We use some essential cookies to make this website work.
We’d like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services.
We also use cookies set by other sites to help us deliver content from their services.
You have accepted additional cookies. You can change your cookie settings at any time.
You have rejected additional cookies. You can change your cookie settings at any time.
Departments, agencies and public bodies
News stories, speeches, letters and notices
Detailed guidance, regulations and rules
Reports, analysis and official statistics
Consultations and strategy
Data, Freedom of Information releases and corporate reports
Did you mean pharmaceutical counterpart
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
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.
Apply to manufacture Extemporaneous preparations, Autogenous vaccines, authorisations for Equine Stem Cell Centre (ESCCA) or Non-Food Animal Blood Bank (NFABBA).
Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Anyone in Northern Ireland selling medicines to the public via a website must still comply with the requirement to apply the EU common logo.
How the MHRA makes decisions on what is a medicinal product (borderline products).
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
Guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.
The way you apply to licence biological products has changed
How traditional herbal medicines and homeopathic medicines will be treated by the MHRA.
Explainer for the pharmaceutical industry on the ongoing implementation of the Veterinary Medicines Regulation relating to applications and authorisations for veterinary medicines.
How to account for VAT on goods and services provided by registered health professionals, including doctors, dentists, nurses and pharmacists.
There are changes to the legislation of Reference Medicinal Products (RMPs) used to support abridged marketing authorisation applications
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
A wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’
Don’t include personal or financial information like your National Insurance number or credit card details.
To help us improve GOV.UK, we’d like to know more about your visit today. Please fill in this survey.