Ukraine is changing the rules for checking imported medicines: control times will be reduced by almost half

The Cabinet of Ministers of Ukraine has updated the procedure for state quality control of medicines imported from abroad. The innovations include reducing the terms of drug testing, simplifying certain procedures for importers, and additional requirements for documentary confirmation of the quality of medicines during martial law.

Imported medicines will be checked faster

One of the key changes was the reduction of the terms for issuing conclusions on the quality of imported medicines.

In particular, it provides for:

From 8 to 5 working days – reduction of the term for issuing a conclusion on the quality of the medicine, if laboratory analysis is not performed.

From 5 to 3 working days – for certain cases of centralized procurement of medicines for state funds.

From 3 to 1 working day – reduction of the term for visual inspection in the event of repeated import of the same batch of medicine.

The government also canceled the requirement to link the submission of applications and inspection of cargo to the place of business of the importer.

It is expected that such changes will simplify the passage of control procedures and reduce the administrative burden on pharmaceutical market participants.

New requirements for importers during martial law

At the same time, the simplification of procedures is accompanied by additional requirements for documentary confirmation of the quality of drugs.

For the period of martial law, importers must provide photographic materials confirming the condition and labeling of medicines.

These include, in particular, photographs of:

group packaging;

external and internal packaging of the drug;

instructions for medical use.

The inspection of the cargo will be carried out by an authorized person of the business entity. After the inspection, he must submit the relevant photographic confirmations and inspection results to the state control body.

Simplifications have been provided for certain medicines

The updated procedure also concerns confirmation of proper conditions for the production of medicines.

For certain countries, the possibility of simplified confirmation of production compliance is provided for in the presence of a GMP certificate – a document certifying compliance with good manufacturing practice standards.

In addition, special rules for laboratory analysis have been established for certain vaccines and other immunobiological drugs.

During inspections, the results of the official release of batches of medicinal products by competent foreign authorities and laboratories may be taken into account.

This will allow the use of the results of preliminary control in cases provided for by the updated procedure.

Will the changes affect the quality of medicinal products

Despite the reduction in inspection periods, the requirements for the safety and quality of imported medicinal products are not canceled.

Importers, as before, must provide the necessary documentation and confirm that medicinal products comply with the established requirements.