Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations 2022.
Statutory Instruments
Source: Statutory Instruments

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paragraphs: (1) These Regulations may be cited as the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations 2022.
(2) The collective citation “the Medicinal Products (Prescription and Control of Supply) Regulations 2003 to 2022” includes these Regulations.
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paragraphs: In these Regulations—
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paragraphs: The Eighth Schedule (as amended by Regulation 3 of the Regulations of 2022) to the Principal Regulations is amended—
(a) in column 5 of the entry for the medicinal product “Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)”, by substituting “pregnancy, living arrangements or otherwise” for “pregnancy or otherwise”,
(b) in column 5 of the entry for the medicinal product “Spikevax (previously Covid-19 Vaccine Moderna) dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)”, by substituting “pregnancy, living arrangements or otherwise” for “pregnancy or otherwise”, and
(c) by substituting for the text in column 5 of the entry for the medicinal product “Comirnaty 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Paediatric pack” the following:
“In accordance with relevant recommendations or guidelines issued by the National Immunisation Advisory Committee and accepted by the Minister for Health, subject to informed consent being obtained from a parent or guardian.
Administered as a course of 2 doses (0.2 mL each) at least 19 days apart.
An additional dose should be administered to children aged 5 to 11 years who are immunocompromised at least 28 days after the second dose to complete the primary series.
Notwithstanding any directions to the contrary in the summary of product characteristics, a booster dose may be administered to children aged 5 to 11 years who—
(a) are immunocompromised and have already received an additional dose of a Covid-19 vaccine, or
(b) have already received a primary vaccine course against Covid-19 and have become immunocompromised since the administration of that primary vaccine course.
The additional and booster doses should be administered in such volumes, at such intervals, in such manner and in such order of prioritisation (whether by reference to age, immune status, living arrangements or otherwise), as may be specified in such recommendations or guidelines.”.
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paragraphs: The Twelfth Schedule (as amended by Regulation 4 of the Regulations of 2022) to the Principal Regulations is amended—
(a) in column 5 of the entry for the medicinal product “Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)”, by substituting “pregnancy, living arrangements or otherwise” for “pregnancy or otherwise”,
(b) in column 5 of the entry for the medicinal product “Spikevax (previously Covid-19 Vaccine Moderna) dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)”, by substituting “pregnancy, living arrangements or otherwise” for “pregnancy or otherwise”, and
(c) by substituting for the text in column 5 of the entry for the medicinal product “Comirnaty 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) Paediatric pack” the following:
“In accordance with relevant recommendations or guidelines issued by the National Immunisation Advisory Committee and accepted by the Minister for Health, subject to informed consent being obtained from a parent or guardian.
Administered as a course of 2 doses (0.2 mL each) at least 19 days apart.
An additional dose should be administered to children aged 5 to 11 years who are immunocompromised at least 28 days after the second dose to complete the primary series.
Notwithstanding any directions to the contrary in the summary of product characteristics, a booster dose may be administered to children aged 5 to 11 years who—
(a) are immunocompromised and have already received an additional dose of a Covid-19 vaccine, or
(b) have already received a primary vaccine course against Covid-19 and have become immunocompromised since the administration of that primary vaccine course.
The additional and booster doses should be administered in such volumes, at such intervals, in such manner and in such order of prioritisation (whether by reference to age, immune status, living arrangements or otherwise), as may be specified in such recommendations or guidelines.”.