MediTox s.r.o.


QUALITY & ETHICS

MediTox s.r.o. strictly adheres to comprehensive quality assurance program covering every aspect of the activities from business negotiations through material supply, personal training, data management and reporting. The facility is regularly inspected by the national authorities, the State Institute for Drug Control (SÚKL) which is the member of OECD Board and NIO ASLAB (Ministry of Environment of the Czech Republic).

Certification:

Good Laboratory Practice Certificate acording to the Principles of OECD C(81)30(Final) issued by State Institute for Drug Control (SÚKL) for pharmaceuticals, medical devices, food additives

Good Laboratory Practice Certificate according to the Principles of OECD C(81)30(Final) issued by Ministry of Environment (NIO ASLAB) for chemicals, agrochemicals, REACH

Authorization for Using of Experimental Animals issued by the Ministry of Agriculture.
Reg. No. 51050/2015-MZE-17214 valid by 31.07.2020

Authorization for Breeding of Experimental Animals issued by the Ministry of Agriculture.
Reg. No. 38715/2015-MZE-17214 valid by 31.07.2020

Other Certification and Approvals

The company has been incorporated into the list of Users for restricted handling with GMO in compliance with Act No. 78/2004 Collection of Laws.

Official Authorization for Psychotropic substance issued by Ministry of Health of the Czech Republic according to Gazette Law No. 167/1998 Coll. of Laws.

Ethics:

Animal care is in compliance with MediTox SOPs and with following guidelines and regulations:

  • Conditions of breeding and work with laboratory animals follow the regulations:
  • Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes
  • Czech Law No. 246/1992 as amended, Public Notice of Ministry of Agriculture of the Czech Republic No. 419/2012 Collect. of Law.
  • Guidelines for the Care and Use of Laboratory Animals, 7th Edition (Institute of Animal Resources, Commission on Life Sciences, National Research Council; National Academy Press; Washington, DC; 1996)

Welfare Codex

  • Laboratory animals are used exclusively for research and development of pharmaceutical preparations designed for human and veterinary medicine.
  • If there is an approved alternative method for the given type of studies, they are given preference to the methods using animals.
  • All the experiments and studies conducted with the use of animals have to be approved by Central committee of protection of animals and the corresponding Expert committee of MediTox s.r.o.
  • The conditions under which the experiments are carried out are specified and checked by the relevant state authorities.
  • The conditions of environment in which the animals are kept correspond to the respective standards specified in legislative of EU, support the welfare of animals and agree with particular specific requirements of individual species of animals.
  • The number of animals used in studies is minimized with regard to the type of the given study.
  • All the activities in a study are performed with respect to the needs of the animals and are directed to minimization of their stress and distress.
  • All the staff members who deal with animals have undergone the respective training and courses, and their education in this area is continuously deepened. Only the workers having positive relationship to animals are allowed to work with animals.
  • All the animals used in experiments come from MediTox own accredited breeding facility or are purchased from other accredited specialized suppliers.
  • The above-mentioned principles are also stuck to if MediTox chooses their business partners.