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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Are punitive damages allowed for product liability claims? The Federal Institute for Drugs and Medical Devices is normally not involved in the placing on arzneimittelpreisverorvnung market of medical devices.

The concerned member state must issue authorisation within 90 days of the application under the mutual recognition procedure. Mail order selling of pharmacy-only medicines is allowed.

Medicinal product regulation and product liability in Germany: overview

Whether such combinations qualify as medical devices or medicinal products, or keep their original qualification, depends very much on the circumstances. There are strict reporting requirements for both the competent authority and the sponsor in section 12 et seq. The appropriate pharmaceutical quality must be proven by tests in accordance with the legal requirements.

PSURs include the results of studies carried out with the arzneimittelpreosverordnung product, both on its authorised and unauthorised uses.

Arzneimittel-Festbeträge – GKV-Spitzenverband

However, the reimbursement of medicinal products in the outpatient sector by the statutory health insurance funds is subject to numerous restrictions, for example:. Stricter before the event control arzneiittelpreisverordnung high-risk devices through a new pre-market scrutiny mechanism, involving a pool of experts at EU level.

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German Federal Patent Court W www. Further, doctors and pharmacists will obtain support for the costs of installing electronic data transmission infrastructure. 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.

Oversight and enforcement for many medicinal products are carried out by the 16 regional governments. The GDPR is particularly relevant to data concerning health, genetic data and biometric data.

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.

Reporting any matter requiring a re-examination of the benefit-risk assessment of the investigational medicinal product within 15 days of becoming known. Various items of legislation apply in specific contexts. Wholesalers are reimbursed with a maximum amount of 3. An advantage is any benefit to which the recipient has no legal claim and which objectively improves his or her economic or personal situation.

An assessment of the readability of the summary of product characteristics. Section 84 et seq. This is an official database containing information on authorised finished medicinal products reported to the Information Centre for Proprietary Medicinal Products.

Germany, Munich bar, Mandatory safety features a unique identifier and arzneimittelpreisverordnuny device on the outer packaging.

When disclosing the data to the sponsor, the data must be anonymised according to internationally standardised encryption practices.

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ABDATA, Pharma-Daten-Service [WorldCat Identities]

Are there further conditions concerning how the drug is distributed and accessible to patients? The manufacturer will receive the manufacturing authorisation it has applied for unless one of the grounds for refusal listed in section 14 1 of the Medicinal Products Act is given.

In relation to sections a and b of the Criminal Code, the key question is whether medical practitioners obtain an “advantage” or not. Ordering medicinal products from foreign mail order pharmacies is only permitted from a few countries. Depending on the chosen procedure, the scope of the documents varies.

The competent authority focuses on the quality and safety of the product being investigated, based on analytical and pharmacological-toxicological data provided by the trial sponsor. The state only regulates surcharges that reimburse the services of wholesalers and pharmacies.

However, information with a promotional character, for example instructions for use, can be provided through the internet. In Arzneimittslpreisverordnung, there are several regulations and industry codes dealing with different aspects of compliance.

They will replace the existing EU medical device directives and make important improvements to modernise the current system, including:. Revocation of consent means that further participation of the subject in the clinical study is prohibited and no further data can be collected.