Registration of the medicines in Ukraine. Overview of the procedures

 

Simplified registration procedures

Standard registration procedures

 

Characteristics

Order of the Ministry of Healthcare of Ukraine (MOH) #1245 dated 17.11.2016 

The Law of Ukraine on Medicines part 4 article 9-1, MoH Order #1391 dated 15.06.2020

 

The Law of Ukraine on Medicines article 9, MoH Order #426 dated 26.08.2005 

The Law of Ukraine on Medicines part 5 article 9-1, MoH Order #426 dated 26.08.2005 (article 10.4, 10.5 chapter V) 

 

MoH Order #426 dated 26.08.2005  (article 10.2 chapter V) 

Description of the registration procedure

Procedure to be applied to the medicines that are registered under the centralized registration procedure by the competent authorities of the USA, Swiss Confederation, Japan, Australia, Canada and the EU.

Procedure to be applied to the medicines that are registered by the competent authorities of the USA, Swiss Confederation, Japan, Australia, Canada and are in use on the territory of these countries. Also those that are registered by the competent authority of the EU through the centralized registration procedure and are in use on the territory of the EU member states.

Standard procedure of the registration of the medicines, which is harmonized with the EU Directive 2001/83/EC.

Standard procedure of the registration of the medicines, which is harmonized with the EU Directive 2001/83/EC.

Procedure to be applied to the medicines for the treatment of tuberculosis, HIV/AIDS or viral hepatitis that already have WHO pre-qualification and are included in the WHO Prequalified Lists

Trade restrictions 

No trade restrictions. The registration allows to supply medicines to the healthcare facilities and further into retail. 

 

Imposes trade restrictions. The registration allows to supply medicines only to the healthcare facilities when purchased under the state’s centralised procurement programs in healthcare.  

No trade restrictions. The registration allows to supply medicines to the healthcare facilities and further into retail. 

Imposes trade restrictions only on the medicines in international package. In international package medicines can be supplied to the healthcare facilities when purchased under the state’s centralised procurement programs in healthcare. 

In Ukrainian package no trade restrictions. The registration allows to supply medicines either to the healthcare facilities or further into retail. 

No trade restrictions. The registration allows to supply medicines to the healthcare facilities and further into retail. 

Packing requirements

Ukrainian package

International package

Ukrainian package

International package and Ukrainian package

Ukrainian package

Quality control requirements

 

When medicine is procured by the specialized procurement agencies under centralised state’s procurement programs there is no need to undergo the state quality control inspection on import (from non-residents). Only visual inspection and verification of the transportation documents takes place. 

When medicine is procured by the CPA under centralised state’s procurement programs the incoming quality control during import is obligatory. Namely visual control, verification of the transportation documents, laboratory analyses (if there are grounds). 

If to be used further in retail the state’s quality control during import of the medicines is obligatory. 

When medicine is procured by the specialized procurement agencies under centralised state’s procurement programs there is no need to undergo the state quality control inspection on import (from non-residents). Only visual inspection and verification of the transportation documents takes place.

When medicine is procured by the CPA under centralised state’s procurement programs the incoming quality control during import is obligatory. Namely visual control, verification of the transportation documents, laboratory analyses (if there are grounds)

When medicine is procured by the specialized procurement agencies under centralised state’s procurement programs there is no need to undergo the state quality control inspection on import (from non-residents). Only visual inspection and verification of the transportation documents takes place.

When medicine is procured by the CPA under centralised state’s procurement programs the incoming quality control during import is obligatory. Namely visual control, verification of the transportation documents, laboratory analyses (if there are grounds). 

If to be used further in retail the state’s quality control during import of the medicines is obligatory. 

When medicine is procured by the specialized procurement agencies under centralised state’s procurement programs there is no need to undergo the state quality control inspection on import (from non-residents). Only visual inspection and verification of the transportation documents takes place. 

When medicine is procured by the CPA under centralised state’s procurement programs the incoming quality control during import is obligatory. Namely visual control, verification of the transportation documents, laboratory analyses (if there are grounds).  

If to be used further in retail the state’s quality control during import of the medicines is obligatory. 

