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 principle, the rules noted in question 4. Companies may issue factual scientific information regarding unlicensed medicinal products or indications only in response to unsolicited inquiries by healthcare professionals. Finally, the Medicinal Products Act Arzneimittelgesetz AMG also imposes legal requirements for interactions with health care professionals and patient organisations.

Therefore, it has to be awaited how the new legislator intends to address this issue.

The documentation relating to a donation must be retained for at least five years. Both bodies have the option to refrain from investigation or punishment in the case of minor infringements. In many cases, the fee paid for the services provided heilmittelwerbegesez health care professionals is inconsistent with the market value of the service. Pharmaceutical companies may support CME through a reasonable financial contribution.

The information may also be published on a pan-European website of affiliated companies if the information relating to the member company of the FSA can be heilmittelwwrbegesetz there separately.

Pharmaceutical Advertising | Germany | ICLG

What is the general legal regime for the marketing of drugs? If the objection has not been successful, a company can file a heilmittelwefbegesetz before the competent administrative courts. Therefore, the control and supervision of advertising material prior to its publication is recommendable to satisfy the legal requirements and to avoid any liability for violating content published by employees, agents, etc.

If so, what restrictions apply? Further regulations prohibit marketing activities using, for example, expert opinions, certain illustrations or samples.


However, prohibition of advertisements by competent authorities is very rare in practice. Required contact information includes the name of the company, domicile, address, legal form, representatives, an email address which enables the user to contact the company quickly and easily, commercial register, registration number of the commercial register, competent regulatory authority, sales heilmittelwerbegeswtz identification number, etc.

Distribution and marketing of drugs in Germany: overview

The responsibility of imposing and enforcing regulatory fines lies with the relevant competent authorities who are responsible for the administrative supervision of the pharmaceutical company in question.

Consequently, the risk of infringement of the HWG is higher the more such scientific information relates to a specific product or product trademark, or is used in relation to the advertising activities for an unauthorised product. Who may bring such an action? The offering of hospitality to healthcare professionals is governed by various German legal provisions, e. Disciplinary procedures of medical associations and associations of statutory health insurance registered doctors can lead to administrative fines.

La novela describe un mundo en el que finalmente se han cumplido los peores vaticinios: This is intended to ensure that when prescribing medical aids and other products, doctors are not influenced in their decisions by their own financial interests and do not benefit from issuing a prescription or from directing insured patients to certain service providers.

If there have not been such cases please confirm. 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. Section 4 HWG see question 3.

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With the exception of the name and address of the pharmaceutical entrepreneur or the sponsor, as well as the name and the address of the consenting investigators, the report may not contain personal or especially patient-related data. In addition, the physician performing the PMS-Study must possess the appropriate professional skills and knowledge.


The medicinal product is imported solely on the basis of a physician’s prescription. When applying for a marketing authorisation of the generic product, reference can be made to the documents, including the expert report, for the previous applicant’s medicinal product reference medicinal product. heilmittelwerbegeserz

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Regulatory authority The competent authorities for supervising marketing activities are the heilmittelwerbegwsetz regional authorities in the federal states in which the pharmaceutical company is established. It is only permissible to refer to studies which are not considered in the SmPC if such studies are not contradictory to each other and meet certain scientific standards. Stricter regulations apply for member companies of the FSA.

Distribution Pre-conditions for distribution. There is a simplified licence procedure for parallel imported drugs that have already been licensed for national distribution heilmittekwerbegesetz another EU country. As described above question 1. Therefore, the potential involvement of hospital physicians in the solicitation of the donation has to be disclosed to and approved by the hospital administration.

As regards the provisions of certain services to the patients, please see question 9. However, in the case of severe infringements it is very likely that enforcement functions will be informed. In principle, Section 7 HWG does not allow the offering or supplying of gifts or other benefits to patients. The Federal Supreme Court Bundesgerichtshof ruled that discounts and bonuses are only permissible regarding insignificant gratuities, such as consumer magazines or small advertising gifts whose value is below EUR1.

Choral Sheet music 2 Voices, piano Gioacchino Rossini: Prescription drugs Under section 43 3 of the Medical Products Act Arzneimittelgesetz AMGmedicinal products can only be dispensed by hsilmittelwerbegesetz on prescription.