Health Care

02/ 03/ 2023

The EBA Health Care Committee expresses its gratitude to the management and leading experts of the State Service of Ukraine on Medicines and Drugs Control for promptly resolving problems during the state quality control of imported medicines. Due to minor inconsistencies that do not affect the quality of the medicinal product and have no impact on patients, the territorial bodies of the State Administration on Quality Control issued information letters to some manufacturers of medicinal products and suspended the process of their release for sale. In the future, such problems could have led to the referral of these medicines for laboratory control, but thanks to the timely clarification of the State Service on Medicines and Drugs Control by letter No. 1618-001.1/002.0/17-23 dated February 22, 2023, this problematic situation for the pharmaceutical business was resolved in practice. According to business, this case confirms the need to update the relevant legislation. The EBA Health Care Committee experts support the proposal of Roman Isayenko, Head of the State Service on Medicines and Drugs Control, regarding the need for a general update of the legislation in the field of state quality control of medicines imported into Ukraine. The current legislation needs to be amended to ensure a unified interpretation of minor discrepancies by the territorial bodies of the State Service on Medicines and other public authorities. It is necessary to ensure full comparability of the documents approved by the Ministry of Health of Ukraine based on the results of the State Expert Center of the Ministry of Health of Ukraines inspection of registration materials and approaches to the evaluation of documents and imported medicinal products. Besides, according to business, it is a priority to update the approaches to the procedure for confirming the compliance of the manufacturing conditions of medicines with the requirements of good manufacturing practice (GMP) in terms of issuing a GMP Conclusion. Firstly, the strengthening of Ukraines eurointegration movement requires the continued implementation of EU approaches. Secondly, the procedural problems that the EBA has previously reported on continue to exist, which complicates the effective planning of the production and supply of medicines. Thirdly, all parties to the process support the need to digitalize the procedure at the State Service on Medicines and Drugs Control to optimize interaction with applicants (manufacturers). The EBA Committee experts consider that the GMP confirmation from countries of recognition, i.e., EU member states, the UK, and countries with which the EU has mutual recognition of GMP documents, should be subject to deregulation in Ukraine. This issue can be worked out within the framework of the Interagency Working Group on Accelerated Review of State Regulatory Instruments for Economic Activity, established at the initiative of the Ministry of Economy of Ukraine. The EBA Committee has repeatedly emphasized that the GMP Conclusion is an ineffective regulatory document, as well as the procedure for obtaining it. It is necessary to provide for the direct application in Ukraine of GMP Certificates issued by the regulatory authorities of the recognition countries. It should be emphasized that the EU does not issue a separate document and does not carry out a separate regulatory procedure for confirming GMPs in respect of countries that are recognized (based on the countrys membership in the EU, the existence of separate international agreements, etc.) The authorized body in such countries does not conduct any additional examination of the original GMP Certificate and does not issue a document confirming it. The European Business Association looks forward to continuing a constructive dialogue and cooperation with representatives of state regulators and readiness to update approaches to the implementation of key regulatory procedures in the pharmaceutical sector. Such an update should serve to improve access to quality, safe and effective medicines for Ukrainian citizens, as well as improve the business climate.

According to business, this case confirms the need to update the relevant legislation. The EBA Health Care Committee experts support the proposal of Roman Isayenko, Head of the State Service on Medicines and Drugs Control, regarding the need for a general update of the legislation in the field of state quality control of medicines imported into Ukraine. The current legislation needs to be amended to ensure a unified interpretation of “minor discrepancies” by the territorial bodies of the State Service on Medicines and other public authorities. It is necessary to ensure full comparability of the documents approved by the Ministry of Health of Ukraine based on the results of the State Expert Center of the Ministry of Health of Ukraine’s inspection of registration materials and approaches to the evaluation of documents and imported medicinal products.

Besides, according to business, it is a priority to update the approaches to the procedure for confirming the compliance of the manufacturing conditions of medicines with the requirements of good manufacturing practice (GMP) in terms of issuing a GMP Conclusion. Firstly, the strengthening of Ukraine’s eurointegration movement requires the continued implementation of EU approaches. Secondly, the procedural problems that the EBA has previously reported on continue to exist, which complicates the effective planning of the production and supply of medicines. Thirdly, all parties to the process support the need to digitalize the procedure at the State Service on Medicines and Drugs Control to optimize interaction with applicants (manufacturers).

The EBA Committee experts consider that the GMP confirmation from countries of “recognition”, i.e., EU member states, the UK, and countries with which the EU has mutual recognition of GMP documents, should be subject to deregulation in Ukraine. This issue can be worked out within the framework of the Interagency Working Group on Accelerated Review of State Regulatory Instruments for Economic Activity, established at the initiative of the Ministry of Economy of Ukraine. The EBA Committee has repeatedly emphasized that the GMP Conclusion is an ineffective regulatory document, as well as the procedure for obtaining it. It is necessary to provide for the direct application in Ukraine of GMP Certificates issued by the regulatory authorities of the “recognition” countries. It should be emphasized that the EU does not issue a separate document and does not carry out a separate regulatory procedure for confirming GMPs in respect of countries that are “recognized” (based on the country’s membership in the EU, the existence of separate international agreements, etc.) The authorized body in such countries does not conduct any additional examination of the original GMP Certificate and does not issue a document confirming it.

The European Business Association looks forward to continuing a constructive dialogue and cooperation with representatives of state regulators and readiness to update approaches to the implementation of key regulatory procedures in the pharmaceutical sector. Such an update should serve to improve access to quality, safe and effective medicines for Ukrainian citizens, as well as improve the business climate.

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