OMS to become mandatory for all submissions to EMA
From 1st October 2021, applicants will have to use the OMS to register with the EMA for medicinal products.
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 sites and organizations that 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)/organizations 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 organization 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 categorized 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 an organization may act as a Marketing Authorisation Holder (MAH) for one product but as a sponsor or manufacturer for another.
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:
Organizations supporting the clinical trial application procedure.
Contract research organizations (CROs).
Clinical trial sites.
MAAs, MAHs, and manufacturers of herbal and homeopathic medicinal products.
MAAs, MAHs, and manufacturers for compassionate use medicines.
What should I use the OMS for?
In addition to applications for new medicinal products, the OMS must be used for, but not limited to:
Pre-submission meeting requests.
Change in contact person requests.
Marketing authorization 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 servicehere.Alternatively, EXTEDO offers all the information you need for digital medicinal registrations for the EMA and other regulatory agencies worldwide.
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 with your product validation and approvals.