EMEA announced that the Eudra GMP database became publicly available on Aug. 1. The database includes manufacturing authorizations approved and GMP certificates issued by competent authorities, as well as manufacturers that have not complied with GMPs. Non-compliance statements are issued in cases of severe GMP infractions. The Eudra GMP database was initially launched in April 2007 to facilitate the exchange of information on compliance with GMPs between EU competent authorities. EMEA said that the database was launched in a drive for more openness and transparency. Commercial, personal and other types of confidential information will not be publicly available. The database will be updated by competent authorities on an ongoing basis. EMEA announced that "for some competent authorities, the publicly available information in the database is limited at this time.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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