HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 356/68
EN
Official Journal of the European Union
22.12.2012
DIRECTIVES
COMMISSION IMPLEMENTING DIRECTIVE 2012/52/EU
of 20 December 2012
laying down measures to facilitate the recognition of medical prescriptions issued in another
Member State
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
for human use ( 2 ), because of the special characteristics of
those products, or of other medicinal products in cases
Having regard to the Treaty on the Functioning of the European
where the prescribing professional considers it medically
Union,
necessary.
Having regard to Directive 2011/24/EU of the European
(5) Medical
devices
do
not
have
common
names
as
Parliament and of the Council of 9 March 2011 on the appli
medicinal products. Therefore the prescription should
cation of patients’ rights in cross-border healthcare (
also include direct contact details of the prescriber

1 ), and in
particular points (a), (c) and (d) of Article 11(2) thereof,
which enable the dispensing professional, where
necessary, to enquire about the prescribed medical
device and correctly identify it.
Whereas:
(6) The
non-exhaustive
list
of
elements
to
appear
on
the
(1) Pursuant
to
Article
11(2)
of
Directive
2011/24/EU,
the
prescriptions should facilitate the comprehensibility of
Commission has an obligation to adopt measures to
the information to patients concerning the prescription
facilitate the recognition of medical prescriptions issued
and the instructions included on the use of the product,
in a Member State other than the Member State where
as referred to in point (d) of Article 11(2) of Directive
the prescriptions are dispensed.
2011/24/EU. The Commission will regularly review the
situation in order to assess whether additional measures
(2) Pursuant
to
point
(a)
of
Article
11(2)
of
Directive
are necessary to help patients understand the instructions
2011/24/EU, the Commission is to adopt a non-
concerning the use of the product.
exhaustive list of elements to be included in those
prescriptions. That list should enable the dispensing
health professional to verify the authenticity of the
(7) To
enable
patients
to
request
appropriate
prescriptions,
it
prescription and whether it was issued by a member of
is important that national contact points referred to in
a regulated health profession who is legally entitled to do
Article 6 of Directive 2011/24/EU provide patients with
so.
adequate information on the content and purpose of the
non-exhaustive list of elements that should appear in
those prescriptions.
(3) The
elements
to
be
included
in
the
prescriptions
should
facilitate the correct identification of medicinal products
or medical devices as referred to in point (c) of Article 11
(8) As
the
overall
impact
of
cross-border
healthcare
is
(2) of Directive 2011/24/EU.
limited, the non-exhaustive list of elements should
apply only to prescriptions intended to be used in
another Member State.
(4) Medicinal
products
should
therefore
be
indicated
using
the common name in order to facilitate the correct
identification of products which are marketed under
(9) As
the
principle
of
mutual
recognition
of
prescriptions
different brand names across the Union and of
derives from Article 56 of the Treaty on the Functioning
products that are not marketed in all Member States.
of the European Union, this Directive does not preclude
That common name to be used should be either the
the Member States from applying the principle of mutual
International Non-proprietary name recommended by
recognition to prescriptions that do not contain the
the World Health Organisation or, if such name does
elements set out in the non-exhaustive list. At the
not exist, the usual common name. In contrast, the
same time, nothing in this Directive prevents the
brand name of a medicinal product should only be
Member States from providing that prescriptions
used to ensure clear identification of biological
drafted on their territory, with a view to be used in
medicinal products as defined in point 3.2.1.1.(b) of
another Member State, contain additional elements that
Annex I to Directive 2001/83/EC of the European
are provided for under the rules applicable on their
Parliament and of the Council of 6 November 2001
territory, as long as these rules are compatible with
on the Community Code relating to medicinal products
Union law.
( 1 ) OJ L 88, 4.4.2011, p. 45–65
( 2 ) OJ L 311, 28.11.2001, p. 67.

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EN
22.12.2012 Official
Journal
of
the
European
Union L
356/69
(10) The
measures provided for in this Directive are in
Article 5
accordance with the opinion of the Committee set up
by Article 16(1) of Directive 2011/24/EU
Transposition
1. Member
States
shall
bring
into
force
the
laws,
regulations
HAS ADOPTED THIS DIRECTIVE:
and administrative provisions necessary to comply with this
Directive by 25 October 2013 at the latest. They shall
Article 1
forthwith communicate to the Commission the text of those
provisions.
Subject matter
This Directive lays down measures for the uniform implemen
When Member States adopt those provisions, they shall contain
tation of Article 11(1) of Directive 2011/24/EU concerning the
a reference to this Directive or be accompanied by such a
recognition of medical prescriptions issued in another Member
reference on the occasion of their official publication. Member
State.
States shall determine how such reference is to be made.
2. Member
States
shall
communicate
to
the
Commission
the
Article 2
text of the main provisions of national law which they adopt in
Scope
the field covered by this Directive.
This Directive shall apply to prescriptions, as defined in point
Article 6
(k) of Article 3 of Directive 2011/24/EU, which are issued
Entry into force
further to a request of a patient who intends to use them in
another Member State.
This Directive shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
Article 3
European Union.
Content of prescriptions
Article 7
Member States shall ensure that prescriptions contain at least
Addressees
the elements set out in the Annex.
This Directive is addressed to the Member States.
Article 4
Information requirements
Done at Brussels, 20 December 2012.
Member States shall ensure that the national contact points
referred to in Article 6 of Directive 2011/24/EU inform
For the Commission
patients about the elements to be included, pursuant to this
Directive, in prescriptions issued in a Member State other
The President
than the Member State where they are dispensed.
José Manuel BARROSO

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L 356/70
EN
Official Journal of the European Union
22.12.2012
ANNEX
Non-exhaustive list of elements to be included in medical prescriptions
Headings appearing in bold in this Annex are not required to feature in prescriptions
Identification of the patient
Surname(s)
First name(s) (written out in full, i.e. no initials)
Date of Birth
Authentication of the prescription
Issue date
Identification of the prescribing health professional
Surname(s)
First name(s) (written out in full, i.e. no initials)
Professional qualification
Details for direct contact (email and telephone or fax, the latter both with international prefix)
Work address (including the name of the relevant Member State)
Signature (written or digital, depending on the medium chosen for issuing the prescription)
Identification of the prescribed product, where applicable
‘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
The brand name if:
(a) the prescribed product is a biological medicinal product, as defined in point 3.2.1.1.(b) of Annex I (Part I) to Directive
2001/83; or
(b) the prescribing health professional deems it medically necessary; in that case the prescription shall shortly state the
reasons justifying the use of the brand name
Pharmaceutical formulation (tablet, solution, etc.)
Quantity
Strength, as defined in Article 1 of Directive 2001/83/EC
Dosage regimen

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Document Outline

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