The Human Medicines Regulations 2012

Analysis of samples: other cases U.K.

330.— [F1 (1) This regulation applies where a person other than an inspector or a person authorised by an enforcement authority has purchased an active substance or a medicinal product.

(2) The person may submit a sample of the active substance or medicinal product for analysis to the public analyst for the area in which the active substance or medicinal product was purchased or, if for the time being there is no public analyst for the area, to the public analyst for another area.]

(3) Paragraphs 2 to 13 of Schedule 31 have effect, in relation to a person proposing to submit a sample in pursuance of paragraph (2), as if in that Schedule references to the sampling officer were references to that person.

(4) A public analyst to whom a sample is submitted under this regulation must analyse the sample, or cause it to be analysed, as soon as practicable (but this is subject to the following provisions of this regulation).

(5) If the public analyst to whom a sample is submitted thinks that a proper analysis cannot be carried out for any reason, the public analyst must send it to the public analyst for some other area, who must as soon as practicable analyse the sample, or cause it to be analysed (subject to paragraph 6).

(6) A public analyst to whom a sample is submitted or sent under this regulation may demand payment in advance of the required fee, and if payment in advance is demanded may refuse to carry out the analysis until the fee is paid.

(7) A public analyst who has analysed a sample or caused it to be analysed must issue a certificate specifying the result of the analysis to the person by whom the sample was submitted under paragraph (2).

(8) Paragraphs 21 to 23 of Schedule 31 have effect in relation to a certificate issued under this regulation as they have effect in relation to a certificate issued under paragraph 19 of that Schedule.

(9) In this regulation “public analyst”—

(a) in relation to England and Wales and Scotland has the meaning given by section 27 of the Food Safety Act 1990 M1 ; and

(b) in relation to Northern Ireland has the meaning given by Article 27(1) of the Food Safety (Northern Ireland) Order 1991 M2 .

Textual Amendments

F1 Reg. 330(1)(2) substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 30

Modifications etc. (not altering text)

C1 Regs. 325-330 applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

Marginal Citations

M1 1990 c.16. Section 27 was amended by the Local Government etc (Scotland) Act 1994 section 180(1) and Schedule 18 paragraph 163(3), the Food Standards Act 1999 section 40(1) and Schedule 5 paragraphs 7 and 8, the Local Government (Wales) Act 1994 section 22(3) and Schedule 9 paragraph 16(2), S.I. 1994/865 regulation 24, and the Local Government and Public Involvement in Health Act 2007 sections 22 and 241, Schedule 1 Part 2 paragraph 17, and Schedule 18 Part 1.

M2 1991 No. 762 (N.I. 7). There are amendments not relevant to these Regulations.