BPOM Further Updates Guidelines on the Provision of EUA

  • The Head of the National Agency for Drug and Food Control (Badan Pengawas Obat dan Makanan/BPOM) has issued Decree No. HK.02.02.1.2.07.21.281 of 2021 as a second amendment to Decree No. HK. 02.02.1.2.11.20.1126 of 2020 on Technical Guidelines for the Implementation of Emergency Use Authorizations ("Second Amendment"), which updates the procedure for the granting of Emergency Use Authorizations (EUA), specifically as it relates to the following aspects: 1) Labeling requirements; 2) Lot release agreements; 3) Distribution; and/or 4) Pharmacovigilance inspections. These aspects are comprehensively broken down under the Appendix to the Second Amendment.
  • The Second Amendment has been in force since 6 July 2021.
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  • The Head of the National Agency for Drug and Food Control (Badan Pengawas Obat dan Makanan/BPOM) has issued Decree No. HK.02.02.1.2.07.21.281 of 2021 as a second amendment to Decree No. HK. 02.02.1.2.11.20.1126 of 2020 on Technical Guidelines for the Implementation of Emergency Use Authorizations ("Second Amendment"), which updates the procedure for the granting of Emergency Use Authorizations (EUA), specifically as it relates to the following aspects: 1) Labeling requirements; 2) Lot release agreements; 3) Distribution; and/or 4) Pharmacovigilance inspections. These aspects are comprehensively broken down under the Appendix to the Second Amendment.
  • The Second Amendment has been in force since 6 July 2021.
......

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