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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.
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
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'
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.
There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.
Information on comparator products used in studies supporting abridged marketing authorisation application.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
How the MHRA processes variations to marketing authorisations.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
Detailed guidance on advertising and promoting medicines.
Who can supply and or administer specific medicines to patients without a doctor under a PGD and which medicines can be administered.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
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.
Information relating to the disapplication of falsified medicines under UK Law.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
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