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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Therefore, such advertisements should be permissible if they are in compliance with the previously mentioned general principles regarding the advertising of medicinal products.
Such items include inexpensive heilmittelwerbeyesetz in particular smart phone apps which support diagnostic analysis and therapy of patients, as long as they are related to products and indications of the member company. If so, what restrictions would apply? It is, however, recognised that a company may grant donations to medical institutions if these donations are made:.
Pharmaceutical companies must also comply with principle of transparency, namely that collaboration and support must be executed in a transparent and open manner. The respective assessment must be carried out on a case-by-case basis and in consideration of numerous factors, such as the difficulty of the service and the qualification of the health care professional.
Does it make a difference whether the product is a prescription-only medicine, or an over-the-counter medicine? Additionally, an action can be brought before the local administrative courts. Furthermore, advertisements for medicinal products — whether for non-prescription or prescription-only products — have to provide certain basic information relating to the product see question 3. However, in anticipation of the legal developments, many companies have already treated self-employed physicians in the same way as privately or publicly employed clinic physicians.
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However, such disease awareness campaigns might become critical in cases where only a specific medicinal product exists for the treatment of the underlying disease. In addition, if an advertisement shall only serve as a reminder of the medicinal product Erinnerungswerbung it does not need to contain the basic information on the medicinal product heilmkttelwerbegesetz above or the invitation to seek the advice of a health professional.
An authorisation application for the medicinal product is pending or clinical trials Phase III for this medicinal product are still ongoing. General — Medicinal Products. If a competent authority considers an advertisement to be unlawful, it has the power to stop further publication of such advertisement. Just recently, a Higher Regional Court considered the limit for gifts of heikmittelwerbegesetz value for the benefit of healthcare professionals to be below EUR 1.
Distribution and marketing of drugs in Germany: overview
A higher lump sum currently EUR However, the exchange of medical and scientific information during the development or marketing authorisation phases of a medicinal product is permissible, provided that such activities are not considered to be part of product-related advertising. Industry guidelines applicable to the collaboration of pharmaceutical manufacturers and patient organisations are the:.
What is the general legal regime for the marketing of drugs? Please note, however, that given the lack of any jurisprudence in this regard, the interpretation of this provision is likely to vary depending on the circumstances of individual cases.
Gifts and Financial Incentives. The question of whether or not the provision of gifts or other benefits is permissible therefore depends on the circumstances of the individual case taking into consideration the different regulations and rules.
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The following are particularly relevant:. According to Section 15 FSA-Code of Conduct Healthcare Professionals, medical samples may only be supplied to a healthcare professional for a limited period of two years after the initial request by each helimittelwerbegesetz professional. There are provisions under German law for both named patient supplies and compassionate use programmes.
Other persons that are involved in the legal trade of medicinal products, procedures, treatment methods, objects or use such products in the course of their professional activity.
The limit is generally set below between EUR 0.
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In this case, in order to avoid a misrepresentation, the total value transferred to heilmittelwerbegeseta individual shall only be disclosed in aggregated form. The following promotional activities, amongst others, are prohibited: In the case of misleading marketing activities addressed to consumers, the infringing company and person in charge can be punished with imprisonment for up to one year or fines. Therefore, the pure funding of a nurse or the costs of a laboratory nurse by a company might also become critical with heilmittelwerbegessetz to a medical institution, provided that this is not part of a proper contractual relationship.
It is, however, acknowledged that a pharmaceutical company may reimburse conference fees, and reasonable travel and accommodation costs. Heilmittelwegbegesetz, the heilmittslwerbegesetz of the report shall be drawn up according to the requirements of good clinical practice.
Moreover, the collaboration has to proceed in a transparent and open manner. If so, what is the procedure for approval? However, such comparisons have to compare relevant, verifiable and typical characteristics of the products concerned, such as their prices and active ingredients.
In general, a marketing activity only falls within the scope of the HWG if the marketing activity is product-related and intended to increase sales of a respective product.
Rebates in kind are prohibited for all kinds of pharmacy-only pharmaceuticals apothekenpflichtige Arzneimittel. Rossini cat duet pdf These industry guidelines are binding for members of the relevant industry associations, and must be observed by non-members since they serve as a means of interpretation for German courts when assessing heilmigtelwerbegesetz a certain collaboration with health care professionals infringes the respective legal provision see Question Institutions may be provided with such information so long as the rules noted in question 2.
What other items, funding or services are permitted to be provided to professionals?