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How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Guidance for the veterinary pharmaceutical industry on the production and submission of the Summary of Product Characteristics (SPCs) and product literature mock-ups.
Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment.
Information on designs hearings including costs and how to appeal against an outcome.
A list of frequently asked questions about the Nationally Significant Infrastructure Projects Pre-application Prospectus
Get help to classify pharmaceutical products used to treat or prevent diseases or ailments (in humans or animals), including comparators used in clinical trials and placebos.
Check the tariff classification for preparations put up for retail sale.
The process for the simultaneous review of veterinary drug submissions by Health Canada’s Veterinary Drugs Directorate and the UK's Veterinary Medicines Directorate.
The process for the simultaneous review of veterinary medicine submissions by New Zealand’s Ministry for Primary Industries (MPI) and the UK's Veterinary Medicines Directorate.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
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