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EBA welcomes simplification of state quality control for imported medicines

16/ 10/ 2026
  On 13 October, the Government adopted Resolution No. 1254, “On Amendments to the Procedure for State Quality Control of Medicinal Products Imported into Ukraine”. The European Business Association welcomes this decision, as it takes into account a number of proposals from the pharmaceutical industry and aims to simplify quality control procedures, shorten medicine delivery times and ensure the continued availability of medicines for Ukrainian patients. Intensified Russian attacks on critical infrastructure, including pharmaceutical warehouses and logistics centres, have already disrupted the supply of certain categories of medicines. As a result, companies have been forced to reorganise numerous processes to ensure that patients continue to have access to medicines, including life-saving treatments and products for which no alternatives are available on the Ukrainian market. The business community has therefore repeatedly highlighted the need to adapt regulatory procedures to the conditions of martial law. Following discussions with the Ministry of Health of Ukraine and consultations with member companies, the Association submitted proposals to simplify certain stages of state quality control for imported medicines, reduce procedural delays and make interactions between businesses and the state regulatory authority more predictable. The adopted Resolution introduces several important changes. For example, an authorised representative of an importing company will be able to inspect a consignment, verify its compliance with the accompanying documents and carry out a visual inspection of medicine packaging, with photographic evidence required. The relevant materials will be submitted to the State Service of Ukraine on Medicines and Drugs Control (the State Medicines Service) to obtain a quality conclusion for the imported medicines. This will reduce the need to wait for physical inspections of consignments by representatives of the state regulatory authority. Another simplification is the possibility of re-importing the same batch of a medicinal product under an expedited procedure. For medicines manufactured in the countries specified in the Resolution, provided that the same importer has previously imported the relevant batch, it has passed state quality control and received a positive conclusion, the importer’s authorised representative will be able to carry out the visual inspection within one working day. This will help companies replenish medicine stocks more quickly and avoid unnecessary supply delays. In addition, the Government’s decision: Shortens the overall state quality control timeframe where there are no grounds for laboratory testing. Provides for the use of GMP certificates issued by the competent regulatory authorities of specified countrieswithout mandatory additional confirmation in Ukraine. Introduces a special laboratory control procedure for certain immunobiological medicines, taking into account documentation confirming the official batch release. Clarifies the conditions for the further import and circulation of medicines manufactured or released using previous packaging materials during a specified period following state re-registration, allowing them to remain in circulation until the end of their shelf life. For the pharmaceutical industry, these changes primarily mean greater flexibility in supply planning and the ability to respond more quickly to market needs. Reducing procedural delays will help prevent large consignments of medicines from accumulating in warehouses, which remain potential targets for Russian attacks, and support more resilient pharmaceutical supply chains. The European Business Association thanks the Ministry of Health and the Government for their constructive dialogue with business and for taking the pharmaceutical community’s proposals into account. Such decisions are important for ensuring that Ukrainian patients have continuous and timely access to the treatment they need.

On 13 October, the Government adopted Resolution No. 1254, “On Amendments to the Procedure for State Quality Control of Medicinal Products Imported into Ukraine”. The European Business Association welcomes this decision, as it takes into account a number of proposals from the pharmaceutical industry and aims to simplify quality control procedures, shorten medicine delivery times and ensure the continued availability of medicines for Ukrainian patients.

Intensified Russian attacks on critical infrastructure, including pharmaceutical warehouses and logistics centres, have already disrupted the supply of certain categories of medicines. As a result, companies have been forced to reorganise numerous processes to ensure that patients continue to have access to medicines, including life-saving treatments and products for which no alternatives are available on the Ukrainian market. The business community has therefore repeatedly highlighted the need to adapt regulatory procedures to the conditions of martial law. Following discussions with the Ministry of Health of Ukraine and consultations with member companies, the Association submitted proposals to simplify certain stages of state quality control for imported medicines, reduce procedural delays and make interactions between businesses and the state regulatory authority more predictable.

The adopted Resolution introduces several important changes. For example, an authorised representative of an importing company will be able to inspect a consignment, verify its compliance with the accompanying documents and carry out a visual inspection of medicine packaging, with photographic evidence required. The relevant materials will be submitted to the State Service of Ukraine on Medicines and Drugs Control (the State Medicines Service) to obtain a quality conclusion for the imported medicines. This will reduce the need to wait for physical inspections of consignments by representatives of the state regulatory authority.

Another simplification is the possibility of re-importing the same batch of a medicinal product under an expedited procedure. For medicines manufactured in the countries specified in the Resolution, provided that the same importer has previously imported the relevant batch, it has passed state quality control and received a positive conclusion, the importer’s authorised representative will be able to carry out the visual inspection within one working day. This will help companies replenish medicine stocks more quickly and avoid unnecessary supply delays.

In addition, the Government’s decision:

  • Shortens the overall state quality control timeframe where there are no grounds for laboratory testing.
  • Provides for the use of GMP certificates issued by the competent regulatory authorities of specified countrieswithout mandatory additional confirmation in Ukraine.
  • Introduces a special laboratory control procedure for certain immunobiological medicines, taking into account documentation confirming the official batch release.
  • Clarifies the conditions for the further import and circulation of medicines manufactured or released using previous packaging materials during a specified period following state re-registration, allowing them to remain in circulation until the end of their shelf life.

For the pharmaceutical industry, these changes primarily mean greater flexibility in supply planning and the ability to respond more quickly to market needs. Reducing procedural delays will help prevent large consignments of medicines from accumulating in warehouses, which remain potential targets for Russian attacks, and support more resilient pharmaceutical supply chains.

The European Business Association thanks the Ministry of Health and the Government for their constructive dialogue with business and for taking the pharmaceutical community’s proposals into account. Such decisions are important for ensuring that Ukrainian patients have continuous and timely access to the treatment they need.

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