Renewal of Marketing Authorisation
(Version 2, 8 February 2021.)
The renewal of a marketing authorisation (hereinafter: renewal) is initiated by the marketing authorisation holder (MAH) by submission of an application to the Agency for Medicinal Products and Medical Devices (HALMED), at least nine months prior to the expiry of the marketing authorisation.
Premature submissions should be avoided, except in cases of earlier renewal due to harmonisation in accordance with paragraph 1 of Article 42 of the Ordinance, as such renewal data may not be sufficiently up to date for HALMED to adopt a decision on the renewal.
For the purposes of renewal, the following documents/documentation should be submitted:
1. Cover letter for renewal in Croatian or English. Cover letter should contain information listed below and should be signed by MAH's responsible/authorised person.
For renewals of NP marketing authorisations, a cover letter should contain the following information:
- name and address of a MAH applying for renewal,
- name of medicinal product(s) and the corresponding marketing authorisation number(s) for packaging(s), for which renewal(s) is(are) requested.
For renewals of MRP/DCP marketing authorisations, a Cover letter template for renewals published by the Co-ordination group for MRP and DCP (CMD(h)) should be used.
2. Application form for renewal, completed in Croatian or English, signed by MAH’s responsible/authorised
EU electronic Application form (eAF) for renewal is available under the following link eSubmisson/EU Electronic Application Forms.
The annexes of the eAF should be enclosed, as applicable, with the submitted application for renewal.
Proof of payment is mandatory with the eAF and includes:
- proof of payment fee(s) for renewal according to HALMEDˈs fees and
- proof of payment of the administrative fee according to the Administrative Fee Tariff.
3. Module 1 and Module 2: submission and the content of the consolidated modules for renewal
- depends on the legal basis of the medicinal product and
- should be prepared in line with the CMD(h) guide "Best Practice Guide on the processing of renewals in the Mutual Recognition and Decentralised Procedures" which applies for the renewals of a marketing authorisations granted by MRP, DCP and NP. This guide, as well as other guides/requirements useful for the renewals, are published on the CMD(h) website on https://www.hma.eu/95.html.
If requested by HALMED, the MAH should provide medicinal product samples and assigned reference standards for quality control for the purpose of the renewal.
The MAH may include changes to the summary of product characteristics, package leaflet and labelling of the medicinal product in the application for renewal only in the cases of the change resulting from:
- harmonisation of the pharmaceutical form and/or its components in line with the Croatian Pharmacopoeia,
- harmonisation of the summary of product characteristics, package leaflet and labelling with the current version of QRD templates, not affecting the content thereof,
- conclusions of the non-clinical and/or clinical overview and affecting the benefit/risk balance of the medicinal product.
For any other change to the terms of a marketing authorisation/approved product information or medicinal product dossier, the MAH is required to submit a separate application for variation, in line with HALMEDˈs instructions for Variations.
The renewal procedure is set out in the following legislation: