The Medicines for Human Use (Prescribing by EEA Practitioners) Regulations 2008

EXPLANATORY NOTE

(This note is not part of these Regulations)

These Regulations provide that subject to the fulfilment of certain conditions in relation to the prescriptions which they give, doctors and dentists who give a prescription for a medicinal product (other than one which is a controlled drug) in an EEA State other than the UK or in Switzerland are appropriate practitioners within the meaning of section 58(2)(a) of the Medicines Act 1968 (“the Act”). The effect of this is to enable the sale or supply in circumstances corresponding to retail sale, of a medicinal product (other than a controlled drug) in accordance with a prescription given by such a doctor or dentist, provided the conditions in relation to the prescription are complied with (regulations 2-5).

Regulation 6 provides that section 58(2)(a) of the Act does not apply to the sale or supply of a medicinal product by a person lawfully conducting retail pharmacy business where the sale or supply is in accordance with a prescription in relation to which the requirements in regulations 3 to 5 appear to be but are not fulfilled and the person selling or supplying the product, having exercised all due diligence, believes on reasonable grounds that those requirements have been fulfilled. The effect of this is that in such circumstances the sale or supply will not contravene section 58(2)(a) of the Act.

Regulation 7 provides that the provisions of article 8 of the Prescription Only Medicines (Human Use) Order 1997 shall apply so that a person lawfully conducting retail pharmacy business may in an emergency situation lawfully sell or supply a medicinal product other than in accordance with a prescription given by an EEA health professional if the conditions set out in article 8 are satisfied.

A full impact assessment has not been produced for this instrument as no significant impact on the private or voluntary sectors is foreseen.