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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The medicinal product or active substance has not been manufactured according to the recognised pharmaceutical rules, or does not possess the appropriate quality under recognised pharmaceutical rules. No, there are no specific rules, laws or guidance, controlling the use of social media by companies.
Pharmaceutical Advertising | Germany | ICLG
In principle, Section 7 HWG does not allow the offering or supplying of gifts or other benefits to patients. The competent authority must decide an application within three months section 17, Medicinal Products Act. Are there any rights of appeal?
Application Manufacturing authorisation is required for the commercial or professional production of medicinal products and arzneimittelpreisvverordnung ingredients for biologicals section 13, Medicinal Arzneimittelpreisverordnjng Act.
An advertisement for medicinal products in the print media or on television must be clearly separated and distinct from the editorial parts of these media. Further, doctors and pharmacists will obtain support for the costs of installing electronic data transmission infrastructure.
Furthermore, an objective connection to the field of activity of the participating physicians must exist.
To what extent are pharmaceuticals prices controlled? Hospitality is only allowed as part of training and further educational events organised by a pharmaceutical company. Are there proposals for reform and when are they likely to come into force?
Press releases referring to unauthorised medicinal products or unauthorised indications have to be considered cautiously. Prior to the federal elections in Autumn a decision has not been taken by the previous legislator. Although it entered into force on 16 Juneits application depends on setting up a fully functional EU clinical trials portal and database, to be confirmed by an independent audit. The competent authorities issue necessary directives to rectify any identified infringements and prevent future infringements section 69 1Medicinal Products Act.
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 27, Medicinal Products Act. Furthermore, advertisements for medicinal products — whether for non-prescription or prescription-only products — have to provide certain basic information relating to the product see question 3.
However, the question whether and to which extent customary cash discounts Skonti are permissible, has not been addressed. Such off-label use is part of the intended use if the pharmaceutical company does not expressly exclude it.
The competent authorities must issue directives to rectify any offences that have been identified and prevent offences in the future section 69, Medicinal Products Act.
The following must be submitted in relation to the medical product:. Are parallel imports of medicinal products into your jurisdiction allowed? If so, what conditions apply? Increases in price may only be made with the consent of the Secretary of State. 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.
The frequency, arnzeimittelpreisverordnung, nature and duration of the corresponding measures depend on the arzneimithelpreisverordnung of each case. Although in this case the value thresholds do not apply, it has to be noted that the items value has to be of subordinate importance compared to the medicinal product to which it arzneimittelpreisverordnujg supposed to be an accessory.
Reinforcing the criteria for designation and processes for oversight of notified bodies.
Arzneimittelpreisverordnung (Ampreisv) (German, Paperback)
What remedies are available to the claimant? Does it make a difference if the hospitality offered to those healthcare professionals will take place in another country and, in those circumstances, should the arrangements be approved by the company affiliate in the country where the healthcare professionals reside or the affiliate where the hospitality takes place?
Change of ownership applications where, for commercial reasons, a company wishes to make a duplicate of a marketing authorisation. Since the most recent reform, this applies to hospital physicians as well as to private practitioners and other healthcare professionals. In general, medicinal products must be made available to patients through pharmacies, including online pharmacies. Chapters 10 and 11 of the Medicinal Products Act contain essential provisions on pharmacovigilance.
Mandatory safety features a unique identifier and anti-tampering device on the outer packaging.
Arzneimittel-Festbeträge
The GDPR is relevant to personal data, that is, any information relating to an identified or identifiable natural person. In principle, the organiser of a scientific meeting is fully responsible for the content and the other elements of the meeting, such as hospitality granted to the participants.
For pharmaceuticals which have been placed on the market before 31 Decemberthe first request of a medical sample by each healthcare professional after 31 December is considered to be the first request. The disclosure of the information shall be made on a publicly accessible website arzneimittelpreisevrordnung the responsibility of the company.
Furthermore, 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. As described above question 1. However, it is permissible to provide educational services e. Review documentation on the development and manufacture of the medicinal products.
Period arxneimittelpreisverordnung authorisation and renewals The competent authorities usually grant unlimited authorisations. Is the position the same with regard to the provision of off-label information i. In addition, the physician performing the PMS-Study must possess the appropriate professional skills and knowledge.
Arzneimittel-Festbeträge – GKV-Spitzenverband
In particular, the focus has been on hospitals and their management of assigning patients after the in-patient treatment for the following treatment by local practitioners.
However, such disease awareness campaigns might become critical in cases where only a specific medicinal product exists for the treatment of the underlying disease. Durch die Nichtannahme der Verfassungsbeschwerde zur Entscheidung erledigt sich der Antrag auf Erlass einer einstweiligen Anordnung.
Do data protection laws impact on pharmaceutical regulation in your jurisdiction?
Restrictions Medicinal products cannot be advertised before the necessary marketing authorisation is obtained section 3a, Law on advertising medicinal products.
In principle, the rules noted in question 4.