Apply for a licence to market a medicine in the UK
How to license a medicine for sale in the UK, including applications through national and international routes.
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This guidance also covers licensing a medicine in Northern Ireland through the centralised, decentralised and mutual recognition European procedures.
Which procedure to follow
There are several routes to obtain a marketing authorisation in the United Kingdom (UK), Great Britain (England, Scotland and Wales) or Northern Ireland. The options available will be determined by the intended market and the type of application. The markets in which each route is applicable are indicated in the following guidance:
Source: UK Government
The ambition of this new licensing and access pathway is to reduce the time to market for innovative medicines. The ILAP combines the MHRA’s globally recognised strengths of independence and high standards of quality, safety, and efficacy, with improved efficiency and flexibility, readying the MHRA for a new era in medicines approvals in the UK.
Central to realising this ambition is how the ILAP provides a single integrated platform for sustained collaborative working between the MHRA, partners and the medicine developer.
By harnessing expertise at the right time from the MHRA’s partners, the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and NHS England and NHS Improvement (NHSE&I), the ILAP allows for enhanced coordination and monitoring of important product development activities. Patients are also key partners and the patient voice will be integrated at every stage.
Guidance on Project Orbis
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Project Orbis is a programme coordinated by the US Food and Drug Administration (FDA) to review and approve promising cancer treatments.
It involves the regulatory authorities of:
Australia (TGA)
Brazil (ANVISA)
It provides a framework for concurrent submission and review of oncology products among international partners. It aims to deliver faster patient access to innovative cancer treatments with potential benefits over existing therapies across the globe.
The MHRA will participate fully in the scheme from 1 January 2021.
While the FDA serves as the primary coordinator for application selection and review, Project Orbis Partners (POPs) may propose products for inclusion in the scheme. Each country remains fully independent on their final regulatory decision.