23.12.2024
To the attention of interested persons
Considering the approval of Order of the Minister of Health no. 5930 of 11.12.2024 regarding the amendment and supplementation of the Annex to Order of the Ministry of Health. 194/2015 on Rules for assessment and approval of advertising of medicinal products for human use, please be advised that the way of transmitting the Forms for declaration of sponsorship activities has been changed:
Article 35, paragraphs (5) and (7) are amended and shall read as follows:
“(5) The declaration of sponsorship activities, as well as of other expenses, other than sponsorship related, carried out under the conditions of paragraph (3) and (4) shall be made according to the forms whose template is provided in Annexes 1 and 2, by electronic signature according to the provisions of Art. 3 points 11 and 12 of Regulation (EU) no. 910/2014, through online applications which can be accessed on the NAMMDR portal: portal.anm.ro.”
Please employ this manner of transmitting the declaration forms, which is the only way of transmitting the forms to the NAMMDR, in line with the legal provisions.
Prior to filling in and transmitting the forms for declaration of sponsorship activities, please consult the completion guide for both sponsors and beneficiaries.