إجراء مقترح من أوكرانيا: المنتجات الصيدلانية

The draft Order proposes to approve a new Procedure for quality control of medicines during wholesale and retail trade, which establishes the mechanism for conducting incoming quality control of medicines by business entities licensed to conduct wholesale and retail trade in medicinal products, as well as for state supervision (control) in the field of medicines during their wholesale and retail trade. The draft has been developed with the aim of bringing the procedures for quality control of medicines into compliance with Law of Ukraine No. 2469-IX of 28 July 2022 'On Medicines', updating the relevant terminology, and establishing requirements for ensuring the quality of medicines during their wholesale and retail trade. The draft Order, in particular: establishes a 5-year retention period for documents confirming the procurement, storage, transportation, trade, destruction or disposal of medicines; proposes to include medicinal products not accompanied by a package leaflet in the list of medicines prohibited from sale; establishes incoming quality control of medicines at receiving areas through visual inspection by authorized persons before a decision is made to release the respective batches for sale; establishes the procedure for sampling medicines where doubts arise as to their quality or where falsification is suspected, and for submitting such samples to the territorial bodies of Ukrpharmagency for state laboratory quality control in accordance with Article 108 of…