AEMPS will hold a conference to report on the new "electronic Application Form” on February 29th 2016. The forms will be used for application of new marketing authorizations for medicines human and veterinary drugs, variations and marketing authorization renewals for mutual recognition procedures, decentralized procedure and / or purely national procedures (Link).
The AEMPS has also published a Q&A document regarding the eAF, in Spanish only (Link).
Regulatory Outsourcing Options
Cyton’s dedicated regulatory procedures team can support you with:
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