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This procedure is carried out on the basis of the MOH Orders 1245 or 1391 by recognising registration in other countries. It is carried out only for medicinal products registered under the centralised registration procedure in one (or more) of the following countries….
from countries: USA, Switzerland, Japan, Australia, Canada, and the European Union.
In this case, no specialised examination is carried out, but only the fact of registration of the medicinal product by the competent authority of another country and the identity of the information in the submitted Application for Registration in Ukraine are checked.
The term for the initial examination of the submitted documents is 1 day.
The term for preparation of documents for submission to the state authorities is 2-5 days.
The period for obtaining the registration certificate is 30-40 business days in the absence of any comments.
The validity of the registration certificate for a medicinal product is 5 years.
The period for the initial examination of the submitted documents is 1 day.
The term for preparing documents for submission to the state authorities is 3-15 days
The period for obtaining a registration certificate is 120-180 working days.
The registration certificate for a medicinal product is valid for 5 years.
Contents of the Registration Dossier – simplified format
Contents of the Registration dossier – CTD format
After registration, the registration certificate is issued for a period of 5 years. Prior to the expiry of this period, it is necessary to undergo the re-registration process, after which a new marketing authorisation is issued without any restrictions on the validity period (except in certain cases that require re-registration due to violation of pharmacovigilance requirements).
The registration certificate consists of:
All amendments (of any type) are also an integral part of the registration certificate.
Registration of a medicinal product is carried out by the State Expert Centre (SEC). Firstly, the Registration Application and a package of documents (micro-dossier) are submitted. After the initial analysis of the Application and micro-dossier and payment of the state registration fees, the full dossier is submitted. The applicant has the right to choose the dossier format – simplified or CTD format.
Before submitting the dossier, it is necessary to conclude an agreement with the SEC for the examination, prepare the Application and micro-dossier, submit documents, obtain the conclusion of the initial examination and invoices for payment, and receive confirmation of payment of invoices from the State Treasury of Ukraine.
There are also a number of things to consider when preparing the dossier:
– It is mandatory for the manufacturer to have a confirmation of the GMP certificate in Ukraine.
(Read more about getting a certificate confirmation here)
– The dossier is submitted in four copies.
– Each copy of the dossier must be accompanied by a sample of the finished medicinal product.
– The dossier must include the quality control method of the finished product developed in accordance with the manufacturer’s documentation and the requirements of the current legislation.
– The dossier must contain instructions for medical use in Ukrainian.
– There are strict requirements for packaging layouts in terms of font size (at least 7 points Dido), Braille labelling, etc.
If necessary, the materials for registration of a medicinal product may be sent by the Centre for additional expert evaluation, which is carried out in expert institutions authorised by the Ministry of Health of Ukraine. The additional expert evaluation is carried out after payment of its cost, established by the agreement between the applicant and the authorised expert institution. The results of the additional examination are sent to the Expert Centre for review.
After receiving a positive conclusion on the chemical and pharmaceutical part of the dossier, it is necessary to confirm the reproducibility of quality control methods in an authorised laboratory. For this purpose, samples, standards and other reagents necessary for a complete analysis in three parallel are imported.
Based on the positive conclusions of the three commissions and the positive results of the laboratory testing, the product is included in the agenda of the next meeting of the State Expert Centre. After approval at the meeting, the draft registration materials are proofread and the original registration certificate is issued.
IMPORTANT! During the specialised expert evaluation, the SEC may request missing documents or information, and the Applicant is given 60 calendar days to respond to such comments or justify the timing. If the Applicant fails to respond in time, the procedure is withdrawn from consideration and the paid fees are not refunded.
The term for the initial examination of the submitted documents is 1 day.
The period for preparing documents for submission to the state authorities is 3-15 days.
The period for obtaining a registration certificate is 120-180 business days plus the period for conducting additional studies (from 60 to 300 days).
The registration certificate for a medicinal product is valid for 5 years.
It is carried out in the same way as state registration.
An application for re-registration of a medicinal product is submitted no earlier than 365 calendar days and no later than 180 calendar days before the expiry of the registration certificate.
The re-registration of a registered medicinal product is carried out once, after which the validity of the registration certificate for the medicinal product is not limited.
The list of documents required for re-registration of medicinal products that have been registered under the centralised procedure:
Contents of the registration dossier
The list of documents required for re-registration of medicinal products that have been registered under the standard procedure:
The applicant is obliged to report to the State Expert Centre of the Ministry of Health of Ukraine any changes that occurred after the registration certificate was received.
Types of changes:
Types of changes:
Deadlines for submitting changes
Transition period
May be applied for Type IA changes when making changes to the instructions for use and/or labelling text, Type IB and Type II changes.
The maximum transition period is 6 months from the date of approval of such changes.
Change of the Applicant (owner): transfer of rights
For this purpose, an application with documentation is submitted. The documentation must include data on the transfer of rights from one entity to another.
Such documentation must be legally correct, and part of the documentation must be legalised.
Procedure and timeframe for making changes
Registration materials for amendments must be submitted within 3 months from the date of submission of the Application.
The initial examination of documents takes 14 business days, and if there are no comments, they are submitted for specialised examination.
Specialised examination period:
During the specialised review, the SEC may request missing documents or information, and the Applicant is given 60 calendar days to respond to such comments or justify the timing. If the Applicant fails to respond in time, the procedure is withdrawn from consideration and the paid funds are not refunded.
Amendments are approved by the Orders of the Ministry of Health, entered into the electronic register and submitted to the Applicant in the form of attachments to the registration certificate.
Registration / re-registration of medicinal products
Certification, declaration of medical devices
Certification of Ukrainian medical devices in Europe
Registration/legalization of cosmetic products
Registration/legalization of Ukrainian cosmetics in Europe and the USA
License for a pharmacy warehouse (wholesale trade in medicines)
Import license (import of medicines)
Licences for a pharmacy/pharmacy outlet (retail sale of medicines)
Licenses for an online pharmacy (electronic commerce in medicines)
License for manufacturing of medicinal products (industrial and pharmacy)
License for narcotic drugs, psychotropic substances and precursors
Conducting clinical/preclinical trials
Obtaining a certificate / conclusion on GMP confirmation
Courses for medical directors and heads of pharmacies
Recruitment for pharmacies and medical institutions
Promotion of your products in Ukraine
ACcreditation of medical institutions “TURKEY”
Resolving issues with antitrust law