As communicated by EMA:

“The new regulatory framework for veterinary medicines requires several changes to EudraGMDP. The most notable change is the integration of EudraGMDP with EMA’s Organisation Management Service (OMS).

From 28 January 2022, users of EudraGMDP from national competent authorities will no longer introduce organisational data (organisation name and location address details) directly into the relevant fields on the EudraGMDP database. Instead, they will select the relevant organisation name and location address details, including the legally registered address, of the manufacturers/importers/distributors from the Agency’s organisation dictionary (so-called OMS).

It is therefore necessary that all organisations currently regulated through EudraGMDP (which appear on documents within EudraGMDP, including EU and non-EU manufacturers, importers and distributors of human and veterinary medicinal products and active substances) are registered in OMS.”

The development of the database – the Manufacturers and Wholesale Distributors database (MWD) – started on 1 July 2021 and is currently in its test phase.

What is the Organisation Management Service (OMS)?

As per EMA the “OMS provides a single source of validated organisation data that can be used as a reference to support EU regulatory activities and business processes.

It stores master data comprising organisation name and location address for organisations such as marketing authorisation holders, sponsors, regulatory authorities and manufacturers. “

OMS has published a Data Quality Standard and integrating EudraGMDP with OMS should ensure more reliable data in the system through the consistent use of organisation master data in EudraGMDP.

What does this mean for access to public data in EudraGMDP?

Our understanding is that “access will continue as before – no changes are foreseen”.  

Webinar

The EMA will organise a webinar on the OMS services for interested manufacturers, importers and distributors on 12 October 2021 at 14:00 – 16:30 CEST. Participants will have the chance to ask questions and seek clarifications on OMS services and activities.

The US Pharmacopeia is proposing a new informational chapter on Supplier Qualification – <1083>. This was previously published as a chapter on good distribution practices and now <1083> is repurposed to focus on a risk-based approach to Supplier Qualifications.

The initiative has its roots in a white paper  “Good Supply Practices for the 21st Century”, published by Xavier Health in 2018 and will discuss the importance of supplier qualification and the application of a quality risk-based approach. 

The chapter outlines examples of supplier types that should be qualified, a six-step process of Supplier Qualification Life Cycle Management along with points to be considered in a risk assessment broken down by risk category.

While the USP general chapters numbered <999> and above are general guidelines rather than being enforceable by law, <1083> contains some good indications on the use of risk-based supplier qualifications. Commenting on <1083> is open until 30 November 2021.