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 (EU). 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.

Applicants may apply in parallel for an EU marketing authorisation under the centralised procedure and an opinion for their medicine to be used outside the EU. For more information, see Medicines for use outside the European Union.

Steps prior to submitting an application (updated)

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

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: Best practice guide on measures improving predictability of submissions/responses and adherence to communicated submission/responses deadlines Update: To notify the Agency of the intended submission date, applicants should send the pre-submission request form via EMA service desk, selecting the tab 'Business Services', category 'Human Regulatory'. The subcategory to be selected is 'Pre-Submission Phase - Human', followed by the sub-option 'Letter of Intent Request'. If you do not have an EMA account, please create it via the EMA Account Management portal. For further information or guidance about how to create an EMA Account reference the guidance 'Create an EMA Account'. Pre-submission request form for a EMA procedure prior to the submission of a marketing authorisation application or Article 58 Application Note: This presubmission request form needs to be opened with a PDF reader. EMA advises to save the document first, and then open with a PDF reader, such as Acrobat Reader. When: 7 months before submission of marketing authorisation application More information: Pre-authorisation guidance – section 2: Steps prior to submitting the application

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

Pre-submission meetings (recommended)

Pre-submission meetings are the best opportunity for applicants to obtain procedural and regulatory advice from the Agency: Marketing authorisation application (MAA) - pre-submission interactions form 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

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: Best practice guide on measures improving predictability of submissions/responses and adherence to communicated submission/responses deadlines Update: If the planned submission date is changed, applicants must inform EMA by re-sending the completed pre-submission request form, stating the new intended submission date in the corresponding field. It must be sent via EMA Service Desk, selecting the category 'Business Services' category 'Human Regulatory'. The subcategory to be selected is 'Pre-Submission Phase - Human', followed by the sub-option 'Notification of Change Request'. If you do not have an EMA account, please create it via the EMA Account Management portal. For further information or guidance about how to create an EMA Account reference the guidance 'Create an EMA Account'. 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

Submission 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: What is eSubmission? Pre-authorisation guidance  - section 4: Submission, valiadation and fees

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: Pre-authorisation guidance - section 4: Submission, valiadation and fees

 

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:  Pre-authorisation guidance – section 5: Assessment of the application The evaluation of medicines, step-by-step How EMA evaluates medicines

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:  Pending EC decisions: summaries of opinion

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

 

Voluntary sharing of market launch intentions: pilot project

From 25 March 2021, marketing authorisation applicants for orphan medicines and medicines to treat cancer will be invited to take part in a pilot project by declaring their market launch intentions on a voluntary and confidential basis.

The pilot aims to help regulators understand why delays may occur in the marketing of certain medicines in EU Member States after they receive a marketing authorisation.

EMA will invite marketing authorisation applicants to share this information via an online survey at the time of validation or when they receive the CHMP opinion. 

They will be also asked to provide feedback on challenges and limiting factors they face in ensuring the availability of their medicines in the EU.

The pilot project ran for 18 months until August 2022. The pilot is now closed.

The European Commission, EMA and the national competent authorities are running this pilot in the context of the Pharmaceutical strategy for Europe.

More information and guidance for applicants is available on the European Commission's website and in the question-and-answer (Q&A) document below.

Pilot project ‘Market Launch Intentions of Centrally Authorised Products’ - practical questions and answers

Reference Number: EMA/90075/2021