Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 15) 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. 15) 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—
“In accordance with relevant recommendations or guidelines issued by the National Immunisation Advisory Committee and accepted by the Minister for Health.
Notwithstanding any directions to the contrary in the summary of product characteristics—
(a) an additional dose may be administered to immunocompromised persons who are 12 years of age or older and have already received a primary vaccine course against Covid-19, and
(b) a booster dose may be administered to—
(i) persons who are 16 years of age or older and have already received a primary vaccine course against Covid-19, and
(ii) immunocompromised persons who are 12 years of age or older and have already received an additional dose of a Covid-19 vaccine,
in such volumes, at such intervals, in such manner and in such order of prioritisation (whether by reference to age, employment sector, pregnancy or otherwise), as may be specified in such recommendations or guidelines, and subject to informed consent being obtained.”,
(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 relevant recommendations or guidelines issued by the National Immunisation Advisory Committee and accepted by the Minister for Health.
Notwithstanding any directions to the contrary in the summary of product characteristics—
(a) an additional dose may be administered to immunocompromised persons who are 30 years of age or older and have already received a primary vaccine course against Covid-19, and
(b) a booster dose may be administered to—
(i) persons who are 30 years of age or older and have already received a primary vaccine course against Covid-19, and
(ii) immunocompromised persons who are 30 years of age or older and have already received an additional dose of a Covid-19 vaccine,
in such volumes, at such intervals, in such manner and in such order of prioritisation (whether by reference to age, employment sector, pregnancy or otherwise), as may be specified in such recommendations or guidelines, and subject to informed consent being obtained.”, and
(c) by inserting the following additional entry—
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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 relevant recommendations or guidelines issued by the National Immunisation Advisory Committee and accepted by the Minister for Health.
Notwithstanding any directions to the contrary in the summary of product chaacteristics—
(a) an additional dose may be administered to immunocompromised persons who are 12 years of age or older and have already received a primary vaccine course against Covid-19, and
(b) a booster dose may be administered to—
(i) persons who are 16 years of age or older and have already received a primary vaccine course against Covid-19, and
(ii) immunocompromised persons who are 12 years of age or older and have already received an additional dose of a Covid-19 vaccine,
in such volumes, at such intervals, in such manner and in such order of prioritisation (whether by reference to age, employment sector, pregnancy or otherwise), as may be specified in such recommendations or guidelines, and subject to informed consent being obtained.”,
(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 relevant recommendations or guidelines issued by the National Immunisation Advisory Committee and accepted by the Minister for Health.
Notwithstanding any directions to the contrary in the summary of product characteristics—
(a) an additional dose may be administered to immunocompromised persons who are 30 years of age or older and have already received a primary vaccine course against Covid-19, and
(b) a booster dose may be administered to—
(i) persons who are 30 years of age or older and have already received a primary vaccine course against Covid-19, and
(ii) immunocompromised persons who are 30 years of age or older and have already received an additional dose of a Covid-19 vaccine,
in such volumes, at such intervals, in such manner and in such order of prioritisation (whether by reference to age, employment sector, pregnancy or otherwise), as may be specified in such recommendations or guidelines, and subject to informed consent being obtained.”, and
(c) by inserting the following additional entry —
“