Annex II — Reference values referred to in Articles 8 and 27

Reference values to be included in the repository of reference values referred to in Article 8(3) 1. Predicted no effect concentrations derived as part of the environmental risk assessment under Directive 2001/83/EC, Regulation (EC) No 726/2004 and Regulation (EU) 2019/6. Those reference values shall be limited to data submitted to the EMA in the context of the relevant procedures that are concluded after the date of entry into force of this Regulation. Where relevant, data held by the EMA resulting from procedures concluded before the date of entry into force of this Regulation shall also be considered for inclusion into the common data platform.