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: Mezticage Nakasa
Country: Uruguay
Language: English (Spanish)
Genre: Art
Published (Last): 27 April 2004
Pages: 302
PDF File Size: 15.48 Mb
ePub File Size: 10.27 Mb
ISBN: 667-5-74206-615-4
Downloads: 35717
Price: Free* [*Free Regsitration Required]
Uploader: Tejar

PSURs include the results of studies carried out with arzneimittelpreisverordbung medicinal product, both on its authorised and unauthorised uses. Key stages and timing Applications for manufacturing authorisations must be filed before the start of the manufacturing process. This register only includes pharmacies that have an official permit for mail order of medicines for Germany section 43 1Medicinal Products Act.

Arzneimittel-Festbeträge – GKV-Spitzenverband

Restrictions on dealings with healthcare professionals However, the authorisation can be revoked in case of non-compliance with the legal requirements. Revocation of consent means that further participation of the subject in the clinical study is prohibited and no further data can be collected.

The trial must be conducted in an arzneiimittelpreisverordnung facility by a suitably qualified investigator in a responsible manner, and managed by an investigator with at least two years’ experience in the clinical trial of medicinal products. When disclosing the data to the sponsor, the arzneimittelpreisverrordnung must be anonymised according to internationally standardised encryption practices.

arzneimitgelpreisverordnung Change of ownership applications where, for commercial reasons, a company wishes to make a duplicate of a marketing authorisation. The EMA evaluates applications to market biological medicinal products, including biosimilars, before they can be approved and marketed in the EU, including Germany. There are statutory prescribed discounts for health insurance companies.


These products can only be authorised for marketing in Germany using the mutual recognition procedure. One key requirement is that all agzneimittelpreisverordnung offices and hospitals must be connected to a national electronic data transmission infrastructure as of mid Section 84 et seq.


The Social Arzneimitteppreisverordnung 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 rate is fixed every year and the same across all statutory health insurance funds.

This happens when a pharmaceutical company does not use the authorisation for a period of three years, that is, does not place the medicinal product on the market. Usually, patients obtain a prescription from their physician and collect the medicinal product from a 201. The competent authorities issue necessary directives to rectify any identified infringements and prevent future infringements section 69 1Medicinal Products Act.

Pricing, state funding and reimbursement 4.

The procedures for these applications and the information applicants can rely on vary widely. Internet advertising The same principles apply to internet advertising. This concept applies primarily to treatments qrzneimittelpreisverordnung areas of high medical need, where it is difficult to collect data through traditional routes and large clinical trials would unnecessarily expose patients who are unlikely to benefit from the medicinal products.

Reinforcing the criteria for designation and processes for oversight of notified bodies. A positive opinion on the study must also be obtained from the responsible ethics committee.

Medicinal product regulation and product liability in Germany: overview | Practical Law

An assessment of the readability of the summary of product characteristics. Before the parallel importer is allowed to market the medicinal product in Germany, it must obtain a simplified national marketing authorisation. What is the structure of the national healthcare system, and how is it funded? Inthe contribution is Mail order selling of pharmacy-only medicines is allowed. The GDPR is relevant to personal data, that is, any information relating to an identified or identifiable natural person.


If the price of a medicinal product is higher than the reference price, the patient generally pays the difference or receives a therapeutically comparable medicinal product with no additional cost.

Chapters 10 and 11 of the Medicinal Products Act contain essential provisions on pharmacovigilance. Tougher rules on importing active pharmaceutical ingredients.

The following must be submitted in relation to the medical product:.

Medicinal product regulation and product liability in Germany: overview

Arzneimittelpreisverordnunb, a prescription drug has the same price in every pharmacy in Germany. 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.

The foreseeable risks and inconveniences are medically justifiable, compared with the benefit for the trial subject and the anticipated benefit for medical science. Often, combination products are medical devices that have been coated or impregnated with a drug substance, for example, antimicrobial coated catheters or stent coated with a special drug. Combination products Many current innovative products are combination products consisting of, if stand-alone, a medical device and a medicinal product.

In particular, the imported medicinal products must have exactly the same active component, formulation, indication and therapeutic effect as the equivalent medicinal products already in Germany.

Non-compliance with the pharmacovigilance regulations can be an administrative offence leading to fines. What commitments and pharmacovigilance obligations apply after a company has obtained marketing authorisation?

Section 84 1Medicinal Products Act.