Annex

Substantial changes have been made to the permit conditions for “Molecular biology kits excluding kits testing for high risk microorganisms”. This permit has also been renamed to “Nucleic acid amplification diagnostic test kits”, to better reflect the updated content.

In general, the import conditions only facilitate the import of polymerase chain reaction (PCR) kits (and similar nucleic acid amplification techniques), which was the intention of the original policy.

The following summary is provided to assist importers in determining whether or not the new permit case remains applicable.

What can I test for?
The previous permit for “Molecular biology kits” did not allow the kits to test for, or include, listed high risk microorganisms (or parts thereof). No such restrictions apply to the new “Nucleic acid amplification” permit.

What can the tests contain?
The previous permit for “Molecular biology kits” allowed for the import of the following components:

• Up to 20ml or gm of purified animal proteins, albumins (including bovine serum albumin), hormones, lipids and enzymes.
  

• Purified genetic material.
  

• Microorganisms (excluding high risk microorganisms) which were not whole viable or whole inactivated.
  

The new permit for “Nucleic acid amplification” only allows for the import of:

• Nucleotides up to 1000 nucleotides
  

• Enzymes
  

• Chemical buffers
  

What happens if I can’t meet the new import conditions?
Please return to the previous BICON menu and determine whether the conditions of one of the other available permits will be suitable. If neither of these permits will suit the goods being imported, please apply for a non-standard permit by following the “Other” pathway. Alternatively you may contact the department to discuss further options.