Import and circulation of medicines, medical devices and food products during the war

Ukraine has been defending itself from Russian military aggression for 20 days. The Armed Forces of Ukraine, territorial defense, and the population of Ukraine are holding back the advance of the aggressor. Russian troops are firing, launching rocket attacks, and bombing our cities, causing huge civilian casualties, destroying civilian infrastructure, and forcing millions of Ukrainians to leave their homes. 
 
According to the UN, at least 579 civilians, including 79 children, were killed in 17 days. The UN Office notes that the real numbers of victims may be significantly higher due to the inability to obtain data from territories where active hostilities are taking place. Seven hospitals were completely destroyed, 104 health care facilities were damaged. 
 
To solve humanitarian problems, a number of legislative acts were approved to significantly simplify and almost completely remove any regulatory requirements for the introduction of medicines, medical devices, and food products into circulation. We have provided some information earlier; please find the updated list below.

General situation: 
Resolution of the Board of the National Bank of Ukraine No. 18 dated February 24, 2022, prohibits Ukrainian banks from making cross-border transfers of currency values from Ukraine, except in cases of import operations of residents to purchase critical import goods according to the list approved by the Cabinet of Ministers of Ukraine. 
The list of critical import goods was approved by Resolution of the Cabinet of Ministers of Ukraine No. 153 dated February 24, 2022. In particular, it includes medicines, medical devices, hygiene products, and food products in accordance with the codes of the Ukrainian classification of goods for foreign economic activity. 
Thus, national operators can make foreign currency payments for healthcare, hygiene, and food products. 
 
A significant part of pharmacies is open. According to “Proxima Research”, pharmacy sales of medicines and medical devices on the first day of military aggression increased by more than 2 times compared to the same day the previous year. Stocks of medicines of some ATC groups will suffice for less than 10 days, stocks continue to decrease, and stocks are approaching a critical level for some items.
 
The procedure for public procurement has been simplified, according to Resolution of the Cabinet of Ministers of Ukraine No. 169 dated February 28, 2022: the Customer independently determines the lists and volumes of purchases, and purchases are made without applying the requirements of the Law of Ukraine “On Public Procurement”. The purchase report is published 20 days after the cessation or abolition of martial law. 
 
Resolution of the Cabinet of Ministers of Ukraine No. 165 dated March 2, 2022 also provides an opportunity for JSC “Ukrainian Railway” to purchase medicines and medical devices under trilateral agreements, the ordering customer of which is the military administration.
 
Centralized purchases of medicines, medical devices and accessories were enacted by Resolution of the Cabinet of Ministers of Ukraine No. 216 dated March 7, 2022. The resolution approved the lists of products that will be purchased by the State Enterprise “Medical Procurement of Ukraine” and specialized (international) procurement organizations.
 
By the Order of the Ministry of Health of Ukraine No. 457 dated March 10, 2022, the State Enterprise “Medical Procurement of Ukraine”, the State Enterprise “Ukrvaktsina” and the State Enterprise “Ukrmedpostach” are allowed to sign and approve documents with counterparties by means of telecommunications (in the form of photocopies).  

Medicines:
By the Order of the Ministry of Health of Ukraine No. 406 dated March 3, 2022 during martial law:

• requirements for the expiration date of medicines imported to Ukraine have been abolished; 
• transportation of medicines is allowed by public transport, including those used for passenger transportation and in mail or baggage items, provided that their storage conditions specified by the manufacturer are met. 

Order of the Ministry of Health of Ukraine No. 416 dated March 5, 2022 approved transportation and temporary storage of medicines by the JSC “Ukrainian Railway” for the period of martial law. 
 
The conclusion on quality during importation is issued according to a simplified procedure and without the mandatory availability of a document on manufacturing compliance with the GMP requirements. The State Service of Ukraine on Medicines and Drugs Control informs about the business continuity under martial law. 
 
Ministry of Health of Ukraine by letter No. 24-04/5397/2-22 dated February 25, 2022, does not object to importing unregistered medicines in foreign packaging into the customs territory of Ukraine to provide healthcare institutions in Ukraine with necessary medicines. 
 
Order of the Ministry of Health of Ukraine No. 384 dated February 26, 2022 approved the procedure for emergency state registration of medicines, immunobiological medical products and blood products for use by medical professionals, in particular in healthcare institutions, without the right of retail sale. Registration is carried out on the basis of the registration in the referent state of manufacturer/MAH, with a minimum set of documents and translation of the labeling text and instructions for use in Ukrainian submitted in electronic form. Registration is carried out within 9 business days, and there is no state payment. Registration is issued for a period of 1 year. 
 
