The German Arzneimittelpreisverordnung – AMPreisV determins prices and price .. Legal basis are FMD /62/EU (Falsified Medicines Directive) and the. Arzneimittelpreisverordnung Mortality and health indicators, – ( selected years). 10 Health care workforce per population, – Umsatzentwicklung des Apothekenmarktes seit Mittel (hier: H.v. pharmazeutischen Erzeugnissen) , , , Arzneimittelpreisverordnung).

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The damage occurred due to labelling, expert information or instructions for use that do not comply with current medical knowledge.

A new implant card containing information about implanted medical devices for a patient. Claimants must file an action with a local court or a district court, depending on the value in dispute. There is sufficient reason to suspect that the medicinal product has harmful effects exceeding. Intellectual property patents, trade marks, unfair competition ; life sciences medicinal products, medical devices, food, cosmetics, digital health.

In the case of a generic, reference can be made to the expert report for the previous applicant’s medicinal product reference medicinal productprovided that the reference medicinal product has been authorised for at least eight years or was authorised at least eight years previously. In case of a breach of the regulations, the regulatory authorities can withdraw, revoke and suspend a marketing authorisation.

When used in accordance with its intended purpose, the medicinal product has harmful effects that exceed the limits considered tolerable in the light of current medical knowledge. German Federal Court of Justice W www.



The medicinal product supplied to the insured must be legally placed on the market in Germany. Intangible benefits can be obtaining an award, promoting career advancement or awarding honorary offices.

Persons insured with a statutory health insurance fund pay income-related contributions. The reference price of a medicinal product is the maximum amount reimbursed by the statutory health insurance fund, not a state-fixed price. What are the restrictions on selling medicinal products? Monitoring compliance and penalties Section 30 of the Medicinal Products Act contains special provisions on the general provisions of the Administrative Procedure Act Verwaltungsverfahrensgesetz VwVfGwhich regulates the revocation and withdrawal of administrative acts.

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. What are the restrictions on marketing practices such as gifts, sponsoring, consultancy agreements or incentive schemes for healthcare establishments or individual medical practitioners?

Packaging and labelling A new risk classification system for in vitro diagnostic medical devices, in line with international guidance.

Section 84 et seq. Such appeals have suspensive effect, unless the authority has declared the administrative act to be immediately enforceable, which is often the case.

From the health care fund, payments are allocated to individual statutory health insurance funds based on, among other things, the number of insured persons, the risk structure of the respective persons and social aspects. How can a product liability claim be brought?

ABDATA, Pharma-Daten-Service [WorldCat Identities]

There are statutory prescribed discounts for health insurance companies. One key requirement is that all doctors’ offices and hospitals must be connected to a national electronic data transmission infrastructure as of mid Official website, containing case law since and up to date.


Class actions For centuries, class actions have not been permitted in Germany. Manufacturers must provide evidence of added benefit to patients for medicinal products with new active substances immediately on launch early benefit assessment. Application Manufacturing authorisation is required for the commercial or professional production of medicinal products and active ingredients for biologicals section 13, Medicinal Products Act.

What defences are available to product liability claims? A marketing authorisation is issued on a national basis in each concerned member state.

Internet advertising The same principles apply to internet advertising. Co-operation with social arzneimittelpreisverrdnung insurance authorised physicians, in particular preventing undue influence on their prescription practice, is regulated in section of the Social Security Code V.

All contributions are transferred to a health care fund administered by the Federal Social Insurance Office Bundesversicherungsamt. Also Found In Patents Product liability and safety. The concerned member state must issue authorisation within 90 days of the application under the mutual recognition procedure.