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Registration in the AEMPS platforms to send documentation and maintenance of licenses

Centralized procedure: translation of national texts (SPC and PL), blue box national information for requesting a National Code, fractioning of texts for CIMA

Decentralized Procedure and Mutual Recognition: translation of national texts, national phase with the AEMPS, approval of packaging materials, fractioning of texts for CIMA

Variations to Marketing Authorizations: Quality, Safety and Efficacy

Renewal of Marketing Licenses

Processing and follow up with Health Authorities

Readability test and texts setting to current legislation

Scientific advice and communication of advertising to the CCAA authorities

Review of promotional materials

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