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Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
An overview of the process to get a marketing authorisation (MA), including submitting, fast-tracking an application, naming your medicine and paying fees.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.
Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
Guidance on manufacturing, importing, distributing and supplying specially manufactured or ordered products, including cannabis-based products for medicinal use in humans (CBPMs), known as 'specials'
Who can supply or administer medicines to patients without a doctor under a PGD, which medicines they can supply, and legal requirements for PGDs.
Using the Integrated Scientific Advice service from the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE).
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
Detailed guidance on advertising and promoting medicines.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
How the MHRA processes variations to medicines' marketing authorisations for the UK and Northern Ireland.
How to get a marketing authorisation (MA) for an advanced therapy medicinal product (ATMP) so it can be sold and/or supplied in the United Kingdom.
By streamlining decision-making, the MHRA–NICE aligned pathway will help patients access new medicines 3–6 months sooner.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
This guidance clarifies the expectations on the application of the further pharmacovigilance provisions set out within the updated CIR 520/2012 for UK authorised products.
Marketing Authorisation Holders should review their manufacturing processes to mitigate the risk of nitrosamine impurities being present.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines
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