European Union marketing authorization

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 . 

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. 

European Commission. Notice to Applicants, Medicinal Products for Human Use, Procedures for Marketing Authorization, Volume 2A of The Rules Governing Medicinal Products in the European Union, EC, 1998. 

In the European Union, a medicinal product may only be placed on the market when the competent authority of a Member State for its own territory (national authorisation) has issued a marketing authorisation or when the European Commission (EC) has granted an authorisation for the entire Community (Commimity authorisation). 

The term substance of very hi h concern, abbreviated SVHC, is associated with a new process that was introduced to the European chemicals policy through the implementation of REACH the authorization process. This procedure aims (1) to encourage the substitution of substances of very high concern with less harmful substances or alternative technologies and (2) assure the proper control of risks arising from SVHC s. A substance being subject to authorization must principally not be used or placed on the market for any use within the European Union. However, specific uses of an authorized substance may be excluded from this general prohibition if, for example, they are a priori exempted from authorization or if the manufacturer, importer, or downstream user successfully applied for their authorization. The authorization process is laid down in REACH Articles 55-66 and may be initiated by the ECHA on behalf of the European Commission or by EU member state competent authorities. Substances which are subject... 

In the European Union, a very comprehensive initiative with the aim to improve the protection of human health and the environment from the hazards of chemicals, and to enhance the competitiveness of the EU s chemical industry, is under way. It is referred to as REACIT, which stands for Registration, Evaluation, Authorization, and Restriction of Chemicals. REACFf places greater responsibility on industry to manage the risk of chemicals and provide appropriate safety information to professional users and, as far as the most hazardous substances, to consumers. New substances need to be registered before they are placed on the market. REACH came in force on June 1, 2007, with a phased implementation over the next decade. There is no doubt that it will affect the UV/EB industry. 

The release of a new drug onto the market must be approved by the regulating authority for that country. For example, in Britain this is the Medicines Control Agency (MCA), in the European Union it is the European Medicines Evaluation Agency (EMEA) and in the USA the US Food and Drugs Administration (FDA). These bodies, which are essentially consumer protection agencies, issue a so called product licence or marketing authority (MA) when they are satisfied... 

To maintain a forum for a constructive dialog between regulatory authorities and the pharmaceutical industry on differences in technical requirements for marketing approval in the European Union, the United States, and Japan in order to ensure a more timely introduction of new drugs and hence their availability to patients. 

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. 

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