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The Human Medicines (Amendment) Regulations 2014

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Amendment of regulation 218

7.—(1) Regulation 218 (requirements for prescriptions: EEA health professionals) is amended as follows.

(2) For paragraph (2) substitute—

(2) Condition A is that—

(a)the prescription is issued in an EEA State other than the United Kingdom or Switzerland; and

(b)the prescribing EEA health professional is legally entitled to issue a prescription of that kind in the EEA State in which the prescription is issued.

(3) For paragraph (3) substitute—

(3) Condition B is that the prescription is signed in ink by the prescribing EEA health professional.

(4) For paragraph (5) substitute—

(5) Condition D is that the prescription contains—

(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)the prescribing EEA health professional’s—

(i)surname,

(ii)first names written out in full,

(iii)professional qualifications,

(iv)direct contact details including—

(aa)email address, and

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

(v)work address, and

(vi)name of the relevant member State in which that EEA health professional works; and

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

(i)common name of the product,

(ii)ii)brand name if—

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

(bb)the prescribing EEA health professional deems it medically necessary for that product to be dispensed and the EEA health professional’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.

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