Project Monitoring of advertising material for medicinal products in 2020
The Austrian Federal Office for Safety in Health Care (BASG) monitors the legal compliance with the provisions concerning the advertisement of medicinal products. In Austria advertising for medicinal products is regulated by the Medicinal Products Act (AMG).
The BASG checks the compliance of all promotional material with the provisions according to Part V. of the AMG.
In 2011 the project was launched by randomly selecting marketing authorization holders and ask for promotional material. Since 2012 material for special indications (ATC-Code) has been requested and in addition to the promotional material the legal compliance of the corresponding websites has been checked.
Monitoring of advertising material in 2020
This year’s focus was put on human medicines with ATC code G04 (urologicals) except G04BE (products for erectile dysfunction) and on veterinary products with ATC code QG04 (urologicals) and ATC QR03 (products for obstructive pulmonary disease).
The promotional material of 13 companies (10 with human and 3 with veterinary products) was examined. Four companies had not planned any promotions for 2019.
The following legal infringements were detected:
- Advertisement for the public with claims not included in the SPC [§ 50 a(4) AMG]: 3 companies
- Claims contrary to the SPC [§ 50a (3) lit 3 AMG], including a non-approved indication: 1 company
- missing essential information [relevant parts of the summary of product characteristics pursuant to § 54 (1) lit 2 AMG]: 3 companies
- references [§ 55 (2) AMG]: - posters as references, only available from the company: 1 company, - Claims/statements in the references not or not clearly comprehensible: 3 companies
Regarding the homepages the following infringements were discovered:
- Layout :The layout was the same for different product catagories. -No obvious differences were made between medicinal products, dietary supplements for human/animals and medical products: 4 companies
- Dietary supplements for human/animals with disease related claims (drug by presentation): 2 companies
Regarding future monitoring projects the Austrian Federal Office for Safety in Health Care asks MA-holders to consider the following points:
- Pursuent to § 52 (4) AMG advertisement solely composed of the trade name of a proprietary medicinal product (= reminder advertising) is only allowed for advertising for the public unless the advertisement is for proprietary medicinal products that increase sport performance and the reminder advertisement is not conveyed via placards, print adverts or acoustic or audio-visual media.
- Pursuent to § 54 (1) lit 2 AMG medicinal product advertising that is targeted at persons licensed to use or dispense medicinal products can be served without the essential information on the proprietary medicinal product, insofar as it does not appear in print media, electronic media or is transmitted via telecommunication. This also includes invitations to advanced training courses, calendars etc. printed with the medicinal product logo.
The submitted promotion material should include only copies of original adverts, as in drafts the essential information is frequently missing.
- Pursuent to § 55 AMG Information on a proprietary medicinal product that is distributed to persons licensed for the prescription or distribution of medicinal products shall be sufficiently precise, up to date, verifiable and complete to enable the recipient to comprehend the therapeutic use of a proprietary medicinal product. From the BASG’s point of view this can only be achieved if the information is based on data publicly available/made accessible to everybody. This is not the case if access to information has to be specifically required (e.g. data on file or posters).
- Pursuent to § 56 (2) AMG the BASG shall be informed without delay when a person designated responsible for information is appointed or a different person is designated responsible for information.
For the submission of the promotional material to the BASG following points have to be considered:
- Data of the person responsible for information should always be up to date. Foreign MAH should nominate a responsible person residing in Austria. In case the MAH has more than one distributors –every single responsible person should be nominated.
- The submitted electronic data should be clearly structured (eg., excel-sheets referring to subfolders).
- Scientific references should be held ready for retrieval (to be provided on demand within 1-3 business days).