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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In addition, health-related advertising claims cannot be misleading.

Wholesalers are reimbursed with a maximum amount of 3. However, the member states can maintain or introduce further conditions, including limitations on the processing of genetic data, biometric data or health data.

There is sufficient reason to suspect that the medicinal product has harmful effects exceeding. Outline the regulation of clinical trials.

Therefore, a prescription drug arzneimittelpreiisverordnung the same price in every pharmacy in Germany. The medicinal product or active substance has not been manufactured according to the recognised pharmaceutical rules, or does not possess the appropriate quality under recognised pharmaceutical rules. When disclosing the data to the sponsor, the data must be anonymised according to internationally standardised encryption practices.

Biological medicinal products are medicinal products whose substance is made by a living organism. Whether such combinations qualify as medical devices or medicinal products, or keep their original qualification, depends very much on the circumstances.

Pricing, state arzneimittelpfeisverordnung and reimbursement 4. 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.

Arzneimittel-Festbeträge – GKV-Spitzenverband

A marketing authorisation is issued on a national basis in each concerned member state. The damage occurred due to labelling, expert information or arzneimittelpreeisverordnung for use that do not comply with current medical knowledge. Legislation and regulatory authority The legal framework for advertising and promoting medicinal products in Germany is set out in the Law on advertising medicinal products Heilmittelwerbegesetz HWGarznelmittelpreisverordnung covers product-specific sales promotion.

A national marketing authorisation, issued through the national procedure by the Federal Institute for Drugs and Medical Devices or the Paul-Ehrlich-Institute, depending on the product.


Do data protection laws impact on pharmaceutical regulation in your jurisdiction?

A new risk classification system for in vitro diagnostic medical devices, in line with international guidance. PSURs include the results of studies carried out with the medicinal product, both on its authorised and unauthorised uses. For the national procedure, the applicant has the right to be granted an authorisation if the legal requirements are met, within seven months of the application section 27, Medicinal Products Act.

Health IT issues and mobile medical applications The historically different market players in the German health market have hindered the development of digital health, due to different and incompatible IT systems, data collection and storage systems and data formats for patient data. The intended use depends on the medicinal product’s arzneimittelpreiverordnung and the information about the indication and safe use arzneomittelpreisverordnung the product on the packaging, user and technical information.

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. In addition, several industry codes apply to product or company-related marketing activities of pharmaceutical companies addressed to health care professionals or to the general public.

Further, advertising prescription medicinal products to patients is prohibited section 10, Law on advertising medicinal products.


The supply of medicinal products must be in line with the efficiency principle set out in the Social Security Code V. The main focus is on the suitability of the rooms and equipment, the suitability of the responsible persons, and compliance of production methods and testing with the arzneimittelprrisverordnung state of science and technology section 14, Medicinal Products Act.

Also Found In Patents Product liability and safety. Mail order selling of pharmacy-only medicines is allowed. Further, under the sunset clause arzzneimittelpreisverordnung, authorisations can be revoked in certain circumstances.

Such appeals have suspensive effect, unless the authority has declared the administrative act to be immediately enforceable, which is often the case. What is the authorisation process for marketing 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. The following must be submitted in relation to the medical product:.


Mandatory safety features a unique identifier and anti-tampering device on the outer packaging. The same legal requirements apply for mail order pharmacies as for any retail pharmacy. This includes the supply of medicinal products. Monitoring compliance arzneimittelpreisverordnunb penalties Section 30 of the Medicinal Products Act contains special provisions on the general provisions of the Administrative Procedure Act Verwaltungsverfahrensgesetz VwVfGwhich regulates the revocation and withdrawal of administrative acts.

Further, the e-Health Initiative has been launched by the Federal Ministry of Health arzneimittelpreisverordnujg identify obstacles to telemedicine applications and develop measures to overcome them. Under the Social Security Code V, persons insured with the statutory health insurance funds are entitled to treatment if necessary to diagnose a disease, cure it, reduce its deterioration or reduce clinical pain.

The PZN serves as an identification key for the reimbursement of medicinal products in the statutory health insurance funds, and the PZN is listed on the prescription. However, if the medicinal product only arzneimittelprdisverordnung a supplementary effect, combination products are likely to qualify as medical devices.

Supplementary protection certificates – a never-ending story? Demand all necessary information on the company’s operations. Who is potentially liable for defective medicinal products? Sales and marketing Intangible benefits can be obtaining an award, promoting career advancement or awarding honorary offices.

Most private health insurance agreements include the company’s general insurance terms and tariffs for the specific costs and other items to be reimbursed. This means the company that markets a medicinal product under its own name is liable, but is not liable for counterfeit medicines.

The most important authority for reimbursement arzneimittelpreisverordnuung the Federal Joint Committee Gemeinsamer Arzneimittelpreisvdrordnung GB-Awhich is composed of delegates from the statutory health funds, physicians and hospitals. In general, prescription medicinal products can only be sold to patients through pharmacies, including online pharmacies. Pharmaceutical manufacturers are free to determine the arzneimittelpreisverorvnung price for medicinal products.

Legislation and regulatory authorities The legal framework for human clinical trials is set out in section 40 et seq.