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

Subject matter

Article 1

This Directive lays down measures for the uniform implementation of Article 11(1) of Directive 2011/24/EU concerning the recognition of medical prescriptions issued in another Member State.

Scope

Article 2

This Directive shall apply to prescriptions, as defined in point (k) of Article 3 of Directive 2011/24/EU, which are issued further to a request of a patient who intends to use them in another Member State.

Content of prescriptions

Article 3

Member States shall ensure that prescriptions contain at least the elements set out in the Annex.

Information requirements

Article 4

Member States shall ensure that the national contact points referred to in Article 6 of Directive 2011/24/EU inform patients about the elements to be included, pursuant to this Directive, in prescriptions issued in a Member State other than the Member State where they are dispensed.

Transposition

Article 5

1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 25 October 2013 at the latest. They shall forthwith communicate to the Commission the text of those provisions. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Entry into force

Article 6

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Addressees

Article 7

This Directive is addressed to the Member States.

ANNEXSupplementary provisions

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