Prescriptions from EU and EEA Member States

Medicinal Products (Prescription and Control of Supply) Regulations 2003 (as amended)

There have been recent amendments to the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (as amended) with a view to facilitating the recognition of medical prescriptions issued in another EU/EEA Member State. The amendments arise from legislative change at a European level regarding patients’ rights in cross-border healthcare and the recognition of medical prescriptions issued in another EU/EEA Member State.

A link to the relevant statutory instrument, entitled Medicinal Products (Prescription and Control of Supply) (Amendment) (No.2) Regulations 2014 (S.I. No. 504 of 2014), can be found on irishstatutebook.ie.

The amending regulations provide that prescriptions from the following practitioners practising in another EEA Member State may be dispensed in Ireland:

(a) a registered medical practitioner,

(b) a registered dentist,

(c) a registered nurse, or

(d) a practitioner of status equivalent to a registered medical practitioner or a registered dentist, practising in an EEA state other than the State, or a member of a regulated health profession within the meaning of Article 3(1)(a) of Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 who is legally entitled to issue a prescription for the medicinal product concerned in the EEA state in which the prescription is issued, if the prescription has not been issued with a view to enabling the supply of a medicinal product by mail order.

The amending regulations also provide that for such prescriptions to be legally valid in Ireland, they must:

(a) be in ink or other permanent and unalterable electronic form and be signed and dated by the person issuing the prescription with his or her usual signature, either in handwriting or by electronic signature;

(b) clearly indicate the full name, including the full first name, of the person issuing the prescription and specify his or her professional qualification;

(c) specify the work address, including the name of the relevant EEA state, of the person issuing the prescription;

(d) specify the email address, and telephone or fax number (with the appropriate international prefix) of the person issuing the prescription;

(e) specify the full name, including the full first name, and date of birth of the person for whose treatment the prescription is issued; and

(f) specify the following details, where applicable, of the product to be supplied on foot of the prescription:

(i) the common name of the medicinal product;

(ii) the brand name of the medicinal product if

• the medicinal product prescribed is a biological medicinal product, or
• the person issuing the prescription has deemed it medically necessary to include the brand name on the prescription and has stated on the prescription the reasons justifying the use of the brand name;

(iii) the pharmaceutical form;

(iv) the quantity;

(v) the strength of the medicinal product; and

(vi) the dosage regime.

Pharmacists should be aware that practitioners are only entitled to prescribe medicinal products for which they are legally entitled to do in the EEA state in which the prescription is issued.

It should be noted that products classified as schedule 2, schedule 3 or schedule 4 part 1 controlled drugs may not be prescribed by practitioners in another EEA state for dispensing in Ireland and that such prescriptions may not be used to authorise the supply of any such controlled drug.

Corresponding arrangements and requirements are applicable to “outgoing” prescriptions.

This practice update was made available in Issue 2, 2015 of the PSI newsletter