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GMP: New Requirements for the Submission of Information on Medicinal Products - EMA publishes New Guidance for MAHs and a revised \"Legal Notice\"

22.03.2012
The background to this catalogue of requirements is the provisions laid down in Article 57(2) of the new Regulation (EU) No 1235/2010. According to that regulation, the EMA requires these data to create a database indexing all authorised medicinal products for human use.