To the attention of applicants

Note

Please be informed that in the marketing authorisation granted in RO through decentralised/mutual recognition/repeat use procedures, the information regarding the name, address and function(s) of each manufacturer shall be written in line with the information declared in the latest eAF submitted during the European procedure.
Therefore, the applicant is requested at any time to align the information in the eAF regarding the name, address and functions of each manufacturer with the correct information in Modules 3.2.S, 3.2.P.3.1, Annexes 5.6, 5.8, 5.9. and 5.22. (Please refer to the User Guide for the electronic Application Form for a Marketing Authorisation, published by the CMDh).

To the attention of applicants/Marketing Authorisation Holders

For medicinal products submitted for marketing authorisation/MA renewal/authorised through decentralised/mutual recognition/repeat use procedures, with regard to the submission of Romanian translations of product information texts (Annexes 1, 2 and 3 to the MA) within the national step of procedures and variations, the following shall be observed:

– Documents in the word “docx” version must comply with the QRD format in force for mutual recognition, decentralised and referral procedures, posted online at: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/product-information/product-information-templates-human#mutual-recognition,-decentralised,-referral-and-psur-single-assessment-(psusa)-(nationally-authorised-products-only)-procedures-section – spacing and text editing included;

– The reference text for the Romanian translation is the common English text of the medicinal product information approved at the end of the procedure/variation;

– Romanian translations of medicinal product information must be accurate, qualitative and compliant with the English version, from a medical and linguistic viewpoint;

– The changes included for the purpose of the variation(s) shall only be inserted in the latest version of Annexes 1, 2 and 3, as applicable, of the Marketing Authorisation approved by the NAMMDR.