Also available as TILEC DP | = .. Germany, the Remedies Advertising Act (Heilmittelwerbegesetz – HWG) were in. heilmittelwerbegesetz pdf MEDICINAL PRODUCTS ACT (The Drug Law) ( Arzneimittelgesetz AMG) Act on Advertising in the Field of Health (Health. Tag Archives: Heilmittelwerbegesetz. German court allows pharma company public promotional statements about Rx-drug to counter a “shitstorm” – a trend also.
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It has to be noted, however, that courts tend to be heilmittelwerbeegsetz strict with regard to items of insignificant value. It is, in any case, not permissible to pay or grant incentives for the publication of a press release or an article written on the basis of such press release.
Under Article 7 1 of the HWG, special offers such as “buy-one-get-one-free” are prohibited.
When applying for a marketing authorisation of the generic product, reference can be made to the documents, including the expert report, for the previous applicant’s medicinal product reference medicinal product. There is no explicit written requirement under German law. Therefore, it has to be awaited how the new legislator intends to address this issue.
About Us Free Newsletter. Such monitoring and control obligations exist prior to establishing the link, as well as after the link is established.
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Is it permitted to provide consumers with free heilmitetlwerbegesetz Please see our terms and conditions page for further details. If so, in what circumstances? Furthermore, such reports shall support the scientific discussion. A reduced fee of EUR97, for an application regarding a generic pharmaceutical product. Does it make a difference if the heilkittelwerbegesetz is sponsored by the company responsible for the product? However, decisions have objected to the general application of such industry guidelines for non-members of the VfA.
Physicians are not allowed to distribute drugs.
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I understand more info. Depending on the state where the drugs are distributed, it may possible to appeal against the competent federal higher state authority’s decision.
Moreover, as with any company that maintains a website, pharmaceutical companies are also obliged to publish on the website contact information regarding the company.
As 20111 general rule, such advertisements relating to non-prescription products have to comply with the general provisions for advertising, i. Enclose a statement in which he or she commits himself in writing to observe the regulations governing heilmittelwerbegdsetz proper operation of a wholesale enterprise. It is not permitted to provide consumers with free samples of drugs section 11 1 No. The collaboration of member companies with patient organisations must not involve recommendations for individual prescription-only pharmaceuticals or groups of pharmaceuticals and the appearance of member company representatives at patient organisations must not be aimed at making promotional references to prescription-only pharmaceuticals.
Only informational and educational materials or items of medical utility and samples may be provided. What regulatory authority is responsible for supervising wholesale distribution activities? Has any guideline been issued on market research of medicinal products? In case of non-compliance, fines of up to EUR, can be imposed by one of the arbitration boards.
However, a mere statement on a website where the details of prescription-only pharmaceuticals are only directed to healthcare professionals, or a simple unverified question asking whether the corresponding person is a health professional, is not sufficient.
It is, however, recognised that a company may grant donations to medical institutions if these donations are made: In Section 1 HWG, a new paragraph 7 has been added: The automatic blockage must be technically possible and economically reasonable. The requirement for any financial support for passive participation in events is that the primary purpose of the event has to convey scientific information and communicate professional knowledge.
Apart from this, a claimant can also sue for damages and compensation, and can request an account of any profit made. The negligent breach of these regulations may be punished by an administrative fine of up to EUR 20, Work-related meals are also permissible. Whether such exceptions apply has to heilmittelwsrbegesetz assessed on a case-by-case basis.
Healthcare professionals may be provided with samples of medicinal products for informational purposes, but only in small numbers and upon their written request.
Distribution and marketing of drugs in Germany: overview
A pharmaceutical company should not bear additional costs. In particularly serious cases, the arbitration board can publicly rebuke the pharmaceutical company.
Companies may not make public displays of off-label information at German national meetings. Engagement with patient organisations is regulated in the relevant industry codes. Generally, with regard to Section 7 HWG, they do neither constitute a rebate in kind nor volume as the package deal provides for one single price, covering both, the medicines and the associated benefit.
Additionally, an action can be brought before the local administrative courts. In addition, it would not be allowed to refer to a study on an off-label indication Section 3a, HWG. Companies should also define clear responsibilities of employees in order to optimise working structures. The offering of hospitality to healthcare professionals is governed by various German legal provisions, e.