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:
Web: http://www.uskvbl.cz
New bulletin ÚSKVBL will be editing at the beginning 2015.This bulletin will be in electronic form as public document on website of ÚSKVBL.