(fra kommisjonsbeslutningen)

(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) The Republic of Singapore requested, by letter dated 11 February 2025, to be listed in accordance with Article 111b(1) of Directive 2001/83/EC.

(3) The Commission assessed the request by carrying out a review of the relevant documentation and an on-site review of Singapore’s regulatory system from 18 to 25 March 2026. This assessment included two observed inspections and took due account of the responses, information and documentation provided during the audit by the Health Sciences Authority (HSA) of Singapore.

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

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