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of March 14, 2025 No. 287
About approval of the Procedure for import to the territory of Ukraine of medicines
According to part six of article 73 of the Law of Ukraine of July 28, 2022 "About medicines" the Cabinet of Ministers of Ukraine decides No. 2469-IX:
1. Approve the Procedure for import to the territory of Ukraine of medicines which it is applied.
2. This resolution becomes effective from the date of enforcement of the Law of Ukraine of July 28, 2022 No. 2469-IX "About medicines".
Prime Minister of Ukraine
D. Shmygal
Approved by the Resolution of the Cabinet of Ministers of Ukraine of March 14, 2025, No. 287
1. This Procedure determines the procedure of import to the territory of Ukraine of medicines by importers, parallel importers, distributors.
2. In this Procedure terms are used in the following value:
the responsible person of the distributor - person who is responsible for ensuring functioning of the quality system carries out quality check of series of the medicine imported on the territory of Ukraine and makes the decision on introduction it in the address;
the distributor - the subject of managing who is performing economic activity on wholesale trade by medicines and having the license for wholesale trade by medicines;
the importer - the subject of managing registered in the procedure established by the legislation of Ukraine, who is performing activities for import of medicines and having the import license of medicines.
Other terms in this procedure are used in the value given in the Law of Ukraine of July 28, 2022 No. 2469-IX "About medicines" (further - the Law) and Licensed conditions of implementation of economic activity on production of medicines, wholesale and retail trade by medicines, import of the medicines (except active pharmaceutical ingredients) approved by the resolution of the Cabinet of Ministers of Ukraine of November 30, 2016 No. 929 (The Official Bulletin of Ukraine, 2016, No. 99, the Art. 3217) (further - Licensed conditions).
3. Action of this Procedure extends to the medicines imported on the territory of Ukraine except:
the medicines determined by Item of 1 part three of article 5 of the Law;
not registered medicines (except medicines which are in parallel imported on the territory of Ukraine by parallel importers);
the researched medicines.
4. In case of import to the territory of Ukraine of the active pharmaceutical ingredients registered in Ukraine and products of "in bulk" the importer, the distributor perform sampling for carrying out laboratory control of their quality on compliance to requirements of the specification of quality of methods of quality control of medicine to the registration certificate or specifications of the registration file, or to requirements of the state pharmacopeia of Ukraine / the European pharmacopeia (for active pharmaceutical ingredients) independently and are responsible for quality of the specified medicines according to the law. Laboratory control of their quality is carried out to laboratories, certified/authorized by state control body.
The importer, the distributor monthly to the 15th submit to state control body in the place of implementation of economic activity such information and data about: to date of import of active pharmaceutical ingredients and products of "in bulk", their name, number and the size of series, quantity, expiration date, producers, number of the registration certificate (in the presence), and also documents on carrying out laboratory quality control (certificates, specifications, control methods, etc.) received within 30 calendar days.
Together with information specified in the paragraph the second this Item, the importer, the distributor submit to state control body in the place of implementation of economic activity documents and information, the stipulated in Article 46 Laws.
Information and supporting documents specified in paragraphs second and third this Item move electronically through the official website of state control body.
In case of identification by results of the laboratory analysis of low-quality active pharmaceutical ingredients and products of "in bulk" subjects of managing not later than within three working days inform state control body in the place of implementation of economic activity on the measures taken in connection with identification of low-quality active pharmaceutical ingredients and products of "in bulk".
5. Medicines which according to the law are subject to the state quality control are imported on the territory of Ukraine and introduced into circulation by subjects of managing according to requirements of the legislation on quality control of the medicines imported on the territory of Ukraine.
6. Narcotic (psychotropic) medicines are imported on the territory of Ukraine and introduced into circulation according to this Procedure and the legislation on drugs, psychotropic substances and precursors.
7. On the territory of Ukraine Medicines are imported:
1) importers - from other countries, except 2 presents of Item specified in the subitem;
2) parallel importers, distributors - from the EU member state or the European Free Trade Association which is the agreement party about the European Economic Area (further - the exporting country).
8. Import of medicines is performed according to Licensed conditions taking into account requirements of the proper production practice (Good Manufacturing Practice, GMP) approved by the Ministry of Health (further - proper production practice).
Each series of medicine shall be followed by the certificate of series of medicine issued by the producer, conforming to the industry standard "The international harmonized requirements for certification of series" approved by the Ministry of Health, adapted for the legislation of the EU.
Certification of series of the medicine imported on the territory of Ukraine by the importer is performed by its authorized person by monitoring procedure of compliance of series of the imported medicine to the registration file based on which medicine is registered in Ukraine, and to requirements of proper production practice.
Information on the importer shall be entered in materials of the registration file on the imported medicine.
9. The importer within certification of each series of the medicines imported on the territory of Ukraine provides carrying out laboratory quality control of medicines, and also the checks established by requirements of proper production practice before carrying out certification and release of series of medicine and import of medicines.
Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info
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