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The Veterinary Medicines Regulations 2007

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Publication following the grant of a marketing authorisation

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25.—(1) When he grants a marketing authorisation the Secretary of State must publish—

(a)the notice granting the marketing authorisation;

(b)the summary of the product characteristics;

(c)the assessment report that he has already prepared but with any commercially confidential or personal information deleted.

(2) He must update the assessment report whenever new information that is of importance and relates to the quality, safety or efficacy of the veterinary medicinal product becomes available.

(3) He must send a copy of the assessment report, and any update, to the holder of the marketing authorisation before he publishes it to enable the holder to make representations to him concerning any confidential or personal information that may be in it, and may specify a date by which representations must be made.

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