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The Human Medicines (Amendment) Regulations 2019
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- UK Statutory Instruments
- 2019 No. 62
- Regulation 15
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Amendment of regulation 327 (powers of inspection, sampling and seizure)
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15. In regulation 327(1)—
(a)after sub-paragraph (2)(g) insert—
“(h)information and documents relating to compliance with the requirements of Commission Regulation 2016/161C.”;
(b)after paragraph (4) insert—
“(4A) The inspector may for the purposes specified in paragraph (1) require a legal entity established to set up and manage the repositories system pursuant to Article 31 of Commission Regulation 2016/161, or a person employed in connection with such a entity, to produce information or documents relating to the repositories system which are in the entity’s possession or under the entity’s control.”;
(c)in sub-paragraph (5)(a), for “or (g)” substitute “, (g) or (h);”; and
(d)in sub-paragraph (5)(b), after “paragraph (4)” insert “or (4A)”.
(1)
Regulation 327 was amended by S.I. 2013/1855.
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