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Authorisations to market medicinal products are granted by the Irish Medicines Board under the Medicinal Products (control of placing on the market) Regulations 2007

An Irish authorisation is called a Product Authorisation (PA).

Applications to the Irish Medicines Board consist of:
·         Administrative data including EU Part IA form
·         Summary of Product Characteristics (SPC)
·         Product label and package leaflet (Module 1)
·         Summaries of the Dosier (Module 2)
·         Quality data (Module 3)
·         Safety data (Module 4)
·         Efficacy data (Module 5)

The documentation to be supplied is outlined in EU Directives 2003/63/EEC and in guidelines in Volume 3 of the Notice to Applicants and on the EMEA's website. A 'full application' consists of all listed above. All new applications have to be submitted in accordance with the CTD (Common Technical Document) format. Further details on the format of the dossier is described in Volume 2B of the Notice to Applicants.

For 'abridged applications', some or all of the Modules 3,4 or 5 may not be required, as outlined in Chapter 1 of the Notice to Applicants. Once a national authorisation has been obtained, the PA holder can extend the marketing of the product to other EU Member States using the Mutual-recognition procedure.

If a product is to be marketed in more than one Member State, the Mutual-Recognition or Decentralised Procedure should be used.

If the Mutual Recognition procedure is used the product should be authorised in one Member State first (the Reference Member State or RMS). Using this authorisation, the company applies to other 'concerned' Member States (CMS) to 'mutually-recognise' the authorisation of the RMS. The RMS provides an assessment report and the CMS may accept it or raise public health concerns within 50 days of the start of the procedure. Any concerns raised by CMS are addressed by the company and should be resolved by day 90 of the procedure, following which marketing authorisations will be issued by the CMSs. The marketing authorisations are national authorisations, so in Ireland, a PA is granted after an MR procedure.

If no marketing authorisation has been granted in the community, the applicant may make use of a Decentralised Procedure and submit an application in all the Member Sates where it intends to obtain a marketing authorisation at the same time, and choose one of them as reference member state. Based on the assessment report prepared by the reference Member State and any comments made by the concerned member state marketing authorisation should be granted in accordance with the decision taken by the reference Member State and concerned Member State in this decentralised procedure. Full details on the mutual recognition and decentralised procedures can be found in Chapter 2 of the Notice to Applicants.

The EU Centralised Procedure should be used for products referred to in the Annex to Regulation (EC) No 726/2004 and may be used for other applications relating to products containing new active substances, products which constitute a significant therapeutic, scientific or technical innovation or products for which the granting of a community authorisation could be in the interest of patients on a community level. This procedure can also be used for a generic medicinal product of a centrally authorised product. Applications under the centralised procedure are made to the European Medicines Evaluation Agency (EMEA).

Further information on making an application under the centralised procedure is available in Chapter 4 of the Notice to Applicants and from the EMEA

For more information you may contact the Customer Service unit of The Irish Medicines Board at :

Customer Service Unit,
Irish Medicines Board,
Kevin O'Malley House,
Earlsfort Terrace
Dublin 2
Telephone: +353-1-6764971
email:    customerservice@imb.ie

The Irish Medicines Board - www.imb.ie

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