The Human Medicines Regulations 2012

This section has no associated Explanatory Memorandum

71.—(1) The Prescription Only Medicines (Human Use) Order 1997 M1 is amended as follows.U.K.

(2) In article 1—

(a)in paragraph (2) omit all the defined expressions except “inhaler” and “maximum strength”;

(b)for paragraph (2A) substitute—

(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.;

(c)in paragraph (5) for “Schedules 1, 2, 3A and 5” substitute “ Schedules 1 and 2 ”; and

(d)omit paragraphs (6) to (9).

(3) In article 5(1) for the words from the beginning of the paragraph until sub-paragraph (a) substitute “A medicinal product that is not the subject of a marketing authorisation is a prescription only medicine for the purposes of the Human Medicines Regulations 2012 if it, or a substance in it, is listed in column 1 of Schedule 1, unless there”.

(4) In paragraphs (1) and (2) of article 10 for the words “The restrictions” to “administration of” substitute “ A medicinal product is not a prescription only medicine for the purposes of the Human Medicines Regulations 2012 by virtue of Article 5(1) if it is ”.