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EU Regulatory Approval

The consultancy for global, pharmaceutical regulatory affairs

Choosing TRAC as your regulatory strategy partner means your product(s) will be brought to market in a safe, effective and timely manner. Here’s some background information that explains the EU regulatory landscape and introduces EU regulatory strategy:


Across the European Union (EU) the European Commission ensures the quality, safety and efficacy of all human and veterinary medicinal products via a regulatory system which consists of regulations and directives implemented by its member states through competent regulatory authorities.

The European Union (EU) is made up of 28 sovereign member states and has 29 competent authorities, with each member state having its own national regulatory agency.

In addition, the European Medicines Agency (EMA) is the central EU body which co-ordinates the existing resources put at its disposal by member states for the evaluation, supervision and pharmacovigilance of medicinal products.

Iceland, Liechtenstein and Norway are also part of the EU regulatory environment. As members of the European Economic Area (EEA) they are allowed to trade in the single EU market without EU membership, but are required to follow parts of EU law.


Read our industry paper to find out more about obtaining European Regulatory Approval


Marketing a product within the EU means obtaining a marketing authorisation (product licence) from the relevant competent regulatory authority. How you do this depends on your products’ active ingredients and the location(s) in which you intend to market your products, so it’s vital to have the appropriate regulatory strategy in place when bringing a product to Europe. Exactly how and where you submit your application – and the process, timelines and costs for approval – will be dictated by whether you’re selling in single or multiple markets.

Applications must be made in the language of the national agency, except for the EMA, which insists on submissions in English. You must provide patient and labelling information in the language (or languages) of the country (or countries) for which you’re seeking marketing authorisation.

Find out how our dedicated regulatory experts can help you