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Refusal by EMA to disclose the identity of the pharmaceutical company which made a request for public access to the latest periodic safety update reports on Zyclara, a drug to treat actinic keratosis


Case 2030/2015/PL - Opened on Thursday | 03 March 2016 - Recommendation on Friday | 07 July 2017 - Decision on Tuesday | 20 March 2018 - Institution concerned European Medicines Agency ( Recommendation agreed by the institution )

Allegation(s)

EMA wrongly refused to grant access to the identity of the pharmaceutical company which on 23 September 2015 made a request for public access to the periodic safety update reports (PSURs) on Zyclara produced by the complainant.

Claim(s)

EMA should grant the complainant access to the identity of the pharmaceutical company.