AxeRegel
Regulatory and pharmaceutical consulting services for the life sciences industry through the lifecycle of their products
Medicines regulation
Marketing Autorisation (MA)
In order to be marketed in the European Union an industrially manufactured medicine needs to have a Marketing Autorisation (MA) issued by the European Agency of Medicines (EMA) or by one of the national competent authorities (ANSM for France, MHRA for UK....).
The MA of a medicine can be obtained through an European or a national Marketing Authorization application.
European Marketing Autorisation procedures (European MA applications):
- Centralised Procedure (CP)
- Decentralised Procedure (DCP)
- Mutual Recognition Procedure (MRP)
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A medicine can only be marketed if it has a Marketing Authorisation (MA).
A MA is associated to a marketing autorisation number (MA number).
The evaluation of a medicine by the Competent Authorities is based on the evaluation of its benefit/risk balance. If the benefit/risk balance is positive, a Marketing Authorisation can be delivered to a medicinal product.
EU pharmaceutical legislation
The European Union legislation framework for medicines is based on a network composed by the European Commission, EMA and the national regulatory authorities of 31 countries of the European Economic Area (28 European Union Member States, Iceland, Liechtenstein and Norway).
A long process of harmonisation of the pharmaceutical legislation of the European Union countries exists since 1965. The legislation progressively implemented the requirements for the granting of marketing authorisation and the post-marketing monitoring,
EU legal framework of medicinal products:
- Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001
Establishes a Community code for medicinal products for human use.
Defines the Mutual Recognition Procedure.
- Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004
Amends Directive 2001/83/EC on the Community code relating to medicinal products for human use.
Defines the decentralized procedure.
- Regulation (EC) n° 726/2004 of the European Parliament and of the Council of 31 March 2004
Lay down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishes an European Medicines Agency (EMA).
Modifies Regulation n° 2309/93/CEE (defines the centralised procedure).
- Commission Regulation (EC) n°1876-2004 of the Commission of 28 October 2004
Amends Annex I of Regulation (EC) No 953/2003 in order to avoid trade diversion into the European Union of certain key medicines.
- Directive 2005/61/EC of the Commission of 30 September 2005
Implements Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events.
European Union procedures for the granting a Marketing Autorisation (MA) of medicinal products
Medicinal products need to follow EU legislation in order to be commercialized in the European Union. They need to follow:
a Community procedure:
- Centralised procedure (CP)
- Decentralised procedure (DCP)
- Mutual Recognition Procedure (MRP)
or a National procedure.
The Community procedures for granting applications for Marketing Autorisations are intended for medicinal products that will be marketed in several countries.
The national procedure for granting applications for Marketing Authorizations concerns medicinal products that are to be marketed in a single Member State of the European Union.
The new medicine must have an acceptable quality, safety and efficacy profile.
The benefit/risk balance of the new medicine must be at least equivalent to the products already on the market.
If there is a favorable evaluation of a Marketing Autorisation application, a Marketing Autorisation is delivered by the competent Authority and a Marketing Authorization or registration number is attributed to the medicinal product.
Marketing authorization application via the National procedure
The national procedure can only be used if the centralised procedure does not applies.
The Marketing Autorisation dossier must be submitted to the concerned national authority. If the evaluation of the MA dossier is positive, the applicant receives a national Marketing Authorization allowing him to market the medicinal product on that Member State of the European Union.
European Union Marketing Autorisation procedures for medicinal products
Mutual Recognition Procedure
In the Mutual Recognition Procedure, the applicant submits an application dossier for a Marketing Autorisation to the national comptent authority of one of the European Union Member states. Once the Marketing Autorisation is approved on that Member State (RMS: Reference member State), the MA can be extended to the other Member States (CMS: Concerned Member States). In this case, the principle of the recognition of the evaluation made by one Member State (the Reference Member State), by the other Member States (the concerned Member States) where the medicinal product is to be marketed applies.
Decentralised procedure
The decentralized procedure (DCP) is used to apply for Marketing Authorizations of medicinal products not authorised in any EU Member State.
The Marketing Auhorisation dossier is simultaneously submitted in all Member States. The evaluation of the dossier is performed by one chosen Member State that will be the Reference Membre State (RMS). If the Marketing Authorization is approved, it will be in all Members States at the same time. The decentralised procedure is also based on the principle of the recognition of the evaluation made made by one Member State (the reference Member State), by the other Member States (the concerned Member States).
Centralised procedure
The centralised procedure allows companies to obtain, from a single evaluation done by the European Agency of Medicines (EMA), a Marketing Autorisation in all European Union Member States and in the European Economic Area (EEA).
To use the centralized procedure the medicinal product must not be registered in a country of the European Union.
The centralised Marketing Authorization procedure is mandatory for:
- Medicinal products for human use containing a new active substance and for which the therapeutic indication is the treatment of acquired immune deficiency syndrome, viral diseases, cancer, Neurodegenerative disorder, diabetes and auto-immune diseases and other auto-immune dysfunctions
- Products derived from biotechnology
- Advanced therapy veterinary medicinal product
- Advanced therapy medicinal product, like gene therapy medicinal products, somatic cell therapy medicinal products or tissue engineered products
- Orphan medicinal products.
Pharmaceutical companies have also the possibility to submit to EMA a Marketing Autorisation application via the centralised procedure, if the concerned medicine constitutes a significant therapeutic, scientific or technical innovation or if the granting of authorisation is in the interest of patients at Community level .
Centralised procedure steps:
In the centralised procedure the pharmaceutical companies submit to EMA a single Marketing Autorisation application.
The scientific evaluation of the Marketing Autorisation dossier is done by EMA's Committee for Medicinal products for Human Use (CHMP) or by the Committee for Medicinal products for Veterinary Use (CVMP) depending of the type of medicine.
The Committee nominates a rapporteur and a co-rapporteur, among its members, to perform the dossier evaluation and prepare the discussion at the committee.
The Committee has a maximum of 210 days to give a favourable or unfavourable opinion for the commercialisation of the medicine. The opinion is then send to the European Commission, which has the authority to deliver Marketing Authorisations in the European Union.
An European Public Assessment Report (EPAR) where every positive or negative opinion is justified is issued. The EPAR is published at EMA's Website.
In case of European Commission positive decision, the Summary of Product Characteristics (SmPC) and the leaflet of the medicinal product are determined.
Once delivered by the European Commission, the Marketing Autorisation is valid in all member states of the European Union and of the European Economic Area (EEA).
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What are medicinal products?
Click on the image to learn the brief definition.
