New disposal claim for medicines in Romania
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22 May New disposal claim for medicines in Romania

Posted at 13:14h in Regulatory Affairs by

On May 20, 2024 the Romanian Drug Agency posted an announcement about the necessity to amend the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) regarding the waste management of unused and/or expired medicines from the population, as follows:

  • Annex 1 (PIL) to the Marketing Authorization (MA) is amended as follows: In Section 5 of the Leaflet, above the last paragraph of the QRD template (Do not dispose of any medicine down the drain. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.), the following warning, clearly visible and easy to read, in Times New Roman font, bold and uppercase, will be added: EXPIRED AND/OR UNUSED MEDICINES MUST BE RETURNED TO PUBLIC OR PRIVATE HOSPITALS. The font size of the warning text must not be more than 2 points smaller than the size of the medicine name; inserting text with a font size equal to or larger than the warning, except for the medicine name, is prohibited.
  • Annex 2 (SmPC) to the MA is amended as follows: In Section 6.6 of the Summary of Product Characteristics, the text from the QRD template will be added: “Any unused medicinal product or waste material should be disposed of in accordance with local regulations.“

We draw the attention of applicants and holders of MAs for human medicines that these changes do not require a special action (regulatory activity) for implementation if the medicines have already been authorized or had their marketing authorization renewed. However, at the time of submission of the next variation involving the modification of Annex 1 and Annex 2 or other regulatory activity (e.g., marketing authorization transfer) which brings changes to the PIL and SmPC, it will be appropriate to update this information, but no later than December 31, 2028.

For medicines under authorization/renewal of the MA through the national or European procedure, this information will be entered during the evaluation stage of the texts, as the case may be, respectively when issuing Annexes 1 and 2 of MA at national level.