When medicine is procured by the specialized procurement agencies under centralised state’s procurement programs there is no need to undergo the state quality control inspection on import (from non-residents). Only visual inspection and verification of the transportation documents takes place.

When medicine is procured by the CPA under centralised state’s procurement programs the incoming quality control during import is obligatory. Namely visual control, verification of the transportation documents, laboratory analyses (if there are grounds).  

If to be used further in retail the state’s quality control during import of the medicines is obligatory. 

Country of origin requirements

Is applicable to the medicines that are registered under the centralized registration procedure by the competent authorities of the USA, Swiss Confederation, Japan, Australia, Canada and the EU.

Is applicable to the medicines that are registered by the competent authorities of the USA, Swiss Confederation, Japan, Australia, Canada and are in use on the territory of these countries. Also those that are registered by the competent authority of the EU through the centralized registration procedure and are in use on the territory of the EU member states.

Does not depend on the country of origin.

Does not depend on the country of origin.

Does not depend on the country of origin. Is applicable to the medicines that already have WHO pre-qualification and are included in the WHO Prequalified Lists. 

Medicine assessment report requirements 

 

An assessment report or similar document, issued by an authorized registration body of the competent authorities of the USA, Swiss Confederation, Japan, Australia, Canada and the EU if the medicine is registered under the centralized registration procedure in these countries and intended to be used on the territory of these countries or of the EU member states.

An assessment report, issued by a competent authority of the country where the medicine is registered

No need

No need

WHO assessment report (WHOPAS (s)) is required.

WHO report on the inspection of the manufacturing site (WHOPIR (s)) is required.

 

 

Requirements on the expertise of the registration materials

Checking the registration (making changes to the registration materials) of medicine made by competent authority of the USA, Swiss Confederation, Japan, Australia, Canada and EU – through the centralized registration procedure, completeness of the submitted registration materials without conducting its expertise.

Checking the authenticity of the translation of application and registration materials without conducting its expertise.

Expertise of the materials of the medicine's registration dossier.

Expertise of the materials of the medicine's registration dossier.

Expertise of the materials of the medicine's registration dossier.

Time period of the verification/expertise and MOH’s decision to be taken *doesn’t include time period, when materials are revised by the applicant (e.g. when answering comments) and/or time period when there are the third parties involved (e.g. Ukraine’s  competent authorities and/or other countries) and/or time period, which is needed for laboratory tests

10 w.d.* + 7 w.d.

7 w.d.* + 5 w.d.

210 w.d.* + 10 w.d.

30 w.d.* + 10 w.d.

45 w.d.* + 10 w.d.

State fee on the registration of the medicines

Paid

Free of charge (however, there are fees for the conduct of the expertise)

Paid

Paid

Paid

Requirements on the approval of the compliance of the medicine manufacture conditions with the requirements of good manufacturing practice

Certified copy of the document, issued by State Service of Ukraine on Medicines and Drugs Control, which approves the compliance of the manufacture conditions of the medicine that is submitted for the registration in Ukraine with the requirements of good manufacturing practice adopted in Ukraine or manufacturer's written commitment to produce mentioned medicine intended to be supplied to Ukraine, on the same production line as the medicines intended for  the markets of the USA, Swiss Confederation, Japan, Australia, Canada and member state of the EU. 

Certified copy of the document, issued by State Service of Ukraine on Medicines and Drugs Control, which approves the compliance of the manufacture conditions of the medicine that is submitted for the registration in Ukraine with the requirements of good manufacturing practice adopted in Ukraine or manufacturer's written commitment to produce mentioned medicine intended to be supplied to Ukraine, on the same production line as the medicines intended for  the markets of the USA, Swiss Confederation, Japan, Australia, Canada and member state of the EU. 

Certified copy of the document, issued by State Service of Ukraine on Medicines and Drugs Control, which approves the compliance of the manufacture conditions of the medicine that is submitted for the registration in Ukraine with the requirements of good manufacturing practice adopted in Ukraine or applicants written commitment to submit this document during the process of specialized expertise. 

