18. Production of and time for keeping of records

A person who is required to keep any record under this Division must —

keep the records for the applicable period specified in paragraph (2) or (3); and

produce the records for inspection when required by the Authority at any reasonable time during the applicable period.

For records relating to any manufacture, assembly and testing of clinical research material, the applicable period is as follows:

in the case of registered and unregistered investigational clinical research material and unregistered auxiliary clinical research material — 5 years after the completion or discontinuation of the last clinical trial in which the batch of that material was used;

in the case of registered auxiliary clinical research material, the longer of the following periods:

one year after the expiry date of the material;

5 years after the date of such manufacture, assembly and testing;

in the case of traceability records relating to clinical research material that is a CTGT product — 30 years after the expiry date of the product or any other shorter period that the Authority allows in a particular case.

For records relating to the receipt and supply of, or the putting to some other use, disposal or export, of clinical research material, the applicable period is as follows:

where the clinical research is not a regulated trial and —

the clinical research material is not a CTGT product — 2 years after the supply, putting to some other use, disposal or export, as the case may be; or

the clinical research material is a CTGT product and —

the records do not relate to traceability — 2 years after the supply, putting to some other use, disposal or export, as the case may be; or

the records relate to traceability — 30 years after the expiry of the CTGT product, or any other shorter period that the Authority allows in a particular case;

where the clinical research is a regulated clinical trial, the period for which records of the trial must be kept under regulation 23(2)(c) of the Health Products (Clinical Trials) Regulations 2016 (G.N. No. S 331/2016) or regulation 23(2)(c) of the Medicines (Clinical Trials) Regulations 2016 (G.N. No. S 335/2016), as the case may be.

A person who is required to keep any record under this Division must —

keep the records for the applicable period specified in paragraph (2) or (3); and

produce the records for inspection when required by the Authority at any reasonable time during the applicable period.

For records relating to any manufacture, assembly and testing of clinical research material, the applicable period is as follows:

in the case of registered and unregistered investigational clinical research material and unregistered auxiliary clinical research material — 5 years after the completion or discontinuation of the last clinical trial in which the batch of that material was used;

in the case of registered auxiliary clinical research material, the longer of the following periods:

one year after the expiry date of the material;

5 years after the date of such manufacture, assembly and testing;

in the case of traceability records relating to clinical research material that is a CTGT product — 30 years after the expiry date of the product or any other shorter period that the Authority allows in a particular case.

For records relating to the receipt and supply of, or the putting to some other use, disposal or export, of clinical research material, the applicable period is as follows:

where the clinical research is not a regulated trial and —

the clinical research material is not a CTGT product — 2 years after the supply, putting to some other use, disposal or export, as the case may be; or

the clinical research material is a CTGT product and —

the records do not relate to traceability — 2 years after the supply, putting to some other use, disposal or export, as the case may be; or

the records relate to traceability — 30 years after the expiry of the CTGT product, or any other shorter period that the Authority allows in a particular case;

where the clinical research is a regulated clinical trial, the period for which records of the trial must be kept under regulation 23(2)(c) of the Health Products (Clinical Trials) Regulations 2016 (G.N. No. S 331/2016) or regulation 23(2)(c) of the Medicines (Clinical Trials) Regulations 2016 (G.N. No. S 335/2016), as the case may be.