EU Pharma legislation
Last Published: 3/5/2018
Competencies in the pharmaceutical sector are shared between the Commission and Member States. Due to national budget responsibilities, pricing and reimbursement remain entirely with the Member States and can vary considerably. European Union-wide pharmaceutical legislation focuses on some aspects of marketing (including packaging), safety, transparency, and authorization procedures.

Marketing Authorization procedure EU-wide authorization for use can be obtained either under
- the “centralized procedure”, handled by the European Medicines Agency (EMEA). This procedure provides one authorization for use that is valid throughout the EU. It is currently required to gain authorization for use for 1) all biotech pharmaceuticals, 2) pharmaceuticals with a newly created active substance used to treat AIDS, cancer, neurodegenerative disorders, and diabetes, and 3) designated “orphan” medical products.

- at the national level, under the “decentralized procedure”. In this case, the principle of “mutual recognition” between European Union Member States applies. The same procedures can be used for products typically considered to be prescription-based or over- the-counter because a product’s EU classification is designated only when authorization is granted.

As stated in article 8 of Directive 2001/83/EC, only organizations established in an EU country may apply for authorization. Therefore, American companies without an office in the European Union must contract with an entity established in the EU to act as their representative. All applicants for marketing authorization must prove that clinical studies were conducted ethically and respected the dignity of individuals, regardless of whether or not the studies were conducted in the EU.

The specific guidelines for clinical studies are set out in the annex to Directive 2003/63/EC. Commission regulations provide strict time limits for the acceptance or rejection of a marketing authorization application. Under both the centralized and decentralized procedures, the EMEA or Member State authorities must make a decision within 210 days. Once a marketing authorization has been granted, companies must obtain a manufacturing authorization if they want to manufacture within the EU or to import to the EU. The time limit for the decision on this application is 90 days. All pharmaceuticals must have labels and package leaflets written in the official language(s) of the country where the product is sold.

The current European policy on data protection provides for a period of “8+2+1” years: generics manufacturers can apply for a marketing authorization of a given drug eight years after the original product was granted marketing authorization, but the generic product in question could be placed on the market only two years later. In the event that new therapeutic benefits are discovered within the first eight years and the rights holder obtains a new authorization for a new therapy, the data protection can be extended by one year. Also, the Paediatric Regulation allows for a six-month patent extension for pediatric medicines that complete certain requirements during their marketing authorization procedure, such as the submission of the results of studies. Advertising of and providing information about prescription pharmaceuticals is severely limited.

In the EU, pharmaceutical prices are not subject to free market forces, and manufacturers are unable to act on the basis of supply and demand. Currently, many EU countries ban the sale of a pharmaceutical until the government fixes a price, and since pharmaceuticals are often either purchased or reimbursed by governments, pricing remains a major issue. The resulting price differences among Member States have allowed for parallel trade, in which medicinal products are placed into circulation in one market and then imported into a second market at a markup, without the permission of the local owner of the intellectual property rights.
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The information provided in this report is intended to be of assistance to U.S. exporters. While we make every effort to ensure its accuracy, neither the United States government nor any of its employees make any representation as to the accuracy or completeness of information in this or any other United States government document. Readers are advised to independently verify any information prior to reliance thereon. The information provided in this report does not constitute legal advice. International copyright, U.S. Department of Commerce, 2018.

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