Certified copy of the document, issued by State Service of Ukraine on Medicines and Drugs Control, which approves the compliance of the manufacture conditions of the medicine that is submitted for the registration in Ukraine with the requirements of good manufacturing practice adopted in Ukraine or applicants written commitment to submit this document during the process of specialized expertise. 

Certified copy of the document, issued by State Service of Ukraine on Medicines and Drugs Control, which approves the compliance of the manufacture conditions of the medicine that is submitted for the registration in Ukraine with the requirements of good manufacturing practice adopted in Ukraine or applicants written commitment to submit this document during the process of specialized expertise. 

Requirements for documents to be submitted 

- application for state registration;

- materials of registration dossier which were submitted for registration and on the basis of which registration was made by the competent authority of the USA, Swiss Confederation, Japan, Australia, Canada and EU – through the centralized registration procedure for using that medicine on the territory of those countries and member countries of the EU (including all changes, made after registration);

- medicines quality control methods (prepared and translated into Ukrainian);

- instruction for medicine`s medical use and its translation into Ukrainian;

- graphic image of package scheduled for import;

- translation of text of primary and secondary (if present) medicine package (mock-up);

- document confirming payment of the registration fee;

- certified copy of document, issued by State Service of Ukraine on Medicines and Drugs Control, which approves the compliance of the manufacture conditions of medicine, that is submitted for registration in Ukraine with the requirements of good manufacturing practice which are in force in Ukraine or manufacturer's written commitment to produce mentioned medicine for its supplying to Ukraine on the same production capacity, that are used for producing medicines for the USA, Swiss Confederation, Japan, Australia, Canada and member countries of the EU markets;

- actual production license for medicine; 

- approval of registration in country of manufacturer or applicant, where that medicine, which is submitted for registration is registered (CoPP or MA or in the presence, assessment report, issued by an authorized body of registration of competent authority of the USA, Swiss Confederation, Japan, Australia, Canada and EU – in a case if medicine is registered through the centralized registration procedure for using on the territory of those countries or on the territory of member countries of the EU or other analogue document, issued by an authorized body of registration of competent authority of the USA, Swiss Confederation, Japan, Australia, Canada and EU – in a case if medicine is registered through the centralized registration procedure for using on the territory of those countries or on the territory of member countries of the EU (including all changes, made after registration)).

* In a case of changing of applicant the submission of the document confirming the ability of such person to act as an applicant (the holder of the registration certificate) on the territory of Ukraine is obligatory.

- application for state registration;

- materials of registration dossier which were submitted for registration and on the basis of which registration was made by the competent authority of the USA, Swiss Confederation, Japan, Australia, Canada and EU – through the centralized registration procedure for using that medicine on the territory of those countries and member countries of the EU (including all changes, made after registration); 

- assessment report, issued by a competent authority of that country where medicine is registered (including all changes, made after registration);

- medicines quality control methods (prepared as a separate document, can be designed in the English language);

- instruction for medicine`s medical use and its translation into Ukrainian;

- graphic image of package scheduled for import;

- translation of text of primary and secondary (if present) medicine package (mock-up);

- certified copy of document, issued by State Service of Ukraine on Medicines and Drugs Control, which approves the compliance of the manufacture conditions of medicine, that is submitted for registration in Ukraine with the requirements of good manufacturing practice which are in force in Ukraine or manufacturer's written commitment to produce mentioned medicine for its supplying to Ukraine on the same production capacity, that are used for producing medicines for the USA, Swiss Confederation, Japan, Australia, Canada and member countries of the EU markets;

- actual production license for medicine; 

- approval of medicine registration by the competent authority of the USA, Swiss Confederation, Japan, Australia, Canada and using on the territory of those countries and registration by the competent authority of the EU through the centralized registration procedure and using on the territory of member countries of the EU (CoPP or MA).

