Regulation 13B(a) of the Gene Technology Regulations 2001 requires an IBC that has assessed an NLRD proposal to make a record of its assessment, in a form approved by the Regulator, and specifies the information that this record must contain.
Regulation 13B(b) further requires that an IBC that has assessed a proposed NLRD must give a copy of the record of assessment of the NLRD to the person or accredited organisation that submitted the proposal to the IBC. The IBC should be able to demonstrate that this has occurred.
In making an NLRD record of assessment (RoA) and recording that it has been given to the proponent, IBCs have the option of using this model form or another recording system/format of their own. Provided the record contains all the information specified in Regulation 13B(a)(i)-(x), the record will be considered to be in a form approved by the Regulator.
An IBC may also require that proponents submitting an NLRD proposal for assessment use this model form (or another form of their own design), in order to ensure that all relevant details are provided and simplify making a RoA.
A document titled Guidance on making a Record of Assessment for an NLRD and on responsibilities for those undertaking NLRDs has also been prepared to assist NLRD proponents and IBCs in complying with NLRD requirements. It is strongly encouraged that this guidance document be consulted when preparing an NLRD proposal or making a RoA.
Model Form - Record of Assessment for a Notifiable Low Risk Dealing (NLRD)
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