The State Institute for the Control of Medicinal Products in Prague informed by notice of 22. 12. 2016 The Ministry of Health of the Slovak Republic that issued the Declaration of non-compliance with the rules of the SDP (Good Distribution Practice) by the following holders of the authorisation to distribute medicinal products:
- Č eská republika s.r.o., IČ 634 79 010, registered office Podolí 78e, 664 03 Valleys which were issued on 21 December 2016 on the basis of the checks carried out Declaration of disagreement with the rules of the SDP for non-approved storage facilities at the address "Rudná Logistics Park," hall DC3, K Vytupova 979, 252 19 Rudná u Prague,
- B. BRAUN Medical s.r.o., ID No 485 86 285 established at V Park 2335/20, 148 00 Praha 4, which was issued on 21. 12. 2016 following an inspection carried out Declaration of disagreement with the rules of the SDP for non-approved storage facilities at the address "Rudná Logistics Park," hall DC3, K Vydnej 979, 252 19 Rudná u Prague.
Authorisation holders are reminded of the obligation to comply with Article 18 (1) (a). (v) point 1 of Law No 362/2011 Coll. on medicinal products and medical devices and amending certain laws as amended.