Since Russia began its large-scale, unprovoked armed invasion of Ukraine, the Cabinet of Ministers (the CMU), the Ukrainian Ministry of Health (the Ministry of Health), along with other state bodies, implemented numerous legislative changes aimed at streamlining and facilitating the supply of medicines and medical devices needed during the war to Ukraine and ensuring that Ukrainian patients and trial participants have uninterrupted access to drugs and medical devices.
Here is a brief overview of these legislative flexibilities in the life sciences and healthcare sectors.
Pharmaceuticals and medical devices
Flexibilities regarding drug registration
In response to martial law, the government quickly introduced a new emergency conditional authorization procedure for medicines, biological products and blood products (except products from Russia). Registration under this procedure should ideally take up to nine working days. The products are authorized for use in hospitals without the right to further resale. The procedure is free.
In addition, the government has extended the validity of registration certificates which expire during martial law and within six months thereafter. After the end of martial law, registration renewal will be carried out as usual. MAHs must apply for renewal of registration within six months of the end of martial law.
MAHs can submit applications, registration dossier and other documents electronically.
These flexibilities apply during martial law and for six months after its end (CMU Resolution No. 471 of April 15, 2022).
Flexibilities regarding the importation of medicines
The authorities have temporarily allowed the importation of drugs that have not expired but do not meet the legislative requirements for the minimum quantity the duration of the conversation.
Furthermore, with regard to the supply of hospitals and pharmacies, the government has authorized parallel imports of certain medicinesspecifically, Ukraine has registered medicines in foreign packaging, if they are accompanied by an approved leaflet in Ukraine and a letter of guarantee confirming that the imported product is identical to that registered in Ukraine.
The government has extended the regular grounds for imports of unregistered drugs: importers can import medicines without authorization in Ukraine (except those manufactured in russia) for the needs of the armed forces and hospitals of Ukraine, without the right of resale, if they are accompanied by the quality certificate of the manufacturer with a Ukrainian translation, as well as a leaflet in Ukrainian.
Temporarily, the state control of drug quality import does not require laboratory testing. The presentation of a GMP certificate for this purpose is also not mandatory.
The above flexibilities for the importation of medicines mainly apply during martial law and for six months after its end (CMU resolution no. 471 of April 15, 2022, Ministry of Health order no. 406 of March 3, 2022 ).
The Ministry of Health has temporarily suspended Order No. 237 of 26 April 2011 establishing a procedure for issuing import permits for unregistered medicines until the end of martial law. Thus, during martial law, customs clearance of drugs without permission in Ukraine is possible without such permissions from the Ministry of Health.
Flexibilities regarding the purchase of medicines and medical devices
In accordance with CMU Resolution No. 169 of February 28, 2022 and Ministry of Health Order No. 408 of March 4, 2022, medical purchases of state enterprises of Ukraine and state/municipal hospitals may procure medicines and medical devices directly from suppliers without resorting to public procurement procedures provided by Ukrainian legislation. At the same time, buyers must observe the basic principles of procurement and additionally disclose the conditions of such procurement in the electronic system within 20 days of the end of martial law in Ukraine.
Flexibilities regarding the transport, storage and supply of medicines
Under the order of the Ministry of Health No. 406 of March 3, 2022, subject to compliance with the storage conditions specified by the manufacturer:
- the Ministry of Health has authorized the transport of medicines by public transport (including passengers), as well as in postal deliveries and luggage;
- holders of import, manufacturing and wholesale/retail licenses may store drugs in unlicensed warehouses.
Under National Drug Service Letter No. 1655-001.1/004.0/17-22 dated March 1, 2022, drug wholesale license holders may supply drugs (except those containing controlled substances) to military administrations, the Ukrainian Armed Forces, and businesses, including those engaged in volunteering and humanitarian aid.
Other flexibilities regarding medical devices
According to the letter of the Ministry of Health No. 24-04/5396/2-22 dated February 25, 2022, during martial law, the Ministry of Health does not oppose the import, placing on the market and the use of medical devices that do not comply with local technical regulations, with labeling and instructions for use in a foreign language.
By Resolution No. 389 of March 29, 2022, during martial law, the CMU authorizes the placing on the Ukrainian market of medical devices that do not comply with local technical regulations if Ukrainian certification bodies recognize the certificates of evaluation of respective conformity issued by foreign notified bodies. .
According to the latest clarifications from the Ministry of Health, during martial law, market operators can choose how to place medical devices on the Ukrainian market: either through regular pre-war procedures (including through recognition of foreign conformity assessment certificates), or by using the temporary waiver of local technical requirements as indicated above.
Flexibilities regarding clinical trials
The clinical trial regulator State Expert Center of Ukraine (the SECOND) published several guidance documents regarding clinical trials during the war. The main recommendations are:
- suspend the launch of new clinical trials, the launch of new study sites and the inclusion of new subjects in ongoing trials;
- if it is not possible to continue the trials on the approved site, carry out the procedure for withdrawing the subjects from the trial, or transferring them to other approved sites (including abroad), and inform the SEC and the relevant ethics committee as soon as possible;
- take all possible steps to maintain patient access to investigational drugs and adhere to trial protocols;
- replace physical visits with telephone and video contact, and postpone or cancel physical visits if necessary;
- to consider another form of administration of experimental medicinal products to patients, taking into account the storage conditions set by the manufacturer.
Flexibilities regarding the engagement of foreign health professionals
According to Ministry of Health Order No. 383 of February 26, 2022, during martial law, Ukrainian health institutions may hire foreign doctors and other medical workers as volunteers to help patients (including by telemedecine). To be eligible for such medical volunteering, foreign health professionals simply need to have documents attesting to medical training and professional qualification, that is to say without notification of foreign diplomas.
Flexibilities regarding healthcare licensing, importation, wholesale and retail of medicines
By resolution No. 314 of March 18, 2022, the government established, during the duration of martial law, a simplified declaratory procedure for obtaining the right to exercise activities, which, in peacetime, were subject to permission. Businesses using this temporary waiver will need to apply for the corresponding licenses within one month of the end of martial law.
Businesses that can apply the relaxed rules include medical practice, drug importation, wholesale and retail trade, and drug manufacturing, but only for current manufacturing license holders. This concerns any extension/variation of current manufacturing activities, for example the manufacture of new pharmaceutical forms. Potential holders of a manufacturing license must apply for a license under the general procedure, regardless of martial law.
The approved changes will: reduce the regulatory burden on the pharmaceutical market; allow the use of all available possibilities for the supply and production of medicines; contribute to the rapid response to market demands; and provide the necessary medicines to the entire Ukrainian population and health institutions, without compromising their quality, effectiveness and safety.
On the other hand, some of these flexibilities, in the absence of control, can lead to an influx of diverted or even counterfeit products on the market. Thus, we recommend marketing authorization holders and medical device manufacturers to carefully monitor the situation.