Module 5 Presentations

05/07/2024

Covering letter

• Cover letter is your main tool to pass the relevant information on the trial and highlight any specificities of your CTA. It may be complemented by additional statements or appendices for specific situations, as needed • Content has evolved from CTD to CTR but certain items remain • Trial identification (EudraCT number / EU CT number) • Information on the trial and population • Location of Reference Safety Information (RSI) for SUSAR assessment (IB or SmPC) • Etc. • In CTIS, cover letter is study-level and circumstantial to a specific application (cannot be updated once submitted, a new one should be included as part of RFI answers)

Refer to CTR Annex 1, Section B for detailed content of cover letter

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

21

IMP Labeling

CTR Annex VI does not provide as much flexibility as GMP Annex 13, i.e. expiry date required on primary packaging. CTR revision published end of 2022 to address expiry issue but others remain.

• Labelling structure and design may influence its legal content • General case • primary package designed to remain together with secondary packaging (secondary packaging carries particulars) • Small primary packaging (blister packs or small units such as ampoules (<10 mL) limiting extent of text • Marketed products bearing overlapping information • “Particulars should appear in the official language(s) of the country in which the Investigational medicinal product is to be used” • Check a few elements to build up your labelling strategy (allowed omissions) • Confirm all units to be labelled (test, comparator, centrally sourced NIMPs) • Is a booklet label going to be used ? • What is the structure of my booklet label ? • Content of booklet label cover page (if any) / nature of fixed and variable information • Is there an IVRS / IxRS system ? Blinding ? • How is this linked to the packaging (kit number if you have one) ? • GMP Annex 13 / Annex VI allows for omission of certain information if those can be obtained via IxRS • Is there a patient emergency card ? • Certain information may be included on the patient card instead of the label itself, but this needs to be made clear to labelling reviewers and described in your labeling strategy. • Certain information cannot be ommitted (Annex VI, D.9) and CTR does not include exemption provisions

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

22