A Ukrainian enterprise belonging to a well-known international group specializing in the production and sale of pharmaceuticals, healthcare products, and household goods filed a complaint with the Business Ombudsman Council against the State Service of Ukraine on Medicines and Drugs Control (SMDC). One of the SMDC’s regional bodies issued a decision stating that the company’s manufactured medical devices did not comply with the Technical Regulation on Medical Devices approved by Cabinet of Ministers Resolution No. 753 (Technical Regulation No. 753).
According to the regulatory authority, the violations consisted of the manufacturer placing the instructions directly on the packaging instead of inserting them inside, issues with labeling, and the expiration date being indicated in an “incorrect” format. As a result, the authority insisted on the need to bring the products into compliance with the established requirements.
The company attempted to independently communicate with the SMDC at the central level to clarify the situation but received no response. Having previous positive experience cooperating with the Business Ombudsman Council, the company submitted a complaint to the institution.
The Council thoroughly examined the case and supported the company’s position in addressing the SMDC and the Ministry of Health (MoH).
The Council emphasized that the format of the usage instructions and the depiction of the “manufacturer” symbol complied with international standards and, therefore, also met the requirements of Technical Regulation No. 753. Regarding the expiration date format, the Technical Regulation does not specify the procedure or sequence for indicating such dates. Furthermore, it turned out that the MoH had previously issued clarification regarding the application of Technical Regulation No. 753 in such cases. In this clarification, the MoH did not object to the correctness of placing the instructions on the inner side of the packaging or to the indication of the expiration date in the format used by the manufacturer, namely “month.year.”
As a result of the Council’s communication with the SMDC, the decisions stating non-compliance of the medical devices with Technical Regulation No. 753 were canceled.
