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The Medicines (Sale or Supply) (Miscellaneous Amendments) Regulations 2008

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EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations make further amendments to—

(a)the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980 (“the Sale or Supply Regulations”) which impose restrictions on the sale or supply of medicinal products for human use and in particular impose a requirement on persons conducting a retail pharmacy business to record the sale or supply of a prescription only medicine except in specified circumstances in particular where the sale or supply is in pursuance of a “health prescription” ; and

(b)the Medicines (Child Safety) Regulations 2003 (“the Child Safety Regulations”) which in particular (subject to exemptions) impose requirements relating to the packaging of certain medicinal products.

Regulation 2 amends regulation 1 of the Sale or Supply Regulations, so that a “health prescription” includes a prescription issued by an optometrist independent prescriber under or by virtue of legislation relating to the National Health Service, and amends Schedule 2 to those Regulations, so that the particulars which must be included in pharmacy records kept pursuant to regulation 6(1) must include particulars relating to optometrist independent prescribers.

Regulation 3 amends regulations 1 and 3 of the Child Safety Regulations so that the packaging requirements do not apply to the retail sale, or supply corresponding to retail sale, of a product by a pharmacy, where that sale or supply is in accordance with a prescription given by an optometrist independent prescriber.

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

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