3. • MARKETING AUTHORISATIONS
• Procedures for application for a marketing
• authorisation
• Centralised procedure
• National procedure
• Mutual recognition procedure
• Decentralised procedure
4. • Centralised Procedure
• Based on Regulation 726/2004.
• The centralised procedure is compulsory for
• products developed by biotechnological
• processes and processes which in the opinion of
• the EMEA constitute a significant innovation.
• Any product containing a new active substance
• that has not yet been authorised in any other
• EU country must also utilise the centralised
• procedure for registration.
5. • Centralised Procedure
• Since the review of the legislation it is also
• mandatory for all medicinal products
indicated
• for conditions such as:
• AIDS
• Cancer
• Neuro-degenerative disorders
• Diabetes
• Orphan medicinal products
6. • Centralised procedure
• The centralised procedure will also be made
• mandatory for:
• Autoimmune disorders
• Viral diseases
7. • Centralised Procedure
• The centralised procedure starts with an
• application to the EMEA. Applicants have the
• opportunity to meet the EMEA to discuss
• procedural, regulatory and legal issues.
• Applicants are also obliged to inform the
• EMEA of their intention to submit an
• application and give a realistic estimate of
the
• month of submission.
8. • Centralised Procedure
• The scientific evaluation of the
• application is caried out within the
• Committee for Medicinal Products for
• Human use (CHMP)and a scientific
• opinion is prepared.. The EMEA and
• CHMP have 210 days to prepare the
• scientific opinion..
9. Centralised Procedure
• If, during the procedure it becomes apparent the
• additional information is necessary, the applicant is
• notified and the clock is stopped. The evaluation of
• the facts is carried out by the rapporteur and
corapporteur
• appointed by the CHMP and these
• prepare the report in collaboration with the assessors
• in the national competent authorities. The opinion is
• sent to the European Commission which drafts a
• decision
10. Centralised Procedure
• Having consulted the Member States through
• the relevant Standing Committee, on which all
• MS sit, the Commission adopts a decision and
• a market authorisation is granted. A
• marketing authorisation granted under the
• centralised procedure is valid for the entire
• community market, which means that the
• medicinal product may be put on the market in
• all Member States.
11. Centralised Procedure
• The product information – mainly the package
• leaflet and the Summary of Product
• Characteristics (SmPC), in all the official
• languages of the community must be included
• in the marketing authorisation. The decision is
• published on the European Commission
• website. The EMEA publishes a public
• assessment report of the product.
12. National Procedure
• The national procedure is the starting point for
• the mutual recognition and decentralised
• procedures.
• In order to obtain a national marketing
• authorisation, an application must be
• submitted to the competent authority of the
• MS. If the product is already authorised in
• any one of the EU/EEA countries, the national
• procedure cannot be used.
13. National Procedure
• The national procedure should be finalised and
• a national marketing authorisation issued
• within 210 days from the receipt of a valid
• application. A valid application is one that
• includes all the requirements for the type of
• application i.e. all documentation has been
• submitted. The assessment can only start once
• all the necessary documentation has been
• received.
14. National Procedure
• When a marketing authorisation is
• issued nationally, the authorisation is
• valid only in the country where it has
• been issued and can be placed on the
• market only in that country.
15. Mutual Recognition and
Decentralised Procedures
• Both the decentralised (DCP) and the mutual
• recognition procedures (MRP) are based on
• the recognition by national competent
• authorities of a first assessment performed
by
• the authority of one Member State. The legal
• basis for these applications is in Directive
• 2001/83/EC as amended – articles 27-39.
16. • In both procedures, a marketing
authorisation or the assessment in one MS
(called the Reference Member State (RMS),
ought to be recognised by the other MS
involved in the procedure [the Concerned
Member States (CMS)].
17. Mutual Recognition Procedure
• The MRP is to be used in order to obtain
• marketing authorisation in several member
• states.
• The MS involved in the procedure have to
• approve the assessment report written by
the
• RMS, the Summary of Product Characteristics
• (SmPC), the package leaflet and the labelling.
18. • During validation the CMS mark that the
• application is valid on CTS and if not, state the
• reasons why it is not valid and the procedure
• cannot start.
• If the CMS do not mark it (as invalid or
• valid) on CTS by Day -7, the RMS assumes
• that it is valid, the clock starts and the
• procedure proceeds.
• The CMS have 50 days to examine the
• assessment report prepared by the RMS and
• give an opinion.
19. • On day 50 at the latest the CMS either:
• Recognises the decision of the RMS and the SmPC
• approved by it and states that it is ready to grant a
• marketing authorisation; or
• Considers there are “potential serious risks to public
• health” and states that it is not ready to grant a
• marketing authorisation.
• In both cases, the CMSs send their comments to the
• applicant and the RMS
20. • By Day 60 the applicant sends the response
• document to CMSs and RMS
• Until Day 68, the RMS circulates their
• assessment of the response document to the
• CMSs
• By Day 75, the CMSs send their remaining
• comments to the RMS and applicant. A break
• out session can be organised between day 73
-
• 80
21. • By day 85, the CMSs send any remaining
• comments to the RMS and applicant
• By day 90, the CMSs notify the RMS and the
• applicant of the final position. If not ready to
• grant a MA the CMS must also inform the
• secretariat at the EMEA.
• If consensus is reached at this point the RMS
• closes the procedure and a MA can be granted
• in all involved MS.
22. • If consensus is not reached, the points of
• disagreement submitted by the CMSs to the RMS
• are referred to CMD(h) within the next 7 days.
• 60-day CMD procedure will follow and the points
• of disagreement are discussed during the first
• monthly CMD(h) meeting held at the EMEA.
• The CMD (Co-ordination group for the Mutual
• Recognition and Decentralised Procedures) has
• been set up by the new legislation (Chapter 4 of
• Directive 2004/27/EC)
23. • If consensus is reach at CMD(h) by Day 150,
• the RMS closes the procedure and a MA can
• be granted in the MS involved in the
• procedure.
• If consensus is not reached the RMS refers the
• matter to the CHMP.
• A decision of the CHMP finally becomes a
• commission decision and effects the product
• also in those MS where it is already authorised.
24. • 5 days after the close of the procedure, the
• applicant has to send in high quality
• translations of the SmPC, PL and labelling to
• the RMS and CMSs.
• Within the next 30 days, the granting of the
• national MA has to take place in the CMSs.
25. Decentralised Procedure
• The decentralised procedure has been created
• with the review of the legislation and added to
• the mutual recognition procedure for
• registration of a product in more than one MS.
• This procedure is intended for medicinal
• products which do not have to be admitted by
• the centralised procedure and which have not
• yet been granted a MA in a MS
26. Herbal Medicinal Products- Simplified
Registration Procedure:---
Directive 2004/24/EC amending Directive 2001/83/EC – to
harmonise procedures in different MS
If a product containing herbal preparation/s satisfies the criteria
outlined in the directive, then a simplified registration
procedure may be applied.
If the product makes certain “medicinal” claims with a view to
preventing or treating a disease, the a full registration
procedure must be followed to demonstrate that the
indications attributed to the product can actually be
demonstrated.
If the product is presented as a food supplement and does not
make any medicinal claims, it may still be classified as a food
supplement (MSA).
