REGISTRATION PROCEDURESFOR MEDICINAL PRODUCTS

PREPARED BY:-SAKSHI

DAHIYA(1456)

• AGENDA• MARKETING AUTHORISATIONS –• DIFFERENT PROCEDURES• TYPES OF APPLICATIONS• COMPLETE/ABRIDGED DOSSIER• DATA EXCLUSIVITY• HERBAL MEDICINAL PRODUCTS• HOMEOPATHIC MEDICINAL PRODUCTS• QUALIFIED LICENCES• PARALLEL IMPORTATION

• MARKETING AUTHORISATIONS• Procedures for application for a marketing• authorisation• Centralised procedure• National procedure• Mutual recognition procedure• Decentralised procedure

• 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.

• 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

• Centralised procedure• The centralised procedure will also be made• mandatory for:• Autoimmune disorders• Viral diseases

• 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.

• 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..

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

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.

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.

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.

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.

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.

Mutual Recognition andDecentralised 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.

• 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)].

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.

• 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.

• 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

• 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

• 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.

• 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)

• 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.

• 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.

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

Herbal Medicinal Products- SimplifiedRegistration Procedure:---Directive 2004/24/EC amending Directive 2001/83/EC – toharmonise procedures in different MSIf a product containing herbal preparation/s satisfies the criteriaoutlined in the directive, then a simplified registrationprocedure may be applied.If the product makes certain “medicinal” claims with a view topreventing or treating a disease, the a full registrationprocedure must be followed to demonstrate that theindications attributed to the product can actually bedemonstrated.If the product is presented as a food supplement and does notmake any medicinal claims, it may still be classified as a foodsupplement (MSA).

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