Application for marketing authorisation in the EU explained
An EU marketing authorisation application needs a legal basis, an eligible route and a CTD dossier. See how to prepare forms and submission documents.
An application for marketing authorisation is the dossier submitted to obtain permission to market a medicine. For an EU human medicine, choose the legal basis and the eligible procedure before you prepare the Common Technical Document (CTD) dossier, the application form and the supporting documents. Directive 2001/83/EC sets out those requirements.
For a centralised application, EMA conducts the scientific assessment and the European Commission grants the authorisation. National authorities grant national authorisations, including those from decentralised and mutual-recognition procedures. This is an EU application, not an MHRA or FDA filing. See EMA's explanation of authorisation routes.
Choose the legal basis for your application
The legal basis sets the evidence for an EU marketing authorisation application (MAA). It's separate from the procedure used to assess it. Routes are not legal bases. Article 8(3) of Directive 2001/83/EC sets out full-application requirements. Articles 10 to 10c provide other legal bases with different evidence requirements:
- A full application under Article 8(3) includes the required quality, nonclinical and clinical documentation.
- Generic applications under Article 10(1) rely on a reference product under that provision's conditions. Hybrid applications under Article 10(3) need appropriate additional nonclinical or clinical evidence for the relevant differences.
- Similar biological products under Article 10(4) require appropriate additional evidence under the provision and relevant guidance.
- Well-established-use applications under Article 10a use appropriate scientific literature, subject to conditions including at least ten years of well-established medicinal use.
- Article 10b covers new combinations of previously authorised active substances, with evidence relating to the combination.
- Article 10c covers informed consent, where an existing holder permits use of its documentation for a qualifying subsequent application.
Don't assume an Article 10(1) generic needs new clinical efficacy trials. An abbreviated legal basis still sits in the CTD structure. The directive's Annex I applies that structure for every procedure, full or abridged.
Select the authorisation route
Use the centralised procedure only when the medicine qualifies. Mandatory categories include specified biotechnology medicines, advanced therapies, orphan medicines, and new active substances for HIV or AIDS, cancer, diabetes, neurodegenerative diseases, auto-immune and other immune dysfunctions, and viral diseases. Optional access covers other medicines with a new active substance for other indications, a significant therapeutic, scientific or technical innovation, or an authorisation in the interest of public or animal health at EU level. Check EMA's eligibility explanation before you plan an EMA submission. For a national, decentralised or mutual-recognition MAA filing, check whether the product is already authorised and which countries are in scope:
| Route | When it applies | Authorisation outcome |
|---|---|---|
| Centralised | Mandatory or optional access conditions are met | European Commission authorisation following EMA assessment |
| National | A single-country application where national authorisation is legally available | Decision by that country's competent authority |
| Decentralised procedure (DCP) | The product is not yet authorised at application | Coordinated assessment, followed by national decisions |
| Mutual-recognition procedure (MRP) | The product is already authorised at application | Recognition through a coordinated procedure, followed by national decisions |
Articles 17 and 18 constrain an independent national application where the same product is already authorised or under examination in another Member State. Article 28 covers DCP and MRP. Both use a reference Member State, concerned Member States and an identical dossier. The outcome is national decisions, not one Commission licence.
And a centrally authorised reference product does not force its generic through EMA. Article 3(3) of Regulation 726/2004 permits national authorisation of that generic under its conditions.
Prepare the application for marketing authorisation
Organise the MAA dossier on the five-module CTD structure in Annex I of the directive:
| Module | Content |
|---|---|
| 1 | EU-specific administrative information |
| 2 | Quality, nonclinical and clinical summaries |
| 3 | Quality: chemical, pharmaceutical and biological documentation |
| 4 | Nonclinical reports |
| 5 | Clinical study reports |
For Module 1, prepare the applicable administrative documents and proposed product information. Annex I examples include the application form, applicant and manufacturer details, manufacturing authorisations, expert declarations and CVs. It also lists the proposed summary of product characteristics (SmPC), labelling, package leaflet and mock-ups. These are examples, not a complete validation checklist. EMA also places product information in Module 1.
A full application under Article 8(3) also needs the listed supporting particulars, including a pharmacovigilance-system summary, a risk-management plan and the specified authorisation history. Other legal bases change that evidence. Don't copy a full dossier across.
The Commission's Notice to Applicants Volume 2B gives CTD guidance. The Commission dates it May 2008 and says the Notice has no legal force. Where the Notice and the legislation diverge, follow the legislation and the current technical instructions.
Check forms and pre-submission requirements
Keep the application form for a marketing authorisation separate from the dossier format: CTD organises the content, eCTD is the electronic format, and the electronic application form (eAF) is the form itself. The Commission states that electronic application forms are mandatory for all procedures. Check the live eAF page for the version and implementation date that apply to your procedure. A centralised date and a national date need not match.
For centralised access, EMA says to submit an eligibility request through IRIS using "Eligibility and letter of intent". Its pre-authorisation guidance recommends eligibility planning 18 to 7 months before submission. Pre-submission interactions usually start 6-7 months beforehand, but not all require a dedicated meeting. These are preparation recommendations, not universal statutory deadlines.
Check paediatric requirements before filing. Where they apply, you need relevant PIP-compliant results, a waiver or a deferral. EMA's pre-authorisation guidance identifies exemptions including Articles 10(1), 10(3), 10(4) and 10a. A PIP is not a filing condition for every legal basis.
For a centralised MAA submission, EMA says the eSubmission Gateway or Web Client is mandatory for the eCTD. IRIS does not take that dossier. These delivery instructions apply to the centralised procedure; check the relevant national authorities for national, DCP or MRP submission channels. Check the eCTD technical page separately from the application form.
Use the chosen authority's live submission calendar, validation checklist, technical rules and fee instructions. Those pages move, and this overview does not replace them.
RegAffairs AI answers the EU marketing authorisation application question here.