• Inicio
  • Formações
  • Formação à Medida
  • News & Trends
  • Sobre nós
  • Contacto

Update to EU GMP Guidelines – Revised Annex 19 on Reference and Retention Samples

The European Commission has published a revised version of Annex 19 of EudraLex Volume 4. The update is focused on Section 9 of the annex which addresses reference and retention samples for parallel traded products.

The revised annex includes expectations around the use of photographic or digital samples as an alternative to physical retention samples for Parallel Imported/Parallel Distributed/Parallel Traded Products.

News & Trends

Procurar

Recentes

  • Commission publishes guidelines on transparency obligations for providers and deployers of certain AI systems
  • MDCG Position Paper: UDI assignment between manufacturers and distributors
  • EMA Questions & answers on Article 31 non-pharmacovigilance referral procedures
  • EXTENSION OF THE MDR TRANSITIONAL PERIOD AND REMOVAL OF THE ‘SELL OFF’ PERIODS
  • MHRA Updated guidance for the International Recognition Procedure (IRP)
  • MDCG 2021-5 Rev. 1 .Guidance on standardisation for medical devices
  • Qualification of novel methodologies (QoNM) for medicinal product development . Procedural Guidance to applicants
  • FDA Guidance for Drug Development

91 257 00 03 (Chamada para a rede móvel nacional)
info@formiventos.com

  • Follow
  • CLIENTES & TESTIMONIALS
  • ASSOCIAÇÕES OFICIAIS
  • CERTIFICAÇÕES E CREDITAÇÕES
  • ADVISORY BOARD
  • Política de Privacidade
  • Contacto