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The ISCVBM bulletin serves as an information medium of the Institute of State Control of Veterinary Biologicals and Medicaments and in compliance with the § 99 of the Act No 378/2007 Coll., on Pharmaceuticals, provides the following information: Information on significant undesirable effects and defects of veterinary medicinal products (VMPs) and appropriate consequential actions Information on marketing authorisation suspensions and withdrawals List of VMPs which are not subject to medical prescription and list of selected VMPs Consumption of VMPs grouped by active ingredients and route of administration Lists of operators (activity licence holders, distributors, manufacturers, etc.) Information on granted parallel import authorisations of VMPs Information on current requirements of the European Pharmacopoeia Information on imposed sanctions Decisions on a relinquishment of the distribution licence List of exceptions to the marketing authorisation granted for VMPs Information relating to use conditions of immunological VMPs according to the § 47 (1) Detailed instructions for data collection, data validation and form of report on undesirable effects
Furthermore the ISCVBM publishes in the bulletin the following: · Specifying guidelines provided by the Act No 378/2007 Coll., on Pharmaceuticals · Information on finalised marketing authorisation procedures (new marketing authorisations - MAs, renewals, variations, MA transfers, MA withdrawals and MA expirations) · Information on authorised non-medicinal veterinary products · List of biocidal products for which the standpoint of the ISCVBM has been granted CONTACTS: Editor: Institute for State Control of Veterinary Biologicals and Medicaments , Hudcova 56a, 621 00 Brno, Czech Republic Tel: 00420/541518411 Fax: 00420/541512607 E-mail:
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Web: http://www.uskvbl.cz Publisher and distributor: Company: RNDr. Ing. F. Skopec, CSc. - NUCLEUS HK Divišova 882 500 03 Hradec Králové 3, Czech Republic Tel./fax/: +420 495 211 630, 495 217 146 E-mail:
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Web: Http://www.nucleus.cz
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