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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.
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'
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
An overview of the systems and processes DHSC and NHS England use for responding to medicine shortages.
Detailed guidance on advertising and promoting medicines.
Who can supply or administer medicines to patients without a doctor under a PGD, which medicines they can supply, and legal requirements for PGDs.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
By streamlining decision-making, the MHRA–NICE aligned pathway will help patients access new medicines 3–6 months sooner.
Using the Integrated Scientific Advice service from the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE).
How the MHRA processes variations to medicines' marketing authorisations for the UK and Northern Ireland.
Information on comparator products used in studies supporting abridged marketing authorisation application.
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
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