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 competent authority focuses on the quality and safety of the product being investigated, based on analytical and arzneimittelpreisvsrordnung data provided by the trial sponsor.

There is sufficient reason to suspect that the medicinal product has harmful effects exceeding. Only individuals can be liable under German criminal law, not health care establishments. This register only includes pharmacies that have arzneimittelpreisverrordnung official permit for mail order of medicines for Germany section 43 1Medicinal Products Act. 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.

The foreseeable risks and inconveniences are medically justifiable, compared with the benefit for the trial subject and the anticipated benefit for medical science. So that the health insurance funds and therefore insured persons do not pay for an expensive drug if cheaper arzneimittelpreisverordnujg equivalent medicinal products are available, there are fixed prices for arzneimittelprdisverordnung of comparable medicinal products, especially generics reference prices.

Pharmaceutical manufacturers are free to determine the selling price for medicinal products. Improved transparency through establishing a comprehensive EU database on medical devices and a device traceability system based on unique device identification.

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

Key stages and timing The key stages and timing vary in the different procedures. A generic must have the same qualitative and quantitative composition of active substances and pharmaceutical form as the reference medicinal product, and this bioequivalence must have been shown in bioavailability studies.

The notified body will then issue a certificate that is required for the CE marking by the manufacturer. Such off-label arzneijittelpreisverordnung is part of the intended use if the pharmaceutical company does not expressly exclude it.


This means the company that markets a medicinal product under its own arzneimiftelpreisverordnung is liable, but is not liable for counterfeit medicines. An assessment of the readability of the summary of product characteristics. Every website offering the public medicinal products by mail order must display the common security logo and be registered in the national register section 67 8Medicinal Products Act.

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.

The medicinal product supplied to the insured must be legally placed on the market in Germany. This applies to any company involved in manufacturing medicinal products, irrespective of whether it also holds the arzneimittelpreisvedordnung authorisation or markets the medicinal product under its name.

Strengthening post-market surveillance requirements for manufacturers. Gifts, sponsoring, consultancy agreements or incentive schemes are likely to be considered such “advantages”, but it depends on the circumstances of the case. The rate is fixed every year and the same across all statutory araneimittelpreisverordnung insurance funds.

Medicinal product regulation and product liability in Germany: overview

However, any use of the medicinal product that is based on scientifically recognised therapeutic habits of which the pharmaceutical company knew or ought to have known is part of the intended use. They will apply three and five years respectively after entry into force.

In relation to sections a and b of the Criminal Code, the key question is whether medical practitioners obtain an “advantage” or not. This includes the supply of medicinal products.

Restrictions Medicinal products cannot be advertised before the necessary marketing authorisation is obtained section 3a, Law on advertising medicinal products. Internet advertising The same principles apply to internet advertising.

Are punitive damages allowed for arzneimitgelpreisverordnung liability claims? Are there further conditions concerning how the drug is distributed and accessible to patients? The entry into application of the Clinical Trials Regulation is currently estimated to occur in However, the reimbursement of medicinal products in the outpatient sector by the statutory health insurance funds is subject to numerous restrictions, for example:. In Germany, as in the rest of arzneimittelprisverordnung EU, medical devices require a CE mark arzneimittelprrisverordnung on a declaration of conformity following an assessment which, depending on the risk potential of the product, is carried out by the manufacturer only or after being verified by a notified body.


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.

Arzneimittel-Festbeträge – GKV-Spitzenverband

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.

Pricing in such foreign pharmacies has been an issue for a long time. PSURs are reports that evaluate arzneimitteloreisverordnung risk-benefit balance of a medicinal product. Consent can be revoked. Recently, the Federal Ministry of Health announced that it aims to draft a second e-Health law in the current legislative period starting The processing of personal data, including data concerning health, for mere scientific purposes may be permitted without consent in certain limited scenarios.

Supplementary protection certificates – a never-ending story? The Lauer-Taxe also includes information on the medicinal product such as product characteristics, form of administration, and package size. Tougher rules on importing active pharmaceutical ingredients.

ABDATA, Pharma-Daten-Service

Mandatory safety features a unique identifier and anti-tampering device on the outer packaging. 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. Combination products Many current innovative products are combination products consisting of, if stand-alone, a medical device and a medicinal product.