On 20 December 2011, the Parliament of Ukraine adopted the Law No. 4196-VI "On Amendments to Certain Healthcare Legislation regarding Strengthening Control over Turnover of Medicinal Products, Food Products for Special Dietary Consumption, Functional Food Products and Dietary Additives" (the "Law"). The law intensifies the state control over the medical products circulating in Ukraine and changes advertising requirements applicable to them.
The main changes introduced by the Law are as follows:
- licenses for production and sale (retail and wholesale) of the medical products may be issued only after the applying entities have successfully passed state audit of their compliance with requirements to the material and technical base, personnel's qualification and, in case of the applicants for production license only, facilities for quality control of the medical products to be manufactured. The aforementioned audits shall be conduced by the licensing authority within the period of relevant license issuance. Procedures for the audits shall be developed by the central executive body in the domain of health protection (Ministry of Health Protection));
- advertising of the OTC medical products is allowed only in respect of those medical products which have not been included into the list of the medical products prohibited from being advertised. Central executive body in the domain of health protection shall (i) approve a list of medical products prohibited from being advertised and (ii) establish criteria according to which medical products shall be included to the aforementioned list. Decision whether each particular OTC medical product shall be included into the advertising ban list shall be adopted at the stage of its registration (re-registration);
- RX medical products are totally prohibited from being advertised (without exception regarding RX advertising in professional medias for healthcare practitioners and/or during professional medical events);
- Information on medical products (including unregistered ones or those being on their development or launch in production stage) may be published in professional periodicals for healthcare practitioners and pharmaceutics and distributed on medical events (symposiums, conferences etc). Such information includes name, characteristics, therapeutic indications and possible side effects.
The Law has become effective as of 13 January 2012, except for provisions relating to advertising of medical products and distribution of the information on medical products that shall become in force as of 14 July 2012.
Law of Ukraine "On Amendments to Certain Healthcare Legislation regarding Strengthening Control over Turnover of Medicinal Products, Food Products for Special Dietary Consumption, Functional Food Products and Dietary Additives", No. 4196-VI dated 20 December 2011.
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The original publication date for this article was 01/02/2012.