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The Medicines (Applications for Grant and Renewal of Licences) (Miscellaneous Amendments) Regulations 1992
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- UK Statutory Instruments
- 1992 No. 755
- Regulation 6
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Insertion of regulation 5A into the Renewal Regulations
6. After regulation 5 of the Renewal Regulations there shall be inserted the following regulation—
“Further requirements as respects the particulars to be contained in or accompany an application for the renewal of a product licence for products for human use
5A. The particulars which, by regulations 4 and 5 of, and the Schedule to, these Regulations, are required to be contained in or to accompany an application for the renewal of a product licence shall—
(a)if they relate to a blood product, comply with the provisions of Part III of the Schedule to these Regulations;
(b)if they relate to a vaccine, toxin, serum or allergen product, comply with the provisions of Part IV of that Schedule;
(c)if they relate to a radiopharmaceutical, comply with the provisions of Part V of that Schedule.”.
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