The Verkhovna Rada has banned advertising prescription drugs
Last reviewed: 16.10.2021
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The Verkhovna Rada adopted the Law "On Amendments to Certain Laws of Ukraine in the Health Care Sector, Regarding Strengthening Control over the Treatment of Medicines, Food for Special Dietary Consumption, Functional Foods and Dietary Supplements."
As the correspondent of UNIAN reports, 237 of the 329 alternative deputies registered in the session hall voted for this decision.
Amendments have been made to the Law on Medicines, which provide that the procedure for the import of medicines into the territory of Ukraine shall be established by the Cabinet of Ministers.
Also, changes are provided that the basis for issuing a license is the availability of a material and technical base, qualified personnel whose compliance with the established requirements and declared in the documents submitted by the applicant for obtaining a license characteristics is subject to mandatory verification before issuing a license within the time limits for issuing a license at the place the activity of the licensing body or its territorial subdivisions in the manner established by the central body executive power in the field of health.
In accordance with the law, the sale (leave) to citizens of medicines under the prescription of a doctor is carried out in accordance with the procedure established by the central executive authority in the field of health.
It is envisaged that information about medicines (including drugs that are not registered or under development or introduction into production) includes the name, characteristics, therapeutic properties, possible indirect effect and is published in publications intended for medical and pharmaceutical workers, and also in materials that are distributed at specialized seminars, conferences, symposia on medical topics.
Advertising of medicinal products, which are issued without a doctor's prescription and not included in the list of drugs prohibited for advertising, is permitted.
The list of medicines prohibited for advertising is approved by the central executive body in the field of public health. Requirements for advertising of such medicines are established by the Law "On Advertising".
Criteria that are used in the determination of medicines, which are prohibited from advertising, are approved by the central executive body in the field of health in accordance with the requirements of the law.
The decision to assign a medicinal product to medicinal products, which advertising is prohibited, is taken during the state registration (re-registration) of the medicinal product with the introduction of the relevant information in the State Register of Medicinal Products of Ukraine.
Advertising of medicinal products, the use and release of which is permitted only by prescription of a doctor, as well as those listed in the list of drugs prohibited for advertising, is prohibited.
Amendments have also been made to Article 9 of the Law of Ukraine "On the Licensing of Certain Types of Economic Activities," which stipulate that economic activities for the circulation of narcotic drugs, psychotropic substances and precursors, as well as economic activities for the production of medicines, wholesale and retail trade in medicines, are subject to licensing in accordance with this law, taking into account the specifics specified by the laws "On narcotic drugs, psychotropic substances and precursors Orach "and" On Medicines ".
Amendments are made to Article 21 of the Law on Advertising, which stipulates that advertising of medicines, medical products, methods of prevention, diagnosis, treatment and rehabilitation should contain:
- objective information about the medicinal product, the medical product, the method of prevention, diagnosis, treatment, rehabilitation and implemented so that it is clear that the above message is an advertisement, and the advertised product is a medicine, a medical device, a method of prevention, diagnosis, treatment, rehabilitation;
- the requirement for consultation with a physician before the use of a medicinal product or medical device;
- recommendation for mandatory familiarization with the instructions for the drug.
A warning text should also be included: "Self-medication can be harmful to your health", which takes up at least 15% of the area (duration) of all advertising.
In advertising goods and methods not related to medicines, medical products, methods of prevention, diagnosis, treatment and rehabilitation, as well as in advertising food for special dietary consumption, functional foods and dietary supplements, it is forbidden to refer to the fact that they have medical properties.