top of page

Ireland HPRA: Guide to Renewal of Marketing Authorisations –Human Medicines

Irelands Health Products Regulatory Authority (HPRA) released guidance on "Guide to Renewal of Marketing Authorisations - Human Medicines" which provides an overview of the renewal process, including the timelines and requirements for submitting a renewal application. It explains the importance of timely renewal to ensure the continuous availability of medicines on the market.

The EU application form for renewal of a marketing authorisation (MA) must be used, regardless of whether the product is authorised nationally or through mutual recognition (MR).

The form is available on the European Commission website. The application must be submitted at least nine months before the current authorisation expires.

Generally, products authorised nationally or by mutual recognition must be renewed within 30 days for all legal grounds of approval. An EU application (without annexes) with a declaration that full documentation will be available upon request is required for a standard 30-day renewal procedure.

The applicant must submit a cover letter following the format of the CMDh template and an EU application form (without annexes). It is not possible to change MA particulars during the standard renewal process. The introduction of minor changes may be accepted during an expanded renewal procedure. If no changes to the product information are proposed, a clean version of the latest product information should be submitted.

An addendum to the clinical overview must be submitted with all expanded renewal applications. The addendum must consist of a critical discussion addressing the current benefit/risk balance for the product, on the basis of the consolidated safety and efficacy data accumulated since the granting of the initial MA or the last renewal.

For sites within the EEA, current manufacturing authorisations or certificates of GMP compliance should be provided for the manufacturer(s) of the medicinal product listed in the application form. For sites outside the EEA, documentary evidence issued by an EEA competent authority or MRA partner authority indicating the date, inspection team and outcome of the most recent inspection at the site is required.


To know more in-depth about the Quality overview, Documentation validation checks, etc. click this LINK.



bottom of page