The EMA safety committee recommends new measures to limit topiramate use in young women based on recent data suggesting more neurodevelopmental disorders for offspring when it s used during pregnancy.
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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: