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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Under section 47 4 of the Medicinal Products Act Arzneimittelgesetz AMGthe number of samples per medicinal product and per health care professional is limited to two samples per year and can only be supplied in response to a written request. Consequently, the involvement of healthcare professionals should not be misused to promote the unauthorised medicinal product or a new indication which has not yet been included in the marketing authorisation.

As Germany is part of the EU, three different marketing authorisation procedures apply:. For product-related advertisements, the law requires, among other things, that the promoted medicinal product must not be ascribed therapeutic efficacy or effects that it does not possess, and that the advertisement gives no false impression that success is guaranteed or that the recommended use has no side effects section 3 No.

The disclosure of the information shall be made on a publicly accessible website under the responsibility of the company. What is the procedure to appeal legal remedy a licensing decision?

Medicines that can be sold by pharmacists only apothekenpflichtig. In cases 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.

Con irona mordiente, el genial autor ingls plasma una sombra metfora sobre el futuro, muchas de cuyas previsiones se han materializado, acelerada e inquietantemente, en los ltimos aos.

Pharmaceutical Advertising 2018 | Germany

Un mundo feliz es una de las obras maestras escritas por Aldous Huxley. Additionally, an action can be brought before the local administrative courts Verwaltungsgericht. The exemptions to this general prohibition in Section 7 HWG allows a company to grant a volume-related discount in kind or in money only in the following cases: For example, would there be any objection to the provision of such goods or services if they could lead either to the expansion of the market for, or an increased market share for, the products of the provider of the goods or services?

An authorisation application for the medicinal product is pending or clinical trials Phase III for this medicinal product are still ongoing. The automatic blockage must be technically possible and economically reasonable.


The Recommendations have been amended in December A special reduced fee of Ehilmittelwerbegesetz, for biological medicinal products. It has become evident that many companies have certain deficiencies as to the legal validity of the allocation and delegation of such duties and responsibilities.

Only pharmacies are entitled to distribute apothekenpflichtige drugs to consumers.

Distribution and marketing of drugs in Germany: overview

However, the judgment is not yet final. Full legal advice should be taken from a qualified professional when dealing with specific situations. Furthermore, a Heilnittelwerbegesetz 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.

As described above question 1. There is a simplified licence procedure for parallel imported drugs that have already been licensed for national distribution in another EU country. This legal provision stipulates the following requirements for distributing medicinal products under the conditions of named patient supply: According to the new Section 15a FSA-Code of Conduct, member companies may only provide healthcare professionals with: This change in the law has incited heiomittelwerbegesetz companies to reassess all advertising activities relating to the provision of benefits heilimttelwerbegesetz healthcare professionals.

There is no legal requirement to disclose the transfer of values to healthcare professionals heilmithelwerbegesetz Germany. In particularly serious cases, the arbitration board can publicly rebuke the pharmaceutical company.

The offering of hospitality to healthcare professionals is governed by various German legal provisions, e.

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

If the medicinal product has already been approved in another member state of the EU when the application is submitted to the competent higher federal authority, this marketing authorisation is recognised under the mutual recognition procedure by German authorities on the basis of the assessment report sent by the other member state section 25b 2Medical Products Act Arzneimittelgesetz AMG.

If so, what is the procedure for approval? In addition, the FSA-Code of Conduct Healthcare Professionals requires that the member companies of the Heilmittelwerbegestez must also specify the date on which such information was granted or last revised. However, in practice, infringements of the regulations of the HWG are only prosecuted in exceptional cases. Action heilmtitelwerbegesetz be taken in order to seek injunctive relief, as well as to seize the illegal advertising material.

In principle, the organiser of a scientific meeting is fully responsible for the content and the other elements of the meeting, such heilmittelwfrbegesetz hospitality granted to the participants. Has any guideline been issued on market research heilmitelwerbegesetz medicinal products? Otherwise, the company may be liable for such content.


There is no explicit written requirement under German law. There are several industry guidelines applicable to product or company-related marketing activities of pharmaceutical companies. EUR 12 or The safest and least complex solution is the installation of heilmittelwerbgesetz password system, in which a service-rendering company such as DocCheck www.

Peter Dieners Clifford Chance.

Rights of appeal In serious cases of breaches, disciplinary procedures can be started. Based on the wording of the amended ordinance, however, it heimlittelwerbegesetz not clear whether the amount of EUR has to be interpreted as a maximum amount for reasonable hospitality costs, thus an amount of EUR being unreasonable, or whether the wording can be understood as setting forth the generally reasonable amount and exceptions thereto may be justified depending on the individual circumstances of each case.

The authorisation can be refused if facts justify the assumption that the applicant or the person responsible for the wholesale does not possess the necessary reliability to perform the activity.

The reference medicinal product must have already been authorised for at least eight years before such an application will be considered. In case of non-compliance, fines of up to EUR, can be imposed by one of the arbitration boards. The authorisation to distribute prescription drugs in pharmacies can be granted as well if the applying pharmacist states that he heimlittelwerbegesetz she operates a pharmacy in another member state of the EU.

With the objective of structuring collaboration with patient organisations in accordance with the principles of neutrality and independence, heilmittelwerbegestez FSA-Code of Conduct Patient Organisations also makes it clear that such collaboration should not be used in a manner to circumvent the laws prohibiting advertising of prescription-only medicines. It is possible to appeal Widerspruch against the federal drug administration’s decision not to grant a licence.

Are there rules on comparisons with other products that are particularly applicable to drugs? Is there a threshold applicable to the costs of hospitality or meals provided to a healthcare professional? The medicinal product can be legally placed on the market in the country of origin.