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 Procedure (MRP), Decentralised Procedure (DCP) or Centralised Procedure may be used.

Mutual Recognition Procedure (MRP): For an MRP, the product should first be authorised in one Member State, known as the Reference Member State (RMS). The company then uses this authorisation to apply to other Concerned Member States (CMSs) to mutually recognise the authorisation.

Decentralised Procedure (DCP): A DCP is used where no marketing authorisation has previously been granted for the product in the European Union.

Centralised Procedure: The centralised procedure should be used for applications involving new active substances, products that constitute a significant therapeutic, scientific or technical innovation, or products for which the granting of a Union authorisation would be in the interest of patients across the Union, as referred to in the Annex to Regulation (EC) No 726/2004. This procedure may also be used for a generic medicinal product of a centrally authorised product.

Where a product is intended for use in Ireland only, a purely national application may be submitted.

Before you apply

• Application requirements are set out in Directive 2001/83/EC and the guidance provided in EudraLex Volume 3: Scientific Guidelines for Medicinal Products.
• Applications must be submitted in the Common Technical Document (CTD) format. Further information is available in Volume 2B: Notice to Applicants.
• Applicants should ensure that organisation names and addresses included in their application match the details recorded in the EMA Organisation Management Service (OMS). If details are missing or require updating, an OMS change request should be submitted to the EMA before the application is filed.
• Certain application types, such as generics under Article 10(1), may not require some or all of 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: Notice to Applicants.

Further resources are available on the CMDh website. For information on submitting a request for Ireland to act as RMS in a DCP, see the AUT-G0065 Guide to submitting a request for Ireland to act as RMS in a DCP.

Applications under the centralised procedure are made to the European Medicines Agency (EMA). Further information is available in Volume 2A: Notice to Applicants, Chapter 1 – Procedures for Marketing Authorisation. Pre-authorisation guidance for the centralised procedure is also available on the EMA website.

Applying for a national product or DCP authorisations in Ireland – Slot booking

The HPRA operates a system of slot allocation (expected submission dates) for new national product and DCP authorisation applications. Upon request, applicants will be allocated a submission slot within an agreed month.

This supports capacity planning for the timely assessment of applications and helps maintain access to 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 a slot. The email subject line should include "National MA submission".

CMDh common request form: Applicants should provide a completed CMDh common request form for Reference Member States (RMS), available on the CMDh website.

Irish market relevance: Applicants should provide a justification outlining the relevance of the application to the Irish market. This may include applications for products intended to address significant medicine shortages or where similar products are supplied in Ireland under the Exempt Medicinal Product framework.

It is important that dossiers are complete before making a request, as delayed submissions may result in the loss of a slot.

Due to the complexities of Article 10a applications, applicants should seek national scientific advice before, or concurrently with, submitting a slot request for such applications. Further information is available on our national scientific and regulatory advice page.

For applications under other legal bases, where a slot is agreed, a pre-submission meeting is strongly recommended to ensure dossier readiness. This can be requested in the cover letter for planning purposes.

If a preferred slot is unavailable, the next available slot will be allocated within a six-month window. Applicants will receive email confirmation of a successful slot booking. While the HPRA is adapting to this new process, every effort will be made to facilitate

Current slot availability

Our current slot availability for generic Article 10(1) applications in 2026 is outlined below. Availability for subsequent quarters will be published on a rolling basis.

2026 Quarter 1

2026 Quarter 2

2026 Quarter 3

2026 Quarter 4

Availability changes dynamically and the table is updated every two weeks. Applicants are therefore encouraged to check regularly if they have a preferred submission slot.

* A cancellation list is available for these timeframes. Slots may become available if another applicant cancels an agreed submission slot.