Marketing Authorisation in Europe

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Authorisation Procedures for medicinal products

Procedures for evaluating medicinal products and granting marketing authorisation

The European system for the authorisation of medicinal products for human and animal use was introduced in January 1995 with the objective of ensuring that safe, effective and high quality medicines could quickly be made available to citizens across the European Union.
The European system offers several routes for the authorisation of medicinal products:
  • The centralised procedure, which is compulsory for products derived from biotechnology, for orphan medicinal products and for medicinal products for human use which contain an active substance authorised in the Community after 20 May 2004 (date of entry into force of Regulation (EC) No 726/2004) and which are intended for the treatment of AIDS, cancer, neurodegenerative disorders or diabetes. The centralised procedure is also mandatory for veterinary medicinal products intended primarily for use as performance enhancers in order to promote growth or to increase yields from treated animals.
    Applications for the centralised procedure are made directly to the European Medicines Agency (EMA) and lead to the granting of a European marketing authorisation by the Commission which is binding in all Member States.
  • The mutual recognition procedure, which is applicable to the majority of conventional medicinal products, is based on the principle of recognition of an already existing national marketing authorisation by one or more Member States.
  • The decentralised procedure, which was introduced with the legislative review of 2004, is also applicable to the majority of conventional medicinal products. Through this procedure an application for the marketing authorisation of a medicinal product is submitted simultaneously in several Member States, one of them being chosen as the “Reference Member State”. At the end of the procedure national marketing authorisations are granted in the reference and in the concerned Member States.
Purely national authorisations are still available for medicinal products to be marketed in one Member State only.
Special rules exist for the authorisation of medicinal products for paediatric use, orphan drugs, traditional herbal medicinal products, vaccines and clinical trials.

The EMA and the authorisation procedure

In 1993 the European Medicines Agency (EMA) was founded with the primary task of providing scientific advice of the highest possible quality to the Community Institutions on all matters relating to medicinal products for human and veterinary use. EMA’s main task is to co-ordinate the scientific evaluation of the safety, efficacy and quality of medicinal products which undergo either procedure. All scientific questions arising in these procedures are dealt with by the EMA.
The agency has today established itself as a world-leading agency for the evaluation of medicinal products. It constitutes a major asset in making Europe an attractive location for new pharmaceuticals and allows for speedy and robust authorisation of new innovative medicines.
EMA’s key tasks are to:
  • provide Member States and Community institutions with the best possible scientific advice on questions about the quality, safety and efficacy of medicinal products for human and veterinary use;
  • establish a pool of multinational scientific expertise (by mobilising existing national resources) in order to achieve a single evaluation via the centralised or mutual recognition marketing authorisation procedures;
  • organise speedy, transparent and efficient procedures for the authorisation, surveillance and where appropriate, withdrawal of medicinal products in the EU;
  • advise companies on the conduct of pharmaceutical research;
  • reinforce the supervision of existing medicinal products (by co-ordinating national pharmacovigilance and inspection activities);
  • create databases and electronic communication facilities as necessary to promote the rational use of medicines.

What is a Marketing Authorisation needed for?

 

Orphan Medicinal Product Designation in the EU

What is an Orphan Medicinal Product?

 

 

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Author: DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries......http://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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