State Institute for Drug Control

For studies carried out voluntarily by  the MAH – from the effective date of the Amendment to AoP (Apr. 2, 2013), for studies imposed as  an obligation in accordance with Section 31a or Section 32a of the Amendment to AoP – from the effective date of the Amendment to AoP, for studies imposed as an obligation  by other authorities including the EMA (Art. 21a and 22a of Dir.2010/84/EC) – applicable from Jul. 2, 2012.On Sep. 1, 2013 the amendment to the Decree on Marketing Authorisation came into force. The new Sub-section of Section 17a, which was inserted in the amended Decree, governs all the safety studies (carried out pursuant to Section 93j of the Act on Pharmaceuticals).