EMA Releases Standard Operating Procedures for Pharmacovigilance and the Paediatric Regulation

Posted 28 June 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) has released two separate standard operating procedures covering, respectively, Article 29 procedures under the Paediatric Regulation (No. 1901/2006) and Article 107 procedures relating to Pharmacovigilance measures (Directive 2001/83/EC).

The SOPs, released 27 June, are specifically intended for EMA staff and outline how they are to adhere to the two procedures. Both documents should be useful for regulatory professionals as well, as they provide flow-charts describing the path of a product submission and a pharmacovigilance report through the agency in a step-by-step process.

Both documents are in effect until June 2015, after which time they will be reviewed again by the agency.

Read more:

EMA - Standard operating procedure: Article 107 procedures - Pharmacovigilance urgent measures

EMA - Standard operating procedure: Article 29 procedures according to the Paediatric Regulation No 1901/2006

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