On July 19 and 20, 2024, the Cabinet of Ministers of the Republic of Azerbaijan adopted Resolutions No. 345 (introduction of state registration of medical devices and in-vitro diagnostic devices, new rules for the registration of medicines) and No. 347 (amendments to the procedure for the examination of medicines, medical devices, and in-vitro diagnostic devices). […]
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Introduction of medical device registration in Azerbaijan from July 2024
Approved methodological recommendations by the Ministry of Health on borderline products
By Order of the Ministry of Health of Ukraine No. 1247 dated July 17, 2024, the methodological recommendations for the application of the Technical Regulation on cosmetic products concerning borderline groups of cosmetic products have been approved. The Technical Regulation defines a cosmetic product as “any substance or mixture intended for application to various external […]
Regulatory newsletter for CIS and EAEU
Dear сolleagues, In this digest, you will find the most important news on the registration, pharmacovigilance and quality control of medicines in Armenia, Azerbaijan, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, Ukraine, Uzbekistan, and the Eurasian Economic Union (EAEU) which came into effect at the end of 2023 and the first half of 2024. In brief: […]
Own brand in the dietary supplements market
The Ukrainian and global dietary supplement markets are growing every year, and this trend will continue. The annual growth rate is forecasted to be over 9%, and by 2030, the global dietary supplements market will reach USD 327.42 billion[1]. The reasons for the increased consumption of dietary supplements include a focus on personal health, changes […]
Private Label (PL) in the Cosmetics Market of Ukraine
The use of Private Label (PL) in the cosmetics market, as in other consumer sectors, is a widespread phenomenon with a constantly growing share. Fashion houses, manufacturers of clothing and consumer goods, retail chains or pharmacies, celebrities, and even bloggers develop their own cosmetic brands. Production usually remains with a company that is not mentioned […]
Abolishing of GMP simplifications, implementation of eCTD, registration of medical cannabis and other regulatory news
We inform you about key updates in the field of registration of medicines, quality control, and pharmacovigilance in Ukraine: Abolition of simplifications for GMP confirmation during the quality control of imported medicinal products; Implementation of eCTD; Adoption of the Law on Medical Cannabis; Scheduled and targeted audits of the Marketing Authorization Holder’s pharmacovigilance systems. Expert […]
Provision of medicines, medical devices and other humanitarian aid for Ukraine
As of April 2024, at least 1,700 healthcare institutions have been damaged in Ukraine, and about 200 of them have been completely destroyed. It is not just the medical infrastructure that has been affected, the war causes high civilian casualties every day and forces people to move within and outside the country. Many international organizations, […]
Production of medical devices under a private label
Today, almost every pharmacy and store carries medical devices, cosmetic products, dietary supplements, and disinfectants under private labels (PL). There are many reasons why a private label is rapidly gaining momentum: PL allows for preserving and multiplying investments in marketing without risking that the invested time, effort, and money might be lost in the future. […]
Cratia is ISO 13485 certified
Since 2017, Cratia has implemented and certified a quality management system under ISO 9001. To further enhance integration with medical device manufacturers’ systems, this year we have initiated the certification process according to the international quality standard ISO 13485, which is industry-specific for companies working with medical devices. We are delighted to announce that our […]