Registration of medicines, dietary supplements, healthcare products

Registration of medicines in Ukraine

Types of registration

  • Medicine under complete dossier (autonomous dossier)
  • Generic, hybrid medicine or biosimilar;
  • Medicine with well-studied medical use;
  • Medicine with fixed combination;
  • Informed consent;
  • Traditional medicine;
  • Medicine for bulk production.

Terms of registration

Materials adjudication for the medicine submitted to obtain marketing authorization under complete dossier (autonomous dossier), under IMBD and biosimilar lasts not more than 210 working days, beginning from the date of the registration dossier official submission to the State Registration Center.

Materials adjudication in reference to alieni generis medicines lasts not more than 90 working days from the date of the official receipt of the registration dossier in the Center.

Reference to regulations and standards

Http://zakon0.rada.gov.ua/laws/show/z1210-15 Order No. 460 dated July 23, 2015

"On amendments being made to the examination procedure of registration materials for medicines submitted for obtaining marketing authorization (re-obtaining), as well as for the materials review on any changes made in registration materials within the period of the registration certificate validity and approval of the verification procedure for the materials attached to the application for obtaining marketing authorization for certain medicines. "

Medicine registration cycle (the way everything happens from the moment of the dossier receipt to MA receipt)

  1. Consultation in the state authority before filing in a dossier;
  2. Internal dossier review for the availability of all necessary documents and communication with the manufacturer regarding provision of administrative documents;
  3. Translation of all documents required;
  4. Development of quality control methods according to the original manufacturer's procedure;
  5. Development of instructions for medical use;
  6. Development of package marking in accordance with legislation;
  7. Formation of registration dossiers;
  8. Agreement conclusion between the Applicant and the State Expert Center;
  9. Submission of application for registration to the Ministry of Health;
  10. Submission of the registration form to the State Expert Center;
  11. Obtaining primary expert evaluation;
  12. Obtaining the invoice for payment, which is sent to the Applicant;
  13. Obtaining of the state fee payment confirmation from the Treasury;
  14. Submission of the dossier to the State Expert Center;
  15. Receipt of the dossier referral for a specialized commission;
  16. Going through specialized examination;
  17. Laboratory control (obtaining the calculation of samples quantity, samples request from the manufacturer, going through laboratory testing in the certified laboratories);
  18. After comments are received, we inform the Applicant/Manufacturer and prepare responses to the comments provided;
  19. Completion of the specialized examination and raising the medicine discussion at the meeting;
  20. We read out registration documents drafts;
  21. After the order is signed we receive the registration documents.

Responses to the comments provided should be submitted within 90 days or the Guaranty Letter with justification should be provided .

Re-registration of medicines in Ukraine

Reference to regulations and standards

http://zakon0.rada.gov.ua/laws/show/z1210-15 Order No. 460 dated July 23, 2015

"On amendments being made to the examination procedure of registration materials for medicines submitted for obtaining marketing authorization (re-obtaining), as well as for the materials review on any changes made in registration materials within the period of the registration certificate validity and approval of the verification procedure for the materials attached to the application for obtaining marketing authorization for certain medicines. "

Medicine re-registration cycle (the way everything happens from the moment of the dossier receipt to MA receipt)

  1. Consultation in the state authority before filing in a dossier;
  2. Internal dossier review for the availability of all necessary documents and communication with the manufacturer regarding provision of administrative documents;
  3. Translation of all documents required;
  4. Development of quality control methods according to the original manufacturer's procedure;
  5. Development of instructions for medical use;
  6. Development of package marking in accordance with legislation;
  7. Formation of registration dossier;
  8. Agreement conclusion between the Applicant and the State Expert Center;
  9. Submission of application for re-registration to the Ministry of Health;
  10. Submission of the registration form to the State Expert Center;
  11. Obtaining the invoice for payment, which is sent to the Applicant;
  12. Obtaining of the state fee payment confirmation from the Treasury;
  13. Submission of the dossier to the State Expert Center;
  14. After comments are received, we inform the Applicant/Manufacturer and prepare responses to the comments provided;
  15. Completion of the specialized examination and raising the medicine discussion at the meeting;
  16. We read out registration documents drafts;
  17. After the Order is signed we receive the registration documents.

Responses to the comments provided should be submitted within 90 days or the Guaranty Letter with justification should be provided .

Terms of re-registration.

