Legislation

Registration procedures (re-registration, changes), quality and safety management of medicines are regulated by a variety of legislative acts. Ukraine has chosen a focus on gradual harmonization of legislation with the regulatory system of the European Union, which leads to regular amendments to legislative acts.

Below are the main legislative acts:

• Law of Ukraine “On Medicines”;
• Resolution of the Cabinet of Ministers of Ukraine No. 902 of September 14, 2005 “On Approval of the Procedure for State Control of the Quality of Medicines Imported into Ukraine”;
• Resolution of the Cabinet of Ministers of Ukraine No. 376 of May 26, 2005 “On approval of the procedure for state registration (re-registration) of medicinal products and the amount of dues for their state registration (re-registration)”;
• Order of the Ministry of Healthcare of Ukraine of August 26, 2005 No. 426 “On approval of the procedure of carrying out of medicinal products materials examination, which are submitted for the state registration (re-registration) and also materials examination on introduction of changes into the registration materials during the validity of the registration certificate”;
• Order of the Ministry of Healthcare of Ukraine No. 1245 of November 17, 2016 “On approval of the procedure of reviewing of registration materials on medicinal products that are submitted for the state registration (re-registration) and materials on the introduction of changes into registration materials during the validity of the registration certificate for medicinal products, which were registered by the competent authorities of the United States of America, Switzerland, Japan, Australia, Canada, medicinal products, which were registered by the competent authority of the European Union according to the centralized procedure”;
• Order of the Ministry of Healthcare of Ukraine No. 1391 of June 15, 2020 “On approval of the Procedure for conducting check of registration materials on their authenticity on medicine submitted for the state registration for the purpose of its purchase by person authorized on implementation of purchases in health sector or by the specialized organization”;
• Order of the Ministry of Healthcare of Ukraine No. 898 of December 27, 2006 “On approval of the procedure of carrying out of supervision of adverse reactions of medicinal products authorized for medical use (Pharmacovigilance)”;
• Order of the Ministry of Healthcare of Ukraine No. 722 dated 25.08.2010 “On approval of labeling of medicinal products with Braille”;
• Order of the Ministry of Healthcare of Ukraine No. 1130 dated December 27, 2012 “On approval of the Procedure for confirming the compliance of the production conditions of medicines with the requirements of good manufacturing practice”.

Our services

Since 2006 we support the pharmaceutical business in regulatory affairs, pharmacovigilance, and quality. We are a leading regulatory consultant in Ukraine and 11 countries of the CIS region. Our extensive team has the necessary knowledge, experience, and skills and is proficient in English.

We have provided regulatory services for more than 200 manufacturers of medicines, many of which recommend us as a regulatory partner. 

We offer: 

• consultation, development of registration strategy;
• establishment of new registration, renewals, and variations;
• establishment and maintaining a pharmacovigilance system, outsourcing the functions of the local contact person;
• confirmation of manufacturing conditions with GMP requirements through recognition or inspection.

In addition to the main services, we also offer:

• translation of the scientific, medical, technical, and legal documentation;
• back-office operations: preparation of the registration dossier or any of its parts without submission;
• development and pre-printing verification of labeling artworks and instructions for use;
• medical writing of parts of the registration dossier;
• development of documentation and import licensing;
• writing of documentation for inclusion of the medicinal product in the National List (HTA).