42. Reporting of defects and adverse effects to Authority

Terms defined in s 2

• adverse effect

  adverse effect

  Defined · s 2

  “adverse effect”, in relation to a health product, means any debilitating, harmful, toxic or detrimental effect that the health product has been found to have or to be likely to have on the body or health of humans when the health product is used by or administered to humans;

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• Authority

  Authority

  Defined · s 2

  “Authority” means the Health Sciences Authority established under section 3 of the Health Sciences Authority Act 2001;

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• health product

  health product

  Defined · s 2

  “health product” means any substance, preparation or device —(a)that —(i)is represented for use by humans;(ii)whether because of its presentation or otherwise, is likely to be taken for use by humans; or(iii)is included in a class of substances, preparations or devices which are or are ordinarily intended for use by humans,solely or principally for a health-related purpose; and(b)that falls within any of the categories of health products specified in the First Schedule;

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• intended purpose

  intended purpose

  Defined · s 2

  “intended purpose”, in relation to a health product, means the use for which the health product is intended according to the specifications of its manufacturer as stated on all or any of the following:(a)the label of the health product;(b)the instructions for use of the health product;(c)the promotional materials in relation to the health product;

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• manufacture

  manufacture

  Defined · s 2

  “manufacture”, in relation to a health product, means to make, fabricate, produce or process the health product and includes —(a)any process carried out in the course of so making, fabricating, producing or processing the health product; and(b)the packaging and labelling of the health product before it is supplied;

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• recall

  recall

  Defined · s 2

  “recall”, in relation to a health product, means any action taken by its manufacturer, importer, supplier or registrant to remove the health product from the market or to retrieve the health product from any person to whom it has been supplied, because the health product —(a)may be hazardous to health;(b)may fail to conform to any claim made by its manufacturer or importer relating to its quality, safety or efficacy; or(c)may not meet the requirements of this Act;

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• registrant

  registrant

  Defined · s 2

  “registrant”, in relation to a registered health product, means the person who applied for and obtained the registration of the health product under this Act;

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• supply

  supply

  Defined · s 2

  “supply”, in relation to a health product, means to transfer possession of the health product by any means whether or not for reward, and includes the following:(a)to sell the health product, whether by retail, wholesale or auction;(b)to expose or display the health product as an invitation to treat;(c)to transfer possession of the health product by exchange, gift, lease, loan, hire or hire-purchase;(d)to supply the health product in connection with —(i)a contract for the provision of any goods or the performance of any service; or(ii)any advertising, sponsorship or promotional activity;(e)to supply the health product by way of administration to or application in any person in the course of any diagnosis, treatment or test;(f)to offer, agree or attempt to supply the health product in any of the ways described in paragraphs (a) to (e) or to cause or permit the health product to be so supplied;(g)to keep or possess the health product for the purpose of supplying it in any of the ways described in paragraphs (a) to (f);

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