The European Business Association (EBA) has asked Ukraine's Ministry of Economic Development and Trade to accelerate the introduction of changes to the requisite government resolution regarding markings on medical products. It says this will help resolve the issue that has arisen because of the uncertainty of the format of a number of an agency that has certified (Conformity Assessment Body, CAB) the medical product.

"The lack of clear rules in legislation, on the one hand, and the lack of current instructions of state agencies, on the other, has led to a situation where producers used the known European rules for assigning conformity assessment numbers to their products. It was not known on the market, probably, whether such a format for assigning numbers could be accepted by state agencies, which will check the medical products on the market," the EBA said.

The association said instructions published in February 2017 recognized the full format CAB format as correct at the same time that on the market of medical products with the abbreviated CAB designation were being used.

The EBA said discrepancy could result in the disruption of products.

A solution to the problem depended on the cooperation of three state agencies, the Economic Development and Trade Ministry, the Health Ministry, and Ukraine's State Pharmaceutical Agency.

Efforts to solve the problem have progressed. Changes to the Economic Development and Trade Ministry's order agreed on with the other two state agencies have been made.

The EBA, meanwhile, has warned that the absence of agreed-upon normative acts could impact the medical products market negatively.

"Until the changes are adopted and the legislative issue is worked out there will remain tension on the medical products market. There are cases of blocking pharmaceutical products and imposing fines on drug producers for their use of the CAB format and product expiration. Retail chains are sending signals about possibly refusing to receive medical products which are 'improperly' marked. The issue has not only led to extra expenses and complications for producers, but also threatens the stoppage of sales of medical products and is becoming the cause for possible levying of fines," the EBA said.

The EBA asks the Economic Development and Trade Ministry to hasten the introduction of needed changes in a directive, and asks Ukraine's Health Ministry to issue instructions on the legitimacy of the requisite format of CAB certification on the market.

"Health Ministry instructions will allow avoiding the stoppage of sale of qualified medical products because of CAB markings," the EBA says.

The association also says the problem bears no relations to the quality of medical products and is purely technical in nature.