Ukraine is one of the largest former Soviet countries with a population of more than 42 million people. In 2014, Ukraine signed the Association Agreement with the European Union, aimed at strengthening the judiciary, improve its efficiency, safeguard its independence and impartiality and combat corruption, cooperation on justice, freedom and security. The country is actively harmonising its national legislation to the EU legislation.
In 2018-2020, Ukraine is reforming the healthcare system. State medical institutions are moving to a new model of financing by the National Health Service of Ukraine (NHSU), on “money follows patient” principle. Patients sign Declarations with family doctors, a list of medical services that are provided free of charge to the patient under the medical guarantee program is approved. A reimbursement program for medicinal products has been introduced.
The total volume of the Ukrainian pharmaceutical market, including retail and hospital segments, is about 3.7 billion Euro per year. The pharmaceutical market of Ukraine is characterized by strong positions of national manufacturers.
State registration is required for import and sale of medicinal products in Ukraine. Since 2005, Ukraine has introduced legislation in the field of medicinal products registration, based on EU legislation. At present, requirements to registration and circulation of medicines in Ukraine are similar to the EU, the procedure is transparent and predictable for international manufacturers.
Since January 2011 Ukraine has become a member of PIC/S (The Pharmaceutical Inspection Co-operation Scheme), a Good Manufacturing Practice (GMP) agreement between regulatory authorities of 52 countries. Since 2013, in order to obtain a conclusion on the quality required to introduce a medicinal product into circulation, a GMP certificate issued or recognized by the competent authority of Ukraine must be provided.
The total volume of the Ukrainian market for medical devices, including retail and hospital segments, is about 1 billion Euro per year, import is app. 80%.
To import and put into circulation medical devices it is necessary to carry out the procedure of national conformity assessment with the requirements of Technical Regulations. Technical Regulations for medical devices were approved in 2013 and are based on EU Directives. The national conformity assessment procedure is close to the EU procedures, for most medical devices the procedure involves contacting the designated conformity assessment body.
The National Accreditation Agency of Ukraine (NAAU), which accredits the designated conformity assessment bodies, is an associate member of the European Co-operation for Accreditation (EA) and a signatory to the EA Bilateral Agreement (EA BLA) in the areas of accreditation of testing and calibration laboratories, product certification bodies, certification bodies for management systems, certification bodies for personnel and inspection bodies.
Products such as dietary supplements, baby food, medical nutrition, sports nutrition, are included in the general legislation on food products. Registration of dietary supplements, medical nutrition and food products for weight control in Ukraine is simplified, however, market operators (supermarkets, pharmacies, special stores) almost always require a supplier to provide documentation to confirm compliance with safety and quality requirements. Registration of baby food in Ukraine is a mandatory requirement for import and sale.
To import and sell cosmetic products it is mandatory to have a sanitary and epidemiological report (SES conclusion), which confirms the quality and safety of the products, as well as determines the scope of sales and sets the safety criteria that the product must meet.
Ministry of Health of Ukraine
The central executive body that implements public health policy
Web site: https://moz.gov.ua/
Ministry of Economic Development, Trade and Agriculture of Ukraine
The central authority responsible for technical regulation
Web site: http://me.gov.ua
State Expert Center of the Ministry of Health of Ukraine
The competent authority responsible for conducting expert work at the registration of medicinal products, and for pharmacovigilance
Web site: https://dec.gov.ua/
State Administration of Ukraine on medical products and control of narcotics
The competent authority responsible for the quality control of medicinal products and medical devices
Web site: http://dls.gov.ua/
The main legislative acts:
- The Law of Ukraine “On Medicines”.
- The Law of Ukraine “On Technical Regulations and Conformity Assessment”.
- The Law of Ukraine “On State Market Supervision and Control of Non-food Products”.
- The Law of Ukraine “On General Safety of Non-food Products”.
- The Law of Ukraine “On Sanitary and Epidemiological Well-Being of the Population”.
- The Law of Ukraine “On Protection of Consumer Rights”.
- The Law of Ukraine “On Basic Requirements for the Safety and Quality of Food Products”.
- The Law of Ukraine “On Baby Food”.
- The Law of Ukraine “On Information for Consumers on Food Products”.
- The Law of Ukraine “On State Control over Observance of Legislation on Food, Feed, By-Products of Animal Origin, Animal Health and Welfare”.
- Decree of the Cabinet of Ministers of Ukraine No. 376 dated May 26, 2005 “On Approval of the State Registration (Re-registration) of Medicines and the Amount of Fees for Their State Registration (Re-registration)”.
- Decree of the Cabinet of Ministers of Ukraine No. 902 dated September 14, 2005 “On Approval of the Procedure for State Quality Control of Medicines Imported into Ukraine”.
- Decree of the Cabinet of Ministers of Ukraine No. 753 dated October 2, 2013 “On Approval of the Technical Regulations for Medical Devices”.
- Decree of the Cabinet of Ministers of Ukraine No. 754 dated October 2, 2013 “On Approval of the Technical Regulations for Medical Products for In-Vitro Diagnostics”.
- Decree of the Cabinet of Ministers of Ukraine No. 755 dated October 2, 2013 “On Approval of the Technical Regulations for Implantable Medical Devices”.
- Order of the Ministry of Health of Ukraine dated August 26, 2005 No. 426 “On approval of the Procedure for expert evaluation of materials for medicinal products that are submitted for state registration (re-registration), and expert evaluation of materials on changes to registration materials during the validity of marketing authorization”.
- Order of the Ministry of Health of Ukraine No. 898 dated December 27, 2006 “On Approval of the Pharmacovigilance Procedure”.
- Order of the Ministry of Health of Ukraine No. 722 dated August 25, 2010 “On Approval of the Labelling of Medicinal Products in Braille”.
- Order of the Ministry of Health 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”.
- Order of the Ministry of Health of Ukraine No. 1245 dated November 17, 2016 “On approval of the Procedure for consideration of registration materials for medicinal products that are submitted for state registration (re-registration), and materials on changes to registration materials during the validity of marketing authorization for medicinal products registered by the competent authorities of the United States of America, Switzerland, Japan, Australia, Canada, medicinal products registered under a centralized procedure by the competent authority of the European Union”.
- Order of the Ministry of Health of Ukraine No. 721 dated November 3, 2015 “On approval of the Procedure for conducting expert evaluation of the authenticity of registration materials for a medicine that is submitted for state registration to be purchased by a specialized organization”.
- Order No. 696 “On approval of hygienic requirements for baby food, safety parameters and individual indicators of their quality”.
- Order No. 1073 “On Approval of the Norms of Physiological Needs of the Population of Ukraine in Basic Nutrients and Energy”.
- Order No. 1114 “On Approval of Hygienic Requirements for Dietary Supplements”.
Cratia provides professional services on state registration of healthcare products in Ukraine. We have a deep knowledge of the national legislation, significant experience and necessary resources. We offer:
- state registration of medicines in Ukraine;
- establishment and maintenance of pharmacovigilance in Ukraine;
- conformity assessment of medical devices in Ukraine;
- registration of special food products in Ukraine;
- registration (certification) of cosmetics in Ukraine.