E ai ki te "Ture Whakahaere Taakaro o te Repupirita Tangata o Haina" me te "Ture Whakahaere Kano Kano o te Tangata o Haina", ki te whakahaere me te arahi i nga mahi pharmacovigilance a nga kaipupuri raihana hokohoko tarukino me nga kaitono rehita tarukino, te State Drug. Kua whakaritea, kua whakatakotohia e te Tari Whakahaere te "Pharmacovigilance Quality Management The Regulations are herely announced, and the relevant matters about the implementation of Pharmacovigilance Quality Management Regulations are announced as follows:

1. Ka whakatinanahia te "Paerewa Whakahaere Kounga mo te Mataara Rongoa" a te Hakihea 1, 2021.

2. Ko nga kaipupuri raihana hokohoko tarukino me nga kaitono rehita tarukino kia kaha ki te whakarite mo te whakatinanatanga o nga "Rekureihana Whakahaere Kounga mo te Maataki Rongoa", ka whakatuu me te whakapai tonu i te punaha rongoa rongoa ina hiahiatia, me te whakataurite i te whanaketanga o nga mahi rongoa rongoa.

3. Me whakaoti e te kaipupuri mana hokohoko tarukino te rehitatanga korero ki te National Adverse Drug Reaction Monitoring System i roto i nga ra 60 mai i te ra o tenei panui.

4. Me akiaki nga mana whakahaere tarukino porowini i nga kaipupuri mana hokohoko tarukino i roto i o raatau rohe whakahaere kia kaha te whakarite mo te panuitanga, te whakatinanatanga me te whakamaoritanga e tika ana, me te tirotiro me te arahi i te whakamanatanga hokohoko tarukino ma te whakapakari i nga mahi tirotiro. Ka whakatinanahia e te kaipupuri nga "Rekureihana Whakahaere Kounga Maataki Rongoa" ina hiahiatia, ka kohia me te whakahoki i nga take me nga whakaaro e pa ana ki te wa tika.

5. Ko te National Adverse Drug Reaction Monitoring Center he riterite te whakarite me te whakarite i te panuitanga, whakangungu me te arataki hangarau o nga "Pharmacological Vigilance Quality Management Practices", me te whakatuwhera i te "Pharmacological Vigilance Quality Management Practices" i runga i te paetukutuku mana hei whakautu i nga patai e pa ana me nga whakaaro i te wa tika.

Panuitanga motuhake.