- Latest available (Revised)
- Original (As made)
This is the original version (as it was originally made).
232.—(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(1), 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.
(8) Condition F is that when the product is supplied, a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration 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.
The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
The Whole Instrument you have selected contains over 200 provisions and might take some time to download.
Would you like to continue?
The Whole Instrument without Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
The Whole Instrument without Schedules you have selected contains over 200 provisions and might take some time to download.
Would you like to continue?
The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
The Whole Instrument without Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
The Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Explanatory Memorandum sets out a brief statement of the purpose of a Statutory Instrument and provides information about its policy objective and policy implications. They aim to make the Statutory Instrument accessible to readers who are not legally qualified and accompany any Statutory Instrument or Draft Statutory Instrument laid before Parliament from June 2004 onwards.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
Impact Assessments generally accompany all UK Government interventions of a regulatory nature that affect the private sector, civil society organisations and public services. They apply regardless of whether the regulation originates from a domestic or international source and can accompany primary (Acts etc) and secondary legislation (SIs). An Impact Assessment allows those with an interest in the policy area to understand:
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
Click 'View More' or select 'More Resources' tab for additional information including: