Buecher Wuermer

Field of Healthcare (Heilmittelwerbegesetz – HWG), last amended on 20 System and their Employees were published in December reading of the proposal in November In the second part of .. Germany, the Remedies Advertising Act (Heilmittelwerbegesetz – HWG) were in line with the. Health on the Net Foundation. (accessed 9 June ). I S. ) vom 26 April Heilmittelwerbegesetz. [18] ICMJE.

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What rules govern such studies? The following marketing activities in relation to consumers are prohibited, among others section 11 1Advertisement of Healthcare Products Act Heilmittelwerbegesetz HWG:. It is not permitted to provide consumers with free samples of drugs section 11 1 No.

There is a simplified licence procedure for parallel imported drugs that have already been licensed for national distribution in another EU country. Healthcare professionals may be provided with samples of medicinal products for informational purposes, but only in small numbers and upon their written request.

There is no legal requirement to disclose the transfer of values to healthcare professionals in Germany.

Heilmittelwebegesetz Introduction Germany bosts Europe’s second largest population after Russia and the strongest economy. Press releases referring to unauthorised 201 products or unauthorised indications have to be considered cautiously. Digital channels allow reps to adapt to GPs’ needs, with instant access to clinical data, guidelines, publications, training, webcasts and websites to back up product information.

At almost 9 per cent, the diabetes rate in the plus group places Germany fourth after US, Canada and Mexico. I have forgotten my password. Is it possible to pay for his expenses travel, accommodation, enrolment fees? Does it make a difference whether the product is a prescription-only medicine, or an over-the-counter medicine? What are the different categories of drugs for distribution?


There are currently no reported instances where the competent authorities have, in practice, investigated such matters. For each individual recipient the disclosure must contain individual information, specifying the name of the recipient, regarding the totality of transfers of value granted during the reporting period to the extent such benefits fall under the respective categories.

This has been interpreted as a strong message from the German people that they resent what they see as an unfair financial burden.

Cash discounts are permitted on over-the-counter drugs only. Comparative advertising to healthcare professionals must not be misleading and the compared products must be similar. In regard to the applicability of various rules, pursuant to Section 20 para. Product advertising means advertising of a specific product, while image advertising is characterised by advertising with the name of the pharmaceutical company or the entire range of products without any reference to a specific product.

Rebates in kind are prohibited for all kinds of pharmacy-only pharmaceuticals apothekenpflichtige Arzneimittel. Rights of appeal In serious cases of breaches, disciplinary procedures can be started.

Heilmittelwerbegesetz | Inside EU Life Sciences

There are provisions under German law for both named patient supplies and compassionate use programmes. Do the authorities take up matters based on an adverse finding of any self-regulatory body? Is the position the same with regard to the provision of off-label information i. What is the legal regime for marketing to consumers? Heilmittelwerbegewetz 4 17 of the AMG defines placing on the market as keeping the product in stock for sale or for other forms of supply, the exhibition and offering for sale and the distribution to others.

Such conference travel support must, in each case, not be made hellmittelwerbegesetz on any prescription or purchase decision.

Distribution and marketing of drugs in Germany: overview

Is it possible to pay him for his time? Any product placed on the market in Germany and that is the subject of heilmittelwetbegesetz marketing authorisation, whether from the German authorities or the European Medicines Agency EMAmust have reports on all the results of confirmatory clinical trials substantiating the efficacy and safety of the medicinal product at the disposal of the competent higher federal authority.


Any of these can be used, as well as a standalone national authorised procedure. According to established case law in Germany, a gift is considered as “inexpensive” if it does not exceed the value of EUR1 to EUR2 purchase price. Sickness funds offer benefits packages covering prevention, screening, treatment and sick pay not covered by employers. The market is fragmented, although some consolidation happened when Bayer bought Schering. For example, may information on such medicines be discussed, or made available, at scientific meetings?

For example, in some cases it will be necessary heilmittelwerbegesegz a physician to obtain supervisory approval. There are no specific legal provisions in Germany which govern the cooperation between companies from the pharmaceutical industry and patient support groups. The reporting period is the calendar year. Rights of appeal In the case of an infringement, the competent authority will issue a prohibition order.

Despite the excellence of German scientific research and business practices, the industry suffers from lack of investment due to risk aversion and a negative image. In heilmittelwdrbegesetz new regulatory landscape, communications have to start much earlier, in the pre-launch phase, with communicators thinking laterally and treading carefully.