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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This concept applies primarily to treatments in areas of high medical need, where it is difficult to collect data through traditional routes and large clinical trials would unnecessarily expose patients who are unlikely to benefit from the medicinal products. If the price of a medicinal product is higher than the reference price, the patient generally pays the difference or receives a therapeutically arzneimittelpreisverordnhng medicinal product with no additional cost.

Depending on the chosen procedure, the scope of the documents varies. Advising an international pharmaceutical company on a revocation action regarding a competitor’s supplementary protection certificate. The trial must be conducted in arzneimittslpreisverordnung appropriate facility by a suitably qualified investigator in a responsible manner, and managed by an investigator with at least two years’ experience in the clinical trial of medicinal products.

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

ABDATA, Pharma-Daten-Service [WorldCat Identities]

Only individuals can be liable under German criminal law, not health care establishments. Under the Medicinal Products Act, the arzneimittelpreiserordnung entrepreneur is liable. Supplementary protection certificates – a never-ending story?

A mutually recognised marketing authorisation, issued through the mutual recognition or decentralised procedure.

ABDATA, Pharma-Daten-Service

This happens when a pharmaceutical company does not use the authorisation for a period of three years, that is, does not place the medicinal product on the market.

Marketing Authorisation and abridged procedure. There are particularly stringent requirements as to the correctness, unambiguity and clarity of health-related advertising claims. In most cases, the public authority inspects the premises before granting the authorisation.

In addition, health-related advertising claims cannot be misleading. The manufacturer will receive the manufacturing authorisation it has applied for unless one of the grounds for refusal listed in section 14 1 arznemiittelpreisverordnung the Medicinal Products Act is given. An assessment of the readability arzneimihtelpreisverordnung the summary of product characteristics. An environmental toxicological assessment.


The E-Health Law also promotes other digital health applications such as electronic medication plans and arzneimittlepreisverordnung files, enabling patients to be better informed of their diagnosis and therapy and more involved in decision-making, and electronic health cards including emergency patient data.

In the case of a generic, reference can be made to the expert report for the previous arzneimittelpreisverorndung 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. German Federal Court of Justice W www.

Product liability claims under the law or tort are based on negligence or fault liability. 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. Legislation and regulatory authority Title V of the Code for Human Medicines Directive, regulating the labelling of medicinal products for human use and package leaflets, has been implemented in the Medicinal Products Act at sections 10 to Usually, patients obtain a prescription from their physician and collect the medicinal product from a pharmacy.

The damage occurred due to labelling, expert information or instructions for use that do not comply with current medical knowledge. They bind their members, and compliance arzneimitrelpreisverordnung monitored arzneimittelpriesverordnung sanctioned. The employer and an insured employee share the costs equally.

Consent can be revoked. Putting certain aesthetic devices with the same characteristics and risk profile as analogous medical devices within the scope of the regulations. They vary between the federal states and are fixed on a case-by-case basis. The Lauer-Taxe also includes information on the medicinal product such as product characteristics, form of administration, and package size.

The Paul-Ehrlich-Institute is responsible for vaccines and biologics.

The supply of medicinal products must be in line with the efficiency principle set out in the Social Security Code V. In case of the death of or injury to a person, the maximum is a capital amount of EUR, or an annuity of up to EUR36, per year. Professional information, texts for labelling and information on package sizes. Period of authorisation and renewals The first marketing authorisation is usually valid for five years from the date of notification of the decision of the Federal Institute for Drugs and Medical Devices.


Intangible benefits can be obtaining an award, promoting career advancement or awarding honorary offices. The medicinal product, when used in accordance with its intended purpose, has harmful effects which exceed the limits considered tolerable in the light of current medical knowledge.

Under trade mark law, a parallel importer must fulfil several requirements, including providing information in advance to the marketing authorisation holder about the planned import.


Health IT issues and mobile medical applications The historically different market players in the German health market have hindered the development of digital health, due to different and incompatible IT systems, data collection and storage systems and data formats for patient data. Which medicinal products can benefit from the abridged procedure for marketing authorisation and what conditions and procedure apply? Further, doctors and pharmacists will obtain support for the costs of installing electronic data transmission infrastructure.

Further, the e-Health Initiative has been launched by the Federal Ministry of Health to identify obstacles to telemedicine applications and develop measures to overcome them. The competent authorities issue necessary directives to rectify any identified infringements and prevent future infringements section 69 1Medicinal Products Act. 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.

German Federal Patent Court W www. Outline the key areas of law applicable to medicinal product liability, including key legislation and recent case law.