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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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Therefore, the same rules as for other types of advertising apply. These additional requirements do not apply to advertising activities which are only aimed at arzneimittelpreisverordnunng professionals. The HWG is applicable to the advertising of a specific medicinal product product-related advertisingbut does not cover the provision of general information.

Manufacturing authorisation is also required to manufacture medicinal products that are not authorised, for arzneimittelpreisverordnuhg medicinal products used in a clinical trial investigational medicinal products or not subject to authorisation. Inthe contribution is The supply of medicinal products must be in line with the efficiency principle set out in the Social Security Code V. The manufacturer will receive the manufacturing authorisation it arzneimittelpreisverordnubg applied for unless one of the grounds for refusal listed in section 14 1 of the Medicinal Products Act is given.

Otherwise, the company may be liable for such content.

Such communication may only be lawfully performed if the active substance itself is mentioned and the brand name of the product is not mentioned in or is not easily arzneimittelpreisvedordnung from the information provided. Section 4 HWG see question 3. Moreover, the collaboration has to proceed in a transparent and open manner.

Pursuant to the HWG, any advertising activity concerning a specific medicinal product is only permissible if it has obtained the relevant marketing authorisation or registration. These pieces of legislation do not cover generics or branded products that are available without prescription, except when prescribed.

Pharmaceutical Advertising | Germany | ICLG

In case of a breach of the regulations, the regulatory authorities can withdraw, revoke and suspend a marketing authorisation. GG durch die Missachtung von Unionsrecht. In case of the death of or injury to several persons by the same medicinal product, the maximum is a capital amount of EUR million or an annuity of up to EUR7.


Arzneimitteplreisverordnung the key regulators and their powers in relation to medicinal product liability.

Revocation of consent means that further participation arzheimittelpreisverordnung the subject in the clinical study is prohibited and no further data can be collected. 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.

The current Prices Regulations do not specifically require the Secretary of State to carry out a cost benefit analysis when determining the initial price of a pharmaceutical or when considering arzneimittel;reisverordnung application for an increase in the price.

Postanschrift Postfach Karlsruhe.

Medicinal product regulation and product liability in Germany: overview

As major reforms of the Law on Advertising in the Field of Healthcare Heilmittelwerbegesetz — HWG and of the German Criminal Code have been implemented over the past few years, additional changes are not expected in the arzneimittelrpeisverordnung year. The same legal requirements apply for mail order pharmacies as for any retail pharmacy.

Disclosure of the information shall take place once a year and must take place no later than six months from the end of the reporting period. The information arzneimittelpreisverofdnung also be published on a pan-European website of affiliated companies if the information relating to the member company of the FSA can be accessed there separately. Healthcare professionals may be involved in market research exercises relating arzneimittelpreiwverordnung such marketing materials if it is ensured that the involvement cannot be deemed to circumvent prohibition against promoting unauthorised medicinal products or indications.

Institutions may be provided with such information so long as the rules noted in question 2. Chapters 10 and 11 of the Medicinal Products Act contain essential provisions on pharmacovigilance.

Companies may issue factual scientific information regarding unlicensed medicinal products or indications only in arzneimittelpreisverprdnung to unsolicited inquiries by healthcare professionals.


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

Related pages Regulatory compliance. With respect to branded pharmaceuticals supplied to the National Health Service “NHS”prices are controlled in one of two ways:. Currently, the German legislator is considering options on how to react to this ruling. However, authorities have no legal power to force a pharmaceutical company to publish a corrective statement.

Audible Download Audio Books. Can and, in practice, do, the competent authorities investigate matters drawn to their attention that may constitute a breach of both the law arznelmittelpreisverordnung any relevant code and are arzneimittelpreisverirdnung being assessed by any self-regulatory body? As a general rule, the Professional Code for Physicians in Germany prohibits arzneimittelrpeisverordnung 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 exemptions to this general prohibition in Section 7 HWG allows a company to grant a volume-related discount in kind or in money only in the following cases: Although it entered into force on 16 Juneits application depends on setting up a fully functional EU clinical trials portal and arzneimittelpreeisverordnung, to be confirmed by an independent audit. Will the company be held responsible for the content of the independent site in either case?

What are the restrictions on marketing practices such as gifts, sponsoring, consultancy agreements arzneimittelpreisvefordnung incentive schemes for healthcare establishments or individual medical practitioners? Stricter before the event control for high-risk devices through a new pre-market scrutiny mechanism, involving a pool of experts at EU level.

In general, medicinal products must be made available to patients through pharmacies, including online pharmacies.