The Cabinet of Ministers has simplified state quality control of imported medicines in order to speed up their delivery to pharmacies and healthcare facilities. Prime Minister Serhiy Koretskyi announced the decision on 14 October. Importers will be able to inspect consignments themselves, with photographic evidence required, whilst repeat deliveries of batches that have already been checked will be processed under a streamlined procedure.
Briefly about the main points
- Importers have been authorised to carry out visual inspections of consignments themselves.
- Quantities, labelling and packaging will be checked and documented with photographs.
- The inspection reports will be sent to the State Service of Ukraine on Medicines and Medical Devices together with the relevant documents.
- A repeat delivery of the verified batch will be processed within one working day.
- The quality and safety requirements for medicinal products remain in force.
Importers will inspect consignments, but the final decision rests with the State Service of Ukraine on Medicines and Medical Devices
An authorised representative of the importing company will be able to carry out a visual inspection of the consignment of medicinal products. They must verify that the actual quantity of goods matches the accompanying documents, and check the labelling and the integrity of the packaging.
The results of the inspection must be documented in photographs. These materials, together with the relevant documents, will be submitted to the State Service of Ukraine for medicines and drug control.
It is the State Service of Ukraine on Medicines that will make decisions and issue opinions on the quality of imported medicines. Consequently, an independent inspection by the importer does not replace the state assessment of the medicines.
An expedited inspection procedure will apply to repeat consignments
If an importer re-imports medicinal products from the same batch that has already been inspected, the inspection should take one working day. This should reduce delays for medicines regularly purchased by pharmacies, hospitals and pharmaceutical distributors.
Previously, the procedure involved checking documents, an inspection of the consignment by representatives of the regulatory authority and, where necessary, laboratory analysis. Large consignments of medicines could remain in warehouses until these procedures had been completed.
The simplified procedure does not remove state control. Imported medicines must meet quality and safety requirements, and in the event of non-compliance or where there are grounds for further inspection, the control mechanisms provided for by law will apply.
The decisions are linked to risks for warehouses and pharmaceutical logistics
The government has approved the changes in the wake of systematic Russian strikes on pharmaceutical warehouses and logistics facilities. In MINISTRY OF HEALTH It has previously been explained that the long-term storage of large consignments of medicines in a single location increases the risk of them being destroyed as a result of shelling.
In September, the Ministry and representatives pharmaceutical market They discussed the distribution of stocks and the continuity of supply. The explanatory notes to the draft resolution stated that the use of photographic evidence during visual inspections should reduce the time medicines spend in warehouses.
In the previously published draft, it was proposed that the temporary mechanism be applied until 1 January 2027, when the new pharmaceutical regulatory system is due to come into force. The practical application of the adopted procedure will depend on the relevant regulatory act coming into force.
