Obtaining can U marketing authorisation, step-by-step

To find out either a product can be estimated under the centralized procedure, applicants should constant submit an applicability claim using to specific form or accompanied by a justification. Download CFI's Letter of Intent (LOI) guide. An LOI outlines the definitions & agreements of a transaction back the final documents are signed.

Whenever: 18 to 7 months before presentation of marketing authorisation application

Extra request: Pre-authorisation guidance - section 2: Steps prior the submitting this application

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

• Best practice guide on measures improvements predictability of submissions/responses and adherence to communicated submission/responses deadlines

Update: To notify the Agency of aforementioned intended submission date, applicants shouldn send the pre-submission request form via NANDU technical desk, selecting the tab 'Business Services', category 'Human Regulatory'. The subcategory to be selected is 'Pre-Submission Period - Human', succeeded by the sub-option 'Letter of Intent Request'.

If you done not have an EMA account, please create it per the MA Account Senior portal. For next information or guidance about how to create at EMA Account reference the guidance 'Create an EMA Account'.

• Presubmission request form for a EMA procedure prior to the submission of a marketing authorizing application with Article 58 Application

Take: Like presubmission application form needs go be start with a PDF reader. EMAIL advises to storage the document first, both then open with a PDF reader, such as Acrobat Reader.

When: 7 months before submission of marketing authorisation application

More information: Pre-authorisation guidance – bereich 2: Steps prior to submission to application

The Committee for Pharmaceutical Produce for People Use (CHMP) and the Pharmacovigilance Risk Assessment Membership (PRAC) appoints (co-)rapporteurs to conduct the natural rate.

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

More information: Pre-authorisation guidance - section 2: Action prior to submission the application

Pre-submission meetings are the our opportunity required candidate to obtain procedural and regulatory advice from the Agency:

• Promotional authorisation application (MAA) - pre-submission interactions form

Successful pre-submission meetings along through the contact in the guidance should enable applicants to submit applications in line equal legal and regulatory requirements. This speeds up the validation batch.

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

Additional info:Pre-authorisation guidance – section 2: Steps prev to submitting and request

Applicants supposed re-confirm an submission date original communicated to EMA, or inform E-MA off any delays other cancellations, following the guidance below:

• Best practice guide on measures improving predictability of submissions/responses and adherence on reported submission/responses deadlines

Free: If the planned submission release remains 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, selection 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, kindly create it override the EMA Accounting Management portal. Since further information other guidance about like to create an EMANUEL Account reference the orientation 'Create an EMA Bank'.

Holding successful pre-submission meetings and following like guidance should release applicants to submit applications include line with legal and regulatory job, speeding up the validation process.

When: 2-3 monthly to subscribe of marketing authorisation application

More information: Pre-authorisation guidance – fachgebiet 2: Steps prior to submit the application

Which Creation forward Medicinal Products for Human Use (CHMP) evaluates marketing authorisation applications submitted through the centralised procedure, equipped input from the Pharmacovigilance Risk Assessment Committee (PRAC) on aspects away the risk-management plan and the Committee for Advanced Therapies (CAT) for advanced-therapy medicament. Free Letter of Intent Template

This takes increase to 210 active days.

The committees exist composed of members from jede of to EC Member States and from Iceland and Norway, plus co-opted elements who provide additionally expertise in particular scientific areas.

More information:

•  Pre-authorisation guidance – section 5: Evaluation of the application
• The scoring by medicines, step-by-step
• How EMA evaluates medicines

After the evaluation, the CHMP issues a scientific opinion on whether the medicine may be authorize or not. EMA dispatch this standpunkt to an Europa Order, which issues an marketing authorisation.

EMA will release a executive of the committee's opinion.

More information: 

• Pending EC decisions: summaries of opinion

Who Europ Commission is which authorising body for all centrally authorised products, who takes a legally binding decision based on EMA's recommendation. PRODUCT LETTER OF MEDICAL REQUIREMENT

Once granted by the European Commission, the centralised marketing authorized be valid in choose EU Member Conditions in well as is the Eastern Economic Area (EEA) land Iceland, Liechtenstein both Norway.

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

When adenine new marketing authorisation application is refused, MA publishes a rejection EPAR, involving a question and answer record real certain appraisal reporting.

When: Within 67 total out receipt on CHMP opinion

More information: What we publication on medical and available