The Prescription Only Medicines (Human Use) Order 1997

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Citation, commencement and interpretation

1.—(1) This Order may be cited as the Prescription Only Medicines (Human Use) Order 1997 and shall come into force on 18th August 1997.

(2) In this Order, unless the context otherwise requires–

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“inhaler” does not include an aerosol;

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“maximum strength” means–

(a)

the maximum quantity of a substance by weight or volume contained in a dosage unit of a medicinal product;

(b)

the maximum percentage of a substance contained in a medicinal product calculated in any of the following ways–

(i)

weight in weight,

(ii)

weight in volume,

(iii)

volume in weight, or

(iv)

volume in volume,

and if the maximum percentage calculated in those ways differs, the higher or highest such percentage;

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[F8(2A) In this Order, unless the context otherwise requires, any expression defined by any provision of the Human Medicines Regulations 2012 has the same meaning as it has for the purposes of those Regulations.]

(3) For the purposes of this Order, the equivalence of a substance to a reference material shall be determined by calculating the amount of that reference material which is contained in that substance either by weight or, where the amount of the reference material is specified in terms of international units of activity, those units.

(4) In this Order, unless the context otherwise requires, a reference–

(a)to a numbered section is to the section of the Act which bears that number,

(b)to a numbered article or Schedule is to the article of, or Schedule to, this Order which bears that number,

(c)in an article or in a Part of a Schedule to a numbered paragraph is to the paragraph of that article or Part of that Schedule which bears that number, and

(d)in a paragraph to a lettered sub-paragraph is to the sub-paragraph of that paragraph which bears that letter.

(5) In [F9Schedules 1 and 2]–

(a)entries specified in columns 2 to 5 relate to the substances listed in column 1 against which they appear and where, in relation to a particular substance listed in column 1, an entry in columns 2 to 5 bears a number or letter it relates only to such entries in the other of those columns as bear the same number or letter;

(b)the following abbreviations are used:

“g” for gram,
“iu” for international unit of activity,
“mcg” for microgram,
“mg” for milligram,
“ml” for millilitre.

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Textual Amendments

F1Words in art. 1(2) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 71(2)(a) (with Sch. 32)

F2Words in art. 1 omitted (1.4.2002) by virtue of The Prescription Only Medicines (Human Use) Amendment Order 2002 (S.I. 2002/549), arts. 1(1), 2(2)(a)

F3Words in art. 1(2) omitted (1.5.2006) by virtue of The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(b)

F4Words in art. 1(2) omitted (1.5.2006) by virtue of The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(c)

F5Words in art. 1(2) omitted (1.5.2006) by virtue of The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(d)

F6Words in art. 1(2) omitted (1.5.2006) by virtue of The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2006 (S.I. 2006/915), arts. 1(1), 2(e)

F7Words in art. 1 omitted (9.7.2003) by virtue of The Health Professions Order 2001 (Consequential Amendments) Order 2003 (S.I. 2003/1590), art. 1, Sch. para. 21(2)(b)

F8Art. 1(2A) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 71(2)(b) (with Sch. 32)

F9Words in art. 1(5) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 71(2)(c) (with Sch. 32)

F10Art. 1(6)-(9) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 71(2)(d), Sch. 35 (with Sch. 32)

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