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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As a general rule, arzneimittelpreisverordnubg Professional Arsneimittelpreisverordnung for Physicians in Germany prohibits the acceptance of any gifts or benefits by physicians that might influence their prescribing, or therapeutic decisions, or which could be considered as a reward for such previous decisions. The current PPRS, which expires at the end ofincludes flexible pricing, which allows a company to increase or decrease its original list price in light of new evidence or a different indication being developed.


The same legal requirements apply for mail order pharmacies as for any retail pharmacy. The broader assessment of the value of a pharmaceutical will focus primarily on new medicines entering the market fromhowever existing medicines may also be affected.

One key requirement is that all doctors’ offices and hospitals must arzneimittelpreusverordnung connected to a national electronic data transmission infrastructure as of mid The concerned member state must issue authorisation within 90 days of the application under the mutual recognition procedure. However, in the case of severe infringements it is very likely that enforcement functions will be informed.

On this basis, the manufacturer agrees with the statutory health insurance fund a reimbursement amount. Shopbop Designer Fashion Arzneimittelpreisverprdnung. What defences are available to product liability claims? If so, are there any restrictions in relation to the type of arzneimittelpreisvrordnung or the circumstances in which they may be supplied?

Depending on the market shares package deals may also be critical under competition law-related aspects. Such items include inexpensive software-applications in particular smart phone apps which support diagnostic analysis and therapy of patients, as long as they are related to products and indications of the member company.

However, the authorisation can be revoked in case of non-compliance with the legal requirements. Gifts and other advertising giveaways. Reinforcing the rules on clinical evidence, including an EU-wide co-ordinated procedure for authorising multi-centre clinical investigations.

In addition, the Professional Rules for German Physicians prohibit the acceptance of any gifts or benefits which might influence their prescribing or therapeutic decisions, or which could be considered as a reward for such previous decisions.


Product liability claims under the law or tort are based on negligence or fault liability. 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.

20113, the member company of the FSA must notify any assistance in an international event in advance to its affiliated companies in the country where the event takes place. In addition, if an advertisement shall only serve as a reminder of the medicinal product Erinnerungswerbung it does not need to contain the basic information on 213 medicinal product mentioned above or the invitation to seek the advice of a health professional.

If so, in what circumstances? Market authorisations are renewable arzenimittelpreisverordnung application by the marketing authorisation holder. Advertising to healthcare professionals, including claims for use of a medicinal product, must contain the following mandatory information:. Application Manufacturing authorisation arzneimittelpreosverordnung required for the commercial or professional production of medicinal products and active ingredients for biologicals section 13, Medicinal Products Act.

However, a mere statement on a website where the details of prescription-only pharmaceuticals are only directed to healthcare professionals, or a simple unverified question asking whether the corresponding person is a health professional, is not sufficient.

In Germany, a large number of preparations of comparable quality, with comparable effect and partly identical composition, are available at very different prices.

Consequently, the risk of infringement of the HWG is higher the more such scientific information relates to a specific product or product trademark, or is used in relation to the advertising activities for an unauthorised product. For the national procedure, the applicant has the right to be granted an authorisation if the legal requirements are met, within seven months of the application section arzneimuttelpreisverordnung, Medicinal Products Act.

Germany does not require a preview of a new website by any official supervisory body. In fact, the same general principles as set forth above apply. No guidelines on market research have been published to date. The employer and an insured employee share the costs equally. If monetary limits apply, please specify. It is only permissible to refer to studies which are not considered in the SmPC if such studies arzneimittwlpreisverordnung not contradictory to each other and meet certain scientific standards.

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.


Pharmaceutical Advertising | Germany | ICLG

There must be a reasonable need for the active participation and the remuneration must be appropriate with regard to the services rendered fair market value. Mail order selling of pharmacy-only medicines is allowed.

Mandatory safety features a unique identifier and anti-tampering device on the outer packaging. However, press releases are most likely to be considered promotional and therefore, unlawful where the anticipated new product name is mentioned.

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

Furthermore, the FSA-Code of Conduct recommends obtaining a declaration of consent from the patient for the participation. Enter your mobile number or email address below and we’ll send you a link to download the free Kindle App.

The report must contain all of the results of the clinical trials, whether they arzneimittelpreisverordnunb favourable or not. In other cases, there may be additional regulatory limitations that must be satisfied, such as the FSA-Code of Conduct Healthcare Professionals as described above. Furthermore, the member companies of the FSA must publish donations exceeding EUR 10, per donation on an annual basis.

Moreover, additional wording has been included in Section 8 HWG: Parallel imports normally occur where a third company, independent of the marketing authorisation holder or manufacturer, acquires medicinal products in another EU or EEA member state and imports them into Germany.

Furthermore, German criminal law and the FSA-Code of Conduct Healthcare Professionals generally prohibit the provision and acceptance of any kind of benefits with arzneimittelpreisverordnunv to physicians that are granted in the context arzneimittelpteisverordnung their work, especially as consideration for carrying out purchasing or prescription decisions.

Pharmaceutical Advertising 2018 | Germany

Competitors may take direct action through the civil courts. However, the question whether and to which extent customary cash discounts Skonti are permissible, has arzneimittelpreisvegordnung been addressed. Is it possible to pay for his expenses travel, accommodation, enrolment fees? The organisation of tours or programmes for spouses or other accompanying persons is not permissible for the same reasons. Supplementary protection certificates – a never-ending story?

Various items of legislation apply in specific contexts.