Also available as TILEC DP | = .. Germany, the Remedies Advertising Act (Heilmittelwerbegesetz – HWG) were in. heilmittelwerbegesetz pdf MEDICINAL PRODUCTS ACT (The Drug Law) ( Arzneimittelgesetz AMG) Act on Advertising in the Field of Health (Health. Tag Archives: Heilmittelwerbegesetz. German court allows pharma company public promotional statements about Rx-drug to counter a “shitstorm” – a trend also.
|Published (Last):||19 January 2016|
|PDF File Size:||17.36 Mb|
|ePub File Size:||15.22 Mb|
|Price:||Free* [*Free Regsitration Required]|
Authorisation Heilmittelwrebegesetz section 21 1 of the Medical Products Act Arzneimittelgesetz AMGa finished medicinal product can only be placed on the market after a marketing authorisation has been issued by the competent German higher federal authority or the European Commission.
Un mundo feliz pdf descargar gratis
Are there rules on comparisons with other products that are particularly applicable to drugs? The interactions between pharmaceutical companies and healthcare professionals or healthcare organisations are also restricted due to recommendations and codes of conduct of the relevant trade associations see question 1.
Carolin Kemmner Clifford Chance.
The intentional breach of the regulations of the HWG on misleading advertising constitutes a criminal offence punishable by an imprisonment for a term of up to one year or by a fine. For product-related advertisements, the law requires, among other things, that the promoted medicinal product must not be ascribed therapeutic efficacy or effects that it does not possess, and that the advertisement gives no false impression that success is guaranteed or that the recommended use has no side effects section 3 No.
Can and, in practice, do, the competent authorities investigate matters drawn to their attention that may constitute a breach of both the law and any relevant code and are already being assessed by any self-regulatory body? Although in this case the value thresholds do not apply, it has to be noted that the items value has to 201 of subordinate importance compared to the medicinal product to which it is supposed to be an accessory. In Section 1 HWG, a new paragraph 7 has been added: An authorisation application for the medicinal product is pending or clinical trials Phase III for this medicinal product are still ongoing.
Usually, competitors take action directly through the civil courts and seek to obtain injunctive relief against unlawful advertisements see questions 1. Promotional activities aimed at the general public must not contain any advertising statements relating to prescription-only medicinal products or to severe diseases explicitly mentioned in the Healthcare Advertising Act. The negligent breach of these regulations may be punished heilmlttelwerbegesetz an administrative fine of up to EUR 20, Heilmirtelwerbegesetz of appeal In serious cases of breaches, disciplinary procedures can be started.
Furthermore, such advertisements to the general public must not contain expert opinions, statements that the product is recommended, tested or used by healthcare professionals, or certain pictorial representations. For generics, a simplified licence procedure is described in section 24b 1 of the AMG.
Pharmaceutical Advertising 2018 | Germany
If a competent authority considers an advertisement to be unlawful, it has the power to stop further publication of such advertisement. Name of the medicinal product. Hospitality is only allowed as part of training and further educational events organised by a pharmaceutical company. According to established case law in Germany, a geilmittelwerbegesetz is considered as “inexpensive” if it does not exceed the value of EUR1 to EUR2 purchase price.
If so, what limitations apply? Such information and consent shall be mandatory where this is required under data protection laws. Please note, however, that given the lack of any jurisprudence in this regard, the interpretation of this provision is likely to vary depending on the circumstances of individual cases.
What regulatory authority is responsible for supervising distribution activities? In addition, the physician performing the PMS-Study must possess the appropriate professional skills and knowledge.
Articles in scientific journals which comply with the conditions outlined in question 2. An adequate system to maintain control and accountability must be established which contains information about the date heilmittlwerbegesetz supply and the amount of supply. The stipulated compensation must be reasonable with respect to the services to be rendered. In addition, administrative fines of up to EUR25, can be imposed.
Section 4 HWG see question heilmittelwsrbegesetz. In the case of non-compliance, heilmittelwerbegesefz penalties can include imprisonment or a fine. However, it can be argued that such rebates would be granted against the purpose of the AMPreisV view of the Heilmittelwerbegestez Ministry of Health. The maximum fee is EUR57, Gifts and other advertising giveaways. If differences apply depending on the target audience e. Section 4 17 of the AMG defines placing on the market as keeping the product in stock for sale or for other forms of supply, the exhibition and offering for sale and the distribution to others.
Cat Duet Vocal duet [Singles Ricordi 5. A supply deficit exists, that is, no identical medicinal products with respect to active substances, and no comparable medicinal products with respect to strength, are available.
It is, however, recognised that a company may grant donations to medical institutions if these donations are made: If so, what are the requirements for pre-launch access? 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.
For the time being, with regard to mail order heilmittelwernegesetz based in other Member States, the German pricing may no longer be applied. Are companies obliged to disclose via a central platform?
Therefore, scientific information material such as heilmittelwerbefesetz of reports on the outcome of clinical studies, or scientific speeches and publications, may be made available at scientific meetings or conferences by mentioning the non-proprietary name of the active ingredient s INNprovided that the anticipated new product name is not heilmittelwergegesetz or otherwise identified.
The content of this website is for general information purposes only and does not purport to provide comprehensive full legal or other advice. In addition, competitors may seek relief in substantive proceedings. The decision on granting the authorisation is taken by heilmtitelwerbegesetz competent federal higher state authority of the state in which the wholesaler is established.
If so, what conditions apply?
Required contact information includes the name of the company, domicile, address, legal form, representatives, an email address which enables the user to contact the company quickly and easily, commercial register, registration number of the commercial register, competent regulatory authority, sales tax identification number, etc. Exceptions Two types of medicinal products described in section 21 2 of the AMG can be placed on the market without a marketing authorisation:.