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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.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
A summary of the types of scientific advice available at the바카라 사이트¯MHRA, 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'
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
Who can supply and or administer specific medicines to patients without a doctor under a PGD and which medicines can be administered.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
Information on comparator products used in studies supporting abridged marketing authorisation application.
There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
Detailed guidance on advertising and promoting medicines.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
How the MHRA processes variations to marketing authorisations.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
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