C1PART 12Dealings with medicinal products
CHAPTER 3Exemptions
Exemptions relating to supply in specific circumstances
Exemption for supply etc under a PGD by dental practices and clinics: England and Wales232
1
Regulations 214, 220 and 221 do not apply to the sale or supply, or administration, of a medicinal product in accordance with the following conditions by—
a
a dental practice in England and Wales to which paragraph (2) applies; or
b
a dental clinic in England and Wales to which paragraph (2) applies.
2
This paragraph applies to a dental practice or dental clinic —
a
in England, in respect of which the registered provider is registered in compliance with section 10 of the Health and Social Care Act 2008 in respect of one or both of the following regulated activities—
i
treatment of disease, disorder or injury, or
ii
diagnostic and screening procedures;
b
in Wales, in which dental services are provided by private dentists and those dentists are registered with Healthcare Inspectorate Wales in accordance with the Private Dentistry (Wales) Regulations 2008 M1, in relation to the services provided by those dentists.
3
Condition A is that the product is sold or supplied for the purpose of being administered to a person in accordance with a patient group direction (“PGD”).
4
Condition B is that the PGD—
a
relates to the sale or supply or (as the case may be) administration of a description or class of medicinal product by the person by whom the medicinal product is sold or supplied or administered; and
b
has effect at the time at which it is sold or supplied.
5
Condition C is that the PGD contains the particulars specified in Part 1 of Schedule 16 (but with the omission of paragraph 4 in the case of a PGD relating to administration only).
6
Condition D is that the PGD is signed—
a
in England—
i
by or on behalf of the registered provider, and
ii
if there is a relevant manager for the practice or clinic, by that manager;
b
in Wales—
i
by the private dentist who is treating the person, and
ii
if there is a manager for the practice or clinic, by that manager.
7
Condition E is that the individual who sells or supplies or (as the case may be) administers the product—
a
belongs to one of the classes of individual specified in Part 4 of Schedule 16; and
b
is designated in writing for the purpose of the sale or supply or (as the case may be) administration of products under the PGD—
i
in England—
aa
by or on behalf of the registered provider, or
bb
if there is a relevant manager for the practice or clinic, by that manager, or
ii
in Wales, by the private dentist who is treating the person.
F18
Condition F is that when the product is supplied, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK) is in force in relation to it.
9
In relation to Wales, in this regulation “manager” means—
a
a person who carries on the dental practice or dental clinic; or
b
if there is no such person, a person who manages the practice or clinic.
Pt. 12 modified (E.W.) (1.10.2015) by The Nicotine Inhaling Products (Age of Sale and Proxy Purchasing) Regulations 2015 (S.I. 2015/895), regs. 1(3), 4(2)