In case of quality defect occurence all relevant measures have to be taken to eliminate negative impact to animal health or life, to human being health or life or to environment.
ÚSKVBL as defined in the legislation is responsible for creation of functional system which should assure in case of quality defect report that:
relevant measures minimasing negative impact of veterinary medicinal product are obliged to stekolders in appropriate timeframe,
all interested parties are informed in appropriate timeframe about risk for animal or human being health or life or for environment and
rights of involved parties are respected (measures are adequate to identified risks).
Who has to report quality defect and how?
Anybody (e.g. veterinarians, breeders, animal owners, pharmacists, wholesalers, manufacturers) can report to ÚSKVBL a quality defect (or suspicion of quality defect) occurred in the territory of the Czech Republic. For this reason ÚSKVBL operates phone, fax and e-amil contact available 24 hours / 7 days a week / 365 days a year.
Is it obligation to report quality defects?
Yes, this obligation is defined in the Act on pharmaceuticals No. 378/2007 Coll., for all stakeholders (including veterinarians, wholesalers, manufacturers, pharmacies) and for marketing authorisation holders.
Stakeholders and MA holders are obliged to use defined form for reporting of quality defects which is part of guideline published by the ÚSKVBL.
Other persons can use phone, fax or e-mail contact but the information souhld be always as complete as possible and should at least identified concerned medicinal product, nature of quality defect a indicate who is sending the information including contact for futher completion of the case.