(1)

In accordance with Article 111b(1) of Directive 2001/83/EC, a third country may request the Commission to assess whether that country’s regulatory framework applicable to active substances exported to the Union, and the respective control and enforcement activities, ensure a level of protection of public health equivalent to that of the Union in order to be included in a list of third countries ensuring an equivalent level of protection of public health.

(2)

Taiwan requested, by letter dated 8 December 2021, to be listed in accordance with Article 111b(1) of Directive 2001/83/EC.

(3)

The Commission has assessed the request by carrying on a review of the relevant documentation and an on-site review of Taiwan’s regulatory system from 20 to 27 April 2023 including an observed inspection and taking due account of the responses, information and documentation provided during the audit by the Taiwanese competent authority, Taiwan Food and Drug Administration (TFDA) within the Ministry of Health and Welfare.

(4)

Based on that equivalence assessment, the Commission concluded that the requirements of Article 111b(1) of Directive 2001/83/EC were fulfilled.

(5)

Commission Implementing Decision 2012/715/EU (2) should be amended accordingly.