- application for state registration;

- registration form with all relevant annexes;

- materials of registration dossier made in accordance with the general requirements to registration dossier materials in CTD format depending on the type of medicine (including all changes, made after registration);

- certified copy of document, issued by State Service of Ukraine on Medicines and Drugs Control, which approves the compliance of the manufacture conditions of medicine, that is submitted for registration in Ukraine with the requirements of good manufacturing practice which are in force in Ukraine or warrantee letter from applicant to submit that document during the process of specialized expertise; 

- instruction for medicine`s medical use and its translation into Ukrainian;

- medicines quality control methods (prepared and translated into Ukrainian);

- translation of text of primary and secondary (if present) medicine package (mock-up);

- actual production license for medicine;

- document confirming payment of the registration fee.

- application for state registration;

- registration form with all relevant annexes (access by link https://dec.gov.ua/materials/order-26-08-2005-426-460/);

- materials of registration dossier made in accordance with the general requirements to registration dossier materials in CTD format depending on the type of medicine (including all changes, made after registration); 

- certified copy of document, issued by State Service of Ukraine on Medicines and Drugs Control, which approves the compliance of the manufacture conditions of medicine, that is submitted for registration in Ukraine with the requirements of good manufacturing practice which are in force in Ukraine or warrantee letter from applicant to submit that document during the process of specialized expertise;

- instruction for medicine`s medical use and its translation into Ukrainian;

- summary of product characteristics and its translation into Ukrainian;

- medicines quality control methods (prepared and translated into Ukrainian);

- graphic image of package scheduled for import;

- translation of text of primary and secondary (if present) medicine package (mock-up);

- actual production license for medicine;

- document confirming payment of the registration fee.

- application for state registration;

- registration form with all relevant annexes;

- the registration dossier for such medicinal products shall be submitted in the format that was provided to WHO for the prequalification procedure;

- WHO assessment report (WHOPAS (s));

- WHO report on the inspection of the manufacturing site (WHOPIR (s));

- an official letter from the applicant (according to the WHO approved form) about state registration of the medicinal product in Ukraine after receiving the access code to the official website of the WHO prequalification program;

- written confirmation from the applicant that the medicinal product applied for registration corresponds to a medicinal product that has been prequalified and included in the official WHO Prequalified list;

- certified copy of document, issued by State Service of Ukraine on Medicines and Drugs Control, which approves the compliance of the manufacture conditions of medicine, that is submitted for registration in Ukraine with the requirements of good manufacturing practice which are in force in Ukraine or warrantee letter from applicant to submit that document during the process of specialized expertise;

- instruction for medicine`s medical use and its translation into Ukrainian;

- summary of product characteristics and its translation into Ukrainian, if applicable;

- medicines quality control methods (prepared and translated into Ukrainian);

- graphic image of package scheduled for import;

- translation of text of primary and secondary (if present) medicine package (mock-up);

- actual production license for medicine;

- document confirming payment of the registration fee.

 

Course of action

- application for the state registration;

- materials of the registration dossier, which were submitted for registration and according to which the competent authorities of the USA, Swiss Confederation, Japan, Australia, Canada and the EU granted registration of the medicine under the centralized registration procedure, for further use of the medicine on the territory of these countries and EU member states(including all changes, made after registration);

- quality control methods of the medicine (prepared and translated into Ukrainian);

- instruction for the medical use of medicine and its translation into Ukrainian;

- graphic image of the package in which medicine will be imported; 

- translation of the text of the primary and secondary (if present) medicine package (mock-up);

- document confirming payment of the registration fee;

- certified copy of the document, issued by State Service of Ukraine on Medicines and Drugs Control, which approves the compliance of the manufacture conditions of the medicine that is submitted for the registration in Ukraine with the requirements of good manufacturing practice adopted in Ukraine or manufacturer's written commitment to produce mentioned medicine intended to be supplied to Ukraine, on the same production line as the medicines intended for  the markets of the USA, Swiss Confederation, Japan, Australia, Canada and member state of the EU;

- actual production license for the medicine; 

- approval of the registration in the country of manufacturer or applicant, where the medicine, which is submitted for registration is registered (CoPP or MA or else, an assessment report or similar document, issued by an authorized registration body of the competent authorities of the USA, Swiss Confederation, Japan, Australia, Canada and the EU if the medicine is registered under the centralized registration procedure in these countries and intended to be used on the territory of these countries or of the EU member states (including all changes, made after registration).

