Contributed By Pakharenko & Partners (Kyiv)
According to the law, publication of information about any medicines, regardless of their inclusion in the list of medicines prohibited for advertising, unregistered medicinal products, or the products that are in the process of development or putting into production, shall be allowed in specialised publications intended for healthcare and pharmaceutical professionals, as well as in the materials distributed at specialised seminars dedicated to medical issues.
Such information may include only the name, characteristics, therapeutic properties and possible side effects of a medicine. The fact that such information is not qualified as advertising of medicinal products indicates that in this part the legislation of Ukraine approximates to the EU practice (in particular, Directive 2001/83).
The law does not specify an exact scope of information to be provided in each of these categories concerning the name, characteristics, therapeutic properties and possible side effects of a medicine, which allows providing a broader scope of information about the medicine. In the course of development of layouts of informational materials, the following approaches are recommended:
Information regarding unauthorised medicines and/or unauthorised indications provided during a scientific conference and directed at healthcare professionals restricted by providing exclusively the name, characteristics, therapeutic properties and possible side effects of a medicine.
Please see 2.2 Difference Between Information and Advertising and 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications for detailed information.
Dissemination of information on medicines on unauthorised medicines or unauthorised indications is limited to:
The scope of issues that can be covered by information on medicines is clearly defined: name, characteristic, therapeutic properties, possible side effect.
The law does not provide for sending information on medicines to healthcare institutions, but it is allowed to provide such information to healthcare professionals. As regards healthcare institutions, the law stipulates that legislative restrictions provided for in Article 21 of the Law of Ukraine "On advertising" are not applied to advertising of medicines placed in specialised publications intended for healthcare institutions.
Namely, there are no restrictions with regard to the advertising of prescription medicines and the ones included in the list of medicines whose advertising is prohibited, doping substances and/or methods of their use in sports. Also, it is not required to include a notice on the need to consult a doctor prior to the use of the medicine; recommendations on obligatory familiarisation with the instructions for the use of medicinal product; and the text of the notice stating as follows: "Self-treatment can be harmful to your health" occupying not less than 15% of the space (duration) of the whole advertisement.
Please see 3.3 Provision of Information to Healthcare Professionals for further details.