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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Official website, containing case law since and up to date.
Change of ownership applications where, for commercial reasons, a company wishes to make a duplicate of a marketing authorisation. Marketing Authorisation and abridged procedure. 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.
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.
According to established practice, original personal data should only be documented by the examiner. Various items of legislation apply in specific contexts. This is an official database containing information on authorised finished medicinal products reported to the Information Centre for Proprietary Medicinal Products.
What are the restrictions on advertising medicinal products? 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.
Further, the e-Health Initiative has been launched by the Federal Ministry of Health to identify obstacles to telemedicine applications and develop measures to overcome them.
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 arzneimitteplreisverordnung physicians using medicinal products. German Federal Patent Court W www. In Germany, a large number of preparations of comparable quality, with comparable effect and partly identical composition, are available at very different prices.
Fees The competent authorities fix the fees according to the legal framework for administrative fees. The sponsor’s immediate reporting requirements include: They will apply three and five years respectively after entry into force.
What remedies are available to the claimant? Sales and marketing The rate is fixed every year and the same across all statutory health insurance funds.
The competent authorities issue necessary directives to rectify any identified infringements and prevent future infringements section 69 1Medicinal Products Act. They will replace the existing EU medical device directives and make important improvements to modernise the current system, including:.
The employer and an insured employee share the costs equally. After inclusion in the Lauer-Taxe, the medicinal product receives a central pharmaceutical number PZNa national identification key for products distributed by pharmacies.
ABDATA, Pharma-Daten-Service [WorldCat Identities]
Restrictions on foreign applicants The legal requirements apply equally to foreign and domestic applicants. Briefly outline how biologicals and combination products are regulated in your jurisdiction. So that the health insurance funds and therefore insured persons do not pay for an expensive drug if cheaper and equivalent medicinal products agzneimittelpreisverordnung available, there are fixed prices for groups of comparable medicinal products, especially generics reference prices.
Chapters 10 and 11 of the Medicinal Products Act contain essential provisions on pharmacovigilance.
A translation of the product information, package leaflet and labelling into the arzneimkttelpreisverordnung member state language must be provided in the application. Enter and inspect during normal business hours properties, office premises, operating rooms and transport facilities.
For arzneimittelppreisverordnung 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: The frequency, intensity, arznneimittelpreisverordnung and duration of the corresponding measures depend on the circumstances of each case.
However, information with a promotional character, for example instructions for use, can be provided through the internet.
Reimbursement by the statutory health insurance funds must not be excluded by the Social Security Code V. They bind their members, and compliance is monitored and sanctioned. In addition, a health insurance company can negotiate further discounts with pharmaceutical companies.
In case of a breach of the regulations, the regulatory authorities can withdraw, revoke and suspend a marketing arzneimittelpreixverordnung. Putting certain aesthetic devices with the same characteristics and risk profile as analogous medical devices within the scope of the regulations.
Is it possible to limit liability for defective medicinal products?