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Guidance for the pharmaceutical industry on how to apply to vary a veterinary Marketing Authorisation (MA) or Homeopathic Remedy.
Use a separate statement of objection form for each Japanese GI product name you object to.
Advice on writing clear notices and maximising replies to your FSNs.
Get help to classify herbal medicines, vitamins, food preparations, supplements and tonics for import and export.
Guidance on the decentralised and mutual recognition reliance procedure (MRDCRP) for marketing authorisation applications including information on how to apply.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Submissions related to human medicines need to be submitted directly to the MHRA.
Applications received to amend the specification of a patent under sections 27 and 75 before the court and the Office.
Explainer for the pharmaceutical industry on the ongoing implementation of the Veterinary Medicines Regulation relating to applications and authorisations for veterinary medicines.
The actions to take for sourcing medicines in different circumstances.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
Find out about applying for the Spirit Drinks Verification Scheme, how to submit brand information, fees and making sure your production process is compliant.
Definitive fees charged for applications under Schedule 7 of the Veterinary Medicines Regulations 2013.
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
Apply for a higher education course, track your application and accept or reject your offers.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
Guidance for the pharmaceutical industry on who can be a Marketing Authorisation Holder, named distributor or local representative and how to make changes to these.
Find registered patents, patent applications and pending patents
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