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The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010

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This is the original version (as it was originally made).

Regulation 3(4)

SCHEDULE 4Standard provisions for wholesale dealer’s licences insofar as those licences relate to exempt advanced therapy medicinal products

This schedule has no associated Explanatory Memorandum

The standard provisions, for the purposes of Part II of the Act, for wholesale dealer’s licences insofar as they relate to exempt advanced therapy medicinal products are—

(a)the licence holder shall not use any premises for the purpose of the handling, storage or distribution of exempt advanced therapy medicinal products other than those specified in the licence holder’s licence or notified to the licensing authority by the licence holder from time to time and approved by the licensing authority;

(b)the licence holder shall provide such information as may be requested by the licensing authority concerning the type and quantity of any exempt advanced therapy medicinal product which the licence holder handles, stores or distributes;

(c)the licence holder shall take all reasonable precautions and exercise all due diligence to ensure that any information the holder provides to the licensing authority which is relevant to an evaluation of the safety, quality or efficacy of any exempt advanced therapy medicinal product which the holder handles, stores or distributes is not false or misleading in a material particular; and

(d)the licence holder shall keep the data referred to in sub-paragraph (k) of Schedule 3 for such period, being a period of longer than 30 years, as may be specified by the licensing authority.

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