Transfer of marketing authorisation holder

Documents for transfer of marketing authorisation holder:

Cover letter.

1. Application form.  Application form for this change you can find in the official site of the State Medicines Control Agency of the Republic of Lithuania by the following address: /Common-information  
2. Proof of payment (proof of payment should be provided with the application form submitting to the State Medicines Control Agency of the Republic of Lithuania together with explanation for which application the fee is paid). All information about fees and how to pay them you will find by this link: /Fees 
3. Proof of establishment of the proposed Marketing authorisation holder in the European Economic Area (EEA).
4. A document certifying that the full, updated dossier of the medicinal product or a copy thereof has/have been made available or transferred to the new marketing authorisation holder.
5. The person to whom the transfer is to be granted shall provide documents showing his capacity to perform all the responsibilities required of a marketing authorisation holder under Community legislation, in particular:
   
   * qualified person for Pharmacovigilance together with a Curriculum Vitea and the address, telephone and fax number;
   * scientific service of the MAH in the EEA (the contact person in the country where the application is made).
    
6. PSMF of proposed Marketing authorisation holder.
7. Modified SmPC, package leaflet, labelling texts (both clean and tracked versions) and Mock-ups of the labelling texts.

Application form and document mentioned in point 4 must be signed by both the Transferor and the Transferee.

In the case the transfer procedure concerns a medicinal product whose name is constructed as (international non-proprietary name (INN) / common name + name of the MAH), the name of the medicinal product needs to be changed to reflect the name of the transferee. As a result, the variation to change the name of the medicinal product constructed as (INN / common name + name of the transferee) should be submitted in parallel of the transfer procedure.

/Approved-variations