Regulation 3 Amendment of regulation 3

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

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

After paragraph (5A), insert—

“(5B)

This paragraph applies where a medicinal product is manufactured or assembled by a pharmacist—

(a)

who is acting in the course of his or her profession; and

(b)

where—

(i)

the conditions in paragraphs (8) and (9) are met, and

(ii)

treatment of the patient with the medicinal product is a treatment decision of the pharmacist.”.

In paragraph (11), after “paragraph (5)”, insert “, (5B)”.

In paragraph (12), in sub-paragraph (b), for “or (5A)” substitute “, (5A) or (5B)”.