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 […]
Martial law, import of unregistered medical products and work of competent authorities
On Thursday, Feb 24 at 5 o’clock in the morning, Russia has attacked Ukraine, simultaneously firing numbers of missiles on strategic objects, cities and invading troops to the territory of our country. We all woke up from the sound of explosions.
Martial law was imposed in Ukraine from 05:30 on February 24, 2022 for a period of 30 days in accordance with the Law of Ukraine of February 24, 2022 № 2102-IX “On approval of the Decree of the President of Ukraine “On martial law in Ukraine “.
From February 24, 2022, Cratia has launched Business Continuity Plan (BCP) measures, which aim to minimize risks for employees and customers, while maintaining all critical business processes. BCP is developed according to ISO 22301:2012 and EU GPvP.
Our team switched to remote work and is doing it’s best to support all processes. However, due to air threats, people spend hours in bomb shelters, basements and subway stations. Thus, some delays may occur.
Regarding force majeure:
By the Letter №2024/02.0-7.1 dated 28.02.2022 the Chamber of Commerce and Industry of Ukraine certifies force majeure due to the military aggression of the Russian Federation against Ukraine.
As of February 24, 2022, until their official end, these circumstances are extraordinary, unavoidable and objective, which make it impossible to implement contracts and regulations.
Regarding the supply of unregistered medicines and medical devices:
According to the Letter №24-04/5397/2-22 of 25.02.2022 of the Ministry of Health of Ukraine, in connection with the introduction of martial law and necessity of providing for population and, first of all, combatants – defenders of Ukraine, with vital medicines, the Ministry of Healthcare of Ukraine does not object to the import of unregistered medicines in foreign packaging into the customs territory of Ukraine to provide healthcare facilities with the necessary medicines.
According to the Letter №24-04/5396/2-22 of 25.02.2022 of the Ministry of Health of Ukraine, it does not object to the import to the territory of Ukraine, placing on the market (putting into circulation and/or operation), intended use of medical devices, medical devices for in-vitro diagnostics, active implantable medical devices medical devices that does not comply with the requirements of the relevant Technical Regulations. Labeling of such devices can be done without complying with the Law of Ukraine “On Ensuring the Functioning of the Ukrainian Language as the State Language”.
Regarding registration procedures for medicines and pharmacovigilance:
On March 1, 2022, the State Expert Center of the Ministry of Health of Ukraine (SEC of the MoH of Ukraine) published a notice to the Applicants and their Authorized Representatives, informing about the occurrence of force majeure, during which:
- extended timelines for the implementation of procedures regulated by legal acts on registration, renewals, variations and pharmacovigilance;
- extended timelines for the performing of obligations of the SEC of the Ministry of Health of Ukraine according the Agreements.
The timelines have been extended for a period equal to the term of military aggression of the Russian Federation against Ukraine established by law.
At the same time, the SEC of the Ministry of Health of Ukraine informs that it does not waive its obligations in any way, employees who have access to the Internet work remotely, full-fledged work will be resumed as soon as possible.
Regarding quality control of medicines:
On February 27, 2022, the State Service of Ukraine for Medicines and Drug Control informs that the submission of applications for the issuance of opinions on the quality of imported medicines and the issuance of opinions on them will be carried out electronically. The responsibility for quality control of batches of medicinal products rests with the authorized persons of economic entities.
Regarding the conformity assessment of medical devices:
With regard to planned supervisory procedures and recertifications, the provisions on force majeure and the corresponding postponement of procedures should apply. Some designated conformity assessment bodies report switching to remote work and maintaining critical business processes, mostly related to annual surveillances and re-certifications.
Our gratitude cannot be measured by any numbers or actions. Gratitude that weighs tons and tons of Ukrainian courage and hope for an even brighter future. We are incredibly grateful to the Ukrainian Armed Forces and the Civil Defense, to the doctors and healthcare professionals, to the infrastructure employees, volunteers, and many others. We are grateful for the spirit and unity that prevails in Ukraine, for the empathy and indifference of all people in the world.
Cratia is donating the Ukrainian Armed Forces and Red Cross of Ukraine, and perhaps personal transfers of the whole team are even greater. Those, who are not in Civil Defence, are supporting Armed Forces with equipment and food, donating blood.
With such strong internal and international support, we believe that peace will be restored soon.
How you can help:
1) Financial donations:
2) Humanitarian aid with medicines or medical devices. Please contact us info@cratia.ua for coordination.
The darkest night before dawn. We will stand!
Slava Ukraini!
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