2.—(1) The Health Services (Cross-Border Health Care) Regulations (Northern Ireland) 2013(1) are amended as follows.
(2) After regulation 5 (National Contact Point: Information about treatment in another member State) insert—
5A.—(1) The NCP must make available to patients information about the elements, specified in the Schedule, to be included in a prescription which is—
(a)issued in one member State, and
(b)intended to be used in another member State.”.
(3) Add the following Schedule—
Regulation 5A
1. The patient’s—
(a)surname,
(b)first names, and
(c)date of birth.
2. The issue date of the prescription.
3. The prescribing professional’s—
(a)surname,
(b)first names,
(c)professional qualification,
(d)direct contact details including—
(i)email address, and
(ii)telephone or fax number with the appropriate international prefix,
(e)work address,
(f)member State in which the professional works,
(g)signature (either written in ink or electronic depending on the medium chosen for issuing the prescription).
4. The details of the prescribed product, including where applicable the—
(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”)(2),
(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.”.
OJ No L311, 28.11.2001, p.67. Directive 2001/83/EC was last amended by Directive 2012/26/EU (OJ No. L299, 27.10.2012, p. 1).