The Medicines (Exemptions and Miscellaneous Amendments) Order 2009

EXPLANATORY NOTE

(This note is not part of the Order)

Article 2 of this Order creates new exemptions from the restrictions imposed by sections 7 and 8 of the Medicines Act 1968 (general provisions as to dealing with medicinal products and provisions as to manufacture and wholesale dealing). It provides that the restrictions imposed by those sections shall not apply to the mixing of medicinal products by a nurse independent prescriber, a pharmacist independent prescriber, a supplementary prescriber who mixes the medicinal products as a part of an individual’s clinical management plan or any other person acting on the written directions of those persons.

The remainder of this Order makes amendments to—

• the Prescription Only Medicines (Human Use) Order 1997 (“the POM Order”) which specifies the description and classes of medicines (“prescription only medicines”) which may be sold or supplied only in accordance with the prescription of an “appropriate practitioner” and may be administered in accordance with the directions of such a practitioner; and

• the Medicines (Pharmacy and General Sale-Exemption) Order 1980 (“the Pharmacy and General Sale Order”) which provides for exemptions from sections 52 and 53 of the Medicines Act 1968 (restrictions on the sale and supply of medicinal products).

Article 3 amends Parts 2 and 3 of Schedule 5 to the POM Order to provide for members of Her Majesty’s armed forces to be able to supply or administer prescription only medicines in some circumstances but only in so far as this is necessary.

Article 4 amends the Pharmacy and General Sale Order in order to provide—

• that registered dispensing opticians are able to sell or supply eye drops or ointment containing chloramphenicol of the specified strength in the course of their professional practice;

• that members of Her Majesty’s armed forces are able to supply pharmacy only or general sale medicines in so far as is necessary for the treatment of sick or injured persons or the prevention of ill-health.

An Impact Assessment has not been prepared for this instrument as there is no impact on the private and voluntary sectors.