European Union marketing authorization applications

Similar to the US requirements, there are two regulatory steps to go through before a drug is approved to be marketed in the European Union. These two steps are clinical trial application and marketing authorization application. There are 27 member states in the European Union (as of August 2007) clinical trial applications are approved at the member state level, whereas marketing authorization applications are approved at both the member state or centralized levels. 

Marketing authorization for medicinal products, i.e., radiopharmaceuticals, is required for importation, manufacture, and sale in the European Union. Presentation and content of the dossier is contained in the rules governing medicinal products in the European Union The Rules Governing Medicinal Products in the European Union, Notice to Applicants, Volume 2B Medicinal Products for Human Use. 

If adopted by the national authority in question, the sponsor can seek marketing licences in other countries on that basis. For this bilateral phase, other states in which marketing authorization are sought have 60 days in which to review the application. The theory, of course, is that no substantive difficulty should arise at this stage, as all countries are working to the same set of standards as laid down in The Rules Governing Medicinal Products in the European Union . 

Compliance with the requirements of Directive 2001/20/EC is important. This is because Annex I to Directive 2001/83/EC (as amended) expressly requires that for the purpose of obtaining a marketing authorization, all clinical trials conducted within the European Union to comply with Directive 2001/20/EC. For clinical trials conducted outside the European Union and the data of which are used in support of an application for a marketing authorization, such clinical trials must be designed, implemented, and reported on the basis of principles that are equivalent to the provisions of Directive 2001/20/ EC and carried out in accordance with the ethical principles that are reflected in the Declaration of Helsinki. 

Under the mutual recognition procedure, the applicant company usually ends up receiving national marketing authorisations from some or all of the national drug regulatory authorities to whom the dossier is submitted. The centralised procedure, on the other hand, is all or none , and under it the applicant company would receive a single marketing approval from the EMEA valid in all European Union countries. Rejection of an application under the centralised procedure means that the product cannot be marketed in any Member State. 

Council of Europe (2005) European pharmacopeia, 5th edn. Maisonneuve, Paris European Economic Community (1997) Pharmaceutical legislation for medicinal products for human and veterinary use in the European Union. Good manufacturing practices. (Directive 91/ 356/EEC). Eudralex, vol. IV. European Economic Community, Luxemboiug European Economic Community (1998) Notice to applicants for marketing authorization for medicinal products for human use in the Eiuopean Union, Volume IIA (III/3567/92)... 

European Union, Commission Note for Guidance, Application for Marketing Authorization of Medicinal Products. 

Compassionate use is a treatment option that allows the use of an unlicensed medicine. Compassionate use programmes are for patients in the European Union (EU) who have a disease with no satisfactory authorised therapies or cannot enter a clinical trial. They are intended to facilitate the availability to patients of new treatment options under development. To qualify for a compassionate use programme, the manufacturer calls on the national authorities for permission. The manufacturer must submit a request for the granting of a marketing authorisation or he must perform research in the context of a research programme with a cohort. Compassionate use procedures are also applicable for unlicensed medicines withdrawn from the market or for off-label use of licensed medicines. 

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