VHG reached a decision regarding mandatory use of the PDF/A format in VNeeS

Please be informed that the VHG reached a decision regarding mandatory use of the PDF/A format in VNeeS, starting after the transition period when the CESP dataset module becomes mandatory for all submission types. The current planning in the new version of the eSubmission Roadmap that was recently adopted by HMA currently says that the [...]

Por |2023-09-07T04:29:37+00:00septiembre 7th, 2023|Noticias|Sin comentarios

Reminder on the working documents provided within the eCTD submissions

As per the structure of the eCTD, the product information should be provided in pdf format within Module 1.1.3. However it is occasionally necessary to provide, in addition to the PDF requirement, product information or the Module 2 documents in Word format. These files should be provided outside of the eCTD structure, in a separate [...]

Por |2023-09-06T04:29:07+00:00septiembre 6th, 2023|Noticias|Sin comentarios

Vendor Readiness Survey

The ICH M8 EWG would like to assess the readiness of eCTD v4.0 Vendors and their development and/or readiness to deliver a production ready eCTD v4.0 solution. We request that the eCTD v4.0 Vendor Readiness Survey be completed by September 15, 2019.

Por |2023-09-05T04:26:57+00:00septiembre 5th, 2023|Noticias|Sin comentarios

An Active Substance Master File…

An Active Substance Master File (ASMF) can be used to replace the documentation for an active substance, required as part of an initial marketing authorisation application (MAA) or subsequent marketing authorisation variation (MAV). Appropriate guidance is given in the CHMP/CVMP guideline on active substance master file procedure. A specific ASMF can be used for multiple [...]

Por |2023-08-28T20:04:23+00:00agosto 28th, 2023|Noticias|Sin comentarios
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