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The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
You must batch and label the beef and veal you sell or supply according to specific rules, which vary from product to product.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
First published during the 2019 to 2022 Johnson Conservative government
Use a separate statement of objection form for each Japanese GI product name you object to.
Find out about the Spirit Drinks Verification Scheme if you produce a UK spirit drink with a protected Geographical Indication.
Find out about applying for the Spirit Drinks Verification Scheme, how to submit brand information, fees and making sure your production process is compliant.
Topiramate is now contraindicated in pregnancy and in women of childbearing potential unless the conditions of a Pregnancy Prevention Programme are fulfilled. This follows a review by the MHRA which concluded that the use of topiramate during pregnancy is associated...
Guidance for service users on the approved indications for polio serological testing.
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