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ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of February 17, 2025 No. 277

Some questions of implementation of the Law of Ukraine of July 16, 2024 No. 3860-IX "About introduction of amendments to some Laws of Ukraine of rather parallel import of medicines"

According to Item 2 parts one of Article 72, Articles 73, paragraph two of part two, part three of article 78 of the Law of Ukraine of July 28, 2022 No. 2469-І X "About medicines", the paragraph of the fourth Item 5, paragraph two of Item 6 of the Section II "Final and transitional provisions" of the Law of Ukraine of July 16, 2024 No. 3860-І X "About introduction of amendments to some laws of Ukraine of rather parallel import of medicines", Item 8 of the Regulations on the Ministry of Health of Ukraine approved by the resolution of the Cabinet of Ministers of Ukraine of March 25, 2015 No. 267 (in edition of the resolution of the Cabinet of Ministers of Ukraine of January 24, 2020 No. 90), for the purpose of ensuring access of the population to high-quality and available medicines which were appointed and released for application in the territory of member states of the European Union or the European Free Trade Association, the being agreement party about European Economic Area, I ORDER:

1. Approve enclosed:

1) Procedure for provision of permission to parallel import of medicine, modification of permission to parallel import of medicine, suspension, cancellation and cancellation of permission to parallel import of medicine;

2) Changes in some regulatory legal acts of the Ministry of Health of Ukraine on settlement of parallel import of medicines.

2. To provide to pharmaceutical management (Alexander Gritsenko):

1) submission of this order in the procedure established by the legislation on state registration in the Ministry of Justice of Ukraine;

2) promulgation of this order on the official website of the Ministry of Health of Ukraine after implementation of state registration in the Ministry of Justice of Ukraine.

3. To impose control over the implementation of this order on the deputy minister of the Eden Adamanov.

4. This order becomes effective from the date of its official publication.

Health of Ukraine of February 17, 2025 No. 277 is approved by the Order of the Ministry of protection

Procedure for provision of permission to parallel import of medicine, modification of permission to parallel import of medicine, suspension, cancellation and cancellation of permission to parallel import of medicine

I. General provisions

1. This Procedure determines the procedure of issue or refusal in issue of permissions to parallel import of medicines (further - permission), modification, suspension, recovery, cancellation and cancellation of permissions by Public service of Ukraine by medicines and control of drugs (further - state control body).

2. In this Procedure terms are used in the following value:

issue of permission - provision to the subject of managing having the license for implementation of economic activity on import of medicines (except active pharmaceutical ingredients) (further - the import license of medicines), the rights to parallel import of ready medicine by adoption by state control body of the decision on issue of permission about what entry in the State register of medicines which are in parallel imported on the territory of Ukraine (further - the Register) is made;

renewal of action of permission - renewal to the parallel importer of the right to parallel import of medicine for which permission, by adoption by state control body of the decision on renewal of action of permission is issued to it about what entry in the Register is made;

secondary package - packaging in which the primary package is placed;

permission - the decision of state control body which to the subject of managing having the current license for import of medicines are granted the right to parallel import of ready medicine to the territory of Ukraine during action of permission;

the file of medicine (further - file files/materials) - the statement and materials/documents attached to it submitted by the applicant to state control body for obtaining, recovery or cancellation of action of permission or modification of file materials;

reference medicine - the medicine registered in Ukraine with which medicine on which permission is provided is identical or similar or at the same time reference or generic medicine;

the commonly accepted name - the international unlicensed name recommended by the World Health Organization (further - MNN), or if that is not present, the regular commonly accepted name;

the applicant - the job seeker of permission or the parallel importer (the owner of permission);

the job seeker of permission - subject of managing which has the current license for import of medicines also addressed according to this Procedure to state control body with the statement for receipt of permission to parallel import of medicine (further - the statement for receipt of permission);

changes, possible during action of permission - offered by the parallel importer (the owner of permission) of change, concerning materials of the file of medicine on which permission is issued;

medicine sample - photo of medicine and any portioning device which is switched on in content of packaging, the device for medicine introduction, etc.;

the short characteristic of medicine - information on medicine for health and pharmaceutical workers;

the exporting country - the member state of the European Union or the European Free Trade Association which is the agreement party about the European Economic Area which competent authority issues permission to marketing of medicine which is planned to import / is imported on the territory of Ukraine for the purposes of parallel import;

leaf tab - the document containing information on medicine for consumers and accompanying medicine;

marking - information specified on primary and secondary packagings of medicine;

marking additional (additional marking) - drawing the label with the text in state language on secondary original foreign package of the medicine imported into Ukraine for the purposes of parallel import;

original foreign packaging - the packaging of the producer of the medicine imported into Ukraine for the purposes of parallel import, executed in original language (language, excellent from state);

the parallel importer (the owner of permission) - the subject of managing having the import license of medicines and permission;

Primary package - any packaging which is directly contacting to medicine;

indications of medicine - therapeutic indications, and also age categories and groups of persons, for which the features of use of medicine specified in medicine leaf tab on which permission is issued/is issued, and in the instruction about use of medicine are established (further - the instruction for medical application), reference medicine;

suspension of action of permission - the temporary termination to the parallel importer of the right to parallel import of medicine for which permission, by adoption by state control body of the decision on suspension of action of permission is issued to it about what entry in the Register is made;

cancellation of permission - expiration of permission in five years from the date of its issue;

the project of leaf tab - transfer of leaf tab or the similar document in the exporting country in state language which authenticity is confirmed with the authorized person of the applicant responsible for issue of permission to release (realization) of series of medicine, together with the additional information which is noted in the project of leaf tab according to appendix 2 to this Procedure (if file materials for receipt of permission move) or appendix 3 to this Procedure (if changes are made to materials of the file of medicine on which permission is issued);

consideration of materials of the file of medicine for parallel import or changes in them - check by the state company "State Expert Centre of the Ministry of Health of Ukraine" (further - the Center) the medicine registration fact that it is planned to import / is imported on the territory of Ukraine for the purposes of parallel import and on what the competent authority of the exporting country issues permission to marketing, fulfillment of requirements of the Law of Ukraine "About medicines" and this Procedure concerning materials of the file of medicinal means / changes to them, and also respect for the criteria of compliance of medicine for the purposes of parallel import to reference medicine established by the Law of Ukraine "About medicines" and the Section VII of this Procedure (further - criteria of compliance);

cancellation of action of permission - deprivation of the parallel importer of the right to parallel import of medicine on which permission, by adoption by state control body of the decision on cancellation of action of permission is issued to it about what entry in the Register is made;

trade name of medicine - the name under which medicine is authorized for the purposes of parallel import and which gives the chance to identify it.

Other terms used in this Procedure are used in the values given in the Laws of Ukraine of July 16, 2024 No. 3860-IX "About introduction of amendments to some laws of Ukraine of rather parallel import of medicines", "About medicines", "About state registration of legal entities, physical persons - entrepreneurs and public forming", "About licensing of types of economic activity" and "About ministerial procedure", and also according to other regulatory legal acts in the field of drug circulation.

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