Medicinal Products

Transfer of Marketing Authorisation

(Version 2.1, 31 August 2021)

The marketing authorisation holder initiates the procedure for transfer of marketing authorisation by submitting the application to the Agency for Medicinal Products and Medical Devices (HALMED) in Croatian or English language.

The application(s) for transfer of marketing authorisation has to be submitted on the application form for transfer of marketing authorisation, the form should be filled in and signed by responsible/authorised person of the current marketing authorisation holder (it is not necessary to prepare a cover letter additionally).

When submitting the application for transfer of marketing authorisation, the applicant should enclose:

• Statement given by the current marketing authorisation holder consenting with the transfer of the marketing authorisation to another natural or legal person, as well as with the transfer of all rights and obligations of the marketing authorisation holder, complete medicinal product dossier based on which the authorisation was granted including all post-authorisation documentation approved via variation and renewal procedures, as well as with transfer of all pending applications within the Agency submitted by the current marketing authorisation holder (statement must include the name and the marketing authorisation number of the medicinal product, as well as the name and the address of the future natural or legal person to whom the marketing authorisation for the medicinal product is being transferred),
• Statement given by the natural or legal persons to whom the marketing authorisation for the medicinal product is being transferred, accepting the transfer of the marketing authorisation, all the rights and obligations of the current marketing authorisation holder, the complete medicinal product dossier based on which the marketing authorisation was granted including all post-authorisation documentation approved via variation and renewal procedures, as well as all pending applications within the Agency submitted by the current marketing authorisation holder (statement must include the name and the marketing authorisation number of the medicinal product, the name and the address of the current marketing authorisation holder as well as the date from which the rights and the responsibilities will be transferred to another natural or legal person),
• Proof that the seat of the natural or legal person to whom the marketing authorisation is being transferred is in the territory of the European Union,
• Authorisation given by the natural or legal person to whom the marketing authorisation is being transferred, authorising the person to submit the application and communicate with the Agency (for the regulatory procedures following the transfer of the marketing authorisation,
• Statement given by the natural or legal person to whom the marketing authorisation is being transferred not seated in the Republic of Croatia appointing the local representative seated in the Republic of Croatia, including all the information stipulated by Article 79 paragraph 2 point 2 of the Ordinance on Granting Marketing Authorisation for Medicinal Products (Official Gazette No. 83/13, 28/20 and 32/21), if applicable,
• Proof that the natural or legal person to whom the marketing authorisation is being transferred has the person responsible for pharmacovigilance residing in the Republic of Croatia approved by the Agency, or proof of the submitted request to the Agency for approval of the person responsible for pharmacovigilance residing in the Republic of Croatia*,
• Proposal of the summary of product characteristics, package leaflet and labelling with data on the natural or legal person to whom the marketing authorisation is being transferred, as well as the data on the local representative, if applicable,
• Statement given by the natural or legal persons to whom the marketing authorisation is being transferred for nationally authorised medicinal product, confirming that marketing authorisation holder has the necessary means to fulfil the tasks and responsibilities listed in the Medicinal Product Act and in Title IX of the Directive 2001/83/EC, or alternatively the Summary of the Pharmacovigilance System Master File (sPSMF) which includes this statement.
  Statement must be provided in case the pharmacovigilance system will be changed due to the transfer.
  For the medicinal product authorised via MRP/DCP, the document published on the CMDh "Q&A - List for the submission of variations according to Commission Regulation (EC) 1234/2008" pages should be followed,
• Proof of payment of the procedural fee for the transfer (for each marketing authorisation).

Application for transfer of marketing authorisation with its attachments should be submitted to HALMED via CESP. For the nationally authorized medicinal product(s), the application for transfer of marketing authorization should be submitted as an eCTD sequence in accordance with the HALMED guidance Upute za dostavljanje elektroničke dokumentacije o lijeku u eCTD obliku u nacionalnim postupcima. For the medicinal product (s) authorised via MRP/DCP, the application for transfer of marketing authorisation should be submitted in accordance with CMDh Best Practice Guide on the use of the electronic Common Technical Document (eCTD) either as an eCTD sequence or outside the eCTD submitted via CESP. HALMED encourages marketing authorisation holders to submit application for marketing authorisation transfer as an eCTD sequence whenever is possible also in MRP/DCP.

After the marketing authorisation transfer, the new marketing authorisation will have the same expiry date as marketing authorisation of the previous marketing authorisation holder.

The medicinal product released on the market according to the previous marketing authorisation may be on the market no longer than 18 months after the marketing authorisation transfer, if medicinal product will not expire before. After the transfer, the new marketing authorisation holder becomes responsible for the medicinal product.

The marketing authorisation transfer procedure is set out in the:

• Medicinal Products Act (Official Gazette, No. 76/13, 90/14., 100/18.),
• Ordinance on granting the marketing authorisation (Official Gazette, No. 83/13, 28/20 and 32/21).

*The application for approval of a local qualified person for pharmacovigilance has to be submitted to the Agency as a separate application. The criteria that the local qualified person for pharmacovigilance must fulfil and documentation that should be submitted in support of the application are set out in the Ordinance on pharmacovigilance (Official Gazette, No. 83/13).