This page provides links to all the information needed for obtaining a marketing authorisation (including parallel import licences) in the UK. It also includes information about marketing authorisations, including RamaXL, our subscription service providing subscribing organisations with direct access to real-time information on their own products and non-confidential information on all other products authorised in the UK.
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Submitting the application All applications must follow the common technical dossier (CTD) format which has been a requirement since 2003. The preferred format for new marketing authorisation (MA) applications is the electronic Common Technical Dossier (eCTD). However, we accept that many companies are not yet ready to submit applications in that format. Therefore, we will accept applications in PDF-only format. The Summary of Product Characteristics (SmPC) will need to be prepared using the Word template. You also need to use the MHRA Adobe Application form which is available via the MHRA Portal. This will produce an XML file that we will be able to upload directly into our database. eCTD applications must be created according to the current specifications: eCTD specification v 3.2, EU Module 1 specification v 1.0, eCTD EU application v 1.0. |
Enquiries about marketing authorisations
Parallel import licence (PLPI) Legislation and guidance, forms and fees
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Regluatory Information Service (RIS)
