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Regulation 5A

[F1SCHEDULEF2SElements that must be included in a prescription issued in a Member State other than the Member State where it is intended to be used

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.

1.  The patient’s—S


(b)first name(s) (written out in full); and

(c)date of birth.

2.  The date on which the prescription is issued.S

3.  The prescribing professional’s—S


(b)first name(s) (written out in full);

(c)professional qualification;

(d)direct contact details including—

(i)email address;

(ii)telephone or fax number with the appropriate international prefix;

(iii)work address;

(iv)Member State in which the professional works; and

(v)signature (either written or electronic depending on the medium chosen for issuing the prescription).

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 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.);


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

(f)dosage regimen.]