Registration of Drugs in Ukrain

State registration of medicinal drugs

Medicinal products can be used in Ukraine only after their state registration. Medicinal products which are prepared in pharmacies of active and supplementary substances upon doctors’ prescriptions (mainline formulas) and upon order of medico-prophylactic institutions (officinal formulas) are not subject to state registration. The procedure for the state drug registration (re-registration) and (re-)registration fee is approved by the Resolution of the CMU dd. 26.05.2005 #376.

The MHC of Ukraine registers and re-registers medicinal products upon results of an expert examination of registration materials (registration file) on such drug and its quality control carried out by the Centre. The fee for the state medicinal product (re-)registration shall be paid to the state budget by the applicant in following amounts:

1. For the state (re-) registration of medicinal products, except for radioactive drugs, diagnostic agents, simple or complex (galenical) drugs made from crude drugs – in the amount equivalent to 100 EUR for each drug form, 10 EUR for each next dose, 10 EUR for each next drug package; 
2. For the state (re-) registration of radioactive medicinal products, diagnostic agents, simple or complex (galenical) medicinal products, active medicinal products with restricted use and such produced pursuant to formulations approved by the MHC of Ukraine (information of composition, manufacture (preparation) technology, quality control and medicinal product application), preparation made from donor blood or plasma – in the amount equivalent to 25 EUR for one name, 5 EUR for each next dose, 5 EUR for each next drug package. 

Additionally, the applicant pays a fee for expert examination under a contract on expert examination concluded between the Centre and the applicant. The fee amount depends on application type and is the same for all business entities (residents and non-residents). 

Only after payment of the fee for the drug (re-) registration and expert examination registration materials will be accepted by the Centre for consideration. If the Centre has examined pre-clinical or clinical materials pursuant to the established procedure, the applicant shall pay only for expert examination for additional materials, if any. The procedure for expert examination of the drug registration file submitted to the state (re-)registration as well as expert examination of materials on amendments to registration file within validity term of the registration certificate is approved by the Decree of the MHC of Ukraine dd. 26.08.2005 #426. 

This procedure shall be applied to active substances (active pharmaceutical ingredients), officinal dugs (except for medical immunobiological drugs) as well as preparations registered upon definition of the MHC of Ukraine as medicinal products, in particular: curative cosmetics, disinfectors and diagnostic agents.

Expert examination of the medicinal product registration file submitted for the state (re-) registration has following stages: 

• Initial expert examination of the application in order to determine that the medicinal product does not belong to drugs prohibited for use in Ukraine and can be (re-) registered and that the application type has been specified correctly. 
• Preliminary expert examination the goal of which is to determine the origin of the medicinal product offered by the applicant, drug manufacturing process (full technological cycle or its packing in bulk or carrying out of a certain stage as well as the level of influence of the manufacturing on the medicinal product characteristics etc.), compliance of the submitted registration file, participation level in the drug manufacturing, accuracy of information sources identification or provision of bibliographical information as to qualities of the drug if the applicant is responsible for final stages of the drug production with proofs that its activity cannot influence the medicinal product characteristics as to its quality, safety and efficacy. 

The preliminary expert examination also determines the completeness of the registration file as to evidence for safety, efficacy and quality of the medicinal product, order and procedure of the specialized expert examination. 

The specialized expert examination of the registration file and results of additional examinations (trials) of the medicinal product is conducted in order to reach a motivated conclusion on the efficacy, safety and quality of the drug.

Expert examination terms: 

• Not more than 210 calendar days beginning with the date of official acceptance of a state registration application: for registration files on medicinal products submitted for state registration based on full and independent/autonomous application;
• Not more than 90 calendar days beginning with the date of official acceptance of a respective application as to:

- medicinal products submitted for state registration under other application types;

- active substances;

- medicinal products submitted for state re-registration.

• Not more than 60 calendar days after receipt by the Centre of the respective application: for files on introduction of changes to registration file type I or II (changes to registration file not subject to new medicinal product registration). 

The expert examination term does not include period when the registration file has been modified by the applicant and period of conduction of additional examinations (trials). Upon results of the expert examination the Centre shall prepare a motivated conclusion as to efficacy, safety and quality of the medicinal product and its recommendations as to approval of or refuse in state (re-)registration of such drug.

Based on conclusion and recommendations of the Centre the MHC of Ukraine shall decide within one month on registration of or refusal in registration of the drug. The Decree of the MHC of Ukraine on drug state registration approves a pharmacopeial item or methods for control of its quality, instruction on medical application, package insert for patients, technological regulation or manufacturing technology as well as assigns a registration number which shall be entered to the State drug register and interdepartmental data bases on drugs registered in Ukraine.

The registration certificate with indication of the term during which the drug may be used in Ukraine shall be issued by the Centre within 10 days term after drug registration. The drug can be administered in Ukraine within 5 years as of its state registration, if the MHC of Ukraine does not decide on complete or temporary prohibition of its administration due to discovery of previously unknown dangerous qualities. After end of the administration term its further application is possible subject to reregistration.

A re-registration application of the drug shall be submitted to the Centre not earlier than one year but not later than 90 calendar days before the end of the certificate validity term. If application on re-registration is submitted after such term, the re-registration shall be carried out under procedure of a new registration.

Information contained in application on drug state registration and annexes to it is subject to state protection against disclosure and unfair commercial use. The MHC of Ukraine and the Centre are obliged to protect such information against disclosure and prevent its unfair commercial use. 

It is prohibited within 5 years as of drug state registration (irrespectively validity of any drug related patent) to use registration information contained in the application and annexes to it regarding safety and efficiency of the registered drug, except for cases when the right to refer to or use such information has been obtained from a person or institution which provided such information according to procedure established by legislation or information has been prepared by or for the applicant. 

Persons responsible for disclosure or illegal use of registration information shall be brought to disciplinary, administrative, civil and/or criminal liability according to the laws of Ukraine. 

For purposes of the state registration of drugs which are based or connected to intellectual property objects having respective patent in Ukraine pursuant to the legislation the applicant shall submit a copy of the patent or a license allowing manufacturing and sale of registered drug and a letter with indication that rights of a third party protected by the patent are not violated in connection with the drug registration.