Chemistry and Manufacture of Veterinary Medicines (Chemical) guidance document
The Ministry for Primary Industries (MPI) is seeking feedback on the information needed to register a chemical veterinary medicine product.
Anyone applying to register a veterinary medicine product under the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997 must provide detailed information on the product’s chemistry and manufacturing process. The current information requirements are being updated in 2 parts:
- The Chemistry and Manufacture of Veterinary Medicines (Chemical) guidance document, which is the subject of this consultation
- Chemistry and Manufacture of Veterinary Medicines (Biological) guidance document, which is under construction. It will be put out for consultation as soon as the draft is completed.
Have your say
MPI wants your feedback on the draft guidance document for the Chemistry and Manufacture of Veterinary Medicines (Chemical). We're particularly interested in answers to these questions:
- Is the level of detail appropriate?
- Are there any areas that need more guidance?
- Draft Chemistry and Manufacture of Veterinary Medicines (Chemical) – guidance document [PDF, 1.3 MB]
Making your submission
Email your feedback by 5pm on 31 August 2018 to ACVM.Consultation@mpi.govt.nz
Make sure you tell us in your submission:
- the title of the consultation document
- the document section numbers for any specific comments or queries you make
- your name and title
- your organisation's name (if you are submitting on behalf of an organisation, and whether your submission represents the whole organisation or a section of it)
- your contact details (such as phone number, address, and email).
While we prefer email, you can post written submissions to:
ACVM Programmes and Appraisals
Ministry for Primary Industries
PO Box 2526
Submissions are public information
Note that any submission you make becomes public information. People can ask for copies of submissions under the Official Information Act 1982 (OIA). The OIA says we have to make submissions available unless we have a good reason for withholding it. That is explained in sections 6 and 9 of the OIA.
Tell us if you think there are grounds to withhold specific information in your submission. Reasons might include that it's commercially sensitive or it's personal information. However, any decision MPI makes to withhold information can be reviewed by the Ombudsman, who may tell us to release it.