Regulation of Health and Social Care Professionals Consultation

Act 1972. For example, the Medicines Act 1968 provides that a registered
pharmacist, known as the responsible pharmacist, must be in charge of a
registered pharmacy and must establish, maintain and review pharmacy
procedures designed to secure the safe and effective running of the pharmacy. 12
Inspection
11.13 The General Pharmaceutical Council is required to establish an inspectorate
which is responsible for enforcing the standards, assisting the Council in any
fitness to practise investigations, securing compliance with Parts 3 and 4 of the
Medicines Act 1968 (which contain provisions about dealings with medicinal
products and about pharmacies) and the Poisons Act 1972, and to enforce the
criminal justice provisions relating to the register. 13 The inspectorate may conduct
inspections of registered pharmacies and has the power to enter any registered
pharmacy or other premises, including through the use of reasonable force if for
example admission is refused or is likely to be refused or in urgent cases. 14
11.14 The inspectors have wide powers to inspect and search premises, remove from
the premises any items and require access to documents including electronic
documents or records. An inspector also has power to do “anything which is
calculated to facilitate the discharge of the inspector's functions or which is
incidental or conducive to the discharge of those functions”. These powers are
supported by a series of criminal offences in relation to those who obstruct or fail
to assist an inspector. 15
Enforcement
11.15 Where there is a failure to meet the relevant standards set by the General
Pharmaceutical Council, the inspectorate can issue an improvement notice which
specifies the measures that must be taken in order to rectify the failure within a
period of not less than 28 days.
11.16 A person carrying on a retail pharmacy business at a registered pharmacy who
fails to comply with an improvement notice commits a criminal offence and is
liable on summary conviction to a fine. In addition, the inspector is required to
inform the Registrar (whether or not proceedings are brought against the person)
who may remove the person from the register or suspend them pending
compliance with any requirements or conditions. There is a right of appeal to the
Appeals Committee. In the case of offences committed by a partnership,
proceedings are brought against the partnership. 16
11.17
The Pharmaceutical Society of Northern Ireland
The Pharmaceutical Society of Northern Ireland is responsible for the registration
of pharmacy premises under section 75 of the Medicines Act 1968. The
responsible pharmacist regulations described above also apply in
12 Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008, SI 2008 No 2789.
13 Pharmacy Order 2010, SI 2010 No 231, art 8.
14 As above, arts 9 and 10.
15 As above, arts 11 and 12.
16 As above, arts14 and 15.
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