<\/p>\n
The war in Ukraine has made the medicines supply system significantly more vulnerable. Today, risks arise not only at the level of logistics or manufacturing, but also within regulatory procedures.<\/p>\n
Following missile attacks that destroyed distributors\u2019 warehouses along with pharmaceutical stock reserves, companies have reported risks of supply disruptions and medicine shortages. According to open sources and statements by affected companies, one such attack alone resulted in the destruction of approximately 20% of the country\u2019s monthly supply of medicinal products. As a consequence, companies have lost the \u201cbuffer stock\u201d intended to ensure market availability of medicines amid lengthy procedures for confirming compliance with Good Manufacturing Practice (GMP) requirements.<\/p>\n
At the same time, the procedure for confirming GMP compliance conclusions \u2014 which under current regulations is a mandatory prerequisite for the importation and subsequent placing of medicinal products on the Ukrainian market \u2014 remains highly bureaucratic and insufficiently predictable. Document review timelines are frequently prolonged, and the import of new batches without the relevant GMP confirmation becomes impossible. According to companies, under the current conditions of institutional restructuring and the regulatory practices applied by the State Service of Ukraine on Medicines and Drugs Control, the timelines for issuing GMP documentation remain unstable and difficult to forecast. This creates additional risks to the continuity of supply.<\/p>\n
Combined with the loss of warehouse facilities, this significantly increases the risk of interruptions in patients\u2019 access to therapy. The consequences are felt first and foremost by patients, particularly those for whom continuity of treatment is critically important \u2014 including individuals with oncological and cardiovascular diseases, diabetes, as well as rare (orphan) conditions, where therapeutic alternatives are often unavailable.<\/p>\n
At the beginning of the full-scale invasion, Ukraine introduced simplified approaches to the importation of medicinal products. These measures allowed the country to maintain uninterrupted supply without lowering standards of quality and safety. Moreover, according to publicly available information, during the period when simplified procedures were applied, there were no public reports of substandard medicinal products that could be linked to the absence of GMP confirmation in Ukraine.<\/p>\n
In the context of Ukraine\u2019s European integration course, a logical step would be for Ukrainian regulatory authorities to accept GMP certificates issued by regulators in countries with stringent supervisory systems, based on data from international registers (EudraGMP, FDA, Swissmedic, MHRA) or certified copies of such certificates, without requiring a repeated confirmation procedure, which currently complicates and delays access of medicinal products to the domestic market.<\/strong><\/p>\n Such an approach would reduce duplication of regulatory procedures, serve as an effective emergency measure to ensure the population\u2019s access to essential medicines, prevent the negative consequences of shortages for patients, and bring Ukraine closer to the practice of mutual or automatic recognition of GMP compliance.<\/p>\n For this reason, the business community of the European Business Association calls on public authorities to adopt emergency regulatory solutions that will help mitigate supply disruption risks and ensure the uninterrupted availability of medicinal products, including through the implementation of such a recognition mechanism.<\/strong><\/p>\n <\/p>","protected":false},"excerpt":{"rendered":" The war in Ukraine has made the medicines supply system significantly more vulnerable. Today, risks arise not only at the level of logistics or manufacturing, but also within regulatory procedures. Following missile attacks that destroyed distributors\u2019 warehouses along with pharmaceutical stock reserves, companies have reported risks of supply disruptions and medicine shortages. According to open […]<\/p>\n","protected":false},"author":33544,"featured_media":709546,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[4,5,22],"tags":[],"yoast_head":"\n