On Friday, July 10th, the EMA released a draft of Version 2 of the ‘EU IDMP/SPOR/PMS Implementation Guide’ for consultation. This new release updates the chapters on SPOR User Registration, User Onboarding, and the critical Chapter 2 – Medicinal Product Information. It also includes a brand-new chapter (Chapter 3) on the future target operating model (TOM), revealing details on how industry will submit their data into the IDMP data base. The consultations on the draft Version 2 will result in the publication of Version 2 planned for the end of this year, triggering the start of the 24 month preparation and transition period, until the use of PMS becomes mandatory for industry. Companies that want to participate in the consultations will need to do so via their industry associations or the IRISS Forum. The EMA is especially keen to receive input from small and medium sized enterprises, but (of course) larger companies can also provide their input. The distribution of the draft documents is restricted.
In parallel, the EMA is also releasing the first draft of Version 1 of the ‘VET EU Implementation Guide on product data’ for consultation. This document defines the details of product data on veterinary medicinal products to be submitted into the Union Product Data Base (UPD) – the veterinary department of the SPOR/PMS system.
If you want to know more about IDMP and the implementation of SPOR contact our expert Karl-Heinz Loebel.