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Abridged registration procedures

Over the past few years, new (special) procedures for registration of medicinal products have appeared in Ukraine, which imply certain simplifications with respect to the registration dossier, or accelerated expert evaluation periods. These procedures are applicable to certain groups of medicinal products only.

 

1. Medicines for the treatment of socially dangerous diseases

The specifics of the registration procedure for this group are described in Sections V and VII of Order of the Ministry of Health of Ukraine No. 426 of August 26, 2005. The following types of medicinal products fall under the special registration procedure:

  • medicinal products that are authorized by EMA (European Medicines Agency) under the centralized procedure;
  • original medicinal products and medicinal products that have undergone the WHO pre-qualification procedure and included in the WHO list of pre-qualified medicinal products intended for treatment of socially dangerous diseases (tuberculosis, HIV / AIDS, viral hepatitis), as well as rare and oncological diseases, and in case of threat of occurrence of dangerous infectious diseases or massive spread of dangerous infectious diseases;
  • vaccines and anatoxins that have undergone the WHO pre-qualification procedure and included in the WHO list of pre-qualified vaccines and anatoxins.

In addition to registration, the Applicant is also required to comply with all national requirements for the management of the safety and quality of the medicinal product in Ukraine, namely:

  • assign a contact person responsible for pharmacovigilance in Ukraine, maintain a pharmacovigilance system during the validity of the registration certificate;
  • receive the conclusion of the State Service of Ukraine on Medicines and Drugs Control (SMDC) for the compliance of manufacturing site with GMP requirements.

For this group of medicinal products, shorter terms of registration are envisaged, namely, specialized expert evaluation is conducted not more than 45 working days from the moment of submitting the registration dossier to the SEC. This period does not include:

  • the period of assessment of the Application and the registration form;
  • payment of the government levy and receiving the payment confirmation;
  • preliminary expert evaluation of completeness of the dossier for registration;
  • the time required for the Applicant to respond to the observations;
  • 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 registration of the medicinal product.

The above actions take an average of 2 to 4 months, and, accordingly, extend the resulting period for registration.  

Also for this group of medicinal product, it is possible to provide some parts of the registration dossier in e-format. The requirements for compilation of those parts of the registration dossier that are submitted in paper form, as well as the requirements for specific national documents (QCM, instruction for use, packaging labeling text) remain the same as for other medicinal products.

However, there are also a number of specific documents that need to be submitted as part of the registration dossier in addition, for example, the official assessment report for the medicinal product drawn up by a competent regulatory authority or the WHO (WHOPAS).

 

2. Medicinal products registered by competent authorities of the United States of America, Switzerland, Japan, Australia, Canada, medicinal products that are registered by the competent authority of the European Union under the centralized procedure

The procedure for registering these medicinal products was approved by Order of the Ministry of Health of Ukraine No. 1245 dated 17.11.2016. The first version of the Order contained a large number of discrepancies, which actually made it impossible the conducting registration under this procedure, some of which were corrected in additions to the Order adopted on 02.10.2017.

This procedure does not imply carrying out specialized expert evaluation, but the fact of registration (introduction of changes) of the medicinal product by the competent authorities of countries with high regulatory standards is checked. At the same time, even the slightest deviations or inaccuracies between the information submitted for registration in Ukraine and registration in the reference country can lead to observations or refusal to register.

In addition to the registration, the Applicant is also required to comply with all national requirements for the management of the safety and quality of the medicinal product in Ukraine, namely:

  • assign a contact person responsible for pharmacovigilance in Ukraine, maintain a pharmacovigilance system during the validity of the registration certificate;
  • receive the conclusion of the State Service of Ukraine on Medicines and Drugs Control (SMDC) for the compliance of manufacturing site with GMP requirements.

