New Products

Authorisations to market new medicinal products are granted by the HPRA under the Medicinal Products (control of placing on the market) Regulations 2007.  An Irish authorisation for a human medicinal product is called a product authorisation (PA).   Details on the content of an application are outlined in EU Directives 2003/63/EEC and in guidelines found in Volume 3 of the Notice to Applicants, all of which are available on the EMA's website.

All “full applications” have to be submitted in accordance with the CTD (Common Technical Document) format.   Details on the format of the dossier are outlined 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.

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

If the Mutual Recognition procedure is used the product should be authorised initially in one Member State (RMS). Using this authorisation, the company applies to other 'concerned' Member States (CMS) to 'mutually-recognise' the authorisation of the RMS. Full details on the mutual recognition procedures can be found in Chapter 2 of the Notice to Applicants 

If no marketing authorisation has been granted in the community, the applicant may make use of a Decentralised Procedure (DCP). Full details on the decentralised procedures can be found in Chapter 2 of the Notice to Applicants.

For detailed information on the process for submitting requests please refer to the Guide to Submitting a Request for Ireland to act as RMS in a Decentralised Procedure for a Human Medicinal Product.

Requests should be submitted to using the CMDh Recommendation for classification of unforeseen variations’ as outlined in the guide above.

Another route for the authorisation of human medicines is the EU Centralised Procedure.  This 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 Agency (EMA). 

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