The Ministry of Health of Ukraine is Planning to Start Granting One-Time Permits for Import of Medicines and Medical Devices For the Needs of Persons Injured During the Period of ATO and Martial Law

On 14 September 2015 the Ministry of Health of Ukraine has made available for public discussion the initiative aimed at simplifying the procedure on granting permits on import of medicines and medical devices during the period of ATO or martial law. Thus, the Draft Resolution of the Ministry of Ukraine "On Approval of the Simplified Procedure of Granting One-Time Permits for Import of Medicines and Medical Devices into Customs Territory of Ukraine".

The Draft Law envisages granting one-time permit for import of medicines and/or medical devices which are intended for treatment of persons who sustained injuries during the conduct of ATO or in case of martial law. Accordingly, such goods should be imported with the purpose of direct provision to injured persons for their treatment or to healthcare institutions where these persons are receiving treatment, and exclusively conditional upon request filed on behalf of such institution.

In view of the above, the Draft Law does not provide for any restrictions in terms of categories or quantity of goods which shall undergo simplified procedure of granting permits for import. At the same time, the Draft sets out clear requirements on the list of documents subject for provision in order to take advantage of the aforesaid opportunity.

Hereby, in case a person is planning to import goods for treatment of those injured during the conduct of the ATO or in case of martial law, the following documents should be submitted to the Ministry of Health of Ukraine:

• application which should contain, in particular, purpose of import, name of goods (trade name and INN), batch number, volume, manufacturing, country of manufacture;
• copy of certificate on quality, issued by manufacturer for every batch of medicines along with its duly notarized translation (for medicines);
• copies of documents confirming registration and use of medicine it the country of its manufacture (for medicines not registered in Ukraine), copies of documents for confirmation of quality and safety of medical devices issued in compliance with the legislation of the country of manufacture (for medical devices not registered in Ukraine);
• request on import of medicines and medical devices stating their name and volume filed on behalf of the healthcare institution or the participant of the ATO;
• instruction for medical use (for medicines and medical devices not registered in Ukraine).

Within 5 working days the Ministry of Health of Ukraine is obliged to review the submitted documents and forward to the applicant the decision on granting one-time permit for import, leaving the application without consideration due to provision of incomplete package of documents or denial of permit.

To note, the Draft prescribes the following grounds for denial of permit:

• detection of inaccurate information in the submitted documents;
• discrepancies between information contained in the application form and the request;
• expiration date of the medicine: less than half of the term specified by the manufacturer if such term expires in less than one year; less than 6 months if such term exceeds one year ;
• improperly executed documents.