The Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations make provision about the duties of responsible pharmacists who are required, by virtue of section 72A of the Medicines Act 1968 (c.68), to secure the safe and effective running of a pharmacy business at the premises from which it is carried on.

Regulation 3(1) and (2) specifies the maximum permitted period that a responsible pharmacist may be absent from the premises during the pharmacy’s business hours. Paragraph (3) provides that certain arrangements must be made in the event of the responsible pharmacist’s absence. Paragraph (4) provides that where it is reasonably practicable for the responsible pharmacist to be contactable throughout the period of absence, arrangements must cover both being contactable during the period of absence and return to the premises with reasonable promptness if necessary. Paragraph (5) then provides that arrangements must cover another pharmacist being available and contactable if it is not practicable to make arrangements under paragraph (4). Paragraph (6) provides expressly that the retail sale of medicinal products on a general sale list may continue from the premises during the period of absence.

Regulation 4 specifies the procedures which the responsible pharmacist must establish (if they are not already established), maintain and keep under review and which persons must be allowed to inspect those procedures.

Regulation 5 specifies the record which the responsible pharmacist must make and keep, which persons must be allowed to inspect the record and the period for which the person carrying on the pharmacy business must keep the record.

An impact assessment has not been produced for this instrument as only a negligible impact on the private or voluntary sectors is foreseen.