Adaptation of the Guidance document Formal requirements HMV4

Section 3.12 “Conditions imposed by Quality Review, Preclinical Review and Clinical Review”: The fulfilment of a condition imposed in respect of a collective application must entail a separate request for each medicinal product concerned. Collective applications are not permitted in relation to the fulfilment of conditions.

The new version of the affected document enter into force as of 08.07.2019.