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The Human Medicines Regulations 2012

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Analysis or other examination

15.  Where the enforcing authority that authorises the sampling officer is the Secretary of State or the Minister for Health, Social Services and Public Safety, if the sampling officer decides to submit the sample for analysis the officer must do so—

(a)to a medicines control laboratory; or

(b)to a laboratory available for the purpose in accordance with any arrangements made by the enforcing authority in question.

16.  Where any other enforcing authority authorises the sampling officer, if the sampling officer decides to submit the sample for analysis the officer must do so to a laboratory available for the purpose in accordance with any arrangements made by the enforcing authority in question.

17.—(1) Arrangements of the kind mentioned in paragraphs 15(b) and 16 made by an enforcement authority in England, Wales or Scotland other than the Secretary of State must be approved by the Secretary of State.

(2) Arrangements of the kind mentioned in paragraph 15(b) made by a district council in Northern Ireland must be approved by the Minister for Health, Social Services and Public Safety.

18.  A laboratory to which a sample is submitted under paragraph 15 or 16 must analyse or examine the sample as soon as practicable,

19.  A laboratory that has analysed or examined a sample submitted under the preceding provisions of this Schedule must issue and send to the sampling officer a certificate specifying the result of the analysis or examination.

20.  A person to whom a part of the sample is to be supplied in accordance with paragraphs 2 to 8 is entitled, on payment of the required fee, to be given a copy of any certificate as to the result of an analysis or examination which is sent to the sampling officer under paragraph 19.

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