Support of medicinal products registration

What is subject to certification?

The medicinal products registration procedure is provided for by the Procedure for Quality Certification of Medicinal Products for International Trade and Validation for Active Pharmaceutical Ingredients Exported, approved by Order of the Ministry of Health of Ukraine No. 1008 of 07.12.2012.

Thus, the quality certification of medicinal products for international trade is carried out in order to create the appropriate conditions for the export of domestic medicines by confirming the compliance of their quality and the conditions of their production with those in force in Ukraine and the international requirements of good manufacturing practice (hereinafter – the GMP).

The quality certification of medicinal products for international trade and validation for active pharmaceutical ingredients exported is carried out by the State Service of Ukraine on Medicines and Drugs Control upon written request of the applicant on a voluntary basis.

The State Service of Ukraine on Medicines and Drugs Control issues the following documents:

  • medicinal product certificate;
  • statement on the licensed status of the medicinal product;
  • certificate of a batch of a medicinal product;
  • validation for active pharmaceutical ingredients exported to the European Union (EU) for medicinal products intended for human consumption in accordance with Article 46b (2)(b) of the Directive 2001/83/EC “On the Community code relating to medicinal products for human use”.

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Documents and procedures for medicinal products registration

The presence of certification allows you to carry out the registration procedure for medicinal products. So, registration, in accordance with the Procedure for state registration (re-registration) of medicinal products and the fee amount for their state registration, is carried out by the Ministry of Health, based on the application and the results of the examination of registration materials for such a drug, carried out by the State Expert Center of the Ministry of Health (hereinafter referred to as the Center). When registering medicinal products, to the Center are submitted:

– materials of the registration dossier;

– materials on the methods of quality control of the medicinal product;

– information on the production technology of the medicinal product and copies of the official manufacturing permit issued by the authorized body of the state where such production is carried out;

– the text of the packaging labeling;

– a duly certified copy of a document issued by the State Service of Ukraine on Medicines and Drugs Control, which confirms the compliance with the production conditions of the medicinal product submitted for registration;

– a document confirming the payment of the registration fee.

The same Procedure regulates the procedure for registration of medicinal products. So, on the basis of the submitted application, conclusions and recommendations of the Center, the Ministry of Health makes:

– within ten working days (for a medicinal product that is registered by the competent authority of the United States of America, the Swiss Confederation, Japan, Australia, Canada, according to a centralized procedure by the competent authority of the European Union and is applied in the territory of such countries or member states of the European Union);

– within seven working days (for a medicinal product subject to procurement based on the results of the procurement procedure carried out by a specialized procurement organization for the implementation of a procurement agreement between the Ministry of Health and the relevant specialized procurement organization);

– within five working days (for a medicinal product that is purchased by a person authorized to carry out procurement in the healthcare sector) a decision to register a medicinal product or to refuse such registration.

Cost of medicinal products registration in ukraine

The main part of the cost of medicinal product registration is the examination of materials for medicinal products, which is determined by the Order of the State Expert Center of the Ministry of Health, the last of which was adopted on September 17, 2021 under No. 221.

Thus, the cost of an examination of medicinal products ranges from UAH 78,600.00 to UAH 209,700.00, depending on the type of medicinal product.

Registration terms

Registration of medicinal products can be carried out both according to the standard procedure and according to the accelerated procedure.

Thus, with the standard procedure:

– the term of the initial examination of the sent documents is 1 day;

– the term for preparing documents for submission to government agencies is 3-15 days;

– preparation of the registration certificate takes 120-160 working days;

– the term of validity of the registration certificate for medicinal product is 5 years.

It should be taken into account that the accelerated procedure is only possible for medicinal products registered under the centralized registration procedure in the USA, Canada, Japan, Australia, and the countries of the European Union:

– the term of the initial examination of the sent documents is 1 day;

– the term for preparing documents for submission to government agencies is 2-5 days;

– preparation of the registration certificate takes 30-50 working days;

– the term of validity of the registration certificate for medicinal product is 5 years.

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