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Consultations and strategy
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An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
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.
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'
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
Marketing Authorisation Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.
Detailed guidance on advertising and promoting medicines.
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.
How the MHRA processes variations to marketing authorisations.
Information on comparator products used in studies supporting abridged marketing authorisation application.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
How to change the ownership from one marketing authorisation (MA) holder to another.
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