 

*In case there is a change of the applicant it is obligatory to submit the document that confirms the ability of the person to act as an applicant (the holder of the registration dossier) on the territory of Ukraine.

- submission of the application to the Ministry of Healthcare (MOH) for registration;

- conclusion of the agreement between the applicant and the State Expert Center (SEC). An applicant should act in accordance to the Contract or Power of Attorney which confirms the ability to act on behalf of the manufacturer;

- submission of the application to the SEC or receiving access to the Information System where the applicant can monitor the stages of the registration procedure;

- payment of the SEC services according to the received bill;

- submitting materials of the registration dossier to the SEC (in line with all above mentioned requirements and annexes);

- the SEC checks all submitted documents (in line with all above mentioned requirements) and provides the conclusion to the MOH for the final decision;

- applicant receives a draft of Registration Certificate at the SEC for the approval;

- as per the conclusion of the SEC, MoH to decide whether to grant registration of the medicine or deny it;

- MOH publishes an order on its official web-site;

- in case the decision is positive applicant receives an original of the registration certificate at the SEC. Registration information is uploaded in the state register.

- submission of the application to the Ministry of Healthcare (MOH) for registration according to the type of the medicine intended to be registered;

- conclusion of the agreement between the applicant and the State Expert Center (SEC). An applicant should act in accordance to the Contract or Power of Attorney which confirms the ability to act on behalf of the manufacturer;

- submission of the application to the SEC for receiving access to the Information System where the applicant can monitor the stages of the registration procedure;

- submission of the registration form with all relevant annexes and all necessary translations into Ukrainian;

- during the review of the registration form and its annexes the SEC can one time provide comments to the applicant and ask to add necessary documents or correct the data, that in needed for further consideration;

- in case the applicant receives such comments the necessary documents should be submitted and/or answers provided; 

- payment of the SEC services according to the received bill;

- preparation and submission of the materials of the registration dossier to the SEC (in line with all above mentioned requirements and annexes): completeness and number of copies of the registration dossier depends on the type of medicine, mentioned in the application;

- the SEC conducts preliminary review of the submitted materials and can one time provide comments to the applicant and ask to add necessary documents or correct data, that in needed for further consideration;

- in case the applicant receives such comments the necessary documents should be submitted and/or answers provided;

- if SEC provides positive conclusion after the preliminary review of the materials, they are further submitted for the specialized expertise; 

- during the specialized expertise (each part of the registration dossier is reviewed by the relevant expert within the advisory group) each expert of the SEC, who is involved in the review process, can two times provide comments to the applicant and ask to add necessary documents or correct the data, that in needed for further consideration;

- in case the applicant receives such comments the necessary documents should be submitted and/or answers provided;

- as a result of the expertise relevant conclusions are drawn. Results of the expertise are submitted to the SEC Commission in order to be analyzed, SEC Commission provides final conclusion about a possibility of a state registration of the medicine;

- according to the results of the SEC Commission meeting applicant receives a draft of Registration Certificate, quality control methods, instruction and mock-ups (package marking) at the SEC for the approval; 

- a final conclusion of the SEC Commission moves to MOH;

- taking into account the conclusion of the SEC, MOH should decide whether to grant registration of the medicine or deny it;

- MOH publishes an order on its official web-site;

- in case the decision is positive applicant receives an original of the registration certificate, quality control methods, instruction and mock-ups (package marking) at the SEC. Registration information is uploaded in the state register.

- submission of the application to the Ministry of Healthcare (MOH) for registration according to the type of the medicine intended to be registered;

- conclusion of the agreement between the applicant and the State Expert Center (SEC). An applicant should act in accordance to the Contract or Power of Attorney which confirms the ability to act on behalf of the manufacturer;

- submission of the application to the SEC for receiving access to the Information System where the applicant can monitor the stages of the registration procedure;

- submission of the registration form with all relevant annexes and all necessary translations into Ukrainian;

- during the review of the registration form and its annexes the SEC can one time provide comments to the applicant and ask to add necessary documents or correct the data, that in needed for further consideration;

- in case the applicant receives such comments the necessary documents should be submitted and/or answers provided; 

