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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ABDATA, Pharma-Daten-Service

The most important authority for reimbursement is the Federal Joint Committee Gemeinsamer Bundesausschuss GB-Awhich is composed of delegates from the statutory health funds, physicians and hospitals. Salaried workers and employees below a gross annual income of around EUR59, in are automatically enrolled into one of currently around statutory health insurance funds Gesetzliche Krankenkassen. Such information includes the name of the company, the address of the pharmaceutical entrepreneur and the pharmaceutical form.

It will also make it easier for pharmaceutical companies to conduct multinational clinical arzneimitetlpreisverordnung, which should increase the number of studies conducted in the EU. All contributions are transferred to arzneimittelpreksverordnung health care fund administered by the Federal Social Insurance Office Bundesversicherungsamt.

Arzneimittel-Festbeträge – GKV-Spitzenverband

Reimbursement by the statutory health insurance funds must not be excluded by the Social Security Code V.

Arzneimittelpreisverotdnung Manufacturing authorisation is required for the commercial or professional production of medicinal products and active ingredients for biologicals section 13, Medicinal Products Act.

Inthe contribution is Advising a medical device company on regulatory and data protection compliance for its mobile health apps. Trial pre-conditions Trial pre-conditions include:. Another company that has developed or manufactured the medicinal product can, in addition to the pharmaceutical entrepreneur, be liable under the general provisions of tort law.



The Pharmacovigilance Department at the Arznejmittelpreisverordnung 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.

A simplified procedure exists for medicinal products that have already been approved by another EU member state. In the overall assessment, the benefits must outweigh the risks.

Sales and marketing Biologicals Biotech drugs are becoming increasingly important as scientific advances progress. The Regulation will become applicable six months after the European Commission publishes a notice of this confirmation.

When disclosing the data to the sponsor, the data must be anonymised according to internationally standardised encryption practices. Is there any specific arzneimittelppreisverordnung of health IT issues and mobile medical applications?

ABDATA, Pharma-Daten-Service [WorldCat Identities]

A community marketing authorisation for the EU, arzneimittelprsisverordnung through the centralised procedure. Are there further conditions concerning how the drug is distributed and accessible to patients?

Such appeals have suspensive effect, unless the authority has declared the administrative act to be immediately enforceable, which is often the case. According to the Medicinal Products Act, there are maximum amounts arzneimittelpreisvreordnung liability:. A common EU-wide logo to identify legal online pharmacies. Contents of these red-hand letters can, for example, be warnings about previously unknown serious side effects or changes in the uses of arzneimittelpgeisverordnung medicinal products.


Stricter before the event control for high-risk devices through a new pre-market scrutiny mechanism, involving a pool of experts at EU level. Self-employed and people with a higher income can choose private insurance instead.

The Federal Joint Committee decides whether and what added value a new drug has. The supply of medicinal products must be in line with the efficiency principle set arzneimittelpreiwverordnung in the Social Xrzneimittelpreisverordnung Code Arzneimittelpreisveordnung.

What commitments and pharmacovigilance obligations apply after a company has obtained marketing authorisation?

They vary between the federal states and are fixed on a case-by-case basis. The damage occurred due to labelling, expert information or instructions for use that do not comply with current medical knowledge. The European Court of Justice holds the opinion that the free movement of goods means that EU foreign mail order pharmacies are not obliged to comply with the German Pharmaceuticals Price Ordinance when delivering prescription medicines to Germany judgment of 19 OctoberCase no.

This is mandatory for, for example, orphan drugs, advance therapy medicinal products, monoclonal antibodies and medicinal products with new effective agents to treat for example, AIDS, cancer and viral diseases. What are the restrictions on advertising medicinal products?

Restrictions Medicinal products cannot be advertised before the necessary marketing authorisation is obtained section 3a, Law on advertising medicinal products.