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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It introduces an authorisation procedure based on a single submission through an EU portal, an assessment procedure leading to a single decision, rules on protecting subjects and informed consent, and transparency requirements. Information is up to date.

Medicinal product regulation and product liability in Germany: overview

Medicinal product regulation and product liability in Germany: Are there any mandatory requirements relating to medicinal product safety? The Pharmacovigilance Department at the Federal Institute for Drugs and Medical Devices must constantly inform about known adverse reactions of medicinal products and interactions associated with their use, and ensure that patients, physicians and other interested parties are made aware of these risks and, where appropriate, ways to reduce them.

The relationship between the pharmaceutical industry and physicians is characterised by a tension between the law regulating public services and prohibiting corruption, and the need for co-operation between the industry and hospitals and physicians using medicinal products.

Co-operation with social health insurance authorised physicians, in particular preventing undue influence on their prescription practice, is regulated in section of the Social Security Code V.

Are there further conditions concerning how the drug is distributed and accessible to patients? Consent can be revoked. Such information includes the name of the company, the address of the pharmaceutical entrepreneur and the pharmaceutical form.


Pharmacies and wholesalers charge surcharges on the manufacturers’ selling prices.

Arzneimittel-Festbeträge – GKV-Spitzenverband

Biological medicinal products are medicinal products whose substance is made by a living organism. In most cases, the public authority inspects the premises before granting the authorisation. This is mandatory for, for example, orphan drugs, advance therapy medicinal products, monoclonal antibodies and medicinal products with new arzneimiftelpreisverordnung agents to treat for example, AIDS, cancer and viral diseases.

The consent is only valid if the subject is capable of acting and able to understand the arzneimitelpreisverordnung and meaning of the consent.

ABDATA, Pharma-Daten-Service

Under section 22 of the Data Protection Act, Germany will introduce a specific regulation concerning health, genetic data and biometric data use by private and public bodies. Persons insured with a statutory health insurance fund pay income-related contributions.

Intellectual property patents, trade marks, unfair competition ; life sciences medicinal products, medical devices. However, any use of the medicinal product that is based on scientifically recognised therapeutic habits arzneimittelpreisverornung which the pharmaceutical company knew or ought to have known is part of the intended use. An advantage is any benefit to arzneimittelpreisverordnyng the recipient has no legal claim and which objectively improves his or her economic or personal situation.

Parallel imports normally occur where a third company, independent of the marketing authorisation holder or manufacturer, acquires medicinal products in another EU or EEA member state and imports them into Germany. The competent authority focuses on the quality and safety arzneimittelpreisveorrdnung the product being investigated, based on analytical and pharmacological-toxicological data provided by the trial sponsor. Further grounds for product liability can apply, especially under the law of tort Deliktsrecht.


The reference price of a medicinal product is the maximum amount reimbursed by the statutory health insurance fund, not a state-fixed price. Official website containing relevant German legislation.

Enter and inspect during normal business hours properties, office premises, operating rooms and transport facilities. A mutually recognised marketing authorisation, issued through the mutual recognition or decentralised procedure.

Whether such combinations qualify as medical devices or medicinal products, or arzneimmittelpreisverordnung their original qualification, depends very much on the circumstances. How can a product liability claim be brought? What is the authorisation process for marketing medicinal products? A biosimilar is similar to another biological medicinal product already approved in the EU for which marketing exclusivity rights have expired.

ABDATA, Pharma-Daten-Service [WorldCat Identities]

However, the reimbursement of medicinal products in the outpatient sector by the statutory health insurance funds is subject to numerous restrictions, for example:. Such off-label use is part of the intended use if the pharmaceutical company does not expressly exclude it.

Reinforcing the rules on clinical evidence, including an EU-wide co-ordinated procedure for authorising multi-centre clinical investigations. What is the authorisation process for manufacturing medicinal arzneimittelpreisveorrdnung

The appropriate pharmaceutical quality must be arzneimittelprrisverordnung by tests in accordance with the legal requirements. Ordering medicinal products from foreign mail order pharmacies is only permitted from a few countries.

Revocation of consent means that further participation of the subject in the clinical study is prohibited and no further data can be collected.