20.05.2024
To the attention of applicants and Marketing Authorisation Holders of medicinal products for human use
Following the publication of Law 269/2023 in the Official Gazette of Romania, Part I, no. 916/11.10.2023, Law for amendment and supplementation of Law 95/2006 on healthcare reform, republished, as further amended and supplemented, and the publication in the Official Gazette of Romania, Part I, Nr. 331/10.04.2024 of Instruction no. 6226/2024 on the manner of handling the waste of unused and/or expired medicinal products from the population, we inform you of the following:
• Annex 1 (Leaflet) to the MA is amended as follows: in section 5 of the Leaflet, above the last paragraph of the QRD template (Do not dispose of any medicinal product down the drain. Ask your pharmacist how to dispose of medicinal products you no longer use. These measures will help protect the environment.>) the following warning shall be inserted, visible and easy to read, in Times New Roman font, in bold and capital letters: EXPIRED AND/OR UNUSED MEDICINAL PRODUCTS MUST BE RETURNED TO PUBLIC OR PRIVATE HOSPITALS.
The size of the warning text cannot be smaller by more than 2 points than the size of the medicinal product’s name; it is forbidden to insert a text whose font size is larger than or equal to that of the warning, except for the medicinal product’s name.
• Annex 2 (Summary of Product Characteristics) to the MA is amended as follows: in section 6.6 of the Summary of Product Characteristics, the text from the QRD template shall be inserted: “Any unused medicinal product or waste material must be disposed of in accordance with local regulations.”
We hereby bring to the attention of applicants and Marketing Authorisation Holders of medicinal products for human use the fact that these changes do not require a special action (“regulatory” activity) for implementation, if the medicinal products have already been authorised/had their MA renewed, but at the time of submission of the next variation involving the amendment of Annex 1 “Leaflet” and Annex 2 “Summary of Product Characteristics”/”regulatory” activity (e.g. MA transfer) which brings changes to the Leaflet and to the Summary of Product Characteristics, it will be opportune to update this information, but no later than the 31st of December 2028.
For medicinal products which are to obtain marketing authorisation, as part of a procedure for authorisation/renewal of the MA through the national or European procedure(s), this information shall be entered during the evaluation of the texts, as the case may be, namely when issuing Annexes 1 and 2 of the MA at national level.