Format Of And Procedure For Submitting The Report On Advertising Of Medicinal Products


Published: 2011-01-01

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Format of and procedure for submitting the report on advertising of medicinal products

Passed 07.03.2005 Annex 40
RTL 2005, 32, 457
Entry into force 25.03.2005
Amended by the following legal instruments (show)

Passed
Published
Entry into force

13.10.2010
RT I 2010, 76, 585
01.01.2011

This Regulation is established on the basis of subsection 83 (7) of the Medicinal Products Act.

§ 1.  General provisions

(1) This Regulation establishes the format of and procedure for submitting to the State Agency of Medicines the report concerning provision of support specified in subsections 86 (2) and (5) of the Medicinal Products Act by a holder of a marketing authorisation in respect of a medicinal product to dispensing chemists, pharmacists and doctors and their associations, organisation of events specified in subsection 86 (6) and patient information events, distribution of samples, and any discounts made.
(2) The submitted data shall be considered public information, with the summarized data published on the website of the State Agency of Medicines by 1 June each year.

§ 2.  Procedure for submitting the report on advertising of medicinal products

(1) A holder of a marketing authorisation in respect of a medicinal product shall submit the report on advertising of medicinal products to the State Agency of Medicines by 1 February each year in the form provided in the Annex to this Regulation.
(2) A holder of a marketing authorisation in respect of a medicinal product shall submit the report on advertising of medicinal products electronically in MS Excel format as well as on paper.

§ 3.  Data to be submitted in the report on advertising of medicinal products

(1) The following data shall be submitted on medicinal products not subject to medical prescription in the report on advertising of medicinal products:
1) presentations of medicinal products or other scientific events organised or initiated by the marketing authorisation holder in Estonia;
2) presentations of medicinal products or other scientific events organised or initiated by the marketing authorisation holder outside Estonia, targeting Estonian citizens;
3) record of samples of medicinal products, broken down by preparations;
4) discounts on medicinal products, broken down by preparations, including the discount recipients;
5) patient information events organised or initiated by the marketing authorisation holder.
(2) The following data shall be submitted on medicinal products subject to medical prescription in the report on advertising of medicinal products:
1) presentations of medicinal products or other scientific events organised or initiated by the marketing authorisation holder in Estonia;
2) presentations of medicinal products or other scientific events organised or initiated by the marketing authorisation holder outside Estonia, targeting Estonian citizens;
3) recording of samples of medicinal products, broken down by preparations;
4) discounts on medicinal products, broken down by preparations, including the discount recipients;
(3) In addition to the data specified in subsections (1) and (2), the following data shall be submitted in the report on advertising of medicinal products:
1) support provided to medical or pharmaceutical events in accordance with subsection 86 (5) of the Medicinal Products Act, broken down by events, specifying the recipient of the support, name of the event, purpose of use of the support, and the amount of the support;
2) support provided for participation in medical events in accordance with subsection 86 (2) of the Medicinal Products Act, broken down by support, specifying the recipient of the support, name of the event, purpose of use of the support, and the amount of the support;
3) health promotion events which are organised or initiated by the marketing authorisation holder, and which, in the opinion of the marketing authorisation holder, are not related to the advertising of medicinal products not subject to medical prescription or medicinal products subject to medical prescription, specifying the target group, purpose of the event, and number of participants.
Annex 

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