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2 Health Systems in Transition. Reinhard Busse • Miriam Blümel World Health Organization (acting as the host Arzneimittelpreisverordnung. Pharmazeutische Unternehmer und Apotheker sind gesetzlich verpflichtet, den Krankenkassen einen Preisnachlass für jede verordnete Arzneimittelpackung zu . Aktuelle Beschlüsse zu Arzneimittel-Festbeträgen. ; ; Stellungnahmeverfahren (Anpassung) vom

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Arzneimittelpreisverordnung (Ampreisv) (German, Paperback)

Advertising to healthcare professionals, arzneimittelpreisverordnuny claims for use of a medicinal product, must contain the following mandatory information: The HWG is applicable to the advertising of a specific medicinal product product-related advertisingbut does not cover the provision of general information.

Furthermore, the member company of the FSA must notify any assistance in an international event in advance to its affiliated companies in the country where the event takes place.

Arzneimittelpreisverordnuhg advertising means advertising of a specific product, while image advertising is characterised by advertising with the name of the pharmaceutical company or the entire range of products without any reference to a specific product. What information can the applicant rely on? Mandatory safety features a unique identifier and anti-tampering device on the outer packaging.

However, such actions may be taken only by direct competitors, arsneimittelpreisverordnung promoting commercial interests Wettbewerbsvereineand consumer associations. Increases in price may only be made with the consent of the Secretary of State.

The same applies if an individual only partly agrees to the disclosure of a transfer of value. Other conditions The specific information must be in easily legible and indelible characters, in easily comprehensible German.

Pharmaceutical Advertising 2018 | Germany

Apart from this, a claimant can also sue for damages and compensation, and can request an account of any profit made. Also Found In Patents Product liability and safety.

This includes the supply of medicinal products. Revocation of consent means that further participation of the subject in the clinical study is prohibited and no further data can be collected. A compensation for the active participation may only be paid on a contractual basis and may only be made if the active participation deals with products of the company or associated treatment forms.

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The interactions between pharmaceutical companies and healthcare professionals or healthcare organisations are also restricted due to recommendations and codes of conduct of the relevant trade associations see question 1.

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?

The packages must be of the smallest commercially available size or may be specially manufactured sample packages with even less content.

Medicinal product regulation and product liability in Germany: overview | Practical Law

PSURs include the results of studies carried out with the araneimittelpreisverordnung product, both on its authorised and unauthorised uses. 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.

The publication requirements set forth in the FSA Transparency Code relate exclusively to transfers of value in connection with research and development, donations monetary or donations in kind and other unilateral monetary or benefits in kind, training events and consultancy services. Is it possible to pay for his expenses travel, accommodation, enrolment fees? Salaried workers and employees below a gross annual income of around EUR59, in are automatically enrolled into one of currently around statutory health insurance funds Gesetzliche Krankenkassen.

Such appeals have suspensive effect, unless the authority has declared the administrative act to be immediately enforceable, which is often the case.

Insurers can and often do charge extra fees, which are currently paid as of July by the insured employee. The broader assessment of the value of a pharmaceutical will focus primarily on new medicines entering the market fromhowever existing medicines may also be affected.


The supply of such samples must be recorded by the company. Moreover, as with any company that maintains a website, pharmaceutical companies are also obliged to publish on the website contact information regarding the company.

Currently, the German legislator is considering options on how to react to this ruling. This means that rebates in kind are only allowed for medical devices and pharmaceuticals which may be sold outside pharmacies.

Arzneimittel-Festbeträge – GKV-Spitzenverband

This change in the law has incited many companies to reassess all advertising activities relating to the provision of benefits to healthcare professionals. However, in practice, infringements of the regulations of the HWG are only prosecuted in exceptional cases. Pricing in such foreign pharmacies has been an issue for a long time. In Germany, as in the arzneimittelpreisverkrdnung of the EU, medical devices require a CE mark based on a declaration of conformity following an assessment which, depending on the risk potential of the product, is carried out by the manufacturer only or after being verified by a notified body.

Aufgrund des Anwendungsvorrangs der Grundfreiheiten Art.

Home Practice area Pharmaceutical Advertising Germany. The competent authorities must issue directives to rectify any offences that have been identified and prevent offences in the future section 69, Medicinal Products Arzneimittelpreisverordnunf. However, such disease awareness campaigns might become critical in cases where only a specific medicinal product exists for the treatment of the underlying disease.