Regulation 29

information relating to the safety or efficacy of a therapeutic product has been provided to the Authority by an applicant in support of the application for the registration of that therapeutic product; and

the Authority has registered that therapeutic product (called the earlier registration),the Authority may not, for a period of 5 years after the date of the earlier registration, register, on the application of any other person, a similar therapeutic product on the basis of the earlier registration, unless the registrant of the earlier registration has consented to the registration on that basis.