The Human Medicines (Amendment) Regulations 2014

Insertion of regulation 217A

6.  After regulation 217 (general requirements for prescriptions) insert—

“Requirements for prescriptions to be dispensed in an EEA state other than the UK

217A.— (1) In this regulation—

“B” means a person who is an appropriate practitioner for the purposes of regulation 214(3) to (5B);

“P” means a person who is the patient of B.

(2) The information specified in paragraph (3) is to be included in any prescription where—

(a) P requests a prescription that is to be dispensed in an EEA state other than UK; and

(b) B determines that such a prescription is appropriate.

(3) The specified information is—

(a) the patient’s—

(i) surname,

(ii) first names written out in full, and

(iii) date of birth;

(b) the issue date of the prescription;

(c) B’s—

(i) surname,

(ii) first names written out in full,

(iii) professional qualification,

(iv) direct contact details including—

(aa) email address,

(bb) telephone or fax number with the appropriate international prefix,

(v) work address,

(vi) confirmation that B works as a health professional in the UK, and

(vii) electronic signature or a signature written in ink;

(d) details about the prescribed product, including where applicable the—

(i) common name of the product as defined by Article 1 of the 2001 Directive,

(ii) brand name if—

(aa) the prescribed product is a biological medicinal product, or

(bb) B deems it medically necessary for that product to be dispensed and B’s reasons justifying the use of the branded product,

(iii) pharmaceutical formulation (tablet, solution, etc.),

(iv) quantity,

(v) strength of the medicinal product as defined in Article 1 of the 2001 Directive, and

(vi) dosage regimen.

(4) A prescription under this regulation may only be issued by B in relation to those products that B is authorised to prescribe under regulation 214(3) to (5B).”