Important features of the procedure:

  1. For registration in Ukraine, it is necessary to declare identical characteristics of the medicinal product (manufacturing sites, dosages, package sizes, etc.), or some of them, according to registration in the reference country.
  2. The same requirements apply to changes that are made during the validity of the registration certificate. The applicant must declare all applicable changes in the territory of Ukraine, and has no right to state any new characteristics (except for those that are required by Ukrainian legislation).
  3. The period for responses to observations of the GEC during registration is reduced to 30 working days.
  4. The procedure for re-registration is carried out in the usual manner (terms, list of necessary documentation), as for any other medicinal products.

Timeframe for consideration of registration materials by the State Expert Center under this procedure cannot exceed 10 working days. This period does not include:

  • the period of consideration of the Application and the registration form;
  • payment of the government levy and receiving the payment confirmation;
  • the time required for the Applicant to respond to the observations;
  • 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 registration of the medicinal product.

The above actions take an average of 2 to 4 months, and, accordingly, extend the resulting period for registration.

It should be added that this procedure still has a significant amount of discrepancies and nuances, for example, the text of the Order describes the requirements for a registration dossier in the CTD format, although a different dossier format could be submitted for registration in the reference country.

 

3. Medicinal products that are subject to procurement by specialized international organizations.

In 2015, in order to combat corruption, centralized purchases of medicinal products and medical devices were transferred to specialized international organizations that carry out procurement. These organizations include specialized funds, organizations and mechanisms of the Organization United Nations, the International Dispensary Association, the Crown Agents, the Global Drug Facility, the Partnership for Supply Chain Management, the NATO Support and Procurement Agency, which provide the governments and / or central government with services in the organization and conduct of procedures for the procurement of medical products, medical devices and related services.

To implement the possibilities of such purchases, the simplified registration procedure was adopted (called as "authenticity" procedure). This registration procedure makes it possible to register the medicinal product as soon as possible. At the same time, a specialized expert evaluation of the registration dossier is not carried out, and the SEC conducts an audit of the accuracy of the translation of the instruction for use and the availability of the necessary documentation (completeness of the dossier).

For the registration of a medicinal product by "authenticity" procedure, the Applicant must comply with the requirements for the management of the safety of the medicinal product, namely, to assign a contact person responsible for pharmacovigilance in Ukraine, to establish and maintain a pharmacovigilance system throughout the validity of the registration certificate.

Important features of the procedure:

  1. The registration certificate does not allow importation for other purposes, except for purchase by international specialized organizations. That is, such a certificate does not give the right to import the medicinal product for retail sale, participating in other purchases, etc.
  2. The procedure does not imply any changes to the registration certificate, or re-registration.
  3. Labeling of the package of the medicinal product, as well as the instruction is carried out in the original language.
  4. The set of documentation that must be submitted for state registration should include, in addition to other documents, an assessment report for the medicinal products drawn up by a competent regulatory authority of the country where this medicinal product is registered or issued by the WHO if the medicinal product is pre-qualified. For many medicinal products registered more than 15 years ago this requirement can be quite a significant problem.

The duration of the procedure for registration under "authenticity" procedure is 5 working days. This period does not include:

  • the period of consideration of the Application and the registration form;
  • payment of the government levy and receiving the payment confirmation;
  • 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 1 to 2 months, and accordingly extend the resulting period for registration.

 

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 registration of medicinal products by special simplified, accelerated registration procedures. Depending on your needs, we are ready to offer both the full range of activities to fulfill all the regulatory requirements, or any of the listed services:

  • regulatory planning and preliminary consulting;
  • 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;
  • juridical analysis and preparation of the administrative documents;
  • preparation of the specific national documents: QCM, instructions, labeling packaging and layouts;
  • preparation of the Application and registration form, compilation and formatting 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;
  • submission of the Application, registration form and registration dossier to the SEC of the MOH of Ukraine;
  • arranging all payments and receiving the payment confirmation;
  • support of the expert evaluation process, communication with competent authorities;
  • analysis of observations, preparation of recommendations to respond to the observations;
  • control of deadlines at all the stages of expert evaluation;
  • checking a draft of the registration certificate and its addenda.
  • preparation of the Application and documents for receiving the Conclusion on recognition or the Certificate of GMP compliance.

 

To start cooperation or get advice 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.