Deadline January 1, 2019: eCTD mandatory for all submissions in the EU!
Are you prepared? You do not want to buy the necessary eCTD software yourself?
We are happy to assist you with the implementation of your submissions.
Important changes to the European EudraVigilance system requirements for marketing authorisation holders
From 22 November 2017 marketing authorisation holders (MAH) no longer need to send ADRs to their relevant national authorities but must instead send both serious and non-serious ADRs to the EMA via EudraVigilance.
The first IDMP standards for the EMA have been published and data mapping can now start
1 July 2017 Preparing, harmonising, registering and maintaining your medicinal product data – the orangeglobal group enables you to make the best possible start in dealing with the issue associated with IDMP.
MDR AND IVDR
As of 5 May 2017 On Friday 5 May 2017 the new EU regulations MDR (2017/745) and IVDR (2017/746) were published in the Official Journal of the European Union and are mandatory from 26 May 2017 for all medical technology companies that want to market their medical devices and medicinal products in the European Union.
XEVMPD obligation for traditional herbal medicinal products
18.05.2017 – From November 2017 – By means of Article 57 of Regulation 726/2004, the European Medicines Agency (EMA) has regulated the submission of medicinal product data in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) for pharmaceutical companies that hold marketing authorisations for medicinal products and clinical research organisation (CROs) that clinically test new medicinal products.
Labelling and publishing of pharmaceutical texts – Save processing time and costs with the orangeglobal group solution
01.12.2016 – You know the situation in your labelling team – the preparation and updating of summaries of product characteristics (SmPCs) and package leaflets (PLs) place ever-increasing demands on your time as a result of continuously changing regulatory requirements and increasing obligations.