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Product Information and Labelling

Any local representative located in the United Kingdom and nominated for Member States other than the United Kingdom will have to be changed to a local representative located in the EU. The corresponding amendments to labelling and package leaflet must be fully completed and implemented by the marketing authorisation holder before the end of the transition period.

'Multi-country packs' including the United Kingdom Multi-country packs are medicinal products that are labelled to allow their placing on the market in several Member States with the same packaging. This possibility is subject to the requirements set out in Directive 2001/83/EC in Title V or Directive 2001/82/EC in Title V and requires that the summary of product characteristics is the same in all the markets concerned.

Source: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/notice-stakeholders-withdrawal-united-kingdom-eu-rules-medicinal-products-human-use-veterinary_en

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