Australia Us Free Trade Agreement Form

Unlike applications for the registration of therapeutic products covered by Section 25AB of the Act and the list of listed drugs assessed pursuant to section 26AE of the Act, an application to register a drug in accordance with sections 26 or 26A must be accompanied by a 26B sub-certificate (1) or a declaration (in accordance with a written approved form). , by the Secretary), that a patent certificate is not required, i.e. the certificate or application is required at the time of filing the application, and not after a decision on the application. For products listed in accordance with Section 26A, no safety, efficacy and quality assessment is required prior to inclusion in the EEA. On the contrary, the applicant certifies that it has information or evidence to substantiate any of the applicant`s right to the drug. Therefore, paragraph 26B (1) is not necessary and the applicant is required to inform the secretary, along with the filing of his application in accordance with Section 26A, that no certificate is required. This communication is made through Article 26B(1) of the communication. These amendments mean that the patent certificate requirements do not apply to filers who register or list drugs that are not required to provide evidence or information to demonstrate the safety or effectiveness of the goods in the registration or listing process. Under these circumstances, applicants are only required to inform the Secretary, in its approved form, that the Section 26B (1) patent certificate is not required for the application. The agreement also improves Australia`s services, trade and investment prospects, improves the regulatory and investment environment between the two countries and promotes increasing business mobility. In the case of applications for marketing authorization for section 25AB drugs, the section 26 exporting list, or the list of drugs listed under Section 26AE, where the section 26B (1) certificate is not required, the secretary must be notified through the approved notification form. However, subsection 26B (1) patent certificate or application is only required when the assessment under Section 25 or Section 26AE of the Act is complete and the secretary decides to register or list the goods in the ARTG.

Fotos: Kathrin Leisch
Impressum | AGB