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).
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Documents for pharmacovigilance branch
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Questions and answers on the amended Act on...
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PASS – Post-Authorisation Safety Studies
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Since when have the new rules for the Post...