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Frequently asked questions

How are medicines authorised within the European Union?

A special system for the authorisation of medicinal products for human and animal use in the European Union was introduced in 1995, with the objective of ensuring that safe, effective and high quality medicines are made available to citizens across the European Union.

Before a medicinal product can be placed on the market in the European Union it must receive a marketing authorization by a competent authority. Within the European Union medicines can be authorised either in one Member State only through the national authorisation procedure of that country, or in more Member States simultaneously through one of the following three procedures: the 'centralised procedure', the 'mutual-recognition procedure' or the 'decentralised procedure'.

How can I be informed when there are new, major safety concerns about a centrally authorised medicine?

Whenever there are new major safety concerns about a centrally authorised medicine, the European Medicines Agency publishes safety alerts to inform patients and healthcare professionals about these developments. This information is published either as a 'Product-safety announcement' or as a 'Public statement', and is sometimes accompanied by a question-and-answer document providing clear and concise information about the issue concerned.

How is the safety of medicines monitored after they are authorised and placed on the EU market?

Once a new medicine is authorised and placed on the market its safety continuues to be monitored throughout its entire life cycle through the EU system of pharmacovigilance. This system ensures that any product, which presents an unacceptable level of risk, is rapidly withdrawn from the market.

What is the role of the European Medicines Agency?

The role of the European Medicines Agency (EMEA) is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health.

The key tasks of the EMEA are to:

  • provide Member States and Community institutions with the best possible scientific advice on questions about the quality, safety and efficacy of medicinal products for human and veterinary use;
  • establish a pool of multinational scientific expertise (by mobilising existing national resources) in order to achieve a single evaluation via the centralised or mutual recognition marketing authorisation procedures;
  • organise speedy, transparent and efficient procedures for the authorisation, surveillance and where appropriate, withdrawal of medicinal products in the EU;
  • advise companies on the conduct of pharmaceutical research;
  • reinforce the supervision of existing medicinal products (by co-ordinating national pharmacovigilance and inspection activities);
  • create databases and electronic communication facilities as necessary to promote the rational use of medicines.

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