<\/p>\n
The Health \u0421are Committee of the European Business Association draws the attention of public authorities and the wider public to the risks associated with the adoption of the draft Order of the Ministry of Health of Ukraine, in its current version, on the approval of the Procedure for confirming compliance of medicinal product manufacturing sites located outside Ukraine with Good Manufacturing Practice (GMP) requirements. The document has been open for public consultation since 29 April.<\/p>\n
From the business perspective, the proposed approach does not bring Ukraine\u2019s system closer to European regulatory practices. On the contrary, it makes it more complex and embeds additional bureaucratic procedures. Instead of the principles of regulatory trust and mutual recognition currently applied in the European Union, the draft effectively introduces a mechanism of repeated verification and individual administrative approval.<\/p>\n
Foreign manufacturers of medicinal products are already subject to strict oversight and obtain GMP certificates from regulatory authorities in the EU and other jurisdictions with high regulatory standards. In addition, these countries cooperate within the Pharmaceutical Inspection Co-operation Scheme (PIC\/S), which is based on mutual confidence in the outcomes of GMP inspections. Ukraine is also a member of this system.<\/p>\n
Nevertheless, the draft provides for the de facto re-verification of GMP compliance for manufacturing sites that have already been assessed by reputable international regulatory authorities. Moreover, this is a formal documentary review that does not relate to the assessment of the quality of medicinal products.<\/p>\n
The business community believes that such an approach contradicts Ukraine\u2019s declared course towards European integration and harmonisation with EU regulatory practices, and does not align with the principles of regulatory reliance enshrined in EU law.<\/p>\n
Of particular concern to businesses is the fact that the proposed approach effectively strengthens elements of discretionary decision-making in the import of medicinal products. The lack of clear, automated and objective decision-making criteria, as well as reliance on case-by-case assessment by competent authorities, may create corruption risks and lead to unequal access to the market.<\/p>\n
For the market, this means additional time and resource costs, increased administrative burden, and reduced predictability of the regulatory environment. Moreover, GMP confirmation is a prerequisite for the import of medicinal products into Ukraine and for participation in public procurement procedures. Therefore, any procedural delays or additional bureaucratic barriers may lead to risks of supply disruptions and affect patients\u2019 access to treatment. From the business perspective, the proposed approach does not provide any additional benefit in terms of verifying product quality, safety or efficacy.<\/p>\n
In the European Union, valid GMP certificates issued by competent regulatory authorities in the EU and partner countries with robust regulatory systems are mutually recognised between Member States and are considered sufficient proof of GMP compliance without additional re-assessment procedures. Modern European regulatory practice is built on the principles of regulatory reliance, mutual recognition and digital data exchange.<\/p>\n
The Association is convinced that, in the context of European integration and recovery, Ukraine should focus on implementing modern and efficient regulatory approaches that have already proven their effectiveness in the European Union. Further harmonisation with EU regulatory frameworks and the avoidance of additional local barriers would serve both the interests of the state and the needs of patients.<\/p>\n
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The Health \u0421are Committee of the European Business Association draws the attention of public authorities and the wider public to the risks associated with the adoption of the draft Order of the Ministry of Health of Ukraine, in its current version, on the approval of the Procedure for confirming compliance of medicinal product manufacturing sites […]<\/p>\n","protected":false},"author":33544,"featured_media":741663,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[4,5,22],"tags":[],"yoast_head":"\n