Dear partners, Kindly be informed that during the current epidemiological context determined by the Covid-19 pandemic, the activity of OSMR is remote, but not less effective. All the communication channels you know, tel: +4037 140 03 48 email : contact@osmr.ro, are available and at your disposal.
Please find below the document published by European Medicines Agency (EMA) and the European Commission concerning Q&A on regulatory expectations for medicinal products for human use during the COVID-19 pandemic. Download pdf
Please consult this Letter of Announcement from EMVO on the consequences following Withdrawal of data & Batch recall. Downloadpdf
[pdf-embedder url=”https://staging.osmr.ro/wp-content/uploads/2020/03/Status-Update_EN_30.03.20.pdf” title=”Status Update_EN_30.03.20″] Download Report 30.03.2020
[pdf-embedder url=”https://staging.osmr.ro/wp-content/uploads/2021/05/Prezentare_SoftwareProviders_26.03.2020.pdf”] Download TeleConf 26.03.20
Please find below a Letter of Announcement from EMVO on the EU Hub Release 1.7 in ITE, IQE & PRD. Download PDF
Please find bellow a Letter of Announcement from EMVO on the European Commission’s Questions & Answers document on “Safety Features for Medicinal Products for Human Use (V.17)”. Download PDF
Clarification of the notion of “Designated Wholesaler” – https://emvo-medicines.eu/new/wp-content/uploads/EMVO_0122_EMVS-Master-Data-Guide-2.pdf – EMVS Master Data Guide, version 3.0 (available on the EMVO website – Knowledge Database page, OBP section)
A document which includes a set of Frequently asked Questions and the respective Answers related to the End-Users’ registration process is now available: Download
SAFETY ELEMENTS FOR MEDICINAL PRODUCTS FOR HUMAN USE FREQUENTLY ASKED QUESTIONS AND ANSWERS Please find below the document that includes a set of frequently asked “Questions and Answers” related to the implementation of the safety elements requirements’ on the packaging of the medicinal products for human use. FAQ – OSMR & ANMDMR