HEILMITTELWERBEGESETZ 2011 PDF
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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The first reporting period was the calendar year Marketing activities that can give rise to uncertainty and anxiety.
The HWG foresees a limited number of exceptional rules, e. Escrita enla novela anticipa el desarrollo en tecnologa reproductiva, cultivos humanos e hipnopedia que, combinadas, cambian radicalmente la sociedad.
Companies may not make public displays of off-label information at German national meetings.
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In 211 where the violation of the provisions of the HWG also constitutes an act of unfair competition, it is possible to take action directly through the civil courts. I understand more info.
Any heilmittelwerbegeseetz these can be used, as well as a standalone national authorised procedure. Monetary contributions by member companies of the AKG and the FSA to patient organisations can only be made on the basis of a written request describing the fundamentals of the collaboration.
It is, however, recognised that a company may grant donations to medical institutions if these donations are made:. Are there particular restrictions on special offers for example, “buy-one-get-one-free”? The collaboration of member companies with patient organisations must not involve recommendations for individual prescription-only pharmaceuticals or groups of pharmaceuticals and the appearance of member company representatives at patient heilmittelwefbegesetz must not be aimed at making promotional references to prescription-only pharmaceuticals.
Following the respective rules of the Heilmittelwerbegeserz of Conduct, the planning, performance, analysis and quality assurance of NIS must be made within the responsibility of the head of the medical department of the member company.
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Is there a threshold applicable to the costs of hospitality or meals provided to a healthcare professional? An exception may, however, be made where such information is not intended to promote the medicinal product itself, but where it is necessary to understand the economic and financial position of the company, i.
This material is intended to give an indication of legal issues upon which heilmittelwerbegesdtz may need advice. The authorisation is granted by the competent higher federal authority of the state where the pharmacy is established.
Supervision See above, Regulatory authority. Such agreements must not be made dependent on any prescription or purchasing decision. It can file an objection to the decision since such decisions by competent authorities are considered to be administrative acts. Physicians can be paid for offering expert services to pharmaceutical or medical device heilmittelweerbegesetz. Discounts Discounts in kind and special offers are permitted on general sales list medicines only see Question A higher lump sum currently EUR Under section 77 2 of the Medical Products Act Arzneimittelgesetz AMGthe PEI is competent for the licensing of sera, vaccines, blood preparations, bone marrow preparations, tissue preparations, allergens, gene transfer medicinal products, somatic cell therapy products, xenogenic cell therapy products and blood components manufactured using genetic engineering.
Samples may be provided to healthcare professionals and to healthcare training institutions, with a maximum amount of two packages per year.
If a competent authority considers an advertisement to be unlawful, it has the power to stop further publication of such advertisement. In this regard, it has to be noted that the MedTech Europe Code of Ethical Business Practice contains a prohibition against the provision of direct conference support to participants who do heilmittelerbegesetz act as speakers.
Therefore, it has to be awaited how the new legislator intends to address this issue. Medicinal products must not be promoted before the required marketing approval is obtained Section 3a HWG.
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This legal provision stipulates the following requirements for distributing medicinal products under the conditions of named patient supply: 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. Under section 13 of the AMG, the parallel importer needs a manufacturing authorisation for repacking, labelling and adding the package leaflet to the medicinal product.
Otherwise, the comparison may be misleading and, therefore, unfair under the rules of the German Act against Unfair Competition. In addition, information regarding subsequent essential modifications to the trial protocol, as well as interruptions and early termination of the clinical trial, shall be included in the report.
However, it may be difficult in practice to avoid unlawfully promoting such information. May an advertisement refer to studies not mentioned in the SmPC? Currently, the German legislator is considering options on how to react to this ruling.
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.
What regulatory authority is responsible for supervising marketing activities to consumers? The limit is generally set below between EUR 0. It was very amusing, and I plan to use this song in an upcoming musical comedy concert. Are companies obliged to disclose via a central platform?
Is it possible to donate equipment, or to fund the cost of medical or technical services such as the cost of heilmittelerbegesetz nurse, or the cost of laboratory analyses?