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The Mission of the Malta Medicines Authority is to safeguard public health through the regulation of medical products and pharmaceutical activities for human use.

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The Malta Medicines Authority participates in EU4Health Joint Action EU4H 11

The Malta Medicines Authority participates in EU4Health Joint Action EU4H 11

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Kick-off meeting of the EU4Health Programme Joint Action IncreaseNET

Organisation Management Service (OMS) integration with EudraGMDP -

Human and Veterinary industry preparedness

Dear Industry Stakeholders,

 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:

 Integration of EudraGMDP with EMA's Organisation Management Service (OMS);

 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 Agency's organisation dictionary (so-called 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 28th 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.). 

 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.

 ·         If your organisation and its relevant locations are already correctly registered in OMS, no further action is needed at this time.

For information regarding the revised national application procedures, we suggest industry stakeholders contact relevant national competent authorities.

Comprehensive information on OMS and its services for any organisation/users is available here:

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 EMA's website and YouTube channel. For more information: Integration of EudraGMPD and OMS - Webinar for industry | European Medicines Agency (europa.eu)