Prior to the introduction of the new pharmacovigilance legislation in July 2012, the GPvP inspectorate requested Marketing Authorisation Holders to submit pre-inspection information in the form of a Summary of Pharmacovigilance Systems (SPS) document. However, there are now a number of options:

 

1. If a MAH has transitioned to the Pharmacovigilance System Master File (PSMF), and formally introduced the Pharmacovigilance System Summary (PSS) to any of their authorisations, the PSMF should be submitted to the MHRA Inspectorate instead of the SPS.

 

2. Until 2015, if a company has not yet transitioned to the PSMF, they must submit:

 

i) an SPS or,

 

ii) a current Detailed Description of Pharmacovigilance Systems (DDPS), supplemented with the additional information requested in the SPS (as described in the SPS guidance notes).

 

Additional information may be requested by the inspection team prior, during and after the inspection. For more information on the inspection process please see the section of our website dedicated to the topic: Good Pharmacovigilance Practice: The inspection process

 

Posted on the UK MHRA website on 21 March 2013