Regulation 26 Lapse of clinical trial approvalF1

Subject to the extension of the period in paragraphs (3) and (5), the clinical trial approval lapses at the end of the period of 24 months beginning with the date of approval of the trial if there are no participants recruited to take part in the trial.

The sponsor may apply for an extension of the time period referred to in paragraph (1), stating why an extension is needed—

Where the sponsor applies for an extension in accordance with paragraph (2), the authorities may, where they consider appropriate, agree to extend the period for up to 36 months beginning with the day after the expiry of the period specified in paragraph (1), for example, where the trial involves the study of a rare disease or the trial is in anticipation of a disease causing a pandemic.

The sponsor may apply for a further extension, stating why the extension is needed, at any time before the expiry of the previous extension.

Where the sponsor applies for a further extension in accordance with paragraph (4), the authorities may, where they consider appropriate, agree to extend the period for up to 24 months beginning with the day after the end of the previous extension period, for example, where the trial involves the study of a rare disease or the trial is in anticipation of a disease causing a pandemic.

The authorities must give written notice of their decision to the sponsor—

If the period has lapsed in accordance with paragraph (1)—