Regulation 27

disclose that confidential supporting information, or use that confidential supporting information for the purpose of determining whether to grant any other application to register a therapeutic product —

with the consent of the applicant who made the application to which the confidential supporting information relates; or

if that disclosure or use is, in the opinion of the Authority, necessary to protect the health or safety of members of the public;

disclose that confidential supporting information to a Government department or statutory body for the purpose of facilitating or assisting such Government department or statutory body in carrying out its duties if, in the opinion of the Authority, the Government department or statutory body, as the case may be, will take reasonable steps to ensure the confidential supporting information is kept confidential; or

disclose that confidential supporting information to, if so requested by, any one or more of the following:

the World Health Organization;

the Food and Agriculture Organization of the United Nations;

any regulatory agency of a country that is a party to the Agreement establishing the World Trade Organization adopted at Marrakesh on 15 April 1994;

any Advisory Committee established under section 10 of the Act.

that applicant —

has notified the Authority in writing that P may grant that consent; and

has not notified the Authority in writing that P’s authority to grant that consent has been withdrawn; or

that applicant’s rights in respect of the relevant confidential supporting information have been transferred to P and the applicant or P has notified the Authority in writing of the transfer.