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The Medicines (Products for Human Use) (Fees) Regulations 2012
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- Northern Ireland Statutory Rules
- 2012 No. 134
- PART 6
- Regulation 21
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Meaning of “set of proposed changes”
21. For the purposes of this Part and Part 5 of Schedule 2, a “set of proposed changes” means a number of proposed changes to the labelling or package leaflet of a medicinal product, where—
(a)if there is more than one version of the labelling or package leaflet for that product, those changes all relate to the same version; and
(b)those changes are submitted to the licensing authority at the same time.
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