- payment of the SEC services according to the received bill;

- preparation and submission of the materials of the registration dossier to the SEC (in line with all above mentioned requirements and annexes): completeness and number of copies of the registration dossier depends on the type of medicine, mentioned in the application;

- the SEC conducts preliminary review of the submitted materials and can one time provide comments to the applicant and ask to add necessary documents or correct data, that in needed for further consideration;

- in case the applicant receives such comments the necessary documents should be submitted and/or answers provided;

- if SEC provides positive conclusion after the preliminary review of the materials, they are further submitted for the specialized expertise; 

- during the specialized expertise (each part of the registration dossier is reviewed by the relevant expert within the advisory group) each expert of the SEC, who is involved in the review process, can two times provide comments to the applicant and ask to add necessary documents or correct the data, that in needed for further consideration;

- in case the applicant receives such comments the necessary documents should be submitted and/or answers provided;

- as a result of the expertise relevant conclusions are drawn. Results of the expertise are submitted to the SEC Commission in order to be analyzed, SEC Commission provides final conclusion about a possibility of a state registration of the medicine;

- according to the results of the SEC Commission meeting applicant receives a draft of Registration Certificate, quality control methods, instruction and mock-ups (package marking) at the SEC for the approval; 

- a final conclusion of the SEC Commission moves to MOH;

- taking into account the conclusion of the SEC, MOH should decide whether to grant registration of the medicine or deny it;

- MOH publishes an order on its official web-site;

- in case the decision is positive applicant receives an original of the registration certificate, quality control methods, instruction and mock-ups (package marking) at the SEC. Registration information is uploaded in the state register.

- submission of the application to the Ministry of Healthcare (MOH) for registration according to the type of the medicine intended to be registered;

- conclusion of the agreement between the applicant and the State Expert Center (SEC). An applicant should act in accordance to the Contract or Power of Attorney which confirms the ability to act on behalf of the manufacturer;

- submission of the application to the SEC for receiving access to the Information System where the applicant can monitor the stages of the registration procedure;

- submission of the registration form with all relevant annexes and all necessary translations into Ukrainian;

- during the review of the registration form and its annexes the SEC can one time provide comments to the applicant and ask to add necessary documents or correct the data, that in needed for further consideration;

- in case the applicant receives such comments the necessary documents should be submitted and/or answers provided; 

- payment of the SEC services according to the received bill;

- preparation and submission of the materials of the registration dossier to the SEC (in line with all above mentioned requirements and annexes): completeness and number of copies of the registration dossier depends on the type of medicine, mentioned in the application;

- the SEC conducts preliminary review of the submitted materials and can one time provide comments to the applicant and ask to add necessary documents or correct data, that in needed for further consideration;

- in case the applicant receives such comments the necessary documents should be submitted and/or answers provided;

- if SEC provides positive conclusion after the preliminary review of the materials, they are further submitted for the specialized expertise; 

- during the specialized expertise (each part of the registration dossier is reviewed by the relevant expert within the advisory group) each expert of the SEC, who is involved in the review process, can two times provide comments to the applicant and ask to add necessary documents or correct the data, that in needed for further consideration;

- in case the applicant receives such comments the necessary documents should be submitted and/or answers provided;

- as a result of the expertise relevant conclusions are drawn. Results of the expertise are submitted to the SEC Commission in order to be analyzed, SEC Commission provides final conclusion about a possibility of a state registration of the medicine;

- according to the results of the SEC Commission meeting applicant receives a draft of Registration Certificate, quality control methods, instruction and mock-ups (package marking) at the SEC for the approval; 

- a final conclusion of the SEC Commission moves to MOH;

- taking into account the conclusion of the SEC, MOH should decide whether to grant registration of the medicine or deny it;

- MOH publishes an order on its official web-site;

- in case the decision is positive applicant receives an original of the registration certificate, quality control methods, instruction and mock-ups (package marking) at the SEC. Registration information is uploaded in the state register.

State Enterprise "Medical Procurement of Ukraine" 

+380 63 651 90 25

[email protected]

22 Khreshchatyk Str., 2nd floor, Kyiv, 01001

 

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