Legal Notice/Terms & Conditions
Biebertaler Blutegelzucht GmbH
Managing Director: Harald Th. Galatis
|Responsible Person for the Internet presentation:
Biebertaler Blutegelzucht GmbH/Harald Th. Galatis
|Manufacturing authorisation for ingredients of animal origin (leeches), human and veterinary medicinal products according to Art. 40 and Art. 111 (1) of Directive 2001/83/EC transposed in the following national legislation: Sect. 13 para 1 German Drug Law (Arzneimittelgesetz AMG)||Terms & Conditions|
Protection of Privacy
- Any personal data are entered voluntarily.
- All information entered is filed and used exclusively for your support service, the sending of information or service offers. Biebertaler Blutegelzucht GmbH warrants to handle all your data according to the applicable current data protection act regulations.
- Copyright belongs to Biebertaler Blutegelzucht GmbH. All rights reserved. Texts, figures, and charts as well as their positioning in the website are subject to the protection of copyright and further protection regulations.The content of this website cannot be copied, distributed, modified, or customised to third parties. Some websites of the Biebertaler Blutegelzucht GmbH contain pictures covered by copyrights of third parties.
Disclaimer of Liability
- This website has been compiled with maximum care and attention. However, the Biebertaler Blutegelzucht GmbH cannot warrant the complete accuracy and absence of defectiveness of information. The Biebertaler Blutegelzucht GmbH excludes any liability for detriments occurring directly or indirectly with the use of this website, except malice or act of gross negligence originating from the Biebertaler Blutegelzucht GmbH. .
- The Biebertaler Blutegelzucht GmbH as content provider according to § 5 sect. 1 of the German telecommunication law (Teledienstgesetz/TDG 22 JUly1997) is only responsible, in accordance with the general law regulations, for the "home made" content to be offered for use.
- This "home made" content matter has to be differentiated from the links referring to the topics of other content providers. By offering these links, the Biebertaler Blutegelzucht GmbH gives access to the use of external contents. The Biebertaler Blutegelzucht GmbH is only responsible for these external topics in case the editors know about the illicit or indictable content and if it is reasonable and feasible to prevent the use of these topics (§ 5 sect. 2 TDG).
- These links are dynamic, i.e. possibly changing cross references. With the first coupling of these links with external topics, the Biebertaler Blutegelzucht GmbH has inspected if any civil liability or penologic responsibility might be involved. According to the TDG law, the editors are not obliged to check continously the links contents for any changes that might redefine their responsibilities. As soon as the Biebertaler Blutegelzucht GmbH becomes aware of or has been informed about a concrete offer related to one of the links triggering civil liability or penologic responsibility, the editors will cancel the link to this offer, if technically feasible.
- The technical feasibility and appropriateness is not affected if after the cancellation of the link from Biebertaler Blutegelzucht GmbH website another access to other servers offering illicit and indictable topics still is possible.
Legal Liability when Purchasing Leeches for Therapeutic Use in Patients
Occasionally, our clients are approached by leech suppliers without legal producer authorisation, not permitted to place medicinal leeches as pharmaceutical products on the market. The legal position of the purchase of leeches is as follows:
Leeches per se dispensed by the distributor are not considered as pharmaceutical products. However, as soon as the leeches are used for therapeutic purposes, they have the legal status of pharmaceutical products. In this case, the complete legal liability is with the therapist, i.e. any risks of possible adverse reactions are now with the therapist. These "medicinal leeches" of the above mentioned suppliers are not pharmaceutical products. Consequently, these suppliers do not have to comply with any standard of quality or safety.
In case of ordering leeches from these suppliers, we strongly recommend to ask for a written certificate of legal authorisation for the distribution as pharmaceutical product. Before ordering,m you should make sure that you obtain the valid certificate number of the GMP (Good Manufacturing Practice) authorisation by the Health Authority in charge.
With the supply of medicinal leeches holding a valid legal authorisation, the Package Insert has to be enclosed. If the Package Insert is missing, the leeches cannot be regarded as legal pharmaceutical products. The physician or alternative practitioner is the responsible person for treating the patient according to the proper legal requirements. This responsibility also covers the compliance with the statutory basis of the pharmaceutical product.