Application for approval or inclusion in Annex I to Regulation (EU) No 528/2012
Article 3
1. An application for approval or inclusion in Annex I to Regulation (EU) No 528/2012 may be submitted only by a participant whose notification has been found compliant by the Agency pursuant to Article 17(5) of this Regulation. Where the application concerns inclusion in Annex I to Regulation (EU) No 528/2012, it may only concern category 1, 2, 3, 4, 5 or 6 of that Annex. 2. Applications referred to in paragraph 1 shall be submitted to the Agency within two years of the declaration of compliance pursuant to Article 17(5).