| (1) |
The duty holder of a high hazard establishment must prepare a comprehensive, site-specific, safety report, which must be— |
| (a) |
developed during the design phase and be continually updated until the start date of operations; and |
| (b) |
maintained for the duration of the life of the establishment. |
| (2) |
The safety report must demonstrate a suitable and sufficiently documented plan to ensure— |
| (a) |
that reliable built-in safety has been incorporated into the— |
| (iv) |
maintenance of any equipment and infrastructure used in the establishment; and |
| (i) |
the major incident prevention policy; |
| (ii) |
the process safety management system; |
| (iii) |
the organisational and necessary measures to prevent major incidents and to limit their consequences; |
| (iv) |
the on-site emergency plan. |
| (3) |
The safety report must also contain information regarding an off-site emergency plan to take the necessary measures in the event of a major incident. |
| (4) |
The duty holder of a proposed high hazard establishment must submit to the chief inspector a— |
| (a) |
preliminary safety report at the design stage of that establishment; and |
| (b) |
final safety report within a reasonable time before the establishment starts operations. |
| (5) |
The duty holder must send a safety report to the chief inspector within 36 months after the entry into force of these Regulations. |
| (6) |
Every duty holder must review the safety report— |
| (b) |
prior to any change to the establishment; or |
| (c) |
whenever there is a change in the process safety management system which could have significant repercussions with respect to the prevention of major incidents or the limitation of the consequences of major incidents: |
Provided that the updated copy of the safety report, revised under this subregulation, is sent to the chief inspector within 60 days.
Medicines and Related Substances Act, 1965
