(8)The specific rules should include a prohibition against displaying the safety features referred to in Directive 2001/83/EC on the outer packaging or, where there is no outer packaging, on the immediate packaging of medicinal products for human use intended to be placed on the market in Northern Ireland and a prohibition against placing on the market in Northern Ireland new and innovative medicinal products that have been granted a marketing authorisation in accordance with Regulation (EC) No 726/2004. Furthermore, the specific rules should include certain labelling requirements for medicinal products for human use intended to be placed on the market in Northern Ireland. As a consequence, Commission Delegated Regulation (EU) 2016/161note should not apply to medicinal products for human use intended to be placed on the market in Northern Ireland.
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