On March 1, 2022, the State Expert Center of the Ministry of Health of Ukraine (SEC MoH of Ukraine) published notice to applicants and their authorized representatives, according to which it informs about the occurrence of force majeure (force majeure circumstances), during which: 

• deadlines for performing procedures regulated by regulatory legal acts on registration, re-registration and making changes to registration materials and pharmacovigilance have been suspended; 
• the fulfillment of obligations of the SEC MoH of Ukraine within the time limits established by the terms of contracts has been suspended. 

The terms of execution 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 MoH of Ukraine informs that it does not cancel obligations in any way; employees who have access to the internet work remotely, full-fledged work will be resumed at the first opportunity. 
 
On March 9, the SEC website published a report on the scientific expertise and scientific and technical councils with recommendations for registration, re-registration, making changes (variations), and clinical trials. 
 
By Order of the Ministry of Health of Ukraine No. 413 dated March 4, 2022 it is allowed to release medicines without a prescription, except for narcotic and psychotropic drugs during martial law. 
 
By letter No. 24-04/5925/2-22 dated March 12, 2022, the Ministry of Health of Ukraine allowed domestic manufacturers to release and sell batches of medicines in primary packaging using multi-unit packages accompanied by the appropriate number of instructions (package inserts). 
 
Medical devices: 
According to letter No. 24-04/5396/2-22 dated February 25, 2022 the Ministry of Health of Ukraine does not object to the import into the customs territory of Ukraine, introduction into circulation and/or operation, use for the intended purpose of medical devices, active implantable medical devices, medical devices for in vitro diagnostics without complying with the requirements of the relevant Technical Regulations. It is allowed to label medical devices, active implantable medical devices, medical devices for in vitro diagnostics and instructions for use for them without complying with the requirements of the law of Ukraine “On ensuring the functioning of the Ukrainian language as the state language”.
 
With regard to planned supervisory procedures, recertifications and changes, the provision on force majeure and the corresponding postponement of procedures can apply. 
 
At the same time, some of the designated conformity assessment bodies report the resumption of activities. 
 
The State Service of Ukraine on Medicines and Drugs Control informed that review and filling the medical device registry is temporarily postponed until the end of the martial law. Competent authority refers to the Letter of the Ministry of Health mentioned above regarding the possibility to import and place on the market medical devices that do not comply with the requirements of the Technical Regulations.  
 
Food products: 
Resolution of the Cabinet of Ministers of Ukraine No. 234 dated March 9, 2022 allowed food market operators who, due to military (combat) operations, are not able to meet the requirements for mandatory information about the food product, to proceed with sales, provided that mandatory information is available in the state language for the batch of products. 
 
Labeling of food and feed products that are imported (sent) to the customs territory of Ukraine as humanitarian aid may be presented in a language other than the state language.
 
Humanitarian aid (medicines, medical devices, food products, etc.): 
Resolution of the Cabinet of Ministers of Ukraine No. 234 dated March 9, 2022 simplified the procedure for registration and moving of humanitarian aid across the customs border. The person transporting the goods submits a declaration on the list of goods recognized as humanitarian aid at the place of crossing the customs border of Ukraine. The procedure for customs clearance of humanitarian aid cargo approved by Resolution of the Cabinet of Ministers of Ukraine No. 544 dated March 22, 2000 does not apply. 
 
If you intend to send humanitarian aid – we can suggest several options for its delivery: 
1. In our opinion, one of the best options for delivering humanitarian aid to Ukraine is a dedicated warehouse in Poland: https://helpukraine.center/  
The cargo can be addressed to a specific healthcare institution, charity organization, or individual in Ukraine. 
If you send it without a specific recipient, then the aid will be distributed according to the decision of volunteers.
 
The site constantly updates the list of the most required products, provides convenient instructions on cargo labeling. 
 
2. Through “Nova Poshta” warehouses in the USA, Germany, France, Romania, Latvia, Great Britain, Poland and Turkey: https://novaposhta.ua/eng/
 
3. Through the Polish Government Agency for Strategic Reserves, https://rars.gov.pl/, according to the letter of the Ministry of Economy of Ukraine.
 
4. Through your importer. Also, our logistics partners can assist. 
 
According to the Ministry of Health, since the Russian invasion, Ukraine has already received more than 500 tons of medicines and medical devices. The Ministry of Health of Ukraine has coordinated assistance from such countries as Poland, Latvia, Lithuania, Germany, United Kingdom, Israel, Denmark and France and expresses its gratitude to everyone who did not stand aside and supports the Ukrainian healthcare system in such difficult times for the country. Medicines and medical devices that came from abroad have already been delivered to the central, southern and eastern regions to ensure the smooth functioning of Ukrainian hospitals. 
 
 
Please contact us if you have any questions. 
 
The night is darkest before dawn. 
 
Slava Ukraine!