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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.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
How the MHRA processes variations to Marketing Authorisations (MAs)
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
This toolkit is for Innovation Passport holders following the Innovative Licensing and Access Pathway (ILAP) and provides activities to support the design and development of medicines.
Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.
How to identify and report harmful trade practices that affect your business when exporting, importing or operating domestically.
How to find export opportunities and overseas customers for your business on great.gov.uk: get help selling online overseas, get help from a trade specialist.
Reduce development overhead and time to deployment by standardising how teams design, launch and manage APIs in your organisation.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
Marketing standards for hatching egg and chick producers, manufacturers, retailers and distributors.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
Crossrail International (CI) was established by the Department for Transport to help promote UK businesses abroad. It is a specialist advisory practice that works with UK partners to provide strategic advice to clients on the development and delivery of complex...
Guidance for holders of Marketing Authorisations approved in Northern Ireland or the EU/EEA member states who want to bring a product to market in Great Britain.
Reclaim VAT you've paid on goods and services bought in the UK to use in your business if you’re registered as a business outside the UK.
Explains how to make sure people can find your data and how to maintain it.
Guidance for the pharmaceutical industry on how to apply for an authorisation to place a veterinary medicine on the UK market or part of, or to expire one.
Find out what makes a person an enabler of tax avoidance, and what to do about legally privileged communications.
Marketing standards for poultry meat producers, manufacturers, retailers and distributors.
This section provides guidance for communications network providers on legislation, regulation, working with local authorities and with property developers.
Don’t include personal or financial information like your National Insurance number or credit card details.
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