Policy

As public health is one of the main social values and concerns, it is highly important for every state to guarantee its inhabitants the access to safe and effective pharmaceuticals of good quality. Therefore, the Ukrainian law includes a number of legislative acts aimed at regulation of the Pharmaceuticals market.

The main and fundamental law in this sphere is the Law of Ukraine "On Pharmaceuticals" regulating the relations concerning the development, registration, production, quality control and distribution of Pharmaceuticals in Ukraine.

Laws of Ukraine "On Narcotic Substances, Psychotropic Substances and Precursors" and "On License of Certain Types of Business Activity" establish the conditions of the production and circulation of such substances in Ukraine.

The following main by-laws regulate the pharmaceutical sphere:

·             Resolution of the CMU "On Approval of the Procedure of State Control of Pharmaceuticals Quality Importing into Ukraine";

·             Resolution of the CMU "On Approval of the Regulation on the State Pharmaceuticals Registry";

·             Resolution of the CMU "On Approval of the Procedure of State Registration (Re-Registration) of Pharmaceuticals and Fees Amounts for State Registration (Re-Registration)";

·             Order of the Ministry of Health of Ukraine "On Licensing Conditions for Performance of Business

·             Activity on Production, Wholesale and Retail of Pharmaceuticals";

·             Order of the Ministry of Health of Ukraine "On Approval of the Procedure of Quality Control of Pharmaceuticals during Wholesale and Retail";

·             Order of the Ministry of Health of Ukraine "On Approval of Licensing Conditions for Performance of Business Activity on Import of Pharmaceuticals".

Regulator

CMU

·             Through other authorities, realizes the state policy in the area of development, production, quality control and distribution of Pharmaceuticals in Ukraine;

·             Organizes development and implementation of the relevant national and other programs, controls over the compliance with the Pharmaceuticals laws;

·             Ensures realization of the state policy in the areas of healthcare, sanitary-epidemic welfare, access to public health services, etc.

Ministry of Health of Ukraine

·             Approves criteria and standards for healthcare institutions, conducts accreditation of healthcare institutions of all property forms;

·             Controls compliance with Ukrainian law while performance of pharmaceutical activity;

·             Conducts state registration of Pharmaceuticals;

·             Maintains state pharmacopoeia of Ukraine;

·             Controls the quality of health care;

·             Stipulates license conditions for production, import, wholesale and retail of Pharmaceuticals.

State Service on Pharmaceuticals and Pharmaceutical Control of Ukraine

·             Controls Pharmaceuticals import to the territory of Ukraine;

·             Controls and supervises compliance with standards and technical requirements during the transportation, storage and use of Pharmaceuticals;

·             Controls the quality of Pharmaceuticals;

·             Issues licenses for production, import, wholesale and retail of Pharmaceuticals.

State Enterprise "State Expert Centre of the Ministry of Health of Ukraine"

·             Examines materials submitted for registration of pharmaceutical products;

·             Examines materials with regard to medical usage of Pharmaceuticals;

·             Rules on effectiveness, safety and quality of pharmaceuticals which is the basis for the state registration granting by the MHU.

Registration, Licensing, Certification and Quality Control

No Pharmaceuticals are allowed to be used without a prior state registration with the MHU. However, Pharmaceuticals prepared in pharmacies in accordance with medical prescriptions for individual use or under the orders of healthcare institutions - from active and auxiliary substances allowed in Ukraine - are not subject to the state registration.

The state registration certificate is granted for a term of up to five years, and during this term the certificate holder is responsible for the quality of the respective Pharmaceuticals product.

If a certain pharmaceutical is registered in Ukraine for the first time based on complete submission of documents, the registration of another pharmaceutical with the same active substance is possible not earlier than in five years after the registration date of the original pharmaceutical. However, this provision does not apply if the second applicant under the law has the right to refer and/or use data from the first applicant's documents or submits its own complete documents.

Handling of narcotic and psychotropic substances and precursors, and production, wholesale and retail of Pharmaceuticals are subject to mandatory licensing by the SSPPCU. Licenses for wholesale and retail of Pharmaceuticals are granted on an open-ended basis. Detailed licensing procedure is stipulated in the relevant order (see "Policy").

For the respective pharmaceutical to be imported in Ukraine, it must, in addition to the state registration and the importer license requirements, be accompanied with a quality certificate from its producer. Such certificate confirms the compliance of the pharmaceutical producer with the requirements set during its state registration.

Detailed quality control procedures are additionally set for pharmaceuticals while conducting wholesale and retail activity. This control is performed by the respective retailers and by state representatives as specified in the relevant order (see "Policy").

Import and Export of Pharmaceuticals

As already mentioned, pharmaceuticals may be imported into Ukraine subject to receipt of the special license by the importer. Such licenses are granted by the SSPPCU.

