Marketing Authorisations

Medicinal products

In the EU, all medicines must be authorised before they can be marketed to patients. Depending on the type of medicine and the countries the medicine will be marketed in, there are four pathways to obtain a Marketing Authorisation (MA) that will allow a medicinal product to be placed on the Irish market:

Centralised Procedure (CP)

The CP allows applicants to make a single application to the European Medicines Agency (EMA), which, once granted, is valid in all EU Member States. The CP is mandatory for certain medicinal products listed in the Annex to Regulation (EC) 726/2004. Products in scope include:

• Certain medicinal products manufactured using biotechnological processes
• Orphan medicinal products
• Human products containing new active substances i.e. those not authorised in the EU prior to 20 May 2024, and
• Medicines intended for the treatment of certain diseases and conditions such as AIDS, cancer, neurodegenerative disorders or diabetes

Decentralised Procedure (DCP)

For products that are not yet authorised anywhere in the EU, the DCP allows an applicant to apply for simultaneous authorisation in multiple Member States. Under the DPC, a ‘Reference Member State’ (RMS) conducts an initial assessment of the product and issues a draft assessment report to the various ‘Concerned Member States’ (CMS). The CMS have the opportunity to raise objections to the report or ask further questions before agreeing with the draft assessment report. Once any objections or other issues are resolved, the respective parallel applications can proceed in each Member State. Subject to a successful application, each Member State will grant an MA for the product in their country.

MAs are valid for five years from the date of issue. To remain valid in Ireland, an application for renewal must be submitted to the Health Products Regulatory Authority (HPRA) at least nine months before the existing MA is due to expire. Once renewed, an MA remains valid indefinitely, unless the HPRA deems further renewals are necessary on drug safety grounds. Drugs authorised under the CP are renewed by submitting an application to the EMA.

Mutual Recognition Procedure (MRP)

The MRP allows an MA already granted in one Member State to be recognised by other Member States. Under the MRP, rather than undertaking their own assessment of the product, the various CMS recognise the authorisation decision of the RMS.

National Procedure

The national procedure is only applicable if the medicine in question is not already authorised in another EU Member State. This occurs where the applicant already holds an MA in another Member State, in which case, they may not apply for authorisation this way.

In Ireland, the HPRA evaluates applications under the Medicinal Products (Control of Placing on the Market) Regulations 2007[1]. When the HPRA grants an MA, it grants a Product Authorisation (PA) number which must appear on the product’s packaging.

Medical devices and IVDs

The EU Medical Devices Regulation[2] (MDR) and EU Regulation (2017/746), also known as the IVDR, require medical devices and in vitro diagnostics medical devices, or ‘IVDs’, to be validly CE marked in order to be placed on the EU market, including Ireland.

Unlike medicinal products, this pre-market process does not require authorisation or approval from regulatory agencies in EU Member States, or a central EU body. Instead, medical device and IVD manufacturers are required to conformity assess their products against the requirements of either the MDR or the IVDR, as necessary. The steps required as part of that conformity assessment process will be dictated by the detailed provisions of the MDR or IVDR, as applied to the characteristics of the product in question.

In some cases, a manufacturer may be able to conformity assess their product in house and then self-certify their product as compliant with applicable legislation before affixing the CE mark. In many instances, however, the risk classification of the product will require the manufacturer to enlist the services of a notified body (NB). An NB is an independent organisation designated by the European Commission to carry out verification of products against EU requirements. The NB will be required to audit the product and where necessary, the quality management system (QMS) of the manufacturer. Although not strictly speaking a marketing authorisation, this process does result in a set of certificates, usually product and QMS, allowing for the product to be validly CE marked and legally placed on the EU market.

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The content of this article is provided for information purposes only and does not constitute legal or other advice.

[1] S.I. 540/2007

[2] Regulation (EU) 2017/745