eCTD submission

Submission of an updated Risk Management Plan (RMP) to TGA (Therapeutic Goods Administration) Australia

TGA has updated RMP for the sponsors of prescription medicines and biologicals making applications to enter or vary Australian Register of Therapeutic Goods (ARTG) entries.

Therapeutic Goods Administration has provided form to be submitted along with updated RMP.

Use this form when submitting an updated RMP after regulatory approval. This form should be submitted in module 1.0.1 and the updated RMP in module 1.8.2.

For information regarding form refer below link:

https://www.tga.gov.au/form/submission-updated-rmp

Submit your updated RMP/ASA as a NeeS/eCTD sequence

See ‘Risk management plans for medicines and biologicals: Australian requirements and recommendations’ for information about when to submit updated RMPs from below link.

https://www.tga.gov.au/publication/risk-management-plans-medicines-and-biologicals

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