EBA points out new wave of blocking medical products on market by public authorities
The European Business Association (EBA) has pointed a new wave of blocking products on the medical products market by public supervision agencies over the unsettled rules of printing the ID number of the appointed Conformity Assessment Body (CAB).
"Over deficiencies in the current legislation and the absence of timely official explanations from public authorities, the issue of printing the CAB ID on medical products in two various forms has resulted in negative consequences on the market," the EBA said in an open letter to the Ukrainian prime minister, economic development and trade minister, acting health minister and head of the State Service of Ukraine for Medicines and Drugs Control.
The association said that these consequences were fines imposed on some companies for wrong labeling, blocking of medical products during the market supervision for several weeks and the refusal to sell products by distributors and retail chains which some manufacturers faced.
The EBA said that the situation on the market received a temporary solution in the form of a letter with tips sent to the territorial departments of the State Service of Ukraine for Medicines and Drugs Control regarding the non-application of restrictive measures and fines on market players, as well as official explanations by the Economic Development and Trade Ministry and the Health Ministry confirming a possibility of using labeling in two forms.
The EBA said that the Cabinet of Ministers of Ukraine should approve the relevant resolution drafted by the Economic Development and Trade Ministry to finally settle the situation.
"Unfortunately, despite the fact that the draft resolution was discussed in public on July 27, 2017, it has not yet been approved. We do not know why it is delayed. We are witnessing a new wave of blocking the medical products by market supervision agencies due to the same reasons," the EBA said in the letter.
The association said that the issue of the CAB ID labeling format does not affect the quality and/or safety of medical products.
