Law of Ukraine

"On Amendments to the Law of Ukraine "On Medicines" to Improve the Procedure for Supplying the Population with Medicines Required for Treating Socially Dangerous and Severe Diseases"

Date of entry into force:
September 5, 2014

The Law of Ukraine "On Medicines" N123/96-VR of April 4, 1996 regulates legal relations associated with creation, registration, production, quality control, and sale of medicines, determines the rights and obligations of companies, institutions, organizations, and citizens, and the competence of executive authorities and officials in this sphere.

Article 9 of the Law of Ukraine "On Medicines" establishes the procedure for state registration of medicines.

The Law amends Article 9, parts 3, 4, 5, 12, and 19 of the Law, which establish the following:
  • the application for state registration of a drug shall include: manufacturer's name and address; manufacturer's location address and production capacities address; name and commercial name of the drug; name of active substance (in Latin); synonyms; pharmaceutical form; complete composition of the drug; indications and contraindications; dosage; sales list; methods of use; shelf life and storage conditions; packaging information; information about registration of the drug in other countries, including country name, and registration number and date;
  • the application for state registration of a drug intended exclusively for treatment of tuberculosis, HIV/AIDS, viral hepatitis, oncologic, and rare (orphan) diseases, which is registered as a drug with a competent authority of the United States of America, Switzerland, Japan, Australia, Canada, or the European Union, requires only the following attachments: materials on the drug quality control methods; samples of drug packaging with labeling in the language used for drug labeling according to the requirements of the Law of Ukraine "On Medicines"; drug use instruction in the language according to the requirements of the Law of Ukraine "On Medicines"; and the document confirming payment of the registration fee;
  • the decision to register or deny registration to a drug intended exclusively for treatment of tuberculosis, HIV/AIDS, viral hepatitis, oncologic, and rare (orphan) diseases, which is registered as a drug with a competent authority of the United States of America, Switzerland, Japan, Australia, Canada, or the European Union, is made within seven days;
  • for a drug intended exclusively for treatment of tuberculosis, HIV/AIDS, viral hepatitis, oncologic, and rare (orphan) diseases, which is registered as a drug with a competent authority of the United States of America, Switzerland, Japan, Australia, Canada, or the European Union, the certified copy of the proof of conformance of the manufacturing conditions of the drug submitted for registration to the requirements to drug manufacturing conditions in Ukraine can be replaced by the manufacturer's written obligation to manufacture the respective drug for supply to Ukraine using the same production capacities used to manufacture drugs intended for use in the United States of America, Switzerland, Japan, Australia, Canada, or the European Union countries;
  • the reason to deny state registration to a drug intended exclusively for treatment of tuberculosis, HIV/AIDS, viral hepatitis, oncologic, and rare (orphan) diseases, which is registered as a drug with a competent authority of the United States of America, Switzerland, Japan, Australia, Canada, or the European Union is: submission of an incomplete set of documents provided for by this article; untrue or incomplete information in the submitted documents; discrepancy between the manufacturer's name, location and address of production capacities as stated in the application for state registration of the drug, to the information based on which such drug is registered with a competent authority of the United States of America, Switzerland, Japan, Australia, Canada, or the European Union.

Article 17 of the Law of Ukraine "On Medicines" establishes the procedure for import of drugs to Ukraine.

According to amendments to Article 17, part 3 of the Law of Ukraine "On Medicines", unregistered drugs can also be imported to the customs territory of Ukraine for treatment of rare (orphan) diseases, by decision of the central executive authority that provides for creation of state policy in the sphere of health care. This provision only applies to drugs developed exclusively for treatment of rare (orphan) diseases, which are permitted for use according to the established procedure on the territory of the United States of America or the European Union countries, regardless of whether they are registered as drugs with competent authorities of the United States of America or the European Union.

The Law supplements Article 17, part 5 of the Law of Ukraine "On Medicines" with a new provision, according to which, by separate resolution of the central executive authority that provides for creation of state policy in the sphere of health care, foreign drugs not registered in Ukraine can also be imported for medical support (medical application) for military servicemen and members of private and command corps that carry out missions during the anti-terrorist operation, during the state of emergency, or the special period, subject to the availability of documents confirming registration and use of such drugs in respective foreign states.
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