Since russia began its unprovoked large-scale armed invasion of Ukraine, the Cabinet of Ministers (the CMU), the Ukrainian Ministry of Health (the MoH), as well as other state bodies, have been implementing numerous legislative changes aimed at streamlining and facilitating the supply of required medicines and medical devices to Ukraine during the war and ensuring that Ukrainian patients and trial subjects have uninterrupted access to medicinal products and medical devices.
Here is a brief overview of these legislative flexibilities in the life sciences and healthcare sectors.
Pharmaceuticals and medical devices
Flexibilities concerning the registration of medicines
In response to martial law, the government swiftly introduced a new procedure of conditional emergency authorisation of medicines, biologics, and blood products (except for products originating from russia). Registration under this procedure should ideally take up to nine business days. Products are authorised for use in hospitals without the right of further resale. The procedure is free of charge.
Additionally, the government extended the validity of registration certificates that expire during martial law and within six months afterwards. After the end of martial law, renewal of registration will be carried out as usual. MAHs shall apply for renewal of registration within six months after martial law ends.
MAHs can submit applications, registration dossier and other documents in electronic form.
These flexibilities apply during martial law and for six months after it ends (CMU Resolution No.471 dated 15 April 2022).
Flexibilities concerning the import of medicines
The authorities have temporarily allowed imports of medicines that have not expired but do not meet the legislative requirements regarding the minimum shelf life.
Furthermore, regarding supplies to hospitals and pharmacies, the government has permitted parallel imports of certain medicines, specifically, Ukraine registered medicines in a foreign packaging, if accompanied by a leaflet approved in Ukraine and a letter of guarantee confirming that the imported product is identical to the one registered in Ukraine.
The government extended the regular grounds for imports of non-registered medicines: importers may import medicines without authorisation in Ukraine (except those manufactured in russia) for the needs of the Ukrainian armed forces and hospitals, without the right to resale, if accompanied by the manufacturer’s quality certificate with a Ukrainian translation, as well as a leaflet in Ukrainian.
Temporarily, the state quality control of medicines on import does not require laboratory control.
The submission of a GMP certificate for this purpose is not obligatory as well.
The above flexibilities for import of medicines mostly apply during martial law and for six months after it ends (CMU Resolution No.471 dated 15 April 2022, MoH Order No.406 dated 3 March 2022).
The MoH has temporarily suspended Order No.237 dated 26 April 2011 establishing a procedure for issuing permits to import of non-registered medicines until the end of martial law. Thus, during martial law customs clearance of medicines without authorisation in Ukraine is possible without such MoH permits.
Flexibilities concerning the procurement of medicines and medical devices
According to CMU Resolution No.169 dated 28 February 2022 and MoH Order No.408 dated 4 March 2022, State Enterprise Medical Procurements of Ukraine and state/municipal hospitals can procure medicines and medical devices directly from suppliers without the use of public procurement procedures provided by Ukrainian legislation. At the same time, purchasers must abide by the basic principles of procurement and further disclose the terms of such procurement in the electronic system within 20 days after the end of martial law in Ukraine.
Flexibilities concerning the transportation, storage and supply of medicines
Under MoH Order No.406 dated 3 March 2022, subject to compliance with storage conditions specified by the manufacturer:
- the MoH has allowed the transportation of medicines by public transport (including passenger), as well as in postal deliveries and luggage;
- holders of import, manufacturing and wholesale/retail licences can store medicines in warehouses not covered by the licence.
Under the Letter of State Medicines Service No.1655-001.1/004.0/17-22 dated 1 March 2022, holders of licences for the wholesale trade of medicines can supply medicines (except those containing controlled substances) to military administrations, the Ukrainian armed forces, and businesses, including those engaged in volunteering and humanitarian assistance.
Other flexibilities concerning medical devices
According to MoH Letter No.24-04/5396/2-22 dated 25 February 2022, during martial law the MoH does not object to the import, placement on the market and use of medical devices that do not conform to local technical regulations, with labelling and instructions for use in a foreign language.
By Resolution No.389 dated 29 March 2022, during martial law the CMU allows medical devices to be placed on the Ukrainian market that do not conform to the local technical regulations if the Ukrainian certification bodies recognise the respective conformity assessment certificates issued by foreign notified bodies.
As per the latest clarifications from the MoH, during martial law market operators can choose how to place medical devices on the Ukrainian market: whether through regular pre-war procedures (including via recognition of foreign conformity assessment certificates), or by using the temporary waiver of local technical requirements as outlined above.
Flexibilities concerning clinical trials
The clinical trials regulatory body State Expert Centre of Ukraine (the SEC) has issued several guidance documents regarding clinical trials during the war. The main recommendations are:
- to suspend the initiation 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 trials at the approved site, to carry out the procedure of withdrawing the subjects from the trial, or transfer them to other approved sites (including abroad), and to notify this to the SEC and the relevant ethics committee as soon as possible;
- to take all possible measures to continue patient access to investigational drugs and to adhere to the trial protocols;
- to replace physical visits with phone and video contacts, and to postpone or cancel physical visits if necessary;
- to consider alternative delivery of investigational drugs to patients, considering the storage conditions set by the manufacturer.
Flexibilities concerning the engagement of foreign healthcare professionals
According to MoH Order No.383 dated 26 February 2022, during martial law Ukrainian healthcare institutions can engage foreign doctors and other medical workers as volunteers to assist patients (including via telemedicine). To be eligible for such a medical volunteering, foreign healthcare professionals shall simply have documents confirming medical training and professional qualification, i.e. without nostrification of foreign diplomas.
Flexibilities concerning the licensing of healthcare, import, wholesale and retail of medicines
By Resolution No.314 dated 18 March 2022 the government introduced, for the duration of martial law, a simplified declarative procedure for obtaining rights to carry on businesses, which, during peace, were subject to licensing. Businesses that use this temporary waiver will have to apply for the relevant licences within one month after martial law ends.
The businesses that may apply the eased rules include medical practice, medicine import, wholesale and retail trade, as well as manufacturing of medicines, but only for current manufacturing licence holders. This pertains to any extension/variation of current manufacturing activities, e.g. manufacturing of new pharmaceutical forms. Prospective manufacturing licence holders need to apply for a licence under the general procedure irrespective of martial law.
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The approved changes will: alleviate the regulatory burden on the pharmaceutical market; allow the use of all available opportunities for the supply and production of medicines; contribute to the rapid satisfaction of market demands; and provide the necessary medicines to the entire population of Ukraine and health care facilities, without jeopardising their quality, efficacy and safety.
On the other hand, some of these flexibilities, in the absence of control, may lead to inflow of diverted and even counterfeit products to the market. Thus, we recommend that MAHs and manufacturers of medical devices carefully monitor the situation.
