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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: ....

United Kingdom , Northern Ireland , Great Britain , Canada Health , Committee For Medicinal Products , National Health Service , Regulatory Authority , National Rules Scheme , Department Of Health , European Union , Swiss Agency For Therapeutic Products Of Switzerland , Scottish Medicines Consortium , Food Branch , European Commission , Drug Administration , National Institute Of Heath Research , Council Of Europe , Community Procedures , Health Products , Group For Mutual Recognition , National Institute For Health , Health Research Authority , National Procedure , Health Sciences Authority , Access Consortium , Commission On Human Medicines ,