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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Such products must comply with the Arzheimittelpreisverordnung notification procedure for parallel distribution. They can, in particular, prohibit the marketing of medicinal products or active substances, order their recall from the market, and seize them if certain conditions are met. The sponsor has immediate and on demand or annual reporting requirements. PMS-Studies may only be conducted if the pharmaceutical company has a legitimate and objective interest in obtaining the data and a written agreement has been concluded with the physician.

For example, in some cases it will be necessary for a physician to obtain supervisory approval. They generally seek injunctive relief to stop advertisements violating their rights on the basis of the UWG.

Medicinal product regulation and product liability in Germany: overview

The Medical Association of Lower Saxony interprets this provision in a very strict way. 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.

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. Moreover, it is possible that competitors will contact enforcement functions to initiate an investigation in addition to seeking incentive relief regarding deviant behaviour. Under the Medicinal Products Act, the pharmaceutical entrepreneur is liable.


Carolin Kemmner Clifford Chance. Kammer des Ersten Senats vom However, a pharmaceutical company should act carefully when providing information on prescription-only medicinal products to the press. Therefore, the same rules as for other types of advertising apply. For pharmaceuticals which are not listed on the reimbursement list of the social securities, the selling price ex works may be fixed without legal restrictions but has to be communicated to the Federal Ministry of Health.

However, it is permissible to provide educational services e. In general, such descriptions are permissible as far as they are necessary to provide for the relevant information to, e. Outline the regulation of clinical trials. 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.

Pharmaceutical Advertising | Germany | ICLG

Diese Entscheidung ist unanfechtbar. A translation of the product information, package leaflet and labelling into the concerned member state language must be provided in the application.

If a competent authority considers an advertisement to be unlawful, it has the power to stop further publication of such advertisement. The manufacturer will receive the manufacturing authorisation it has applied for unless one of the grounds for refusal listed in section 14 1 of the Medicinal Products Act is given.

However, the question whether and to which extent customary cash discounts Skonti are permissible, has not been addressed.

Talitha Shkopiak Talitha is an arznfimittelpreisverordnung in the Intellectual Property group based in our London office. The automatic blockage must be technically possible and economically arzneimttelpreisverordnung. If so, what companies are affected i. In relation to sections a and b of the Criminal Code, the key question is whether medical practitioners obtain an “advantage” or not. Outline the key areas of law applicable to medicinal product liability, including key legislation and recent case law.


In Germany, there is no pharmaceutical price regulation scheme or other price controlling instrument as in the UK or other countries.

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

Durch die Nichtannahme der Verfassungsbeschwerde zur Entscheidung erledigt sich der Antrag auf Erlass einer einstweiligen Anordnung. With regard to rebates granted by mail order pharmacies established in other Member States and which are in contradiction with the German pricing rules set out in the AMPreisV, a political discussion is ongoing on how to implement arzneimittelpreisberordnung ECJ ruling described above see question 4.

The HWG foresees a limited number of exceptional rules, e. Professional information, arznwimittelpreisverordnung for labelling and information on package sizes.

What rules govern such studies? Results of examinations on pharmaceutical quality, therapeutic efficacy and safety, and appropriate expert opinions.

This means the company that markets a medicinal product under its own name is liable, but is not liable for counterfeit medicines.