Published by EMA on 10-Feb-2014
Following the receipt of the requested information from the marketing authorisation holders, the Agency has re-allocated the ownership of the organisation entities previously created and owned by the Agency to the owner organisations as identified by marketing authorisation holders. Marketing authorisation holders are therefore able to review the organisation entities assigned to their organisation ID, and if necessary, correct the organisation information, remove duplicates and amend their authorised medicinal product entities to reference the correct MAH organisation as required.
Between 16 June and 31 December 2014 MAH must perform the following activities on their organisation entities:
• Review organisation entities assigned to their organisation ID.
• Correct or amend any information within the organisation entity including providing additional information as per amended XEVPRM schema using operation type ‘Update (2)’.
• Amend their authorised medicinal product entities to reference the correct MAH organisation as required using operation type ‘Update (2)’.
• Make obsolete any duplicated organisation entities or organisation entities which are no longer valid and which will not be used in any future medicinal product submission using operation type ‘Nullification (4)’.