NEWS

NATIONAL PROCEDURES. IMPLEMENTATION OF eCTD FROM JANUARY 2019

IMPLEMENTATION OF SAFETY DEVICES IN MARKETING AUTHORIZATIONS FOR HUMAN USE MEDICINES

Spanish Evaluation Agency has published data on the procedure to include safety devices in the Marketing Authorization of Medicines for human use.

PRODUCT INFORMATION OF CENTRALIZED PRODUCTS

17/05/2017

The AEMPS has enabled the possibility to break up the Product Information (SmPC and PIL) of medicines authorized by procedure centralized. The Spanish Medicines Agency (hereinafter AEMPS) and the Pharmaceutical

BREXIT

EMA and the European Commission have published a notice to marketing authorisation holders of centrally authorised medicines intended to remind them of their legal obligations in preparation for Brexi

INFORMATION ON RISK PREVENTION ON HUMAN MEDICINES

19/08/2015

RESPONSIBLE PERSON FOR PHARMACOVIGILANCE

REGULATIONS OF MEDICINES AND HEALTHCARE PRODUCTS IN SPAIN

13/11/2014

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