Preferred Terms


Marketing authorisation

Abbrev:

Synonym Terms:

Licencing

Definition:

A licence issued by a medicines agency approving a medicine for market use based on a determination by authorities that the medicine meets the requirements of quality, safety and efficacy for human use in therapeutic treatment. There are four application procedures possible in the European Union:
Centralised procedure (CP): Way of approval of medicines valid in all Member States. The CP is administered by the European Medicines Agency (EMEA) in London. It consists of a single application which, when approved, grants marketing authorisation for all markets within the European Union. This procedure is available to all new, innovative medicines, and is obligatory for 1. biotechnology-derived products, 2. new active ingredients for treating AIDS, cancer, diabetes and "neuro-degenerative illnesses" as well as 3. orphan medicines. Under certain conditions the CP can be limited for one year. If the medicine is important for public health (especially therapeutic innovations) the appraisal period can be abbreviated.
Mutual recognition procedure (MRP): The MRP is the most common marketing authorisation procedure in the EU. It states that the marketing authorisation granted in one EU Member State (the so-called "Reference Member State") being "mutually recognised" as valid in other Member State (the "Concerned Member State") upon request. The legal basis is Directive 2001/83/EC, as amended by Directive 2004/27/EC, and further guidance is given in the Notice to Applicants, which forms Chapter 2 of the Rules Governing Medicinal Products in the EU.
Decentralised procedure: The decentralised procedure came into operation in late 2005. It is applicable in cases where a marketing authorisation does not yet exist in any of the EU Member States. Identical dossiers are submitted to all Member States where a marketing authorisation is sought. A Reference Member State, selected by the applicant, will prepare draft assessment documents within 120 days and send them to the Concerned Member States. They, in turn, will either approve the assessment or the application will continue into arbitration procedures. The new decentralised procedure will involve concerned Member States at an earlier stage of the evaluation than under the MRP in an effort to minimise disagreements and to facilitate the application for marketing authorisation in as many markets as possible.
National procedure: Independent national marketing authorisation procedures are still applicable during the initial stage of the mutual recognition procedure in the country that is to act as Reference Member State. They are also applicable in situations in which the mutual recognition procedure is not compulsory, namely: 1. Bibliographical applications for medicines with a well-established medicinal use for which no reference product is available in the EU. 2. Line extensions of nationally registered medicines for which no harmonised product information is available within the EU. Although some changes to dossiers for nationally registered medicines (such as a change in the strength, pharmaceutical form or route of administration) require the submission of a new marketing authorisation application, these changes are considered as variations to a nationally issued marketing authorisation.
Registration: For herbal medicines, homeopathic medicines and medical devices no authorisation but a registration procedure is necessary.