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An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
皇冠体育app UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
A summary of the types of scientific advice available at the鈥疢HRA, the process for getting advice and the fees involved.
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 get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
皇冠体育app process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
Detailed guidance on advertising and promoting medicines.
How the MHRA processes variations to marketing authorisations.
Who can supply and or administer specific medicines to patients without a doctor under a PGD and which medicines can be administered.
Information on comparator products used in studies supporting abridged marketing authorisation application.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
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.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines
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