October 2022
Real Regulatory Tips and Insights

published 10 Nov 2022

Please find below a roundup of our weekly Regulatory Tips and Insights from our Regulatory experts on our Real Regulatory LinkedIn page. The tips we published in October 2022 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

Clinical Trials: Substantial Amendments

If there is no change in the substantial amendment that affects the EudraCT (Annex 1) Form other than the Protocol version number and date, then you should not include an updated EudraCT Form in the submission package.

eVariation eApplication Forms

When applying for a grouping of variations, particularly large groupings, ensure that all the required types of application are selected in Section 1 of the eAF before proceeding to choose the types of changes required in Section 3. Any changes (both the addition and deletion of variation types) made to Section 1 will automatically result in the loss of all changes selected and details entered in Section 3, and Section 3 will need to be completed again from scratch.

Clinical studies and sponsor responsibilities

For a sponsor of a clinical study, it must be remembered that the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor, even if some or all of the tasks associated with conducting the study are outsourced to third parties. Sponsor oversight of a study is a key element of the sponsor’s responsibilities under ICH E6(R2) (available at

Submission of renewals to HPRA

Based on the most recent update of the HPRA Guide to Renewal of Marketing Authorisations: - Products authorised under Directive 2001/83/EC may follow a shortened renewal procedure, i.e. a 30-day timetable under certain circumstances. The applicant should submit a cover letter and an application form (without annexes) with a declaration that full documentation will be available for submission upon request. Changes to MA particulars will not be accepted during the shortened renewal procedure. - It is no longer necessary to submit product information at the end of the renewal procedure unless minor editorial changes are being introduced. In these cases revised product information should be submitted as the agreed national text



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