Ablis helps you find the government licences, permits, approvals, registrations, codes of practice, standards and guidelines you need to know about to meet your compliance responsibilities. Australian veterinary chemical manufacturers need to comply with the gmp code to apply for a manufacturing licence, as well as to retain it. Under this scheme, overseas manufacturers need to prove they meet gmp standards equal to those applied to manufacturers in australia.
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Manufacturers of veterinary chemical products (veterinary medicines) are required to hold an apvma gmp manufacturing license.
Manufacturers licensed by the apvma who wish to export veterinary medicines to europe must be inspected by the tga.
Australian veterinary chemical manufacturers need to comply with the. (2) a holder of a licence must display publicly, at the premises to which the licence relates, a copy of the licence and of any notice issued by the apvma imposing, varying or removing the conditions. The apvma must be satisfied the applicant’s site of. Once the high level risk assessment has been performed, a detailed gmp compliance audit (by our consultants) against each line item of apvma code can be conducted.
This inspection must be requested by the apvma, not by the manufacturer. Ab initio holds a number of licences for the formulation, manufacture and release of pharmaceutical products.
