Textual Amendments
4. The details of the prescribed product, including where applicable the—N.I.
(a)common name as defined by Article 1 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (“Directive 2001/83/EC”),
(b)brand name if—
(i)the prescribed product is a biological medicinal product, as defined 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.]