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Circumstances where protection under section 19A does not apply

Medicines Act 1975

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Wrong or mistyped textWrong structure or numberingWrong title or detailsDuplicated content

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—(1) Despite section 19A, the licensing authority may, during the protected period in relation to confidential supporting information —(a)disclose that confidential supporting information, or use that confidential supporting information for the purposes of determining whether to grant any application other than the application to which it relates or related, as the case may be —(i)with the consent of the applicant who made the application to which the confidential supporting information relates or related; or(ii)if that disclosure or use is, in the opinion of the licensing authority, necessary to protect the health or safety of members of the public;(b)disclose that confidential supporting information to —(i)a Government department or statutory body for the purposes of the Government department or statutory body; or(ii)any adviser engaged by the licensing authority to advise on any aspect of the medicinal product to which the confidential supporting information relates or is related,if, in the opinion of the licensing authority, the Government department, statutory body or adviser (as the case may be) will take reasonable steps to ensure the confidential supporting information is kept confidential; or(c)disclose that confidential supporting information to any one or more of the following:(i)the World Health Organisation;(ii)the Food and Agriculture Organisation;(iii)any regulatory agency of a WTO Country;(iv)any advisory committee established under section 73;(v)any person or organisation, or a person or organisation within a class or classes of persons or organisations, approved by regulations made under this Act, if the disclosure is in accordance with any conditions that may be specified in the regulations.(2) The power to grant consent under subsection (1)(a)(i) may be exercised by a person other than the applicant mentioned in that subsection if —(a)that applicant —(i)has notified the licensing authority in writing that that other person may grant that consent; and(ii)has not notified the licensing authority in writing that that person’s authority to grant that consent has been withdrawn; or(b)that applicant’s rights in respect of the relevant confidential supporting information have been transferred to that person and the applicant or that other person has notified the licensing authority in writing of the transfer.(3) In this section, “WTO Country” means a country that is a party to the Agreement establishing the World Trade Organisation adopted at Marrakesh on 15 April 1994.

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