Statutory Instruments
2024 No. 729
MEDICINES
The Human Medicines (Amendments relating to Registered Dental Hygienists, Registered Dental Therapists and Registered Pharmacy Technicians) Regulations 2024
Made
29th May 2024
Coming into force in accordance with regulation 1(2)
The Secretary of State in relation to England and Wales and Scotland and the Department of Health in Northern Ireland and the Secretary of State acting jointly in relation to Northern Ireland make these Regulations in exercise of the powers conferred by sections 2(1), 3(1)(n), 3(2)(a), (c) and (d) and 43(2) of the Medicines and Medical Devices Act 2021( 1 ) (“ the Act ”).
The Secretary of State and the Department of Health in Northern Ireland have carried out a public consultation in accordance with section 45(1) of the Act.
In accordance with section 2(2) to (4) of the Act, the Secretary of State’s and the Department of Health in Northern Ireland’s overarching objective in making these Regulations is safeguarding public health. The Secretary of State and the Department of Health in Northern Ireland have had regard to the matters specified in section 2(3) of the Act and consider that, where these Regulations may have an impact on the safety of human medicines, the benefit of making these Regulations outweigh the risks.
In accordance with section 47(3) and (6)(c) of the Act, a draft of this instrument was laid before Parliament and the Northern Ireland Assembly and approved by a resolution of each House of Parliament and the Northern Ireland Assembly.
Citation, commencement and extent
1. —(1) These Regulations may be cited as the Human Medicines (Amendments relating to Registered Dental Hygienists, Registered Dental Therapists and Registered Pharmacy Technicians) Regulations 2024.
(2) These Regulations come into force on the 28th day after the day on which they are made.
(3) These Regulations extend to England and Wales, Scotland and Northern Ireland.
Amendment of the Human Medicines Regulations 2012
2.The Human Medicines Regulations 2012( 2 ) are amended as follows.
Amendment of regulation 213
3. In regulation 213(1) (interpretation)( 3 ) after the definition of “registered orthotist and prosthetist” insert—
“ “ registered pharmacy technician ” means a person registered in Part 2 of the Register of pharmacists and pharmacy technicians established and maintained under article 19(1) and (2) of the Pharmacy Order 2010 ( 4 ) ; ” .
Amendment of Schedule 16
4. In Schedule 16 (patient group directions), in Part 4 (classes of individuals by whom supplies may be made), after “Registered paramedics.” insert “Registered pharmacy technicians.” .
Amendment of Schedule 17
5. —(1)Schedule 17 (exemption for sale, supply or administration by certain persons) is amended as follows—
(2) In Part 2 (exemption from the restriction on supply of prescription only medicines)( 5 ), in paragraph 1, after item 12 insert—
| “ 13. Registered dental therapists or registered dental hygienists who are qualified to use the medicines specified in column 2. | 13. The following prescription only medicines— (a) Lidocaine 2% with 1:80,000 adrenaline, (b) Articaine hydrochloride 4% with 1:100,000 adrenaline, (c) Articaine hydrochloride 4% with 1:200,000 adrenaline, (d) 3% Mepivacaine hydrochloride, (e) 3% Prilocaine with 0.54 microgram/ml felypressin, (f) 2.5%/2.5% Lidocaine and prilocaine peridontal gel, (g) Sodium fluoride varnish, 50mg/ml (2.26%) dental suspension (containing 22600ppm fluoride), (h) Minocyline 2% periodontal gel, (i) Sodium fluoride 0.619% (2800ppm fluoride) dental paste, (j) Sodium fluoride 1.1% (5000ppm fluoride) dental paste, (k) 15% Lidocaine, 0.15% cetrimide oromucosal spray, (l) Nystatin oral suspension. | 13. The supply shall be only in the course of their professional practice. ” . |
(3) In Part 3 (exemptions from the restriction on administration of prescription only medicine)( 6 ), in paragraph 1, after item 11 insert—
| “ 12. Registered dental therapists or registered dental hygienists who are qualified to use the medicines specified in column 2. | 12. The following prescription only medicines for parenteral administration— (a) 2% Lidocaine with 1:80,000 adrenaline, (b) Articaine hydrochloride 4% with 1:100,000 adrenaline, (c) Articaine hydrochloride 4% with 1:200,000 adrenaline, (d) 3% Mepivacaine hydrochloride, (e) 3% Prilocaine with 0.54 microgram/ml felypressin. | 12. The administration shall be only in the course of their professional practice. ” . |
(4) In Part 4 (exemption from the restriction in regulations 220 and 221 for certain persons who sell, supply, or offer for sale or supply certain medicinal products)( 7 ), in paragraph 1, after item 13 insert—
| “ 14. Registered dental therapists or registered dental hygienists who are qualified to use the medicines specified in column 2. | 14. All medicinal products on a general sale list, all pharmacy medicines and the following prescription only medicines which are not for parenteral administration— (a) 2.5%/2.5% Lidocaine and prilocaine periodontal gel, (b) Sodium fluoride varnish, 50mg/ml (2.26%) dental suspension (containing 22600ppm fluoride), (c) Minocycline 2% periodontal gel, (d) Sodium fluoride 0.619% (2800ppm fluoride) dental paste, (e) Sodium fluoride 1.1% (5000ppm) dental paste, (f) 15% Lidocaine, 0.15% cetrimide oromucosal spray, (g) Nystatin oral suspension. | 14. The sale, supply or offer for sale or supply shall be only in the course of their professional practice. ” . |
Signed by authority of the Secretary of State for Health and Social Care
Andrea Leadsom
Parliamentary Under Secretary of State,
29th May 2024
Department of Health and Social Care
Sealed with the Official Seal of the Department of Health in Northern Ireland
(L.S)
Cathy Harrison
A senior officer of the Department of Health in Northern Ireland
28th May 2024
2021 c. 3 . The powers in section 2(1) of the Act and the provisions that relate to it are exercisable by the “appropriate authority”. As defined in section 2(6)(a) of the Act, the appropriate authority for England and Wales and Scotland is the Secretary of State. In relation to Northern Ireland, as defined in section 2(6)(b)(ii), the appropriate authority can mean the Secretary of State and the Department of Health in Northern Ireland acting jointly.
There are amendments but none is relevant.
S.I. 2010/231 , amended by S.I. 2019/593 .
Item 12 was added to the table in paragraph 1 by S.I. 2016/186 . There are other amending instruments but none is relevant.
Item 11 was added to the table in paragraph 1 by S.I. 2017/715 . There are other amending instruments but none is relevant.
Item 13 was added to the table in paragraph 1 by S.I. 2016/186 and amended by 2017/715 . There are other amendments not relevant to these Regulations.