- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Pwynt Penodol mewn Amser (01/10/2014)
- Gwreiddiol (a wnaed Fel)
The Human Medicines Regulations 2012
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Point in time view as at 01/10/2014.
Changes to legislation:
The Human Medicines Regulations 2012, Section 252 is up to date with all changes known to be in force on or before 19 February 2025. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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252.—(1) Where, together with the particular name specified as described in paragraph (1), (2) or (3) of regulation 251, there was specified a particular edition of a particular publication, “the relevant monograph” in that paragraph means—
(a)the monograph (if any) headed by the name in that edition; or
(b)if there is no such monograph, the appropriate current monograph (if any) headed by that name.
(2) Where, together with the particular name specified as described in paragraph (1), (2) or (3) of regulation 251, there was specified a particular publication, but not an edition of that publication, “the relevant monograph” in that paragraph means—
(a)the monograph (if any) headed by the name in the current edition; or
(b)if there is no monograph of the kind mentioned in sub-paragraph (a), the appropriate current monograph (if any) headed by that name; or
(c)if there is no monograph of the kinds mentioned in sub-paragraphs (a) or (b), the monograph headed by that name in the latest edition of the specified publication that contained a monograph headed by that name.
(3) Where no publication was specified with the particular name specified as described in paragraph (1), (2) or (3) of regulation 251, “the relevant monograph” in that paragraph means the appropriate current monograph (if any).
(4) In this regulation “publication” means—
(a)the British Pharmacopoeia; or
(b)a compendium published under Part 15 (British Pharmacopoeia).
(5) In this regulation “current” means current at the time when the medicinal product is demanded, described in a prescription or offered or exposed for sale (as the case may be).
(6) In this regulation “the appropriate current monograph”, in relation to a particular name, means—
(a)the monograph (if any) headed by that name in the current edition of the British Pharmacopoeia; or
(b)if there is no such monograph, the monograph (if any) headed by that name in the current edition of a compendium published under Part 15 (British Pharmacopoeia).
(7) For the purposes of regulation 251 and this regulation, any monograph in an edition of a publication must be construed in accordance with any general monograph or notice, or any appendix, note or other explanatory material, that is contained in that edition and applies to that monograph.
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