Últimas noticias

User Acceptance Testing (UAT)

junio 8th, 2023|0 Comments

From 23 May 2016 it will be possible to use XML delivery files instead of the existing filenaming conventions for number submission types via eSubmission Gateway/Web Client. We would like to involve industry representatives in [...]

System maintenance work

junio 7th, 2023|0 Comments

MAHs are advised that due to system maintenance work the product refresh for the PSUR Repository will be stopped during the following planned dates, which are currently: 11th March to 18th March 2016 22nd March [...]

Version of the eAFs

junio 3rd, 2023|0 Comments

Version of the eAFs has been made available to fix technical issue related to the locking of the variation form and issues with the availability of the controlled terminologies in all forms. If you [...]

electronic Application Forms

mayo 29th, 2023|0 Comments

New versions of the electronic Application Forms (eAF v. 01.19) are now available and can be found here. These versions provide usability improvements to the existing forms and reflect the changes in the NtA application [...]

Fluarix Tetra (Influenza virus…

mayo 26th, 2023|0 Comments

Fluarix Tetra (Influenza virus (inactivated, split) of each of 4 strains (two A subtypes and two B lineages)) End of procedure: 31/03/2023 Date of publication: 02/16/2023

Meeting with Interested Parties -…

mayo 26th, 2023|0 Comments

Meeting with Interested Parties - 31 May 2023 Agenda Presentations CMDh - Multilingual Labelling in MRP/DCP CMDh - Renewal improvements CMDh - Availability of updated PI following safety reviews Medicines for Europe Europharm SMC

PSUR bulletin

mayo 25th, 2023|0 Comments

The PSUR bulletin for the week commencing 29 June 2015 is now available.

Added in May 2023 22 May NEW -…

abril 24th, 2023|0 Comments

Added in May 2023 22 May NEW - 23-25 May agenda 3 May UPDATE - Assessment report template for the nitrosamine risk assessment for the outcome of step 2 – “nitrosamine detected”  UPDATE - CMDh practical guidance [...]

The ICH M7(R2) Guideline reaches Step 4 of the ICH Process

abril 6th, 2023|0 Comments

The ICH M7(R2) Guideline on the “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” and the accompanying M7(R2) Addendum “Application of the Principles of the ICH M7 Guideline [...]


enero 27th, 2023|0 Comments

Report from the meeting held on 23-25 May 2023 Report from the meeting held on 24-25 April 2023 Report from the meeting held on 28-30 March 2023 Report from the meeting held on 21-22 February [...]