Updated instructions for the Transfer of Marketing Authorisation
21.05.2026
The Agency for Medicinal Products and Medical Devices (HALMED) hereby informs applicants/marketing authorisation holders in the Republic of Croatia that an updated instruction for the Transfer of Marketing Authorisation and the revised Application Form for the Transfer of Marketing Authorisation, have been published on the HALMED website.
Compared to previous versions, the updated documents specify that if the Marketing Authorisation transfer results in a change of holder of the Pharmacovigilance System Master File (PSMF), a Type IAIN C.8.a variation must be submitted. This submission must comply with the current Variations Classification Guideline and document published on the CMDh website "Q&A - List for the submission of variations for human medicinal products according to Commission Regulation (EC) 1234/2008 as amended."
This requirement applies to medicinal products authorised via national or MRP/DCP procedure.
Marketing Authorisation Holders should submit the above-mentioned variation in a timely manner and in accordance with applicable regulatory requirements in order to ensure that regulatory data remains up to date and the pharmacovigilance obligations are continuously fulfilled
