And sponsors of clinical trials will pay a fixed fee of MDL 5,000 within 10 days of authorization. These fees will be transferred to the account of the Agency for Medicines and Medical Devices (AMDM) and used for waste disposal. It is planned to launch the system of collection of expired medicines in Moldova by December 31, 2025.
The Ministry of Health initiated public consultations on the draft Regulation on pharmaceutical waste management. The document contains provisions on the responsibility of economic operators, as well as the procedure for collection, temporary storage of expired medicines and their transfer to authorized operators. The latter will be selected by the Agency for Medicinal Products and Medical Devices through a public tender, and until its appointment, waste management procedures will be performed by the agency itself.
According to the regulation, waste is classified by type, including cytotoxic and cytostatic medicines, psychotropic and narcotic substances, and infusion solutions. They will be collected in special containers labeled with information on the producing company, type of waste and other data (code, capacity, terms of use, etc.).
It is also stipulated that hazardous waste will have to be collected and treated separately, and information on the quantity, expiration date and batch will be specified in accounting documents. Pharmaceutical companies are required to collect waste from the public and store it in secure facilities that are inaccessible to consumers.
Wholesale drug distributors will be obliged to accept waste from pharmacies and transfer it to authorized operators for disposal. And drug manufacturers will be required to handle waste in secure facilities and enter into contracts with authorized operators for its disposal.
According to preliminary estimates, as a result of the implementation of the new rules, the average annual amount of expenses incurred by economic operators will exceed 12 million lei.
