07.01.2011
To the attention of Marketing Authorisation applicants and holders
On request of the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human= CMDh), the National Agency for Medicines and Medical Devices has informed on its decision to receive dossiers for Marketing Authorisation (MA) renewal and the renewal of variations to MA in electronic format (non-eCTD/NeeS or eCTD) for the Mutual Recognition Procedure (MRP), the Decentralised Procedure (DCP) and the national procedure, in accordance with the attached document.
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National Agency for Medicines and Medical Devices of Romania
