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How to make a payment by credit or debit card or a bank transfer for all applications except Device Registration and Certificates of Free Sale applications.
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions early access to medicines that show early signs of having a major advantage over existing therapeut…
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.
Webinar recordings providing information about plans for implementing the new Clinical Trial Regulations.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
Information on comparator products used in studies supporting abridged marketing authorisation application.
A step-by-step guide on using the MORE Platform for Submissions of device related incidents.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines
A list of herbal medicines currently holding a traditional herbal registration (THR) granted by the Medicines and Healthcare products Regulatory Agency (MHRA).
Information on the new regulations for the post-market surveillance of medical devices which come into effect on 16 June 2025.
What you need to do before your product can be placed on the Great Britain market with a UKCA mark.
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.
How to renew marketing authorisations for products granted through different routes and at different times.
How to write clear and effective field safety notices (FSNs) for medical devices.
How to change the ownership from one marketing authorisation (MA) holder to another.
How to register as a manufacturer, importer or distributor of active substances.
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