EMA releases updated distribution requirements and address list for PSURs

An updated list of addresses and distribution requirements for Periodic Safety Update Reports (PSURs) has been released today by the European Medicines Agency. The list contains the contact addresses for each Member State as well as the distribution requirements (such as no. of CDs required, additional paper copies, etc) for the submission of PSURs in the Centralized Procedure (CP), MRP/DCP and National Procedures.

The new revision 6, dated April 06, 2011 contains updated addresses for Italy, Romania, Iceland, and the United Kingdom. In addition, the requirements for Denmark were updated to reflect DKMA`s implementation and acceptance of electronic-only submissions. Consequently, paper copies of PSURs in MRP/DCP and National Procedures are no longer required in Denmark. (Note: for centrally authorized products, paper copies are generally not required in case of eCTD submissions).

The updated list is available for download from the Agency`s website (see link at the bottom of this article).

[Source: European Medicines Agency website]

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