The competent authority of the Czech Republic confirms the IMTM has been inspected in accordance with Art. 3 of Directive 2004/9/EC and Section 101 paragraph 3 of the Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), as amended and during this inspection assessment of conformity with GLP according to Directive 2004/9/EC has been performed.
From the knowledge gained during inspection of the IMTM facility, the latest of which was conducted on 02/06/2022, it is considered that it complies with the principles of good laboratory practice given by:
- OECD Principles of Good Laboratory Practice (C(97) 186 final)
- Directive 2004/10/EC and
- Decree No 86/2008 Coll. on GLP principles