To the attention of interested persons
After publication in the Official Gazette of Romania of Government Emergency Ordinance no. 35/2012 amending and supplementing certain healthcare regulations, Part I, No. 434/30.06.2012, errors have been detected under section 49, concerning amendment of Article 739 of Law 95/2006 on healthcare reform, Title XVII – The medicinal product.
As a consequence, the NAMMD will undertake the required steps in to rectify such errors in in the Official Gazette, as soon as possible, by replacement with the text below.
Rectifications are written in red.
49. Article 739 is amended and will read as follows:
“Article 739 – (1) Before any decision is reached on an application for a marketing authorisation or on the suspension or revocation of a marketing authorisation, or on any other variation of the marketing authorisation which appears necessary, in specific cases where the interests of the European Union are involved, the National Agency for Medicines and Medical Devices, Member States, the Commission, the applicant or the marketing authorisation holder shall refer the matter to the Committee for Medicinal Products for Human Use, for application of the procedure laid down in Articles 32, 33 and 34 of Directive 2001/83/EC.
(2) Where the referral results from the evaluation of data relating to pharmacovigilance of an authorised medicinal product, the National Agency for Medicines and Medical Devices refers the matter to the Pharmacovigilance Risk Assessment Committee and provisions of Article 81910 (2) shall apply. The Pharmacovigilance Risk Assessment Committee shall issue a recommendation according to the procedure laid down in Article 32 of Directive 2001/83/EC. The final recommendation shall be forwarded to the Committee for Medicinal Products for Human Use or to the Coordination group, as appropriate, and the procedure laid down in Article 81911 shall apply. Where urgent action is considered necessary, the procedure shall apply as laid down in Articles 8199-81911. The National Agency for Medicines and Medical Devices, the competent authority of any other Member State concerned or the European Commission shall clearly identify the question which is referred to the Committee for Medicinal Products for Human Use for consideration and duly inform the applicant or marketing authorisation holder.
(3) The National Agency for Medicines and Medical Devices and the applicant or the marketing authorisation holder shall supply the Committee for Medicinal Products for Human Use with all available information relating to the matter in question
(4) Where the referral to the Committee for Medicinal Products for Human Use concerns a range of medicinal products or a therapeutic class, the procedure may be limited to certain specific parts of the authorisation; in that event, Article 743 shall apply only if they were covered by the authorisation procedures referred to in this section.”