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Establishment of new registration

State registration of the medicinal product is carried out by the Ministry of Health of Ukraine (hereinafter – MOH) through expert evaluation of the quality, safety and efficacy of the medicinal product. Expert evaluation is conducted by the State Enterprise "State Expert Center of the Ministry of Health of Ukraine" (hereinafter – SEC).

The Certificate is issued after registration for a period of 5 years, and after re-registration the Certificate is issued without expiration (except for cases when the MOH decides to conduct additional re-registration after 5 years for well-grounded reasons related to pharmacovigilance).

In addition to carrying out registration procedure itself, it is also necessary to meet a number of requirements for safety management (pharmacovigilance) and quality management of medicinal products, namely:

  • Prior to registration (the information must be indicated in the Application):
    • to assign a contact person responsible for pharmacovigilance in Ukraine, to create and maintain the pharmacovigilance system;
    • to assign a contact person responsible for the medicinal product quality in Ukraine.
  • In the process of registration:
    • to obtain the Conclusion or the Certificate of Compliance of the medicinal product manufacturing conditions with the GMP requirements.
  • After registration:
    • to register the layouts of the primary and secondary packaging in the Unified Automated Information System (UAIS) of the State Service of Ukraine on Medicines and Drugs Control (hereinafter referred to as SMDC).

Therefore, it is very important to assess the objective situation and manufacturer's capabilities before the start of registration, to plan in advance the chronological order of the necessary actions and the persons involved.

Both a resident and a non-resident of Ukraine (e.g. the manufacturer himself) may act as an Applicant (MAH – Marketing Authorization Holder). In accordance with the law it is the MAH who has responsibility for the quality, safety and efficacy of the medicinal product during marketing within the territory of Ukraine. A non-resident MAH doesn't have to establish a local representative office or another corporate entity within the territory of Ukraine.

If the MAH and the manufacturer are different entities, it is necessary to include the legal documentation clarifying association between them in the registration materials.

Fulfillment of MAH's commitments with regard to registration, quality and safety management may be delegated to a third party under a delegation agreement (for example, to company Cratia).

In order to represent his interests, the MAH issues a Power of Attorney, which describes authorized representative's authority and must be drawn up according to the set of national requirements and legalized appropriately.

 

Stages and timelines of new registration:

Registration starts from the moment of submission of the Application to the MOH. Registration procedure may be divided into the following main stages:

I. Preliminary stage.

1. Preliminary consultation – if needed.

2. Submitting the Power of Attorney to the SEC and signing the Agreement for expert evaluation.

II. Submission of the Application and payment.

3. Submitting the Application for registration to the MOH.

4. Submitting the Registration form (Addendum to the Application) to the SEC.

5. Obtaining the positive opinion (or observations) in regard to the Application and Registration form.

6. Obtaining the invoices for payments of government levy and expert evaluation cost.

7. Carrying out payments, obtaining the payments confirmations and submitting to the SEC.

III. Primary expert evaluation.

8. Checking the completeness of the registration dossier materials according to the Application type.

9. Obtaining observations, or submitting the dossier with the registration materials for expert evaluation.

IV. Specialized expert evaluation.

10. Transfer of the dossier to expert commissions, the number of these commissions depends on the Application type:

- Department of expert evaluation activities;

- Department of expert evaluation of instructions and nomenclature;

- Department of expert evaluation of vaccines and immunobiological preparations;

- Department of expert evaluation of materials on bioequivalence;

- Department of expert evaluation of materials on clinical and preclinical trials;

- Department of pharmacovigilance.

11. Obtaining observations, in-person communication with the corresponding expert on the substance of the observations (if needed).

12. Responding to the observations, editing the Instruction for medical use of the medicinal product.

13. Carrying out quality control of samples of the medicinal product in the authorized laboratory.

14. Making the decision (recommendation) in regard to the registration of the medicinal product in Ukraine at the SEC meeting.

15. Verifying and reconciling a draft of the Registration Certificate, QCM, Instruction for medical use of the medicinal product and the text of the packaging material labeling.

