The EMA has recently informed all potential applicants and Marketing Authorization Holders (MAHs) that the registration in Organisational Management Service (OMS) will become mandatory from the 1st of August 2021 for new site and organizations who wish to be registered for a medicinal product as part of any regulatory procedure submitted to the EMA. End of July, this timeline has been slightly postponed: “In order to allow applicants and MAHs to timely register in OMS, the previously communicated deadline of 1 August 2021 is extended until the end of September 2021. Early registration of site(s)/organisations in OMS is encouraged.”
The OMS has provided an alternative for applicants who want to submit new medicinal products for registration with the EMA. While applicants always had the option to enter their organization details manually, this will no longer be the case from the 1st of October 2021. From October onwards, the EMA will require organizations to use the OMS to submit their data. Read on to find out more details on the EMA’s decision, and what you need to do in anticipation of it.
What is the OMS?
The Organization Management Service (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 information for applicants such as name, location and address to be used automatically during product registrations to the EMA. It acts as a common platform for managing data that defines organizations and locations, and will be used to help fill regulatory forms without error.
Organizations are categorised in the OMS by type, such as ‘Industry’, ‘Regulatory Authority’ or ‘Educational Institution’ and by size, such as ‘Micro’, ‘Small’, or ‘Medium’, however, the OMS does not define roles an organization performs, which are context-specific. This means that while an organization may act as a Marketing Authorisation Holder (MAH) for one product but as a sponsor or manufacturer for another.
You can learn more about the OMS in the official EMA video here.
Who is the OMS for?
Any applicant, sponsor, MAH or manufacturer that wishes to authorize their products with the EMA has to use the OMS from October 1st, 2021 and onwards as part of the registration process. In addition, the EMA intends to expand the scope of the OMS by including other types of organizations such as:
- Organisations supporting the clinical trial application procedure.
- Contract research organisations (CROs).
- Clinical trial sites.
- Academic institutes.
- Wholesale distributors.
- MAAs, MAHs and manufacturers for herbal and homeopathic medicinal products.
- MAAs, MAHs and manufacturers for compassionate use medicines.
What should I use the OMS for?
In additions to applications for new medicinal products, the OMS must be used for, but not limited to:
- Eligibility requests.
- Pre-submission meeting requests.
- Change in contact person requests.
- Marketing authorisation applications.
- Line extensions and variations (type IA, IB and II).
How can I prepare for using the OMS?
As noted before, using the OMS will soon become mandatory for applicants wishing to register with the EMA. In order to prepare for this, organizations must register in the OMS before any regulatory submissions. This will avoid any delay in the processing of these applications.
In addition, all applicants or MAHs must register their organizations with the OMS, including data that has been entered into the Digital Application Dataset Integration (DADI), the new electronic application form for electronic submissions.
How can I access the OMS?
The OMS manages one of the four domains of substance, product, organization and referential (SPOR) master data in pharmaceutical regulatory processes. As such, organizations can access the OMS via the SPOR portal.
If you would like to find out more about the OMS, you can visit the EMA webpage for the service here. Alternatively, EXTEDO offers all the information you need for digital medicinal registrations for the EMA and other regulatory agencies around the world.
EXTEDO’s services provide a streamlined process to help you keep up to date with changing regulations and agency policies for multiple countries. Our direct connections with agencies and pre-approved templates help you stay in-line with agency expectations while assisting your product validation and approvals.