Obtaining an EU marketing authorisation, step-by-step

The European Medicines Agency (EMA) is responsible for the scientific evaluation of applications for centralised marketing authorisations in the European Union. This authorisation procedure allows pharmaceutical companies to submit a single marketing authorisation application to EMA and to market the medicine and make it available to patients and healthcare professionals throughout the European Economic Area on the basis of a single marketing authorisation.

Steps prior to submitting an application

Submission of eligibility request

To find out whether a product can be evaluated under the centralised procedure, applicants should always submit an eligibility request using the specific form and accompanied by a justification.

When: 18 to 7 months before submission of marketing authorisation application

More information: Pre-authorisation guidance - section 2: Steps prior to submitting the application

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Notification of intention to submit an application

Applicants should consider the date of submission carefully, referring to the published submission dates and the guidance below:

To notify the Agency of the intended submission date, they should email the pre-submission request form (intent to submit MA) to pa-bus@ema.europa.eu. The selected scope of request should be: 'Centralised Procedure – Intent to submit a MAA'.

When: 7 months before submission of marketing authorisation application

More informationPre-authorisation guidance – section 2: Steps prior to submitting the application

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Appointment of rapporteurs

The Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC) appoints (co-)rapporteurs to conduct the scientific assessment.

For advanced therapy medicinal products, (co-)rapporteurs are also appointed from members of the Committee for Advanced Therapies (CAT), who will lead the assessment.

More information: Pre-authorisation guidance - section 2: Steps prior to submitting the application

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Pre-submission meetings (recommended)

Pre-submission meetings are the best opportunity for applicants to obtain procedural and regulatory advice from the Agency:

Successful pre-submission meetings along with the information in the guidance should enable applicants to submit applications in line with legal and regulatory requirements. This speeds up the validation process.

When: 6 to 7 months before submission of marketing authorisation application

More information: Pre-authorisation guidance – section 2: Steps prior to submitting the application

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Re-confirmation of communicated submission date

Applicants should re-confirm the submission date initially communicated to EMA, or inform EMA of any delays or cancellations, following the guidance below:

If the planned submission date is changed, applicants must inform EMA by re-sending the completed pre-submission request form to pa-bus@ema.europa.eu, selecting 'notification of change' as the scope of the request and stating the new intended submission date in the corresponding field.

Holding successful pre-submission meetings and following this guidance should enable applicants to submit applications in line with legal and regulatory requirements, speeding up the validation process.

When: 2-3 months before submission of marketing authorisation application

More information: Pre-authorisation guidance – section 2: Steps prior to submitting the application

 

Submission of the application

Sumission of the application

Applicants should use the electronic common technical document (eCTD) format and submit the application through the eSubmission gateway or web client.

If EMA needs additional information to complete its validation of the application, it will ask the applicant to supply this by a deadline.

More information:

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Validation of the application

EMA performs a technical validation of the applications it receives. The objective is to make sure all essential regulatory elements required for scientific assessment are included in the application prior to the start of the procedure..

If EMA needs additional information to complete its validation of the application, it will ask the applicant to supply this by a deadline.

More information:

 

Assessment of the application

Scientific evaluation

The Committee for Medicinal Products for Human Use (CHMP) evaluates marketing authorisation applications submitted through the centralised procedure, with input from the Pharmacovigilance Risk Assessment Committee (PRAC) on aspects of the risk-management plan and the Committee for Advanced Therapies (CAT) for advanced-therapy medicines.

This takes up to 210 active days.

The committees are composed of members from each of the EU Member States and from Iceland and Norway, plus co-opted members who provide additional expertise in particular scientific areas.

More information:

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CHMP scientific opinion

After the evaluation, the CHMP issues a scientific opinion on whether the medicine may be authorised or not. EMA sends this opinion to the European Commission, which issues the marketing authorisation.

EMA then publishes a summary of the committee's opinion.

More information: 

European Commission decision on the marketing authorisation

European Commission decision

The European Commission is the authorising body for all centrally authorised products, who takes a legally binding decision based on EMA's recommendation.

Once granted by the European Commission, the centralised marketing authorisation is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.

Commission decisions are published in the Community Register of medicinal products for human use. EMA publishes a European public assessment report (EPAR) for each medicine.

When a new marketing authorisation application is refused, EMA publishes a refusal EPAR, including a question and answer document and an assessment report.

When: Within 67 days of receipt of CHMP opinion

More information: What we publish on medicines and when

 

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