CRED SMPC 2024

23/09/2024

Useful links – European Medicines Agency (EMA)

Human Regulatory/Marketing authorisation/Product-information requirements

https://www.ema.europa.eu/en/human-regulatory/marketing authorisation/product-information-requirements

• Product information templates - QRD

• How to prepare and review a SmPC

• Product information : Reference documents and guidelines

Wording of therapeutic indication A Guide for Assessors of Centralised Applications – October 2019 https://www.ema.europa.eu/en/human-regulatory/marketing authorisation/product-information/how-prepare-review-summary-product characteristics

The Organisation for Professionals in Regulatory Affairs

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Useful links – EMA

Article 30 or Article 31 referrals agreed wording

https://www.ema.europa.eu/en/medicines/ema_group_types/ema_referral

Periodic safety update single assessment (PSUSA) reports: ref

https://www.ema.europa.eu/en/search/search/field_ema_web_categories%25 3Aname_field/Human/ema_group_types/ema_document psusa?search_api_views_fulltext=periodic%20safety%20update%20report%2 0single%20assessment

Latest excipient guidelines (section 4.4 of SmPC) Ref:

https://www.ema.europa.eu/en/documents/scientific-guideline/annex european-commission-guideline-excipients-labelling-package-leaflet medicinal-products-human_en.pdf

The Organisation for Professionals in Regulatory Affairs

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