Drug Evaluation Committee Guidance for Notification of "Electronic Annexes of Ethical Drugs" (August 2023 edition)
Pharmacovigilance Subcommittee
August 2023
As the transitional measures period for the computerization of accompanying documentation under the revised Pharmaceutical Affairs Law will expire on July 31, 2023, the Drug Evaluation Committee PV Subcommittee Continuing Issues Team 4 has prepared the "Guidance for Notification of Electronic Attached Documents for Prescription Drugs (August 2023 Edition)" in response to the expiration date.
This document was prepared based on information as of July 31, 2023. Please be aware that the contents of this document may be subject to change due to notices, etc. to be issued in the future.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
PV Subcommittee Continuing Issues Team 4
Guidance for Notification of Electronic Attachment of Ethical Drugs (August 2023 Edition) (1.9MB)