The Veterinary Medicines Regulations 2013

Publication following the grant of a marketing authorisationU.K.

This section has no associated Explanatory Memorandum

25.—(1) On granting 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 has already been prepared but with any commercially confidential or personal information deleted.

(2) The Secretary of State 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) The Secretary of State must send a copy of the assessment report, and any update, to the holder of the marketing authorisation before publication to enable the holder to make representations concerning any confidential or personal information that may be in it, and may specify a date by which representations must be made.