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Detailed guidance, regulations and rules
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Data, Freedom of Information releases and corporate reports
How to carry out a clinical trial to apply for a marketing authorisation, manage your authorisation and report safety issues.
How to apply for marketing authorisation via this new procedure.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
How to use an ethnographic study to evaluate your digital health product.
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
How to conform with the legal requirements for placing medical devices on the market.
Check if you need a tuberculosis (TB) test to support your visa application and find an approved clinic in your country
Apply for a Temporary Work – International Agreement visa if you're working under international law (including diplomatic households) - extend or switch, family members
Advice on writing clear notices and maximising replies to your FSNs.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home
Explainer on product information templates to be used by applicants and Marketing Authorisation Holders (MAHs) of veterinary medicines.
Submissions related to human medicines need to be submitted directly to the MHRA.
The epidemiology, symptoms, diagnosis and management of human T-cell lymphotropic virus types 1 and 2 (HTLV-1 and HTLV-2).
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Guidance for people with symptoms of a respiratory infection including COVID-19, or a positive test result for COVID-19.
Qualified Persons (QPs) should follow the below guidance on the flexible approaches we are taking for medicines imported from third countries.
Apply for a higher education course, track your application and accept or reject your offers.
How to do a Getein Biotech rapid nose-only test for COVID-19. Rapid tests show the result on a device that comes with the test.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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