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Medicines Act 1968

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Version Superseded: 14/08/2012

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115 Analysis of samples in other cases. U.K.

(1)A person who, not being a person authorised in that behalf by an enforcement authority, has purchased a medicinal product may submit a sample of it for analysis to the public analyst for the area in which the product was purchased, or, if for the time being there is no public analyst for that area, then to the public analyst for some other area.

(2)Paragraphs 2 to 13 of Schedule 3 to this Act shall have effect in relation to a person proposing to submit a sample in pursuance of the preceding subsection, as if in those paragraphs any reference to the sampling officer were a reference to that person.

(3)Subject to the following provisions of this section, a public analyst to whom a sample is submitted under subsection (1) of this section shall as soon as practicable analyse the sample or cause it to be analysed by some other person under his direction.

(4)If the public analyst to whom a sample is submitted under subsection (1) of this section determines that for any reason an effective analysis of the sample cannot be performed by him or under his direction, he shall send it to the public analyst for some other area, and (subject to the next following subsection) that other public analyst shall as soon as practicable analyse the sample or cause it to be analysed by some other person under his direction.

(5)A public analyst to whom a sample is submitted or sent under this section may demand payment in advance of the prescribed fee, and, if he demands such payment, he shall not be required to analyse the sample or cause it to be analysed until the fee has been paid.

(6)A public analyst who has analysed a sample or caused a sample to be analysed under this section shall issue a certificate specifying the result of the analysis to the person by whom the sample was originally submitted.

(7)Any certificate issued under subsection (6) of this section shall be in a form prescribed by the Ministers and shall be signed by the public analyst who issues the certificate.

(8)Paragraphs 21 to 23 of Schedule 3 to this Act shall have effect in relation to a certificate issued under subsection (6) of this section as they have effect in relation to a certificate issued under paragraph 19 of that Schedule.

(9)Any regulations prescribing a fee for the purposes of this section shall be made by the Ministers.

(10)In this section “public analyst” has the meaning assigned to it by paragraph 1(2) of Schedule 3 to this Act.

Modifications etc. (not altering text)

C1Pt. VIII (ss. 104–136) extended by S.I.s 1982/425, art. 3, 1984/187 art. 2; and extended with modifications by S.I. 1985/403, art. 3(1)

C2S. 115 modified by S.I. 1985/273, reg. 2 Sch. 1 Pt. I

S. 115 applied (1.1.1995) by S.I. 1994/3142, reg. 18(2)

S. 115 applied (with modifications) (1.1.1995) by S.I. 1994/3144, reg.10, Sch. 4

S. 115 applied (31.3.1997) by S.I. 1997/322, reg. 34, Sch.5

C3Ss. 108-115 modified (3.4.1992) by S.I. 1992/605, regs. 2(3), 3

Ss. 108-115 applied (3.10.1994) by S.I. 1994/2328, reg. 11(c)

C4Ss. 107-116 applied (with modifications) (1.5.2004) by Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), regs. 1, 47, Schs. 9

C6Ss. 107-116 amendment to earlier affecting provision SI 2004/1031 reg. 47 Sch. 9 (29.8.2006) by Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 32

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