According to the legislation, submission of the Application for state re-registration of the finished medicine should take place not earlier than a year and not later than 90 days before the current registration certificate validity is over.

The examination period for the re-registration dossier should not exceed 90 working days from the moment the relevant materials are submitted to the State Expert Center.

Amendments made to MA in Ukraine

Reference to regulations and standards

http://zakon0.rada.gov.ua/laws/show/z1210-15 Order No. 460 dated July 23, 2015

"On amendments being made to the examination procedure of registration materials for medicines submitted for obtaining marketing authorization (re-obtaining), as well as for the materials review on any changes made in registration materials within the period of the registration certificate validity and approval of the verification procedure for the materials attached to the application for obtaining marketing authorization for certain medicines. "

By nature the variations are classified into:

  • Changes of type IA minor variations that have minor or no effect on the quality, safety and efficiency of the medicine and concern amendments to the contents of the registration dossier submitted at the time of the decision making regarding the medicine registration and do not require its new registration;
  • Changes of type IB minor variations which cannot be changes of type IA and type II and do not require new registration;
  • Type II variations any variations to the registration dossier materials, do not require new medicine registration and can have strong impact on its quality, safety and effectiveness, but cannot be considered to be changes of type IA or IB.

Variation process cycle (the way everything happens from the moment of the dossier receipt to MA receipt)

  1. Consultation in the state authority before submitting variation request to the Ministry of Health;
  2. Internal dossier review for the variation and availability of all necessary documents;
  3. Translation of the documents required ( if required);
  4. Dossier formation for introduction of changes;
  5. Agreement conclusion between the Applicant and the State Expert Center;
  6. Submission of application for re-registration to the Ministry of Health;
  7. Submission of the registration form to the State Expert Center;
  8. Submission of variation request to the Ministry of Health;
  9. Submission of the registration form to the State Expert Center;
  10. Obtaining the invoice for payment, which is sent to the Applicant;
  11. Obtaining of the state fee payment confirmation from the Treasury;
  12. Submission of the dossier to the State Expert Center;
  13. After comments are received, we inform the Applicant/Manufacturer and prepare responses to the comments provided;
  14. Receiving of the dossier referral to a specialized commission;
  15. Going through specialized examination;
  16. Completion of the specialized examination and raising the medicine discussion at the meeting;
  17. We read out registration documents drafts;
  18. After the Order is signed we receive the registration documents.

Terms of verification implementation

Materials review on changes introduction to the medicine registration dossier lasts not more than 60 working days after the receipt of the relevant materials in the Center.

Responses to the comments provided should be submitted within 90 days or the Guaranty Letter with justification should be provided .

A technical error is reported with a letter in any form to the State Expert Center "Single point of contact", in which an error is indicated and there is justification for its correction.

Variation process cycle (the way everything happens from the moment of the dossier receipt to MA receipt)

  1. Registration form formation;
  2. Obtaining the invoice for payment, which is sent to the Applicant;
  3. Going through specialized examination;
  4. Completion of the specialized examination and raising the medicine discussion at the meeting;
  5. We read out registration documents drafts;
  6. After the Order is signed we receive the registration documents.

The period for the technical error correction is 20 working days.

API registration

Materials review for API registration lasts not more than 60 working days after the receipt of the relevant materials in the Center.

Responses to the comments provided should be submitted within 90 days or the Guaranty Letter with justification should be provided .

Variation process cycle (the way everything happens from the moment of the dossier receipt to MA receipt)

  1. Consultation in the state authority before submitting API registration request to the Ministry of Health;
  2. Internal registration dossier review for availability of all necessary documents;
  3. Translation of the documents required ( if required);
  4. Dossier formation for API registration;
  5. Agreement conclusion between the Applicant and the State Expert Center;
  6. Submission of application for API registration to the Ministry of Health;
  7. Submission of the registration form to the State Expert Center;
  8. Obtaining the invoice for payment, which is sent to the Applicant;
  9. Submission of the dossier to the State Expert Center;
  10. After comments are received, we inform the Applicant/Manufacturer and prepare responses to the comments provided;
  11. Receiving of the dossier referral to a specialized commission;
  12. Going through specialized examination;
  13. Completion of the specialized examination and raising the medicine discussion at the meeting;
  14. We read out registration documents drafts;
  15. After the Order is signed we receive the registration documents.

All terms of expert work do not include the time spent on finalizing materials.

Registration of medical products.

