With the support of the EMA/ CVMP, the European Commission appears well on track with the process of drafting the delegated act (Art.146) on Annex II of the Regulation (EU) 2019/6. The scientific recommendations provided by EMA/CVMP on Annex II will require a variety of further guidance documents, which need to be adapted for the development of new and innovative products. Dr. Klaus Hellmann and Dr. Regina Wolf at Klifovet examine how the contents of Title IIa, Title III.8 and IV define new specific requirements to obtain marketing authorisations for non-immunological biological veterinary medicinal products (VMPs) and novel therapies.