The Branded Health Service Medicines (Costs) (Amendment) (No. 2) Regulations 2023

e

any item of new active substance presentation during the period beginning on the date on which the marketing authorisation is granted for the first therapeutic indication of the presentation and ending on the last day of the 36th month after that date;

f

any item of presentation which is a line extension of a new active substance presentation to which sub-paragraph (e) applies which is supplied during the period referred to in sub-paragraph (e) for the new active substance presentation;

g

any item of exceptional centrally procured presentation;

h

any item of centrally procured vaccine presentation.

5D

For the purposes of paragraph (4)(e)—

a

“new active substance presentation” means a presentation containing a new active substance with a marketing authorisation incorporating the first therapeutic indication for that active substance, but not other presentations marketed under a different brand name which nevertheless contain that new active substance (whether alone or in combination with other active substances); and

b

a presentation is only to be considered to contain a new active substance where confirmation that the presentation contains a new active substance is provided by—

i

a European Public Assessment Report published by the European Medicines Agency in relation to the presentation in accordance with Article 13.3 of the Regulation (EC) 726/2004 of the European Parliament and of the Council of 31st March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency3, or

ii

a assessment report published by the licensing authority in accordance with regulation 64(6) of the 2012 Regulations.

5E

For the purposes of paragraph (4)(f), “line extension” means a new presentation with the same active substance as another presentation which is marketed under the same brand name and by the same manufacturer or supplier but is distinguishable by reference to its strength, an excipient, its pack size, its method of administration or its formulation.

5F

For the purposes of paragraph (4)(g), “exceptional centrally procured presentation” means a presentation which—

a

is part of stock procured by the Secretary of State;

b

is procured for the purpose of emergency preparedness or stockpiling for national security or pandemic preparedness; and

c

either—

i

UKHSA manages the stockpiling and distribution of the relevant presentation, or

ii

the Secretary of State gives a direction to the manufacturer or supplier to the effect that paragraph (i) need not be satisfied in relation to the relevant presentation.

5G

For the purposes of paragraph (4)(h), “centrally procured vaccine presentation” means a presentation which—

a

is part of stock procured by the Secretary of State;

b

is a vaccine procured in accordance with a recommendation made or advice given by the Joint Committee on Vaccination and Immunisation4—

i

for a national vaccination programme, or

ii

for a branded medicine to be included in a national vaccination programme; and

c

either—

i

UKHSA manages the distribution of the vaccine as part of a national vaccination programme, or

ii

the Secretary of State gives a direction to the manufacturer or supplier to the effect that paragraph (i) need not be satisfied in relation to the relevant presentation.

5H

In this regulation—

• “active substance” has the meaning given in regulation 8(1) of the 2012 Regulations;

• “licensing authority” is to be construed in accordance with regulation 6 of the 2012 Regulations;

• “UKHSA” means the executive agency of the Department of Health and Social Care known as the United Kingdom Health Security Agency; and

• “vaccine” has the meaning given in regulation 8(1) of the 2012 Regulations.