Human Medicines

Under European and Irish legislation, all medicinal products must be authorised before being marketed. Medicinal products marketed in Ireland must be authorised by the Irish Medicines Board (IMB).

EU directive 2001/83/EC as amended defines a medicinal product as:

'Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; Or Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis'.

For further guidance, particularly for vitamins, minerals, herbals and other 'borderline' products, see the IMB Guide to the Definition of a Human Medicine
Marketing authorisations may be obtained using one of the following procedures.

National procedure, with an application directly to the IMB. This procedure should be used only to market the product in Ireland and not in any other Member State or as the basis for a future mutual-recognition application to other Member States.

Mutual-recognition and Decentralised procedures Both the mutual recognition procedure and the decentralised procedure aim at facilitating access to a single market by relying on the principle of mutual recognition. Thus with the exception of those medicinal products which are the subject to the centralised procedure (see Chapter 4 of the Notice to Applicants), a marketing authorisation or the assessment in one member state (the reference member state) is recognised by the competent authorities of the other member states (the concerned member state), unless there are grounds for supposing that the authorisation of the medicinal product concerned may present a serious risk to public health. Further information on the mutual recognition and the decentralised procedures is available from Chapter 2 of the Notice to Applicants and from the Heads of Agencies website.

Centralised procedure The European Medicines Agency (EMA) is responsible for the scientific evaluation of applications via the centralised procedure. Under the centralised procedure, companies submit one single marketing authorisation application to the EMA. All medicinal products for human use derived from biotechnology and other high technology processes must be approved via the centralised procedure. The same applies to all human medicines containing a new active substance intended for the treatment of acquired immune deficiency syndrome, cancer, diabetes or new degenerate diseases and for all designated orphan medicines intended for the treatment of rare diseases.

For medicinal products that do not fall under any of the above mentioned categories companies can submit an application for a centralised marketing authorisation to the EMA for consideration if it is a new active substance or the medicinal product constitutes a significant therapeutic, scientific or technical innovation or the product is in any other respect is in the interest of patients in the Community.

A marketing authorisation granted under the centralised procedure is valid for the entire Community market, which means the medicinal product may be put on the market in all Member States.

Further information on the centralised procedure is available in Chapter 4 of the Notice to Applicants and from the EMA website.

The Irish Medicines Board - www.imb.ie

Human Medicines