The National Health Service (Cross-Border Health Care) (Scotland) Amendment Regulations 2015

“Directive 2001/83/EC” means Directive 2001/83/EC of the European Parliament and of the Council of 6th November 2001 on the Community Code relating to medicinal products for human use3;”;

“NCP: information about prescriptions intended to be used in another Member State5A.

(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.”; and

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

Regulation 5A

1.

The patient’s—

(a)

surname(s);

(b)

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

(c)

date of birth.

2.

The date on which the prescription is issued.

3.

The prescribing professional’s—

(a)

surname(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—

(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.”.