The consumption term of pharmaceuticals imported into Ukraine must not be less than half of the consumption term determined by the producer in case the determined term is less than a year, or not less than six months in case the consumption term of the producer is more than a year. However, some types of Pharmaceuticals may be imported into Ukraine without special license. The following are examples:

·             Transit through the territory of Ukraine;

·             Import of Pharmaceuticals for the following:

§  Pre-clinical research, pharmaceuticals development and clinical trials;

§  Their state registration;

§  Exhibitions, conferences, etc. without the right of distribution;

§  Medical supply (without the right of distribution) of foreign military units admitted at the territory of Ukraine;

§  Treatment of orphan deceases under the decision of the respective state authority (this provision is applicable only to Pharmaceuticals admitted for use on the territory of the US or EU members);

§  Personal use by individuals.

In addition to the above, pharmaceuticals may be imported, under the special permit of the MHU into Ukraine without special license in case of disasters, catastrophes or epidemics, as well as for medical supply of the military participating in antiterrorist operations, during the state of emergency and special period.

To export pharmaceuticals, the producer must confirm their quality by passing the respective certification procedure.

Labeling, Advertising and Distribution of Pharmaceuticals

Ukrainian law requires certain information on pharmaceuticals labels, both outer and inner package, including the following:

·             Name of the pharmaceutical;

·             Name and address of the producer;

·             Registration number;

·             Series number;

·             Consumption methods;

·             Dosage of the active substance in each product unit and their amount per package;

·             Consumption term;

·             Storage conditions;

·             Possible restrictions.

The external package of pharmaceuticals must provide in Braille the Pharmaceutical's name, the dosage and the dosage form. The MHU is entitled to form the list of pharmaceuticals which package does not require Braille labeling or indicate in Braille the pharmaceutical name only.

All pharmaceuticals distributed shall be accompanied with the relevant instruction with the information as provided by Ukrainian law. Such instructions (as well as labeling) must be in Ukrainian and in the regional language of the respective territory (if any).

The MHU adopted the list of criteria which are applied to determine a decision on whether a certain pharmaceutical could be advertised. Thus, the pharmaceutical could not be advertised if the pharmaceuticals were as follows:

·             Contains narcotic and psychotropic substances and precursors;

·             May lead to addiction syndrome (except for medicines for external (local) use);

·             Used only for pregnant women or while breast-feeding;

·             Used only for children under 12;

·             Designated for treatment of certain deceases (tuberculosis, cancer, HIV/AIDS, STD, diabetes, obesity, etc.).

Any pharmaceuticals advertising must follow the following rules:

·             Contain objective information on such product;

·             Be recognizable as advertising of a pharmaceutical;

·             Have a requirement to consult a doctor before the pharmaceuticals use and to read the instruction before using;

·             A disclaimer "Self medication could be hazardous" occupying at least 15 percentof the advertising area or duration.

In addition to the above, Ukrainian law sets a list of requirements for the content of pharmaceuticals advertising, e.g. advertisements of Pharmaceuticals shall not contain, inter alia:

·             References to actual cases of successful application;

·             Guarantees on the eventual medical effect of the product;

·             Comparisons to other pharmaceuticals intended to enhance the advertising effect;

·             Recommendations or references to the recommendations of medical professionals or scientists;

·             Thank-you letters of individuals;

·             Images and/or names of popular personalities, movie, TV or cartoon characters or reputed organizations, etc.

Certain additional restrictions apply depending on the advertising type (television, radio, in the printed media, other electronic means of communications). Advertising in the Internet shall comply with the general legislative provisions regarding the types of information allowed for dissemination.

To end consumers, pharmaceuticals are allowed for distribution either over-the-counter or under a doctor's prescription. Retail pharmaceuticals must be conducted only through pharmacies and with the relevant retail license.

The minimum mandatory assortment of pharmaceuticals present in pharmacies is envisaged by the MHU. In addition, the CMU adopted the list of essential pharmaceuticals which are subject to state price regulation.

Contemplated Reforms

It is expected that during 2015-2020 the Ukrainian Government will implement the following reforms:

·             Amend Ukrainian legislation to guarantee physical and economical availability of Pharmaceuticals;

·             Review the list of essential pharmaceuticals to ensure it consists of Pharmaceuticals with proven efficiency and safety;

·             Ensure professional training for management of the health care sector;

·             Reform the public procurement system regarding the procurement of Pharmaceuticals in line with European standards and principles, including electronic procurement, direct purchase of vaccines and Pharmaceuticals from their producers, etc.

The information contained herein is not a legal advice or clarification of the current legislation. 

If you need more information, please refer to Lavrynovych & Partners:
www.lp.ua | office@lp.ua

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