admin 15 May, 2019 0


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).

Author: Mazushakar Malaktilar
Country: Thailand
Language: English (Spanish)
Genre: Health and Food
Published (Last): 3 April 2006
Pages: 319
PDF File Size: 15.60 Mb
ePub File Size: 15.86 Mb
ISBN: 993-8-15420-646-8
Downloads: 35305
Price: Free* [*Free Regsitration Required]
Uploader: Melabar

The GDPR is particularly relevant to data concerning health, genetic data and biometric data. The processing of personal data, arzneimittelpreisverorxnung data concerning health, for mere scientific purposes may be permitted without consent in certain limited scenarios. In relation to the manufacturing of investigational medicinal products, the requirements of good manufacturing practices must be met.

Oversight and enforcement for many medicinal products are carried out by the 16 regional governments. Advising an international pharmaceutical company in a series of unfair competition proceedings against a German organisation for the protection of fair trade.

All contributions are transferred to a health care fund administered by the Federal Social Insurance Office Bundesversicherungsamt. Co-operation with social health insurance authorised physicians, in particular preventing undue influence on their prescription practice, is regulated in section of the Social Security Code V.

Key stages and timing The key stages and timing vary in the different procedures. A description of the pharmacovigilance system and the risk management system. The Social Security Code X will continue to cover the processing of social data, that is, personal data, including data concerning health processed by stakeholders of the health care system, including health insurance funds.

The E-Health Law also promotes other digital health applications such as electronic medication plans and patient files, enabling patients to be better informed of their diagnosis and therapy and more involved in decision-making, and electronic health cards including emergency patient data.

These are administrative acts that can be challenged by an opposition and an annulment action. 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.


Claimants must file an action with a local court or a district court, depending on the value in dispute.

The consent is only valid if the subject is capable of acting and able to understand aezneimittelpreisverordnung nature and meaning of the consent.

The arzneimittelpreosverordnung committee assesses ethical aspects of the trial in relation to the trial subjects or patients safety issues, informed consent, data protection and so on. Manufacturing authorisation is also required to manufacture medicinal products that are not authorised, for example medicinal products used in a clinical trial investigational medicinal products or not subject to authorisation.

ABDATA, Pharma-Daten-Service

One key requirement is that all doctors’ offices and hospitals must be connected to a national electronic data transmission infrastructure as of mid Persons insured with a statutory health insurance fund pay income-related contributions. Section 84 1Medicinal Products Act.

Material benefits include, for example, financial contributions, arranging and granting additional income, rebates, provision of consumer goods, invitations to holidays or premiums. PSURs are reports that evaluate the arzneimittelpreisverordnunb balance of a medicinal product.

The EMA evaluates applications to market biological medicinal products, including biosimilars, before they can be approved and marketed in the EU, including Germany. The supply of medicinal products must be in line with the efficiency principle set out in the Social Security Code V. After inclusion in the Lauer-Taxe, the medicinal product receives a central pharmaceutical number PZNa arzneimittelpreisberordnung identification key for products distributed by pharmacies.

Briefly outline how medical devices and diagnostics are regulated in your jurisdiction. The competent authorities cannot impose fines or criminal penalties. The EMA provides an adaptive pathways approach to improve timely access for patients to new medicinal products.

However, any use of the medicinal product that is based on scientifically recognised therapeutic habits of which the pharmaceutical company knew or ought to have known is part of the intended use. 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 current state of science and technology section 14, Arxneimittelpreisverordnung Products Act.

  JIS B1188 PDF

The Clinical Trials Regulation will ensure greater harmonisation of the rules for conducting human clinical arzneimiytelpreisverordnung in the EU. Restrictions on dealings with healthcare professionals The state arzneimittelpreisverordnunf regulates surcharges that reimburse the services of wholesalers and pharmacies. Also Found In Patents Product liability and safety.

ABDATA, Pharma-Daten-Service [WorldCat Identities]

Application There are three different types of marketing authorisation:. Other conditions The specific information must be in easily legible and indelible characters, in easily comprehensible German. They will replace the existing EU medical device directives and make important improvements to modernise the current system, including:. In most cases, the public authority inspects the arzneimittelpreisverordnungg before granting the authorisation.

The concerned member state must recognise the first marketing authorisation unless there are serious objections based on a potential risk to public health. Such appeals have suspensive effect, unless the authority has declared the administrative act to be immediately enforceable, which is often the case.

Section 84 et seq. A positive opinion on the study must also be obtained from the responsible ethics committee. Medicinal products must generally be available in pharmacies only, even though statutory health insurance fund companies can reimburse the costs of over-the-counter medicinal products OTCs. Combination products Many current innovative products are combination products consisting of, if stand-alone, a medical device and a medicinal product.