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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What is the structure of the national healthcare system, and how is it funded?

Marketing Authorisation and abridged procedure. Data protection requirements must also be met. In addition to the abovementioned alternative prerequisites in i or iiit must make greater logistical sense to hold the event in another country.

With the objective of structuring collaboration with patient organisations in accordance with the principles of neutrality and independence, the FSA-Code of Conduct Patient Organisations also makes it clear that such collaboration should not be used in a manner to circumvent the laws prohibiting advertising of prescription-only medicines. German Federal Patent Court W www. Institutions may be provided with such information so long as the rules noted in question 2.

Insurers can and often do charge extra fees, which are currently paid as of July by the insured employee. Reforms include new regulations on medical devices and health IT see Question 3 and on clinical trials see Question 7. 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, Medicinal Products Act.

Most medical care is now provided with reference-price medicinal products. Furthermore, enforcement authorities often demand documentary proof, which companies are unable to provide in the requested format. Biologicals Biotech drugs are becoming increasingly important as scientific advances progress.

Therefore, the same rules as for other types of advertising apply. One prerequisite of cost reimbursement of a medicinal product is a health-economic evaluation. Off-label use is not part of the intended use. It introduces an authorisation procedure based on a single submission through an EU portal, an assessment procedure leading to a single decision, rules on protecting subjects and informed consent, and transparency requirements.

Monitoring compliance and penalties Section 30 of the Medicinal Products Act contains special provisions on the general provisions of the Administrative Procedure Act Verwaltungsverfahrensgesetz VwVfGwhich regulates the revocation and withdrawal of administrative acts.


Legislation and regulatory authority The legal framework for advertising and promoting medicinal products in Germany is set out in the Law on advertising medicinal products Heilmittelwerbegesetz HWGwhich covers product-specific sales promotion. Mail order selling of pharmacy-only medicines is allowed.

Arzneimittel-Festbeträge – GKV-Spitzenverband

The newly introduced Section 2 SGB V prohibits special benefits fees or other financial benefits in connection with the prescription of medical aids, prescription-only drugs, medical products similar to drugs, dressing materials and enteral feeding. The Paul-Ehrlich-Institute is responsible for vaccines and biologics. Comparisons with the medicinal products of competitors are only permissible with respect to advertisements to healthcare professionals; such comparative advertising is not allowed to the general public.

However, the arzneimittelprisverordnung collected up to the time of revocation can continue to be used. If so, what companies are affected i.

However, the provision of such SOPs is advisable due to the general obligation to introduce appropriate rules and proceedings as part of the overall compliance organisation. 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.

In addition, it must be ensured that donations are made independently of sales transactions and are not adzneimittelpreisverordnung to influence procurement decisions.

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. If the company is aware that the linked content violates any law or third-party rights, the company is obliged to remove the link. A compensation for the active participation may only be paid on a contractual basis and may only be made if the active participation deals with products of the company or associated treatment forms.

Apart from the judicial sanctions noted above, a breach of the regulations of the HWG on misleading advertising may, provided that a member company of the FSA committed the infringement, also result in a sanction by this organisation. An exception may, however, be made where such information is not intended to promote the medicinal product itself, but where it is necessary to understand the economic and financial position of the company, i.

Aufgrund des Anwendungsvorrangs der Grundfreiheiten Art.

Pharmaceutical Advertising 2018 | Germany

Visit our Help Pages. Further grounds for product liability can apply, especially under the law of tort Deliktsrecht. If so, what is the procedure for approval? Advertising to the General Public. For example, in some cases it will be necessary for a physician to obtain supervisory approval.


This leads to the following rules: Are companies obliged to disclose via a central platform? From the health care fund, payments are allocated to individual statutory health insurance funds based on, among other things, the number arzneiittelpreisverordnung insured persons, the risk structure of the respective persons and social aspects. With regard to rebates granted by mail order pharmacies established in other Member States and which are in contradiction with the German pricing rules set out in the AMPreisV, a political discussion is ongoing on how to implement the ECJ ruling described above see question 4.

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. Briefly outline how medical devices and diagnostics are regulated in your jurisdiction. The collaboration of member companies with patient organisations must not involve recommendations for individual prescription-only pharmaceuticals or groups of pharmaceuticals and the appearance of member company representatives at patient organisations must not be aimed at making promotional references to prescription-only pharmaceuticals.

The employer and an insured employee share the costs equally. Here’s how terms and arzneimittel;reisverordnung apply.

Pharmaceutical Advertising | Germany | ICLG

According to the Medicinal Products Act, there are maximum amounts of liability:. The cumulative effect of using marketing materials or advertising slogans, or making exaggerated, ambiguous or incomplete claims may lead arzneimittelpresverordnung the press release being characterised as promotional.

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. A national marketing authorisation, issued through the national procedure by the Federal Institute for Drugs and Medical Devices or the Paul-Ehrlich-Institute, depending on the product.

However, the question whether and to which extent customary cash discounts Skonti are permissible, has not been addressed.