SCHEDULES
SCHEDULE 33Transitional arrangements: pharmacovigilance
Pharmacovigilance system master fileF21
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F32
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Post-authorisation safety studies3
Regulations 198, 199, 200, 201 and 202 (provisions relating to post authorisation safety studies) do not apply to post authorisation safety studies commenced before 21st July 2012.
4
Regulation 210(3)(g) (offences relating to pharmacovigilance obligations under Regulation (EC) No 726/2004) does not apply to post authorisation safety studies commenced before 21stJuly 2012.
Reporting obligationsF15
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F16
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F17
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F18
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Periodic safety update reportsF19
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F110
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