16. Transfer of the documentation set to the MOH.

V. Final stage:

17. Obtaining the documentation by the Ministry of Health and including into a draft of the Order on the registration.

18. Signing the Order on the registration of the medicinal product.

19. Including the medicinal product into the State Registry of Medicinal Products of Ukraine.

20. Issuing the original of the Registration Certificate and its Addenda.

NB! It is mandatory to obtain a Conclusion or a Certificate of Compliance of the medicinal product manufacturing conditions with the GMP requirements during registration of the medicinal product. This procedure runs parallel to registration procedure and is performed by the SMDC.

Manufacturers having PIC/S GMP Certificate undergo "simplified" procedure of the Certificate recognition based on specialized expert evaluation of documents. For all other manufacturers the inspection of the production site is required.

 

Time terms of specialized expert evaluation:

Specialized expert evaluation starts with the submission of the registration dossier and ends with making the decision on recommendation to register the product at the SEC meeting. The following time terms of specialized expert evaluation are described in legislative acts:

not more than 210 working days for:

  • medicinal products submitted for registration in accordance with the full (autonomous) dossier;
  • medicinal immunobiological products and biosimilars;

not more than 90 working days for:

  • generic medicinal products;
  • hybrid medicinal products;
  • medicinal products with well-known medical use;
  • medicinal products with fixed dose combination;
  • informed consents;
  • traditional medicinal products;
  • medicinal products made from in-bulk;
  • medicinal immunobiological products reclassified into medicinal products;

not more than 45 working days for:

  • medicinal products licensed under EMA centralized procedure;
  • innovative medicinal products and prequalified by WHO medicinal products for treatment of socially dangerous diseases: tuberculosis, HIV/AIDS, viral hepatitis, as well as for treatment of rare and oncological diseases;
  • vaccines and anatoxins prequalified by WHO;

not more than 10 working days for:

  • registration in Ukraine under special procedure of medicinal products registered by competent authorities of the United States of America, Switzerland, Japan, Australia, Canada; medicinal products registered under centralized procedure by EU competent authority;

not more than 5 working days for:

  • registration in Ukraine under specialized procedure of "authenticity" for medicinal products, which are subject to purchase by specialized international organizations.

NB! The specified terms are defined only taking into account the duration of the documents expert evaluation, and do not include:

  • the period of consideration of the Application and the registration form;
  • payment of the government levy and receiving the payment confirmation;
  • preliminary expert evaluation of the completeness of the registration dossier;
  • the time required for the Applicant to respond to the observations;
  • the time required for the Applicant to import samples and standards and conduct laboratory analysis (if necessary);
  • final actions after expert evaluation (verification/proofreading of drafts of the Registration Certificate and its Addenda);
  • period of signing the Order of the MOH on the registration of the medicinal product.

The above actions take an average of 2 to 5 months and accordingly extend the final duration of the registration period.

 

Time terms for responses to the observations:

The competent authorities during registration procedure may request missing documents or information. Such requests can occur at any stage, for example:

  • in respect of an incorrectly executed Power of Attorney, at the stage of signing the Contract for expert evaluation;
  • regarding the content of the Application for registration and the registration form;
  • regarding the completeness of the registration dossier during initial expert evaluation;
  • during specialized expert evaluation;
  • during laboratory approbation of samples quality etc.

During specialized expert evaluation each commission of SEC is authorized to request twice all necessary additional materials regarding the quality, safety and efficacy of the medicinal product from the Applicant. The Applicant has 90 working days to respond to these observations or to justify the timing of the response.

In case the Applicant doesn't provide the requested data or provided data are incomplete, registration materials are withdrawn from consideration and paid amounts are not returned.

 

Requirements for the registration dossier:

The national requirements for the registration dossier are based on the CTD format.

Module 1 is compiled according to the national requirements, and Modules 2-5 meet the requirements of ICH CTD. There are also a large number of specific national requirements.

For some types of applications there are also additional requirements (for example, for biosimilars), while for other types there are simplifications (for example, for orphan medicinal products).

Documentation for standard procedure of new registration consists of the next parts:

1. Application for registration.

2. Registration form along with accompanying legal and administrative documentation.

3. Registration dossier in CTD format, consisting of 5 Modules arranged according to the legislative requirements and SEC recommendations, including:

- Translation of parts of registration dossier into Russian or Ukrainian;

- Specific national documentation, namely:

o QCM (quality control methods for the medicinal product);

o Instruction for medical use (package leaflet);

o text of the packaging material labeling.

