Article 8 Standards of conduct, ethics and performance related to authorisations

Article 48 of the Pharmacy Order 2010^f1 (standards of conduct and performance) is amended in accordance with paragraphs (2) and (3).

After paragraph (1B) insert—

“(1C)

The standards set under this article may include standards which relate to the conduct, ethics and performance expected of registered pharmacists giving authorisations for the purposes of regulation 220B(1)(b) of the Human Medicines Regulations 2012.

(1D)

Where the standards set under this paragraph include standards of the type mentioned in paragraph (1C), the standards may include a description of the professional responsibilities that the registered pharmacists have—

(a)

for the documentation of authorisations given orally, as mentioned in regulation 220B(1)(b)(i) of the Human Medicines Regulations 2012; and

(b)

as a consequence of the professional accountability that the registered pharmacists retain for any selling or supplying that is done pursuant to the authorisation that they have given, and in particular for ensuring due regard for patient safety.”.

After paragraph (1D) insert—

“(1E)

The standards set under this article may include standards which relate to the conduct, ethics and performance expected of registered pharmacists giving authorisations for the purposes of—

(a)

section 10(1A)(b)(i) or (ii) of the Medicines Act 1968;

(b)

regulation 37(4)(a)(i) or (ii) of the Medicines for Human Use (Clinical Trials) Regulations 2004; or

(c)

regulation 220A(1)(a) or (b) of the Human Medicines Regulations 2012.

(1F)

Where the standards set under this article include standards of the type mentioned in paragraph (1E), the standards may include a description of the professional responsibilities that the registered pharmacists have—

(a)

for the documentation of authorisations given orally, as mentioned in section 10A(1)(b) of the Medicines Act 1968, regulation 37(6)(b) of the Medicines for Human Use (Clinical Trials) Regulations 2004 and regulation 220A(2)(b) of the Human Medicines Regulations 2012; and

(b)

as a consequence of the professional accountability that the registered pharmacists retain for any preparing, assembling, dispensing, selling or supplying that is done pursuant to the authorisation that they have given, and in particular for ensuring due regard for patient safety.”.

In paragraph 1 of Schedule 3 to the Pharmacy (Northern Ireland) Order 1976 ^f2(standards of conduct and performance), after sub-paragraph (1B) insert—

“(1C)

The standards set under this paragraph may include standards which relate to the conduct, ethics and performance expected of registered pharmacists giving authorisations for the purposes of regulation 220B(1)(b) of the Human Medicines Regulations 2012.

(1D)

Where the standards set under this paragraph include standards of the type mentioned in paragraph (1C), the standards may include a description of the professional responsibilities that the registered pharmacists have—

(a)

for the documentation of authorisations given orally, as mentioned in regulation 220B(1)(b)(i) of the Human Medicines Regulations 2012; and

(b)

as a consequence of the professional accountability that the registered pharmacists retain for any selling or supplying that is done pursuant to the authorisation that they have given, and in particular for ensuring due regard for patient safety.”.