Since 01 July, 2015, the legislative requirements for medical products have changed to assess compliance with the Technical Regulations approved by Resolution of the Cabinet of Ministers of Ukraine No. 753, No. 754, No. 755 as of 02.10.2013.

http://zakon2.rada.gov.ua/laws/show/753-2013-%D0%BF

Procedure for medical products evaluating

The procedure for assessing compliance is carried out in different ways and depends on the class of the medical products, manufacturing facilities inspection and each party medical products evaluation with samples testing.

The class of the medical product determines the need to involve the conformity assessment body: for the safest products self-declarations is sufficient .

For other medical products it is required either to go through documents expert proceedings and manufacturing facilities inspection, having obtained the Certificate for the following 5 years, or the procedure of each lot conformity assessment, having obtained the Certificate for a certain batch.

To go through compliance evaluation with the involvement of the appointed body, there is a choice from 2 options:

  • Evaluation of the quality control system at the production facilities (inspection), resulting in the Conformity Certificate issue for a medical product for the period of 5 years;
  • By-party conformity assessment, supposing certificate issue for a specific batch (delivery) of medical products in the result of documentation examination and product samples testing.

To obtain the Conformity Certificate for the period of 5 years you should:

  • To appoint a manufacturer authorized representative in Ukraine to complete all related legal formalities;
  • To choose the appropriate procedure, according to the product class, manufacturer's documentation and other factors;
  • To complete technical documentation, translate it partly, issueing in accordance with the requirements of the relevant regulations, fill in the application form and a questionnaire (check-list);
  • Select the appointed body for conformity assessment and submit documents, pay for the authority work;
  • Undergo the procedure of documentation examination, respond the comments (if any);
  • To agree the dates and an inspection plan;
  • To obtain authority decision regarding the approval of the quality control system and the medical product Conformity Certificate with the requirements of the technical regulations;
  • To create and sign the Conformity Declaration.

To obtain the Conformity Certificate for the batch you should:

  • appoint a manufacturer authorized representative in Ukraine to complete all related legal formalities;
  • complete technical documentation, translate it partly, issuing in accordance with the requirements of the relevant regulations;
  • select the appointed body for conformity assessment and submit documents, pay for the authority work;
  • undergo the procedure of documentation examination and samples testing;
  • obtain the conformity certificate with the requirements of the technical regulations for a batch of medical products;
  • create and sign the Conformity Declaration;
  • apply conformity sign and the number of the body on the medical product marking, make sure that other marking requirements and instructions (user's manual) comply with the requirements of the technical regulations and current legislation.

Our services:

  • Check for availability of a complete documentation set before submitting to the authorities.
  • Translation of the required documents.
  • Objective and professional advice for designated authority selection.
  • Conclusion of the Agreement with the relevant authority.
  • Submitting a full set of documents.
  • Respond to all experts’ comments informing the Customer.
  • Development of package marketing design and instructions.
  • Development of the Conformity Declaration issued on the base of the works performed in terms of conformity assessment.
  • Registration of alimentary products.

The registration procedure for food dietary supplements is regulated by the main regulatory documents:

Law of Ukraine No. 771/97-VR dated 23.12.1997 "About Basic Principles and Requirements to the safety and quality of food products". http://zakon3.rada.gov.ua/laws/show/771/97-%D0%B2%D1%80

Law of Ukraine No. 142-V dated September 14, 2006 "About infant's food." рttp://zakon5.rada.gov.ua/laws/main/142-16

Decree as of 4 January, 1999 N 12 "About the approval of the food dietary supplements allowed to use in alimentary products." http://search.ligazakon.ua/l_doc2.nsf/link1/KP990012.html

At the present time the procedure for the state registration of food dietary supplements (the old name FDS) is not carried out in Ukraine. Since September 20, 2015 Verkhovna Rada of Ukraine adopted the Law of Ukraine No. 1602-VII "About Amendments to Certain Legislative Acts of Ukraine Regarding Alimentary Products", conclusions of sanitary and epidemiological examination are not issued. Legalization of these products is carried out by issuing an expert report by the authorized laboratory.

Our services:

  • Check for availability of a complete documentation set;
  • Translation of the required documents.
  • Conclusion of the Agreement with the relevant authority.
  • Submitting an application to the appropriate authorities;
  • Getting samples and submittal to the certified laboratory;
  • Marking development in accordance with the legislation requirements.

The period for alimentary products registration is 1-1.5 month.