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An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
Guidance for industry on flexible approaches we are taking on good distribution practices.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Find out if anti-dumping duty, countervailing duty and safeguard measures apply to your goods and how to claim a repayment.
PRIME is the Programme for Improving Mental Health Care
The CMA gives notice of its intention to release 3 merger remedies which the CMA considers to have expired.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
The CMA is consulting on remedies that it should consider reviewing across its portfolio of market and merger remedies.
Submission dates and how the submissions using the EC decision reliance procedure work.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
To help you protect, manage and enforce your intellectual property (IP) rights in Philippines.
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.
How to renew marketing authorisations for products granted through different routes and at different times.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
An alert to the review and implementation of homecare medicines and the associated implementation arrangements has been sent to the NHS.
How the UK’s Trade Remedies Authority investigates whether trade remedy measures are needed to counteract unfair import practices.
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