Official Medicinal Control Laboratory - OMCL

The ISCVBM carries out a laboratory control of medicinal products quality pursuant to the § 16 of the Act No 378/2007 on Pharmaceuticals. A laboratory quality control of veterinary medicinal products, active substances or excipients are carried out in the following case:

a) need of a method confirmation, analysis of active ingredients or excipients in connection with an application submission within a marketing authorisation procedure;

b) quality control carrying out within a veterinary medicinal products market surveillance;

c) suspicion of a quality defect recognized within an inspection by a manufacturer;

d) suspicion of a quality defect within the context of a report of undesirable effect (pharmacovigilance);

e) re-testing of selected immunological veterinary medicinal products involved in the official batch release mode (Official Control Authority Batch Release - OCABR) in compliance with the § 102 of the Act No 378/2007 on Pharmaceuticals;

f) upon a request

The laboratory has participated in a quality control of veterinary medicinal products in frame of survey of a market of the European Union, PTS and Collaborative studies through the European Directorate for the Quality of Medicines & HealthCare (EDQM) – OMCL European Network.

Attachments:

Žádanka o vyšetření biologického materiálu	[ ]	36 Kb
Žádanka o vyšetření krmné směsi, VP, VTP	[ ]	38 Kb

Last Updated on Tuesday, 11 August 2009 07:13

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