CRED 8 Presentations

01/07/2024

Module 1.5.5 Conditional Marketing Authorisation

Where the applicant requests a ‘conditional marketing authorisation’ to be granted in accordance with Article 14(7) of Regulation (EC) No 726/2004.

The applicant should include a justification in this section, covering the following aspects: • Evidence that the product falls under Article 3(1) or 3(2) of Regulation (EC) No 726/2004 and belongs to one of the categories set-out in Article 2 of Commission Regulation (EC) No 507/2006; • Evidence that the product satisfies the requirements laid down in Article 4 of Commission Regulation (EC) No 507/2006; • Applicant’s proposal for completion of ongoing studies, conduct of new studies and/or collection of pharmacovigilance data (as appropriate), in accordance with Article 4(1)(b) of Commission Regulation (EC) No 507/2006.

Please also refer to the “Guideline on the scientific application and the practical arrangements on the Conditional Marketing Authorisation” published on the EMA website

The Organisation for Professionals in Regulatory Affairs

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• Mandatory for initial MAA and for a new indication which involves a significant increase in the extent of use. • ‘ERA relates to those risks to the environment arising from use, storage and disposal of medicinal products and not for risks arising from the synthesis or manufacture of medicinal products’, Notice to Applicants. • Refer to the “Guideline on the Environmental Risk Assessment for medicinal products for human use” as published on the EMA website: Environmental risk assessment of medicinal products for human use | European Medicines Agency (europa.eu) • Usually prepared by a nonclinical contact or specialised department in most companies. Some companies may outsource. • Note : not required for amino acids, peptides or proteins (such as mAbs) because they are unlikely to result in significant risk to the environment. Module 1.6 Environmental Risk Assessment (ERA) (CP, MRP and DCP)

The Organisation for Professionals in Regulatory Affairs

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