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Enduring GMP compliance of overseas veterinary chemical manufacturers
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has released the following documents:
The APVMA received submissions on the Draft (Consultation) Regulation Impact Statement that was published in September, 2004. These are discussed in this document. The Office of Regulation Review has reviewed the Statement and advises that the Statement satisfies RIS Requirements as specified in the Council of Australian Government’s A Guide to Regulation.
The following key points concerning the document should be noted:
- Registrants of veterinary chemicals that are manufactured overseas will be required to assure GMP compliance throughout the life of a product.
- Conditions of product registration will assure this GMP compliance.
- The type of evidence required to demonstrate GMP compliance has not been altered.
2. A Gazette Notice on the Introduction of new procedures to assure the ongoing GMP compliance of overseas manufacturers of veterinary chemical products.
3. A Gazette Notice on The Reconsideration of Veterinary Chemical Product Registrations relating to assuring the GMP compliance of overseas manufacturers of veterinary chemical products.
4. A list of Questions and Answers on the APVMA’s new procedures for assuring the GMP compliance of overseas manufacturers of veterinary chemical products (‘Overseas GMP scheme’). This has been provided to assist registrants of veterinary chemical products that are manufactured overseas.
For further information contact:
Dr Toni Pike
Quality Assurance Reviewer
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Kingston ACT 2604
Fax: (02) 6271 6442
Email: toni.pike@apvma.gov.au