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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Furthermore, the rules for the contractual cooperation with healthcare professionals as set forth in questions 5. Sheet music PDF Original: To be considered as possessing the necessary expert knowledge, the person in question must provide proof of experience and skill in respect of the heilmiittelwerbegesetz filing, packaging, labelling, storing and marketing of medicinal products that are released for trade outside pharmacies.
Federal higher state authorities are responsible for the supervision of distribution of drugs to consumers. Appoint a responsible person who possesses the required expert knowledge to perform the activity. If so, what rules apply?
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The stipulated compensation must be reasonable with respect to the services to be rendered. The reporting period is the calendar year. Furthermore, advertising of prescription-only medicinal products to patients is prohibited Section 10, HWG. Furthermore, a German court decided that PMS-Studies are only permissible provided that pharmaceutical companies perform such studies in strict compliance with the principle of non-intervention, i.
Enclose a statement in which he or she commits himself in writing to observe the regulations governing the proper operation of a wholesale enterprise. The Recommendations have been amended in December This legal provision stipulates the following requirements for distributing medicinal products under the conditions of named patient supply: With regard to the relationship between the pharmaceutical industry and physicians, the reform of the German Criminal Law to combat corruption in the healthcare sector which entered into force in June can still be considered as the key development.
The packages must be of the smallest commercially available size or may be specially manufactured sample packages with even less content. These changes provide for concrete limits of amounts and preconditions to be met if physicians located in the state of Bremen shall attend educational events and receive funding. What is the legal regime for marketing to consumers? Are companies obliged to disclose via a central platform?
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In such cases, a court might argue that it is obvious for the end-consumer that only this specific medicinal product on the market can treat the disease and that this disease awareness campaign is therefore non-permissible as it circumvents the general prohibition on advertising for prescription-only medicines to the general public. If so, what companies are affected i. They increasingly require the involvement of widely diverse institutions in the healthcare system.
Whether such exceptions apply has to be assessed on a case-by-case basis. In addition, companies are also obliged to monitor and control, on heilmittrlwerbegesetz regular basis, the content of the sites that may be accessed by links. There are several industry guidelines applicable to product or company-related marketing activities of pharmaceutical companies.
A pharmaceutical company should not bear additional costs. A reduced fee of EUR97, for an application regarding a generic pharmaceutical product.
Extensive experience in advising companies on all matters concerning pricing and reimbursement in the out- and in-patient sector that is, AMNOG, NUB, rebates, reference pricing, DRGs and pre-market access strategies.
Promotional contests, drawings, and raffles. Likewise, if the benefit granted to the physicians by providing the associated benefits is able to induce the prescription of the medicine, the package deal is prohibited subject to the new Sections a and b German Criminal Code.
Unsolicited information, as well as material sent upon request, will be considered as a prohibited advertisement if the company distributed the information within its product promotion. Furthermore, German criminal law and the FSA-Code of Conduct Healthcare Professionals generally prohibit the provision and acceptance of any kind of benefits with respect to physicians that are granted in the context of their work, especially as consideration for carrying out purchasing or prescription decisions.
heilmittelwerbegexetz 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. Pharmaceutical companies must also comply with principle of transparency, namely that collaboration and support must be executed in a transparent and open manner.
However, a mere statement on a website where the details of prescription-only pharmaceuticals are only directed to healthcare heilmittelwerbeesetz, or a simple unverified question asking whether the corresponding person is a health professional, is not sufficient.
Physicians can be paid for offering expert services to pharmaceutical or medical device companies.
heilmittelwerbegesefz An adequate system to maintain control and accountability must be established which contains information about the date of supply and the amount of supply. The limit is generally set below between EUR 0. Who may bring such an action? Recent developments and outlook However, such payments may only be made under a contractual relationship between the physician and the company, e. According to the new Section 15a FSA-Code of Conduct, member companies may only provide healthcare professionals with: If the company is aware that the linked content violates any law or third-party rights, the company is obliged to remove the link.
A volume-related discount is — as a general rule — considered to be a benefit within the meaning of Section 7 HWG, and therefore, is not permissible.