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Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.
How the MHRA treats traditional herbal medicines and homeopathic medicines.
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by marketing authorisation holders (MAHs).
Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Information about how approved bodies help regulate medical devices and how to apply for approval.
Supplementary information on the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
The locations for a Marketing Authorisation Holder (MAH) and a Qualified Person responsible for Pharmacovigilance (QPPV)
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
An overview of the legal requirements for children’s medicines that marketing authorisation holders (MAHs) need to abide by.
Guidance for holders of marketing authorisations (MAs) approved in Northern Ireland (NI) who want to bring a product to market in Great Britain (GB).
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
Supplementary information for international regulators on packaging changes and the export of UK medicines.
A pathway summarising the processes pharmaceutical companies should follow when preparing to launch new products in the UK.
Guidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements.
If pharmacies wish to ‘pack down’ larger packs of a medicinal product, they need to follow these instructions
How to use RamaXL, including system availability, running reports and how to subscribe.
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