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[F1SCHEDULESElements that must be included in a prescription issued in a Member State other than the Member State where it is intended to be used

4.  The details of the prescribed product, including where applicable the—S

(a)common name as defined by Article 1 of Directive 2001/83/EC;

(b)brand name if—

(i)the prescribed product is a biological medicinal product as referred to in point 3.2.1.1.(b) of Annex 1 (Part 1) to Directive 2001/83/EC; or

(ii)the prescribing professional deems it medically necessary for that product to be dispensed and, in that case, the prescribing professional’s reasons justifying the use of the brand name;

(c)pharmaceutical formulation (such as tablet, solution etc.);

(d)quantity;

(e)strength as defined in Article 1 of Directive 2001/83/EC; and

(f)dosage regimen.]

F21972 c.68. Section 2(2) was amended by the Scotland Act 1998 Act (c.46) (“the 1998 Act”), Schedule 8, paragraph 15(3), (which was amended by section 27(4) of the Legislative and Regulatory Reform Act 2006 (c.51) (“the 2006 Act”), section 2(2) was also amended by section 27(1)(a) of the 2006 Act and the European Union (Amendment) Act 2008 (c.7), section 3(3) and Schedule Part 1. The functions conferred upon the Minister of the Crown under section 2(2), insofar as within devolved competence, were transferred to the Scottish Ministers by virtue of section 53 of the 1998 Act.