Legal notice on the implementation of Article 57(2) of Regulation (EC) No. 726/2004

5 February 2016

EMA/505633/2011, Rev. 21

"Electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency"

SEE DOCUMENT

As of 1 February 2016 changes in qualified person responsible for pharmacovigilance (QPPV), including contact details (telephone and fax numbers, postal address and email address) and changes to the pharmacovigilance system master file (PSMF) location (street, city, postcode, country) shall be updated through the Article 57 database only, without the need to submit a type IAIN variation to the Agency or the national competent authority (as applicable). Changes to the QPPV and/or PSMF shall be notified to the Agency via the Article 57 database immediately and no later than 30 calendar days from the date the change applies. No variation to include in the marketing authorisation dossier a cross reference to Article 57 as the source of QPPV and PSMF information is required.