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 is only permissible to refer to studies which are not considered in the SmPC if such studies are not contradictory to each other and meet certain scientific standards. There are no particular provisions regarding the advertising of medicinal products on the internet. In principle, the rules noted in question 4. The patients suffer from a life-threatening disease or a disease leading to heilkittelwerbegesetz disability.
This means that rebates in kind are only allowed for medical devices and pharmaceuticals which may be sold outside pharmacies. There is a simplified licence procedure for parallel imported drugs that have already been licensed for national distribution in another EU country. Marketing to professionals must contain the following product information:. Consequently, such campaigns would not be subject to the strict regulations of the HWG but, nevertheless, would need to be in compliance with the general rules of the UWG, i.
Pharmaceutical Advertising | Germany | ICLG
However, the question whether and to which extent customary cash discounts Skonti are permissible, has not been addressed. It has to be noted, however, that courts tend to be very strict with regard to items of insignificant value.
Can and, in practice, do, the competent heilmittelwerbegseetz investigate matters drawn to their attention that may constitute a breach heilmittelwerbeegsetz both the law and any relevant code and are already being assessed by any self-regulatory body? Recent developments and outlook This leads to the following rules: Contributions made by member companies must be specified and described in detail.
Enclose a statement in which he or she commits himself in writing to observe the regulations governing the proper operation of a wholesale enterprise. As the package deals could vary significantly as to their effect of inducement and influence on physicians, they have to be assessed on a case-by-case basis. Furthermore, such advertisements to the general public must not contain expert opinions, statements that the product is recommended, tested or used by healthcare professionals, or certain pictorial representations.
Heilmittelwerbegesetz | Inside EU Life Sciences
In addition, the German Criminal Code Strafgesetzbuch StGB sets out in sections and legal requirements regarding attempts to influence health care professionals who work in public hospitals. Is virtual drug distribution possible from your jurisdiction?
It is permissible to inform the media about medicinal products which have not heilmittelwebregesetz been authorised or registered, as heilmiittelwerbegesetz as about indications or pharmaceutical forms which are not covered by the marketing authorisation, provided that the conditions noted in question 2.
For example, in heilmittellwerbegesetz cases it will be necessary for a physician to obtain supervisory approval. The decision on granting the authorisation is taken by the competent federal higher state authority of heiljittelwerbegesetz state in which the wholesaler is established. Is it possible for the press release to refer to developments in relation to as yet unauthorised medicines or unauthorised indications?
Authorisation Under section 21 1 of the Medical Products Act Arzneimittelgesetz AMGa finished medicinal product can only be placed on the market after a marketing authorisation has been issued by the competent German higher federal heilmittelwerbegeserz or the European Commission. Who has responsibility for enforcement and how strictly are the rules enforced? Furthermore, advertisements for medicinal products — whether for non-prescription or prescription-only products — have to provide certain basic information relating heilmittelwerbehesetz the product see question 3.
The packages must be of the smallest commercially available size or may be specially manufactured sample packages with even less content. In addition, an action can be brought before the local administrative courts. Medicines that can be sold by pharmacists only apothekenpflichtig.
Industry and Commercial Chambers are also entitled to such claims. Therefore, the potential involvement of hospital physicians in the solicitation of the donation has to be disclosed to and approved by the hospital administration.
What other items, funding or services are permitted to be provided to professionals? heilmittelwerebgesetz
Pharmaceutical Advertising 2018 | Germany
Likewise, if the benefit granted to the physicians by providing the associated benefits is able to induce the prescription of the medicine, the package deal is prohibited subject to the new Sections a and b German Criminal Code.
Prior to the federal elections in Autumn a decision has not been taken by the previous legislator. Under section 4 201 of the HWG, all marketing activities to consumers must include the following notice: There also has to be a specific relationship of the special benefit to prescription practice.
Pursuant to Section 11 HWG, an advertisement addressed to the general public i.
The wholesale of drugs is defined in section 4 22 of the AMG as any professional or commercial activity for the purpose of doing business that consists of the procuring, storing, dispensing or exporting of medicinal products, with the exception of the dispensing of medicinal products to consumers other than physicians, dentists, veterinarians or hospitals. It was very amusing, and I plan to use this song in an upcoming musical comedy concert.
Un mundo feliz es una de las obras maestras escritas por Aldous Huxley. However, physicians are allowed to give lectures or render expert opinions on the aforementioned products for non-promotional reasons. In particular, the focus has been on hospitals and their management of assigning patients after the in-patient treatment for the following treatment by local practitioners. Medicinal products that are intended for use in clinical trials on human beings.