News Category: Regulatory news
As a result of new legislation, the EMA is introducing some changes that will involve integration of the EudraGMDP database with another database, the Organisation Management Service (OMS), which is also hosted by the EMA. This will affect how documents are issued on EudraGMDP, including MIAs, WDAs, GMP certificates, GDP certificates and API registration documents. Further details on these changes and the implications for industry stakeholders are described in the communication below, which was issued by the EMA.
The EMA will run a webinar on 12 October 2021 for industry stakeholders and this provides an opportunity to learn more about these changes and ask questions. For information on the webinar, please see the EMA's webinar page.
Communication from the EMA
The text below has been communicated by the EMA.
The new regulatory framework for veterinary medicines (Regulations 2019/6 and 2021/16, Article 9(h)) requires the following changes to the EudraGMDP database which will come into effect from 28 January 2022:
The most notable change is the integration of EudraGMDP with 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 EMA's organisation dictionary (the OMS). This change will be reflected in the associated human and veterinary associated documents (including MIAs, WDAs, GMP Certificates, GDP certificates, API Registration) and investigational medicinal products (including MIAs, GMP Certificates).
This change will ensure more reliable data in the system through the consistent use of organisation master data in EudraGMDP, reduce the need for data entry and cleansing, and enhance consistency of these master data across other EU IT systems and projects, e.g. Clinical Trials Information System and Union Product Database.
It will only be possible for a national authority to issue a document on EudraGMDP from 28 January 2022 if the relevant organisation master data is available in OMS. This applies whether the document is being issued on EudraGMDP for the first time following a new application (e.g. new MIA, WDA, Active Substance Registration) or where a document is being re-issued (e.g. a new version of the MIA following a variation to the existing information). The same applies for certificates issued on EudraGMDP following an inspection process.
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.
In order to assist in populating data into OMS, EMA has undertaken a project to map existing organisation data associated with sites which are listed on various documents within EudraGMDP to OMS. As the data is introduced into OMS, it is checked for accuracy and cleansed through a standardised process. As a result of the standardisation used by OMS, it is possible that this could result in minor changes to the organisation data currently in EudraGMDP. This process will not affect existing documents on EudraGMDP (e.g. MIA, GMP Certificates, WDA etc.).
Registering with OMS
As of 28 January 2022, before applying for a new/updated manufacturing or wholesale distribution authorisation with national competent authorities, please check whether your organisation is correctly registered in OMS.
Read only access and searching of OMS is possible without having an ‘EMA account’. However, you need to ensure that relevant personnel in your organisation have registered for an EMA Account and requested a SPOR role for your organisation to maintain existing master data.
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If your organisation and its relevant locations are already correctly registered in OMS, no further action is needed at this time.
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If your organisation and its relevant locations are not registered in OMS, or if the information in OMS is not up-to-date: please raise a change request with the OMS team to register new or updated organisation master data in OMS after 28 January 2022. The Service Level Agreement (SLA) for change requests on OMS is 5-10 working days, based on the type of change needed. Raising a change request prior to a formal application for new authorisation or variation to details on an existing document (e.g. MIA or WDA) will ensure that national competent authorities SLA timeframes for new/updated authorisations are not shortened due to the time needed to validate the change request in OMS. This is particularly important if your site is to undergo inspection.
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If you are an EEA manufacturer or importer using manufacturing sites located in third countries: please liaise with the sites you use, which will need to be correctly registered in OMS. This is particularly relevant for any sites where an inspection is foreseen shortly and the related potential certificate may be issued after 28 January 2022. The same guidance applies:
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If the site is already correctly registered in OMS, no further action is needed at this time.
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If the site is not registered in OMS, or in case the information in OMS is not up-to-date: a change request needs to be raised with the OMS team to register new or updated master data in OMS. The SLA to process change requests on OMS is 5-10 working days, based on the type of change needed. Any registered SPOR user can submit change requests providing the relevant supporting information and documentation – it is up to you to coordinate submission of the needed change requests.
For information regarding the revised national application procedures, please contact the HPRA.
Comprehensive information on OMS and its services for any organisation/users is available here:
Webinar - 12 October 2021
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. Interested participants should register via this online form by 5 October.
The webinar will be recorded and published on the EMA’s website and YouTube channel. For more information on the webinar, please see the EMA's webpage: Webinar - Integration of EudraGMPD and OMS.
Queries
Queries on the above can be sent to:
HPRA: compliance@hpra.ie
EMA: vetchange.programme@ema.europa.eu