The documentation is submitted in paper form, in several copies. Part of the administrative documentation must be properly legalized; another part of the documents must be certified by the seal of the Applicant or his representative.

 

The language of the documentation and correspondence:

Ukrainian language is the only state language in Ukraine.

All official correspondence with competent authorities has to be performed using the state language only.

The Application form, registration form and covering letters have to be submitted only in Ukrainian. Also in Ukrainian all the specific national documents have to be submitted, namely:

  • Quality Control Methods (QCM);
  • Instruction for medical use;
  • text of the packaging material labeling.

The Registration dossier is submitted in Ukrainian, or in Russian, or in English. If dossier is submitted in Russian or in English, the following sections of the dossier should be submitted in Ukrainian:

  • Module 1: fully translated into Ukrainian;
  • Module 2: experts' reports on quality, non-clinical (2.4) and clinical (2.5) information is recommended (but not obligatory) to translate into Ukrainian;
  • Module 3: Section 3.3.P. should be partially translated;
  • Module 4: usually is not translated;
  • Module 5: statement on bioequivalence may be translated, other sections usually are not translated.

 

Special requirements to the dossier:

There are a large number of specific national requirements for execution of registration documentation, described in a number of acts of legislation and recommendations. Non-compliance with the requirements may lead to registration dossier return at the primary expertise stage, or to observations made during specialized expert evaluation.

The most important specific requirements:

  • one part of documentation is developed according to the national requirements on the basis of manufacturer's documentation, namely:
    • Instruction for medical use;
    • Quality Control Methods (QCM);
    • text of the package labeling;
  • all documentation is submitted in paper form (Application, registration form, registration dossier in 5 Modules, specific national documents);
  • correspondence during expert evaluation of the registration materials is performed in paper form only, as well as any additional materials (responses to the observations);
  • one part of documentation shall be submitted as translated into Ukrainian;
  • registration dossier has strict requirements for execution, namely: maximum quantity of pages in a folder, lateral side label, pages numbering and list of contents etc.;
  • registration dossier shall be submitted in a few non-identical copies;
  • certain number of documents (for example, Instruction for use) may be edited several times during expert evaluation.

 

Requirements for packaging and Instruction for medical use:

Labeling text shall be approved during state registration of the medicinal product and is the integral part of the Registration Certificate. Any amendments are allowed only after submitting the appropriate Application, expert evaluation and approval by the MOH of Ukraine.

During state registration the layouts (graphic images) are not subject to approval; their description and text should be only agreed. Packaging material labeling shall be done in Ukrainian, any other languages (for example, Russian, English) may be also present providing the identity to the Ukrainian text.

Subsequently the graphic layouts of the packaging are created based on the approved text and are submitted under special procedure for registration in the Unified Automated Information System (UAIS) of SMDC.

During incoming quality control (at the import stage) the packaging of the medicinal product undergoes very strict assessment of compliance with the layouts registered in UAIS. Even the smallest deviations (font type, text flow, size and position of elements, differences in color gamma, presence of technical symbols etc.) lead to observations, delay in issuing the statement regarding quality, and necessity of corrective actions.

Information on the secondary packaging of the medicinal product must contain information in Braille in Ukrainian (with the exception of medicines that are only used by appropriate specialists: orphan preparations, parenteral preparations, radiopharmaceuticals, specific immunobiological agents). For these groups of medicinal products Braille marking remains at the discretion of the manufacturer.

Instruction for medical use shall be approved during sate registration of the medicinal product and is the integral part of the Registration Certificate. Any amendments to the Instruction are allowed only after submitting the appropriate Application, expert evaluation and approval by the MOH of Ukraine.

Instruction for medical use shall be approved in Ukrainian, any other languages (for example, Russian, English) may be also present providing the identity to the Ukrainian text.

The basis for writing the Instruction for medical use of the medicinal product registered in the EU is the SmPC (Summary of product characteristics). For generic (equivalent) drugs the text of the Instruction should match the text of the originator.

