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Updated Belgian guidelines for the labelling and packaging of medicinal products

Updated Belgian guidelines for the labelling and packaging of medicinal products

by In2Pharma | Feb 11, 2025 | News

Belgium An update of the Belgian guidance regarding labelling and packaging of medicinal products for human use was published based on the most recent adaptations of the European directives. FAMHP has provided a shortlist of the most important updates: Updated...
Update instructions for distribution of DHPC/aRMM in Luxembourg + introduction MA overview

Update instructions for distribution of DHPC/aRMM in Luxembourg + introduction MA overview

by In2Pharma | Aug 23, 2024 | News

Luxembourg La Division de la Pharmacie et des Médicaments de la Direction de la Santé (DPM) has published updated instructions for the distribution of DHPC (version 3.0 – 06/2024) and aRMM (version 4.0 – 06/2024) in Luxembourg. A change in the updated version is...
Notifying a change of marketing status for centralized procedures

Notifying a change of marketing status for centralized procedures

by In2Pharma | Sep 3, 2021 | News

Europe On 26 July 2021, EMA has launched the IRIS platform, a secure online platform to report marketing status changes and withdrawn product notifications of centrally authorised medicinal products (CAPs) to EMA.The marketing status overview will provide to EMA and...
Quality documentation for medicinal products when used with a medical device

Quality documentation for medicinal products when used with a medical device

by In2Pharma | Sep 3, 2021 | News

Europe EMA published a guideline, effective from 1 January 2022, on quality documentation for medicinal products when used with a medical device (first version). The guideline describes the information that should be presented in the Quality part of a MA dossier for a...

Recent Posts

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  • Verify Luxembourg MA Numbers in XEVMPD
  • Rates advice KOAGKAG
  • Announcement of changes in EU pharmacovigilance legislation

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