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What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
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.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
How to apply for an authorisation to manufacture authorised veterinary medicines or medicines marketed under the Exemptions for small pet animals.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
These temporary good manufacturing practice (GMP) flexibilities will be allowed to address the current exceptional circumstances
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
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)’
Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
How to account for VAT on goods and services provided by registered health professionals, including doctors, dentists, nurses and pharmacists.
You must get permission to export certain drugs and medicines.
Pharmaceutical Assessor vacancy, working in the regulation of veterinary pharmaceutical medicines.
Qualified Persons (QPs) should follow the below guidance on the flexible approaches we are taking for medicines imported from third countries.
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment.
Guidance on the Specific Batch Control (SBC) scheme for release of product on to the UK market.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
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