 

Pharmacovigilance

Applicant shall create and maintain the pharmacovigilance system in Ukraine. Designated person responsible for pharmacovigilance in Ukraine has to be assigned for this activity. Such person shall have university degree in medicine or pharmaceutics (pharmacist, clinical pharmacist) and essential training.

Information about the designated person shall be included in the Application for registration, and his/her CV shall be submitted along with the registration form.

After the registration of the medicinal product the Applicant shall maintain the pharmacovigilance system, including:

  • to communicate with competent authorities for all matters regarding the safety of the medicinal product;
  • to create information gathering and transmission system on adverse effects of the medicinal product in Ukraine;
  • to submit reports on adverse effects of the medicinal product in Ukraine and other countries to SEC;
  • to monitor specialized media on monthly basis etc.

SEC is authorized to make scheduled and unscheduled inspections of the pharmacovigilance system of Applicants. Critical observations can lead to suspension of the Registration Certificate.

See more on creating and maintaining the pharmacovigilance system on the appropriate page of our website.

 

Recognition or certification of GMP compliance.

During registration of medicinal products in Ukraine the Applicant has to submit the Certificate or the Conclusion regarding confirmation of manufacturing compliance with the GMP guidelines.

The process of obtaining the Conclusion regarding confirmation of manufacturing compliance with the GMP guidelines is performed in form of expert evaluation of the documentation and doesn't require inspections of the production site. Such procedure is also called "Recognition the GMP Certificate".

Recognition is acceptable only for the manufacturers that already have the GMP Certificate issued by competent authorities of a member state of PIC/S (https://www.picscheme.org/en/members).

Certificates issued by WHO or by other authorities and organizations that are non-members of PIC/S cannot be objects of recognition.

Recognition is not an unconditional procedure and requires preparation and submission of a set of documents, passing through procedure of expert evaluation and obtaining the Decision. The Decision is issued for a period of validity of the Certificate that underwent recognition.

SMDC performs the certification procedure regarding compliance with the GMP guidelines. Such procedure presumes preparation and submission of a set of documents, signing an agreement and making the payment for expert evaluation by the competent authorities, conducting inspections (performed usually by two or three inspectors), expert's report preparation and correction of the observations, issuing the Certificate of compliance with the GMP guidelines.

As Ukraine since 2011 is a member state of PIC/S, locally issued GMP Certificate can be recognized by other members of PIC/S according to their legislative requirements.

 

Services and activities of Cratia:

For more than 12 years our company professionally performs the activities of registration of medicinal products in Ukraine. We have extensive experience in registering all types of medicinal products. Depending on your needs, we are ready to offer both a full range of activities to fulfill all the regulatory requirements, or any of the listed services:

  • Regulatory planning and preliminary consulting;
  • Patent search;
  • Checking whether the registration dossier complies with the legislative requirements;
  • Preliminary consultations with the competent authorities;
  • Confirmation of the status and/or type of the Application;
  • Translation of scientific, medical, technical and legal documents;
  • Legal analysis and preparation of the administrative documents;
  • Preparation of the specific national documents: QCM, Instruction, packaging materials labeling, layouts of packaging and Instruction;
  • Preparation of the Application and registration form, collection and compilation of the registration dossier according to all requirements and recommendations;
  • Creation and maintenance of the pharmacovigilance system in Ukraine;
  • Development of the documents in the pharmacovigilance system;
  • Outsourcing of the contact person responsible for pharmacovigilance in Ukraine;
  • Outsourcing of the contact person responsible for the quality, safety and efficacy of the medicinal product in Ukraine;
  • Preparation and submission of the Application, registration form and registration dossier to the SEC of the MOH of Ukraine;
  • Organization of all payments and receiving the payment confirmation;
  • Support of the examination process, communication with the competent authorities;
  • Analysis of observations, preparation of recommendations to respond to the observations;
  • Obtaining permission to import samples and standards for the quality control within the registration;
  • Import (customs clearance) of samples and standards;
  • Control of deadlines at all the stages of expert evaluation;
  • Verification of a draft of the Registration Certificate and its Addenda;
  • Preparation of the Application and documents for obtaining the Conclusion on recognition or the Certificate of GMP compliance.

 

To start cooperation or get advice please call +38 044 361-48-28, +38 044 221-71-29, write a letter to info@cratia.ua or come and meet us in our office.