Licensing a New Product Authorisation
What is a Product Authorisation?
A product authorisation (PA) is an Irish authorisation for a human medicinal product. Applications for authorisations to market new medicinal products are granted by the HPRA under the Medicinal Products (control of placing on the market) Regulations 2007.
Which Licensing Procedure should I use for a New Product Authorisation application?
If a product is to be marketed in more than one Member State, the Mutual Recognition, Decentralised Procedure which results in a national authorisation in relevant member states, or Centralised Procedure can be used.
- Mutual Recognition Procedure (MRP): For an MRP, the product should be authorised initially in one Member State, the reference member state (RMS). The company uses this authorisation to apply to other 'concerned' Member States (CMS) to 'mutually-recognise' the authorisation in the RMS.
- Decentralised (DCP): A DCP is used if no marketing authorisation has been granted in the community for the product.
- Centralised Procedure: The centralised procedure should be used for product applications 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 as referred to in the Annex to Regulation (EC) No 726/2004. This procedure can also be used for a generic medicinal product of a centrally authorised product.
- Where a product is for use in IE only, a purely national application may be made.
Before you apply
Certain application types e.g generics under article 10(1), may not require some or all of the Modules 3, 4 or 5 as outlined in Volume 2A Notice to Applicants Chapter 1 Procedures for marketing authorisation.
Further Information and How to Apply
For full details on MRPs and DCPs, see Chapter 2 of Volume 2A of Notice to Applicants. Further resources are available on the Co-ordination Group for Mutual Recognition and Decentralised Procedures (CMDh) website. For details on the process for submitting requests to the HPRA for DCPs, see the Guide to Submitting a Request for Ireland to act as RMS in a Decentralised Procedure for a Human Medicinal Product.
Applications under the centralised procedure are made to the European Medicines Agency (EMA). For further information on making an application see Volume 2A Notice to Applicants Chapter 1 Procedures for marketing authorisation. Preauthorisation guidance for the Centralised Procedure is available on the EMA website.
Applying for a national product or DCP authorisations in Ireland – slot booking
The HPRA is moving towards a system of slot allocation (expected submission dates) for new national product and DCP authorisation applications. Upon request, applicants will be given a submission slot in an agreed month.
This will help capacity planning for timely assessment of applications and will help maintain access for products on the Irish and European markets.
Slot-booking for national product authorisations
Applicants should contact RMS@hpra.ie no later than two months before their preferred submission date to request their preferred slot. The email subject title should include ‘National MA submission’.
The following documents should be provided when requesting a slot.
- A CMDh common request form for reference Member States (RMS) which is available on the CMDh website.
- A justification of the relevance of the application to the Irish market.
It is important that dossiers are complete before making a request, as delayed submissions may result in the loss of a slot.
If your preferred slot is not available, the next available slot will be allocated within a six-month window. Applicants will receive an email confirmation of a successful slot booking. While the HPRA are adapting to this new process we will try to facilitate applications which require an earlier start date.
Slot-booking for DCP authorisations
If you would like the HPRA to function as an RMS, please contact RMS@hpra.ie as least three months before your preferred submission date to request your preferred slot. The email subject title should include ‘DCP submission’.
When requesting a slot applicants should provide a completed CMDh common request form for an RMS which is available on the CMDh website. It is important that dossiers are complete before making a request, as delayed submissions may result in the loss of a slot.
If your preferred slot is not available, the next available slot will be allocated, within a two-year window. Applicants will receive an email confirmation of a successful slot booking. The HPRA also operates a cancellation list for slots which become available at short notice.
Due to the complexities of Article 10a applications, applicants should obtain national scientific advice before submitting requests for such new applications. Further information can be found on our national scientific and regulatory advice page.
Furthermore, IE routinely participates as a Concerned Member State (CMS) in standard DCP procedures. A zero-day procedure as a CMS may be possible for medicines where Ireland is experiencing a critical shortage of a particular medicine.