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You are here: Pharmya > All news > Questions and answers on describing adverse events in the product information (summary of product characteristics (SPC) and package leaflet (PL))

https://www.ema.europa.eu/en/documents/other/questions-and-answers-describing-adverse-events-product-information-summary-product-characteristics-spc-and-package-leaflet-pl_en.pdf

AMarignan 18 December 2023 All news
  • ← First version of the Union list of critical medicines agreed to help avoid potential shortages in the EU
  • Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation →

Pharmya – Pharmacovigilance

PHARMYA is a French based company, dedicated to providing Pharmacovigilance services. Its mission is to support the pharmaceutical industry, biotechnology companies, research centers and their service providers in their efforts to comply with international Pharmacovigilance regulations.

In partnership with the region

Contact

  • PHARMYA
  • 315 Av. Saint Sauveur du Pin
  • 34980 Saint Clément de Rivière (Montpellier), France
  • Phone: +33 411 93 21 10
  • Email: info@pharmya.com
  • Website: www.pharmya.com

News

  • A common EU approach to data transparency in medicine regulation
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 November 2024
  • European regulation on clinical trials for medicinal products: The end of the transition period
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