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Health law  · Pharmaceutical law  · Foodstuff law  · Medical devices  · Medical Law  · Health care system  · Pharmacies Law  · Case law  ·

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Georgstr. 48
30159 Hannover

Fon +49/511/357356-0
Fax +49/511/357356-29

Health law

Health law is a diversified area of law, which can be outlined as follows on the basis of food law and medicines law:

The legislative structure of food law itself is so complex – not only due to the constant stream of European regulations – that it never ceases to challenge even legal experts themselves. In the era of the extensive consumer information, it is always necessary to check if the advertising of your foodstuff or pharmaceutical product is not misleading. Moreover, there are numerous detailed regulations with respect to food additives or functional food advertising. We will be happy to check whether your new foodstuffs, also with respect to their composition, can be placed on the market. We will check whether your whole product communication is admissible, too. We are of course well familiar with the guidelines and directives of the European Commission as well as with the case law of the European Court of Justice. We know that foodstuffs can be in fact high tech products. We handle both liability and consumer protection issues.

The Pharmaceutical Act stipulates that medicines cannot be distributed to consumers until their quality, effectiveness and safety have been sufficiently tested and they have been authorised by the competent higher federal authority. Medicines for which a marketing authorisation has been granted are closely watched, so that it is possible to recognise any risks and take necessary measures promptly in order to protect the consumer. Furthermore, regulations are being continuously tightened up obliging pharmaceutical companies to inform the competent authority of any case of serious suspected side effects or interactions with other products. The requirements for the labelling of medicines have been extended and the export provisions explicitly included in the pharmaceutical regulations. Each pharmaceutical entrepreneur is obliged to employ an information officer who will provide scientific information on the medicines and will be responsible for the content of the advertising. The provisions applying to blood products have been tightened up, too, especially those concerning the manufacturing permission and the import of blood products. The Pharmaceutical Act also contains provisions concerning the marketing authorisations issued for a medicine by a member state of the European Union and the so-called central authorisation issued by the European Agency for the Evaluation of Medicinal Products (EMEA). Thanks to our understanding of the pharmaceutical branch we are able to offer comprehensive advice and assistance to parties participating in the development of a pharmaceutical product. Moreover, we deal with matters concerning the trade in medicines as well as with all other issues of health law.

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© Attorney at law Michael Horak 2002-2018

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