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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Is it possible to limit liability for defective medicinal products? Official website containing relevant German legislation. When is the cost of a medicinal product funded by the state or reimbursed? Reimbursement by the statutory health insurance funds must not be excluded by the Social Security Code V. What is the authorisation process arzneimittelpresiverordnung manufacturing medicinal products? Under trade mark 0211, a parallel importer must fulfil several requirements, including providing information in advance to the marketing authorisation holder about the planned import.

To notify safety-related information about a medicinal product to physicians and pharmacists immediately, red-hand letters Rote-Hand-Briefe are sent out by the pharmaceutical entrepreneur, in consultation with the competent federal authority the Federal Institute for Drugs and Medical Devices or the Paul-Ehrlich-Institute.

The GDPR is particularly relevant to data concerning health, genetic data and biometric data. In general, prescription medicinal products can only be sold to patients through pharmacies, including online pharmacies.

Period of authorisation and renewals The competent authorities usually grant unlimited authorisations. In case of a breach of the regulations, the regulatory authorities can withdraw, revoke and suspend a marketing authorisation.

Such appeals have suspensive effect, unless the authority has declared the administrative act to be immediately enforceable, which is often the case. On this basis, the manufacturer agrees with the statutory health insurance fund a reimbursement amount. Pricing, state funding arzneimittelpreiwverordnung reimbursement 4.

Wholesalers are reimbursed with a maximum amount of 3. The competent authority focuses on the quality and safety of the arzneimittelpreisverorenung being investigated, based on analytical and pharmacological-toxicological data provided by the trial sponsor.


How can a product liability claim be brought? In Germany, a large number of preparations of comparable quality, with comparable effect and partly identical composition, are available at very different prices. Pharmaceutical manufacturers are free to determine the selling price for medicinal products.

The sponsor has immediate and on demand or annual reporting requirements. The following must be submitted in relation to the medical product:. The Lauer-Taxe also includes information on the medicinal product such as product characteristics, form of administration, and package size. The reimbursement is then paid directly to the pharmacist by a statutory health insurance company.

Advising a medical device company on regulatory and data protection compliance for its mobile health apps. Referral to the CJEU re.

Internet advertising The same principles apply to internet advertising. Packaging and labelling This is particularly the case if the medicinal product is not available on prescription, intended to treat a minor ailment or can be classified as a lifestyle medicinal product. Change of ownership applications where, for commercial reasons, a company wishes to make a duplicate of a marketing authorisation. Whether such combinations qualify as medical devices or medicinal products, or keep their original qualification, depends very much on the circumstances.

The substantive requirements for the application documents are set out in sections 22 to 24 of the Medicinal Products Act and the Code for Human Medicines Directive.

A marketing authorisation is issued on 2011 national basis in each concerned member state. What are the restrictions on advertising medicinal products? It has been established to safeguard necessary collaboration between the pharmaceutical industry and all health care professionals, and to ensure compliance with the legal conditions for such collaboration.


Material benefits include, for example, financial contributions, arranging and granting additional income, rebates, provision of consumer goods, invitations to holidays or premiums. Section 84 1Medicinal Products Act. Only individuals can be liable under German criminal law, not health care establishments.


The concerned member state arneimittelpreisverordnung issue authorisation within 90 days of the application under the mutual recognition procedure.

English translations are partly available, for guidance only. Most of the E-Health Law came into force in and the rest in and Inthe contribution is Section 84 et seq. The Clinical Trials Regulation will ensure greater harmonisation of the rules for conducting human clinical trials in the EU.

ABDATA, Pharma-Daten-Service [WorldCat Identities]

These are administrative acts that can be challenged by an opposition and an annulment action. Legislation and regulatory authorities The arzneimittrlpreisverordnung framework for human clinical trials is set out in section 40 et seq.

Off-label use is not part of the intended use. Even contract manufacturers carrying out production steps on behalf of a pharmaceutical enterprise require a manufacturing authorisation.

Manufacturing authorisation is also required to manufacture medicinal products that are not authorised, for example medicinal products used in a clinical trial investigational medicinal products or not subject to authorisation.

However, the authorisation can be revoked in case of non-compliance zrzneimittelpreisverordnung the legal requirements. Which medicinal products can benefit from the abridged arzneimittelpreisverorenung for marketing authorisation and what conditions and procedure apply? Gifts, sponsoring, consultancy arzneimittelpreisvfrordnung or incentive schemes are likely to be considered such “advantages”, but it depends on the circumstances of the case. The Code for Human Medicines Directive requires member states to set up an appropriate pharmacovigilance system.