Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 13) Regulations 2021.
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. 13) Regulations 2021.
(2) The collective citation “the Medicinal Products (Prescription and Control of Supply) Regulations 2003 to 2021” 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 2021) to the Principal Regulations is amended—
(a) by substituting for the text in column 5 of the entry for the medicinal product “Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)” the following:
“In accordance with the summary of product characteristics of the product administered and relevant recommendations or guidelines issued by the National Immunisation Advisory Committee and accepted by the Minister for Health.
Notwithstanding any guidance to the contrary in the summary of product characteristics, an additional or booster dose may be administered to—
(a) immunocompromised persons who are 12 years of age or older,
(b) persons who are 50 years of age or older,
(c) persons who reside in long term care facilities and are 16 years of age or older,
(d) persons who have underlying conditions associated with very high risk or high risk of severe COVID-19 disease and are 16 years of age or older, and
(e) health care workers,
at such volumes, intervals and manner as may be specified in such recommendations or guidelines and subject to informed consent being obtained.”, and
(b) by substituting for the text 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)” the following:
“In accordance with the summary of product characteristics of the product administered and relevant recommendations or guidelines issued by the National Immunisation Advisory Committee and accepted by the Minister for Health.
An additional or booster dose may be administered to—
(a) persons who are 50 years of age or older, and
(b) persons who are 30 years of age or older and—
(i) reside in long term care facilities,
(ii) have underlying conditions associated with very high risk or high risk of severe COVID-19 disease, or
(iii) are health care workers,
at such volumes, intervals and manner as may be specified in such recommendations or guidelines and subject to informed consent being obtained.”.
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paragraphs: The Twelfth Schedule (as amended by Regulation 4 of the Regulations 2021) to the Principal Regulations is amended—
(a) by substituting for the text in column 5 of the entry for the medicinal product “Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)” the following:
“In accordance with the summary of product characteristics of the product administered and relevant recommendations or guidelines issued by the National Immunisation Advisory Committee and accepted by the Minister for Health.
Notwithstanding any guidance to the contrary in the summary of product characteristics, an additional or booster dose may be administered to—
(a) immunocompromised persons who are 12 years of age or older,
(b) persons who are 50 years of age or older,
(c) persons who reside in long term care facilities and are 16 years of age or older,
(d) persons who have underlying conditions associated with very high risk or high risk of severe COVID-19 disease and are 16 years of age or older, and
(e) health care workers,
at such volumes, intervals and manner as may be specified in such recommendations or guidelines and subject to informed consent being obtained.”, and
(b) by substituting for the text 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)” the following:
“In accordance with the summary of product characteristics of the product administered and relevant recommendations or guidelines issued by the National Immunisation Advisory Committee and accepted by the Minister for Health.
An additional or booster dose may be administered to—
(a) persons who are 50 years of age or older, and
(b) persons who are 30 years of age or older and—
(i) reside in long term care facilities,
(ii) have underlying conditions associated with very high risk or high risk of severe COVID-19 disease, or
(iii) are health care workers,
at such volumes, intervals and manner as may be specified in such recommendations or guidelines and subject to informed consent being obtained.”.