Regulation 4 Amendments to regulation 3

Regulation 3 (scope of these Regulations: special provisions)^f1 is amended as follows.

In paragraph (2), after “paragraph (5)” insert “, (5A)”.

After paragraph (5) insert—

“(5A)

This paragraph applies where a medicinal product is assembled in a registered pharmacy on behalf of a doctor with a view to its supply as part of arrangements of the type mentioned in regulation 222A(1)(b), where—

(a)

an order for the supply of that medicinal product to or for the use of a particular patient was submitted by or on behalf of the doctor as part of the provision of NHS pharmaceutical services; and

(b)

the condition in paragraph (8) is met.”.

In paragraph (10), after “paragraph (11)” insert “, (11A)”.

After paragraph (11) insert—

“(11A)

This paragraph applies where a medicinal product is the result of a process of assembly to which regulation 17(1) does not apply by virtue of paragraph (5A).”.

In paragraph (12)(b), for “or (5)” substitute “, (5) or (5A)”.