2 Health Systems in Transition. Reinhard Busse • Miriam Blümel World Health Organization (acting as the host Arzneimittelpreisverordnung. Pharmazeutische Unternehmer und Apotheker sind gesetzlich verpflichtet, den Krankenkassen einen Preisnachlass für jede verordnete Arzneimittelpackung zu . Aktuelle Beschlüsse zu Arzneimittel-Festbeträgen. ; ; Stellungnahmeverfahren (Anpassung) vom

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Such monitoring and control obligations exist prior to establishing the link, as well as after the link is established. The requirement for any financial support for passive participation in arzneimittelpreisvedordnung is that the primary purpose of the event has to convey scientific information and communicate professional knowledge.

Action can be taken in order to seek injunctive relief, as well as to seize the illegal advertising material.

Under the Social Security Code V, arzneimittelpreisverordnujg 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.

No guidelines on market research have been published to date.

To what extent are pharmaceuticals prices controlled?

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 arnzeimittelpreisverordnung shown in bioavailability studies. The competent authorities cannot impose fines or criminal penalties. Are companies obliged to disclose via a central platform?

arzneimittelpreisveroednung Dezember Antrag auf Erlass einer einstweiligen Anordnung gestellt und mit Schriftsatz vom In the event of a conflict of the applicable codes, the more restrictive code will apply. The Recommendations have been amended in December Please arzneimittelpreiverordnung our arzneimittelprisverordnung and conditions page for further details. In addition, competitors may claim further remedies including damages in substantive proceedings.


Is there any specific regulation of health IT issues and mobile medical applications? Mandatory safety features a unique identifier and anti-tampering device on the outer packaging.

The EMA evaluates applications to market biological medicinal products, including biosimilars, before they can be approved and marketed in the EU, including Germany. What are the main legislation and regulatory authorities for pharmaceuticals in your jurisdiction? Only individuals can be liable under German criminal law, not health care establishments.

An exception is the parallel distribution of centrally authorised medicinal products. The most important authority for reimbursement is the Federal Joint Committee Gemeinsamer Bundesausschuss GB-Awhich is composed of delegates from the statutory health funds, physicians and hospitals. Whether such combinations qualify as medical devices or medicinal products, or keep their original qualification, depends very much on the circumstances.

The FSA-Code of Conduct is even stricter and prohibits the promise, offer or granting of gifts to healthcare professionals irrespective to product-related or non-product-related advertising. The same applies to indications or pharmaceutical forms which are not covered by the marketing authorisation off-label information.

However, such actions may be taken only by direct competitors, associations promoting commercial interests Wettbewerbsvereineand consumer associations.

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. In addition, information regarding subsequent essential modifications to the trial protocol, as well as interruptions and early termination of the clinical trial, shall be included in the report.


Strengthened record-keeping requirements for wholesale distributors. However, the reimbursement of medicinal products in the outpatient sector by the statutory health insurance funds is subject to numerous restrictions, for example:. International events within the meaning of the FSA-Code of Conduct Healthcare Professionals are internal or external training events in a country in which the company organising, holding or supporting the event or supporting its participants is not domiciled.

Insurers can and often do charge extra fees, which are currently paid as of July by the insured employee.

What information can the applicant rely on? However, the data collected up to the time of revocation can continue to be used. Full legal advice should be taken from a qrzneimittelpreisverordnung professional when dealing with specific situations. A new implant card containing information about implanted medical devices for a patient. However, it may be difficult in practice to avoid unlawfully promoting such information. Non-compliance with the pharmacovigilance regulations can be an administrative offence leading to fines.

A mutually recognised marketing authorisation, issued through the mutual recognition or decentralised procedure.