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    Advertising of medicinal products

    28.04.2017
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    The advertising of medicinal products is regulated by two legal acts – the Advertising Act and the Medicinal Product Act. The Advertising Act provides the definition of advertising, the general requirements, prohibitions and restrictions established for advertising in general. According to the Act § 2 the advertising means information which is made public in any generally perceived form for a charge or without charge for the purpose of the provision of a service, increasing the sale of goods, promoting an event or directing the conduct of a person in public interests.

    The specific requirements for advertising of medicinal products are stipulated in the Medicinal Product Act (§ 82-86) and the classes of advertising of medicinal products is divided into two broad categories:

    1) advertising of medicinal products to the general public;
    2) advertising of medicinal products to persons qualified to prescribe them, to dispensing chemists or pharmacists.

    The general requirements for advertising and for advertising of medicinal products (§ 83) will be applied to the both categories of advertising and specific rules are provided in separate articles (§ 84 and § 85). The inducement designed to promote prescription or sales is considered equal to advertising of medicinal products and the stipulated rules should be followed when sponsoring, giving gifts or providing services to the persons qualified to prescribe medicinal products, dispensing chemists and pharmacists (§ 86).

    The liability for the violation of the requirements of advertising of the medicinal products or the prohibition of inducement designed to promote the prescription or sales is also provided in the Medicinal Product Act.

    Medicinal Products Act

    Advertising FAQ

     

    Procedure for Submitting the Report regarding Advertisement of Medicinal Products

    According to § 83(6) of the Medicinal Products Act by February 1st each year, the holder of a marketing authorization in respect of a medicinal product must submit to the State Agency of Medicines a report concerning support awarded last year under § 86(2) and § 86(5) of the Medicinal Products Act to pharmacists, assistant pharmacists, persons qualified to prescribe medicinal products and their associations for the purpose of participation in or organisation of medical or pharmaceutical events, and on the meetings and patient information events organised, samples distributed and discounts made based on § 86(6) of the Medicinal Products Act.

    The requirements for submitting the report are laid down in Regulation no 40 of the Minister of Social Affairs of March 7th 2005.

    Please note that the reporting requirement is a mandatory rule for holders of a marketing authorisation. The reporting requirement covers medicinal products both for human and for veterinary use. We accept reports which are submitted from your local representatives in Estonia. If you do not have one, please note the following.

    The report must be submitted to the State Agency of Medicines online through our Client Portal. If a holder of a marketing authorisation has not engaged in any activities described in § 83(6) of the Medicinal Products Act, then they need to inform us via e-mail (info@ravimiamet.ee). We kindly ask You not to submit blank reports indicating lack of advertising activity.

    The Client Portal of the State Agency of Medicines can be accessed at https://kliendiportaal.ravimiamet.ee/RAKP/public/Login.aspx?ReturnUrl=%2fRAKP%2fDefault.aspx

    On the above referenced web link You can find a registration manual for the Client Portal.

    The State Agency of Medicines publish aggregated data from the reports on its website the latest by June 1. If you have technical questions related to the Client Portal, please contact us via e-mail (kliendiportaal@ravimiamet.ee).

    For additional information please contact the State Agency of Medicines via e-mail (info@ravimiamet.ee) or phone +372 7 374 140.