This document summarizes the different types of marketing authorizations (MAs) in the European Union. There are national MAs granted by individual countries, as well as mutual recognition procedures (MRP), decentralized procedures (DCP), and centralized procedures (CP) which allow approval in multiple EU states. The MRP and DCP rely on one state conducting an initial assessment, while the CP provides a single approval valid across all EU states. Applications must demonstrate a positive benefit-risk assessment based on quality, safety, and efficacy considerations.

2. Marketing Authorization (MA)
• A license to sell a medicine
• License granted by “Competent Authorities”
• Assessment is benefit/risk based on:
o Quality
o Safety
o Efficacy
Positive risk-benefit balance in favour of patients
& users of products once they reach the market place

3. MAs Types
National MRP DCP CP
National
Application
in individual
countries
Mutual recognition
procedure
• Application
intended for more
than one country
involving at least two
Member States (MSs)
• Product has already
received in a MS a MA
at the time of
application
Decentralized
procedure
• Application
intended for more
than one country
• Product has not
received in a MS a
MA at the time of
application
Centralized Procedure
• 1 marketing
authorization
• 1 (invented) name
• 1 common product
information involving
all EU MSs
Repeat
Use’
Procedures
(RUP)
Duplicate
application

4. National Procedure
1. MA in a single EU MS
(No MA in any other MS & no pending application in a MS)
2. National phase MRP
o Timelines: national
o Result: National approval, national SmPC (difference between MS)

5. Centralized Procedure (CP)
• One single MA application to EMA
• One assessment procedure (scientific committee opinion) based on individual
assessments by Member states (MSs)
• Common decision making process (one European Commission decision)
• One MA valid in all EU member states & EEA
• Timeline CP: 210 days * Accelerated assessment: from 210 to 150 days

6. Mutual Recognition Procedure (MRP)
• Principle of recognition of an already existing national MA by one or more
EU MSs
• Mutual recognition must be used when a product is already authorized in at
least one MS on a national basis & the MAH wishes to obtain a MA for the
same product in at least one other MS.
• The MS that has already authorized the product is known as the Reference
Member State (RMS).
• The RMS submits their evaluation of the product to other MS/s, these are
known as Concerned Member States (CMS).
• The CMS is asked to mutually recognize the MA of the RMS.
• If the applicant is successful, the CMS will then issue a MA for that product
permitting the marketing of that product in their country.
• Allows MSs to rely on each other’s scientific assessments

7. Decentralised procedure (DCP)
• DCP may be used if:
o The product is not already authorized in any MS, but does not want to
use the CP,
o Or the product is not eligible for the CP.
• No existing MA in the EU
• One of the proposed MSs will be asked by the applicant company to act as
RMS.
• The RMS does the initial evaluation of the product & issues a draft
assessment report.
• The other MSs, known as CMS, either agree with the RMS's evaluation or
they ask further questions/raise objections.
• If all the issues are resolved and the application is successful, each MS will
then issue a MA for that product permitting it to be marketed in their
country.
• Simultaneous MAs in more than one MS

8. Repeat Use’ Procedures (RUP)
• RUP is the use of the MRP after the completion of a first MRP or DCP for the
recognition of a MA by other MS “i.e. to include additional MSs that were
not involved in the initial RMP/DCP”
• This procedure can be used in the following situations:
- Either by application to new CMS not involved in the first MRP or DCP
- Or by reapplication to CMS withdrawn from the first procedure
Prior to the repeat use procedure
o The MAH should finalize all ongoing procedures and update the dossier.
o Approximately 90 days before the submission, send a written request for
the Repeat Use Procedure to the RMS and agrees a date of submission.
o Updating of the assessment report
o Submission of the documentation & validation phase
o Mutual recognition phase

9. Duplicate application
Duplicate application is defined by reference to the first application or MA as follows:
- same dossier (copy of modules 1, 2, 3, 4 and 5);
- same legal basis according to Directive 2001/83/EC, as amended;
- different trade name;
- same or different applicant/MAH.
Submission of duplicate applications
By submitting simultaneously or subsequently duplicate applications, the applicants should indicate
in the cover letter and in the m1 of the dossier:
- Application is a duplicate;
- Dossier is identical to the medicinal product taken as reference (first application or MA);
- if other duplicate applications are pending or submitted simultaneously. The applicants should
indicate the procedure number(s), the RMS and all CMSs and in the case of several applicants, if
they are linked or not.
- You have to use the first national MA for the MRP
- You need a national MA to start the MRP, but you don’t have to use an existing MA (submission
of an “updated-copy” application for DCP)
- The CMDh has agreed that a duplicate application of a medicinal product authorized via the
Mutual Recognition Procedure can be accepted via the Decentralised Procedure, provided that the
same Reference Member State issued

10. Legal Basis
Article 8(3) Full Application
• Full dossier; quality, nonclinical and clinical data
Article 10 (1) Generic
• Reference product on the market no less than 8 years
• Same qualitative, quantitative compositions
• Same pharmaceutical form
• Bioequivalence
Article 10 (3) Hybrid (mixed) Application
• Additional non-clinical/clinical data in case:
o Product does not meet definition of generic
o No bioequivalence
o in case of changes in the active substance(s),
o Change to active substance, therapeutic indications, strength, pharmaceutical form or route of administration
Article 10 (4) Biosimilars
• Additional non-clinical/clinical data required in case of:
o Product does not meet definition of generic, esp. differences relating to raw materials or differences in
manufacturing processes of biological product and reference biological product
Article 10(a) Well established use
• Well-established medicinal use of active substance for at least 10 years
• Non-clinical and clinical trial results replaced by appropriate scientific literature
Article 10(b) Fixed combination products
• Active substances used in composition of authorized medicinal products but not in combination
• New non-clinical and clinical data relating to the combination are required
Article 10 (c) Informed consent / Duplicate
• MAH allows reference to data on file to support assessment of other medicinal products with same qualitative &
quantitative composition of active substance & same pharmaceutical form

11. MRP/DCP Overview
Applicant For MRP and DCP applications, the applicant should be the same as the MAH/Applicant
in the RMS
DCP/MRP:
• Flexible - choice of MSs, with different trade names and MA holder
• Possibility of repeating procedure
• Applicant to choose RMS
MRP
• National registration in RMS
• Dossier submission to CMS
DCP
• Submission to RMS and CMS
• Timelines MRP national plus 90 Days
• Timelines DCP 210 Days

12. Contact Details
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