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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In addition, several industry guidelines govern the interaction between pharmaceutical manufacturers and health care professionals. The offering of hospitality to healthcare professionals is governed by various German legal provisions, e. A pharmaceutical company should not bear additional costs.

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Therefore, 2101 pure funding of a nurse or the costs of a laboratory nurse by a company might also become critical with respect to a medical institution, provided that heilmittelwerbegsetz is not part of a proper contractual relationship. Does it make a difference if the hospitality offered to those healthcare professionals will take place in another country and, in those circumstances, should the arrangements be approved by the company affiliate in the country where the healthcare professionals reside or the affiliate where the hospitality takes place?

German companies and companies acting in Germany regardless of whether any marketing authorisation has already been granted to the respective company. This leads to the following rules: About Us Free Newsletter.

Pharmaceutical Advertising 2018 | Germany

In each case, providing information to the readers should be the main purpose of such press releases and any advertising would only be considered as an unavoidable side effect of the publication. Infringements of rules for the heilmittelwerbegesezt of fair competition by pharmaceutical manufacturers can be pursued by the competent national authorities.

Responding to such unsolicited questions regarding a specific medicinal product heilmittelwerbegesettz not considered as promotion, but as company-related information.

However, please note that this regulation is still highly disputed due to its ambiguous wording and the fact that no relevant case law yet exists. The number of medical samples is limited to two samples per year. When advertising a product to consumers, comparisons with other medicinal products are not permitted.

It is possible to appeal Widerspruch against the federal drug administration’s decision not to grant a licence.



Heilmittelwerbegesetz | Inside EU Life Sciences

We use cookies to maximise functionality and improve your experience. Section 74a of the German Drug Act Arzneimittelgesetz — AMG stipulates that any hellmittelwerbegesetz who, as a pharmaceutical entrepreneur, places medicinal products on the market, shall appoint an information officer who is responsible for ensuring that the labelling, the package leaflets, the expert information and advertisements correspond with the content of the marketing authorisation.

As a result, pharmaceutical companies must make available to the public a list of the patient organisations that are financially supported in Germany and throughout Europe, or that receive indirect or non-financial benefits. Unlike in other countries, in Germany nurses are not allowed to write prescriptions.

The organisation of tours or programmes for spouses or other accompanying persons is not permissible for the same reasons.

There are no explicit rules stating maximum amounts or limits relating to hospitality and meals. If there is a medical rationale heilmittelwerbegseetz providing an item to the patient which is either necessary for the administration of the medicinal product or which supports the overall compliance of the patient, this may also qualify as an accessory to the goods which is customary in the trade.

In this regard, the State Chambers of Physicians of Lower Saxony has expressed the view that costs in connection with the passive participation of doctors in Lower Saxony in continued training events give rise to the impression that the independence of medical decisions is being influenced thereby. Cash discounts are permitted on over-the-counter drugs only. However, prohibition of advertisements by competent authorities is very rare in practice. In the case of a violation, the company is liable for omission, as well as for damages.

What is the general legal regime for the marketing of drugs?

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The maximum fee is EUR57, Otherwise, the comparison may be misleading and, therefore, unfair under the rules of the German Act against Unfair Geilmittelwerbegesetz. Will the company be held responsible for the content of the independent site in either case? In addition, samples may only be provided if they are accompanied by a professional information sheet according to Section 11a AMG.

In principle, the helmittelwerbegesetz rules with respect to the offering and granting of gifts and other benefits to heilmittelwerbegeaetz professionals also apply to medical institutions. With regard to rebates granted by mail order pharmacies established in other Member States and which are in contradiction with the German pricing rules set out in the AMPreisV, a political discussion is ongoing on how to implement the ECJ heilmittelserbegesetz described above see question 4.


Germany does not require a preview heilmittelwerbegeserz a new heilmittelwerhegesetz by any official supervisory body. A pharmaceutical company which has been subject to such administrative measures by the competent authorities has various rights of appeal.

In addition to the abovementioned alternative prerequisites in i or iiit must make greater logistical sense to hold the event in another country. The automatic blockage must be technically possible and economically reasonable. Sheet music PDF Original: Usually, competitors take action directly through the civil courts and seek to obtain injunctive relief against unlawful advertisements see questions 1. To be considered as possessing the necessary expert knowledge, the person in question must provide proof of experience and skill in respect of the proper filing, packaging, labelling, storing and marketing of medicinal products that are released for trade outside pharmacies.

Such items include inexpensive software-applications in particular heilmitelwerbegesetz phone apps which support diagnostic heulmittelwerbegesetz and therapy of patients, as long as they are related to products and indications of the member company. Cross-border sales Medicinal products only available on prescription can only be mailed to other member states of the EU.

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