sec.224Period and way of keeping records

sec.224 Period and way of keeping records

This section applies to a person if a provision of this regulation states the person is required to keep a record. However, this section does not apply to— a pharmacist keeping a record under section 162 ; or the chief executive keeping information in the monitored medicines database. The person must keep the record for— if the record is the details of an appointment of a system administrator under section 185 —2 years after the appointment ends; or if the record is an entry in a medicine register kept on paper—2 years after the last entry in the register is made; or otherwise—2 years after the record is made. Maximum penalty—40 penalty units. During the period for which the record must be kept, the person must take all reasonable steps to ensure the record is— kept in a retrievable form; and kept securely to ensure it can not be altered, obscured, deleted or removed without detection. Maximum penalty—40 penalty units. If the record is kept electronically, the person must— ensure any data stored in the record is secure and tamper-proof in accordance with acceptable industry standards; and backup the record regularly during the period for which the record must be kept. Maximum penalty—40 penalty units. However, subsection (5) does not apply if the record is kept in an electronic prescription management system. See chapter 8 , part 1 for requirements for electronic prescription management systems. In this section— record includes a copy of a record or information contained in a record. (sec.224-ssec.1) This section applies to a person if a provision of this regulation states the person is required to keep a record. (sec.224-ssec.2) However, this section does not apply to— a pharmacist keeping a record under section 162 ; or the chief executive keeping information in the monitored medicines database. (sec.224-ssec.3) The person must keep the record for— if the record is the details of an appointment of a system administrator under section 185 —2 years after the appointment ends; or if the record is an entry in a medicine register kept on paper—2 years after the last entry in the register is made; or otherwise—2 years after the record is made. Maximum penalty—40 penalty units. (sec.224-ssec.4) During the period for which the record must be kept, the person must take all reasonable steps to ensure the record is— kept in a retrievable form; and kept securely to ensure it can not be altered, obscured, deleted or removed without detection. Maximum penalty—40 penalty units. (sec.224-ssec.5) If the record is kept electronically, the person must— ensure any data stored in the record is secure and tamper-proof in accordance with acceptable industry standards; and backup the record regularly during the period for which the record must be kept. Maximum penalty—40 penalty units. (sec.224-ssec.6) However, subsection (5) does not apply if the record is kept in an electronic prescription management system. See chapter 8 , part 1 for requirements for electronic prescription management systems. (sec.224-ssec.7) In this section— record includes a copy of a record or information contained in a record.