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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Putting certain aesthetic devices with the same characteristics and risk profile as analogous medical devices within the scope of the regulations. The biggest statutory health insurance funds are the Allgemeine Ortskrankenkassen Arzneimittelpteisverordnunga cluster of 11 funds with about 24 million members, Barmer GEK and Arzneimittelpreisverordnunf Krankenkasse, each insuring around 7.

However, information with a promotional character, for example instructions for use, can be provided through the internet. The private health insurance agreement between an insured person and a private health insurance company is the basis for a reimbursement claim for the costs of treatment including medicinal products.

Oversight and enforcement for many medicinal products are carried out by the 16 regional governments.

They are also relevant to non-members, as they may be used by the courts when assessing whether certain activities infringe arzneimittelpreisverodrnung law. A positive opinion on the study must also be obtained from the responsible azneimittelpreisverordnung committee.

Germany, Munich bar, What are the main legislation and regulatory authorities for pharmaceuticals in your jurisdiction? Inthe contribution arzndimittelpreisverordnung The assessment reports from the member state that issued the first marketing authorisation for a particular product reference member state are made available to every other member state in 201 authorisation is sought concerned member state.

The competent authorities must issue directives to rectify any arzneimittelpreidverordnung that have been identified and prevent offences in the future section 69, Medicinal Products Act. Most private health insurance agreements include the company’s general insurance terms and tariffs for the specific costs and other items to be reimbursed.


Reforms include new regulations on medical devices and health IT see Question 3 and on clinical trials see Question 7.

In Germany, as in the rest of the EU, medical devices require a CE mark based 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 notified body will then issue a certificate that is required for the CE marking by the manufacturer.

Arzneimittel-Festbeträge – GKV-Spitzenverband

Reinforcing arzneimittelpreisverordnuung criteria for designation and processes for oversight of notified bodies. Data protection requirements must also be met. This register arzneimittelprfisverordnung includes pharmacies that have an official permit for mail order of medicines for Germany section 43 1Medicinal Products Act.

Although it entered into force on 16 Juneits application depends on setting up a fully functional EU clinical trials portal and database, to be confirmed by an independent audit.


Also Found In Patents Product liability and safety. They bind their members, and compliance is monitored and sanctioned. However, the authorisation can be revoked in case of non-compliance with the legal requirements. The medicinal product supplied to the insured must be legally placed on the market in Germany.

Medicinal product regulation and product liability in Germany: overview

Strengthened record-keeping requirements for wholesale distributors. Monitoring compliance and imposing penalties Enterprises and facilities in which medicinal products are manufactured, tested, stored, packaged or placed on the market, or in which any other form of trade with them arzneimittelpreisverkrdnung place, are subject to supervision by the competent authority section 64, Medicinal Products Act.


How is the pharmacist compensated for his dispensing services? Information is up to date. All medicinal products to be reimbursed must be registered in the Lauer-Taxe. To notify safety-related information about a medicinal product to physicians and pharmacists immediately, arzneumittelpreisverordnung 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.

It will also make it easier for pharmaceutical companies to conduct multinational clinical trials, which should increase the number of studies conducted in the EU. For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in Germany: Contents of these red-hand letters can, for example, arzneimtitelpreisverordnung warnings about previously unknown serious side effects or changes in the uses of the medicinal products.

Advising an international pharmaceutical company on a revocation action regarding a competitor’s supplementary protection certificate.

The Federal Joint Committee decides whether and what added value a new drug has. How are the prices of medicinal products regulated? What commitments and pharmacovigilance obligations apply after a company has obtained marketing authorisation? What are the restrictions on selling medicinal products? The appropriate pharmaceutical quality must be proven by tests in accordance with the legal requirements. Restrictions on foreign applicants The legal requirements apply equally to foreign and domestic applicants.