Please note that transfer of marketing authorisation holder (the new marketing authorisation holder is a different legal entity) is a national variation to marketing authorisation documentation that will be evaluated by the State Agency of Medicines (SAM) for medicinal products authorised in the national, mutual recognition (MRP) and decentralised (DCP) procedures.
In order to change the marketing authorisation holder, the current marketing authorisation holder must submit to the SAM an application for type II variations. The following data and information should be indicated in the application:
- Name and marketing authorisation number of a medicinal product;
- Name, surname or company and address of current marketing authorisation holder and name, surname or company and address of the new marketing authorisation holder;
- Confirmation of the availability of a complete and updated marketing authorisation dossier (documentation) prior to transfer or availability of its copy and its transfer to the new marketing authorisation holder;
- Confirmation by the new marketing authorisation holder of its ability to ensure the conduct of marketing authorisation holder responsibilities in accordance with the requirements stipulated by normative acts regarding marketing authorisation, medicinal product manufacturing, control, import, export, distribution, labelling and package leaflets, advertising, pharmacovigilance procedure and clinical research, indicating:
- Qualified Person for pharmacovigilance (QPPV), the address of site of operation, e-mail address, phone number (also for contact outside of working hours), their qualification and short description of their work and experience;
- Pharmacovigilance contact person at national level who is residing and working in Latvia. If the person responsible does not reside and work in Latvia, their name, surname, address of site of operation, e-mail address, phone number – also for contact outside of working hours – should be indicated;
- Scientific service that, in accordance with the normative acts regarding advertising of medicinal products, is responsible for information provided about medicinal products – address of the scientific service, e-mail address, phone number and fax number;
- Summary of product characteristics, labelling text and package leaflet where the new marketing authorisation holder is indicated;
- Date when the person, to whom the marketing authorisation will be issued, will take over the responsibilities of the previous marketing authorisation holder;
- Document verifying payment for evaluation in accordance with the Cabinet of Ministers Regulation No. 873 of 17 September 2013 “State Agency of Medicines Publicly Available Paid Service Price List” (Articles 4.5 and 11.5).
Please note that the documents must be signed by both the current and proposed marketing authorisation holder.
If the medicinal product is authorised in MRP or DCP procedure, the transfer of marketing authorisation holder should be submitted via national variation procedure, but changes in the pharmacovigilance system (C.I.8.a) and, if applicable, change of the medicinal product name (type IB A.2) should be submitted as MRP/DCP variations to marketing authorisation documentation. Please see more information on requirements for transfer of marketing authorisation holder in the Cabinet of Ministers Regulation No. 376 of 9 May 2006 “Procedure for Registration of Medicinal Products” (Paragraph 82 and 83).
Submission of documents for transfer of marketing authorisation holder:
- Application form and verifying documentation for marketing authorisation must be submitted electronically, complying with the European guidelines for preparation and submission of documents in the eCTD (electronic Common Technical Document) format;
- The application form is available on eSubmission: EU Electronic Application Forms;
- Upon submission documents for transfer of marketing authorisation, a pre-payment must be made.