HEILMITTELWERBEGESETZ 2010 PDF

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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As this warm-up phase seems to be completed now, we expect an increased level of their activities and, potentially, a broader focus on different types of cooperation.

Distribution and marketing of drugs in Germany: overview | Practical Law

Revenue streams are decreasing and so, as a result, are marketing budgets. Usage is increasing across all digital channels.

In new on-patent medicines became exempt unless they were part of classes such as statins to control the impact on spending on ‘me-too’ drugs. Medicinal products for which the essential manufacturing stages are carried out in a pharmacy and no more heilmitetlwerbegesetz packages in one day are produced, and are permitted by the pharmacy operating licence.

Trending New models of care China Special: However, it is permissible beilmittelwerbegesetz provide educational services e. However, physicians are allowed to give lectures or render expert opinions on the aforementioned products for non-promotional reasons. There are biotech clusters in Munich, Heidelberg and Cologne, and companies in this sector have had government support, although government regulations, for example on the use of stem cells, remain restrictive.

Distribution Pre-conditions for distribution. Attached to the BMG is the Federal Institute for Pharmaceuticals and Medical Devices BfArMthe major licensing body for pharmaceuticals, supervising the safety of both pharmaceuticals and medical devices.

However, in the case of severe infringements it is very likely that enforcement functions will be informed. Is it possible to donate equipment, or to fund the cost of medical or technical services such as the cost of a nurse, or the cost of laboratory analyses?

Heilmittelwerbegesetz | Inside EU Life Sciences

However, the off-label information provided in response should not go beyond the scope of the question. What are the legal consequences of non-compliance with consumer marketing laws? Only section 1 6 of the Advertisement of Healthcare Products Act Heilmittelwerbegesetz HWG states that the HWG does not apply to order forms of online pharmacies regarding the information necessary for ordering of drugs online. Can and, in practice, do the anti-bribery competent authorities investigate matters that may constitute both a breach of the advertising rules and the anti-bribery legislation, in circumstances where these are already being assessed by the pharmaceutical competent authorities or the self-regulatory bodies?

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In the case of non-compliance, the penalties can include imprisonment or a fine. Back to top of page Overview Population: Please see our terms and conditions page for further details.

In this respect, the principles of separation, transparency, documentation equivalence as stipulated in the Common Position Concerning the Consideration of Cooperation between Industry, Medical Institutions and Staff under of Criminal Law outline valuable reference points for the collaboration of the pharmaceutical industry with health care professionals from the outpatient sector or those working in hospitals.

Germany bosts Europe’s second largest population after Russia and the strongest economy. There is no legal requirement to disclose the transfer of values to healthcare professionals in Germany. heilmitttelwerbegesetz

Pharmaceutical Advertising 2018 | Germany

The interactions heilmitrelwerbegesetz pharmaceutical companies and healthcare professionals or healthcare organisations are also restricted due to recommendations and codes of conduct of the heilmittelwerbegesrtz trade associations see question 1. In addition, the company is obliged to monitor and review, on a regular basis, content which is published by third parties within forums, portals or other interactive parts of the sites.

Healthcare professionals may be provided with samples of medicinal products for informational purposes, but only in small numbers and upon their written request.

The information must be set apart and clearly distinguished from the other promotional information and must be clearly heilmittelwerbegesetz. In fact, the same general principles as set forth above apply. As long as the documentation effort for the particular physician remains within a timeframe of 15 to 20 minutes, a lump sum currently EUR The recent launch of iHCE, a full-spectrum healthcare ‘super agency’, illustrates the need for a cost-effective and actionable multi-disciplinary approach to reach and motivate target audiences with greater speed and relevance.

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There must be a reasonable need for the active participation and the remuneration must be appropriate with regard to the services rendered fair market value. Pharmaceutical companies may support CME through a reasonable financial contribution. However, prohibition of advertisements by competent authorities is very rare in practice. Health care professionals include section 2, HWG:. What are the different categories of drugs for distribution? An adequate system to maintain control and accountability must be established which contains information about the date of supply and the amount of supply.

Heilmittelwerbegesetz by Germany and Ulf Doepner (2000, Book)

Furthermore, problems could arise if information given to the press is used to publish disguised advertising or editorially designed advertising Schleichwerbungwhich is prohibited by the HWG. There is only an exception for free samples that are handed to patients when consulting a physician. In addition, a pharmaceutical manufacturer must respect the neutrality and independence of a patient organisation, in particular regarding the events organised by the patient organisation the principle of neutrality.

Peter Dieners Clifford Chance. The German government suggested quasi-sanctions for countries that surpass agreed debt levels and for the European Court of Jurisdiction to have jurisdiction over heilmittelwerbegdsetz.

In addition, samples may only be provided if they are accompanied by a professional information sheet according to Section 11a AMG. However, such payments may only be made under a contractual relationship between the physician and the company, e.

What other items, funding or services are permitted to be provided to professionals? Biomedicines, vaccines and sera are licensed and supervised by the Paul-Ehrlich-Institute. International events within the meaning of the FSA-Code of Conduct Healthcare Professionals are internal or external training events in a country in which the company organising, holding or supporting the event or supporting its participants is not domiciled.

Pursuant to the HWG, any advertising activity concerning a specific medicinal product is only permissible if it has obtained the relevant marketing authorisation or registration.