Central authorisation of medicines

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In the European Union (EU), medicines can be authorised by the centralised authorisation procedure or national authorisation procedures.

Centralised authorisation procedure

The European Medicines Agency is responsible for the centralised procedure for human and veterinary medicines.

This procedure results in a single marketing authorisation that is valid in all European Union countries, as well as in Iceland, Liechtenstein and Norway.

The centralised procedure is compulsory for:

  • human medicines for the treatment of HIV/AIDS, cancer, diabetes, neurodegenerative diseases, auto-immune and other immune dysfunctions, and viral diseases;
  • veterinary medicines for use as growth or yield enhancers;
  • medicines derived from biotechnology processes, such as genetic engineering;
  • advanced-therapy medicines, such as gene-therapy, somatic cell-therapy or tissue-engineered medicines;
  • officially designated 'orphan medicines' (medicines used for rare human diseases).

For medicines that do not fall within these categories, companies have the option of submitting an application for a centralised marketing authorisation to the Agency, as long as the medicine concerned is a significant therapeutic, scientific or technical innovation, or if its authorisation would be in the interest of public or animal health.

Applications through the centralised procedure are submitted directly to the Agency. Evaluation by the Agency's scientific committees takes up to 210 days, at the end of which the committee adopts an opinion on whether the medicine should be marketed or not.

This opinion is then transmitted to the European Commission, which has the ultimate authority for granting marketing authorisations in the EU.

Once a marketing authorisation has been granted, the marketing-authorisation holder can begin to make the medicine available to patients and healthcare professionals in all EU countries.

National authorisation procedures

Each EU Member State has its own procedures for the authorisation, within their own territory, of medicines that fall outside the scope of the centralised procedure. Information about these national procedures can normally be found on the website of the national medicine authority in the country concerned.

There are also two possible routes available to companies for the authorisation of these medicines in several countries simultaneously:

In some cases, disputes arising in these procedures can be referred to the Agency for arbitration as part of a referral procedure.

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