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
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
Actions that trial sponsors should consider to build resilience into clinical trial design
Information for NHS trusts on the Crown Commercial Service (CCS) health temporary staff frameworks approved by NHS Improvement.
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
Helping public health practitioners conducting evaluations – using outcome evaluations to find out if an intervention works.
Information about the EU Regulations and their implementation in Northern Ireland
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment.
How to use a budget impact analysis to evaluate your digital health product.
Advice for manufacturers of Class I medical devices for placing products on the UK market
How investigators and sponsors should manage clinical trials during COVID-19
VDEC provides a number of services for vaccines post-licensure
Guidance for the pharmaceutical industry on Marketing Authorisations for veterinary medicines in the UK.
Guidance for the veterinary pharmaceutical industry on the production and submission of the Summary of Product Characteristics (SPCs) and product literature mock-ups.
How the MHRA makes decisions on what is a medicinal product (borderline products).
How to get a marketing authorisation for an Advanced Therapy Medicinal Product (ATMP) so it can be sold and/or supplied in Great Britain.
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)’
Pharmacovigilance system requirements
Check the regulations on aircraft parts imported with a certificate of airworthiness.
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 (opens in a new tab).