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.

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.