Correction to APA message "APA0151 5 WI 0205 WB/CI" dated Thursday, April 12, 2018.
With regard to the APA report "APA0151 5 WI 0205 WB/CI" of Thursday, April 12, 2018, the Federal Office for Safety in Health Care (BASG) takes the liberty of making the following correction:
The procedure in question is an official procedure of the BASG and not of AGES GmbH; accordingly, any coordination must take place exclusively with the BASG.
Sanochemia Pharmazeutika AG was, of course, involved as a party in the present inspection proceedings of the BASG, which ended with the withdrawal of the license for the control of medicinal products, with the exception of certain sub-areas, and with the withdrawal of the license for the production of certain medicinal products.
The statement that Sanochemia Pharmazeutika AG had no prior knowledge of the measures taken by the BASG must therefore be rejected as incorrect. On the contrary, it is correct that the facts underlying the BASG's decision were discussed intensively with Sanochemia Pharmazeutika AG on several occasions during the hearing of the parties. For example, the measure concerning the withdrawal of the license to manufacture certain pharmaceuticals was taken in advance in agreement and consultation with Sanochemia Pharmazeutika AG.
The statement that Sanochemia Pharmazeutika AG only became aware of the matter due to the entry in the GMP database is also not covered by the ad hoc notification of the company on the subject in question:
"Restricted GMP certificate of Sanochemia Pharmazeutika AG Vienna, 12 April 2018The listed Sanochemia Pharmazeutika AG, Vienna (ISIN AT0000776307, ISIN DE000A1G7JQ9), announces that the GMP certificate of Sanochemia Pharmazeutika AG was restricted as of 11.04.2018 according to the EUDRA GMP database. The restriction relates to the production of individual medicinal products and their quality testing. For the period of the restriction, this production and its testing will be outsourced and the production of the affected drugs will be resumed successively after approval. The Company has not yet received a written decision from the Federal Office for Safety in Health Care (BASG) in this regard. A complete and final factual review will be possible on the basis of the written decision. The Company reserves the right to appeal the decision."
Pursuant to Section 66a of the Austrian Medicines Act (AMG), an operating license must be revoked if the requirements for it are no longer met. The BASG must immediately notify the other contracting parties to the Agreement on the European Economic Area, Switzerland and the Commission of any revocation of an operating license. This obligation was fulfilled with the amendment of the entry in the European database EudraGMDP, as well as the associated transmission of the "Non-Compliance Report".
The corresponding notification has already been processed by the BASG and will be sent to Sanochemia Pharmazeutika AG shortly.
