the route (NtA §5):

Legal basis (Dir. 2001/83/EC)	Application type
Art. 8(3)	Full ("stand-alone") application with pharmaceutical, preclinical and clinical data. A "mixed" application combines limited own studies with literature.
Art. 10	Generic, hybrid or biosimilar application relying on a reference medicinal product
Art. 10a	Well-established use, supported by bibliographic literature
Art. 10b	New fixed combination of active substances
Art. 10c	Informed consent from the holder of an authorised product

Published assessment reports, such as EPARs, "cannot be considered to meet the requirements of Annex I." Every application also needs an environmental risk assessment under Art. 8(3)(ca) (NtA §5, §5.1.4).

Special routes exist for homeopathic products (simplified registration under Arts. 14–15) and traditional herbal products (traditional-use registration). Paediatric requirements also apply (NtA §3.3–3.5).

3. Centralised procedure, step by step

These steps are from EMA:

1. Eligibility request: 18 to 7 months before you submit.
2. Notice of intention to submit: about 7 months before, using the pre-submission request form via the EMA Service Desk. The CHMP and PRAC then appoint (co-)rapporteurs.
3. Pre-submission meeting: 6 to 7 months before. EMA calls this the "best opportunity" to get procedural and regulatory advice.
4. Re-confirm the submission date: 2 to 3 months before.
5. Submit and validate: the dossier goes in as an eCTD through the eSubmission Gateway. EMA then checks it for completeness.
6. Assessment: "up to 210 active days" by the CHMP, with PRAC and CAT input, ending in a CHMP opinion.
7. Commission decision: "within 67 days of receipt of CHMP opinion." The authorisation is valid in all EU Member States plus Iceland, Liechtenstein and Norway.

Fees are on EMA's fees page.

Other options under the centralised procedure (NtA §3.1–3.1.2):

• Accelerated assessment (Art. 14(9), Reg. 726/2004) for products of major public health interest.
• Conditional marketing authorisation (Art. 14(7), Reg. 507/2006), available "only" under the centralised procedure.
• Authorisation under exceptional circumstances, possible under both centralised and national/DCP/MRP routes.
• Orphan designation incentives (Reg. 141/2000), including 10 years of market exclusivity and the possibility to request EMA fee reductions.

4. Dossier and after authorisation

• Dossier format: follow Notice to Applicants Volume 2B (CTD presentation and content). Each authorisation must include an SmPC (Art. 11) and labelling and package leaflet that meet Title V (NtA §2.1–2.2, §5).
• Disclose other applications: you must include copies of authorisations already obtained in other Member States and list the Member States where applications are still under examination (Art. 8(3)(l)) (NtA §3.2).
• Keep the dossier current: it must be regularly updated (Art. 23, Dir. 2001/83/EC; Art. 16, Reg. 726/2004). Variations are handled under Reg. 1234/2008 (NtA §5.1.1).

Pending change

A Council press release dated 28 September 2026 is titled "'Pharma package': Council adopts new rules for a fairer and more competitive EU pharmaceutical sector". That reform would replace parts of this framework. I couldn't open the release, so I can't confirm what it changes or when it applies. Until a new act appears in the Official Journal, the procedures above are the current framework.

If you tell me the product type (new active substance, generic, biosimilar, ATMP, OTC) and the target markets, I can set out the specific route and dossier requirements.