CRED 8 Presentations

01/07/2024

Module 1.0 Cover letter

CP: • In addition to the cover letter, users are required to fill in all the submission attributes for the XML delivery file to be submitted via the EMA Gateway since all attributes are used to support important searches in the Common Repository. • For orphan drugs, if including a cover letter, state the article/legal basis you are submitting the application under e.g ‘This application is in accordance with Article 3(1) – Indent 3 of Regulation (EC) No 726/2004: Criterion #3 (Medicinal products that are designated as Orphan Medicinal Products) pursuant to Regulation (EC) No 141/2000 for mandatory scope for Centralised Marketing Authorisation; and Article 8 (3) of Directive 2001/83/EC • Include indication and any prior agreements with the EMA.

MRP/DCP: • Use cover letter template from Heads of Agencies website ( http://www.hma.eu/219.html ). • Include indication and any prior agreements with other HAs for MRP/DCP.

The Organisation for Professionals in Regulatory Affairs

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Module 1.0 Cover letter attachments (CP, MRP and DCP)

• Summary table of Good Clinical Practice (GCP) inspections conducted by regulatory authorities for clinical studies included in the MAA (recently has become much more detailed). • Summary table listing the nonclinical studies conducted according to Good Laboratory Practice (GLP). • Manufacturing schedule for your medicinal product to facilitate the planning of regulatory agency Good Manufacturing Practice (GMP) Inspections. • Email correspondence with the EMA (CP) or other HAs (MRP/DCP) which record agreements relating to the MAA submission. • Minutes from Scientific Advice meetings (if applicable) • Notes to Reviewers (NtR) • Tracking table for all CP variation procedures

The Organisation for Professionals in Regulatory Affairs

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