[PDF] eu regulatory

What makes the European medicines regulatory system unique?

The European medicines regulatory system is based on a network of around 50 regulatory authorities from the 30 EEA countries (27 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and EMA. This network is what makes the EU regulatory system unique.

Who is involved in the European regulatory network?

The regulatory network also includes the European Commission, whose principal role in the European system is to take binding decisions based on the scientific recommendations delivered by EMA.

What is EU legislation?

Find legislation EU legislation takes the form of: Treaties establishing the European Union and governing the way it works EU regulations, directives and decisions - with a direct or indirect effect on EU member states. Legislation in force EU law (EUR-Lex) Search for directives, regulations, decisions, international agreements and other act

What is EU law (Eur-Lex)?

EU law (EUR-Lex) Search for directives, regulations, decisions, international agreements and other act Most recent legislative documents A selection of the latest legislative documents available on EUR-Lex Summaries of EU legislation Overview of legislation by subject area Legislation under preparation European Parliament – legislative observatory