The BAFA (Federal Office for Economic Affairs and Export Control in Germany) has once again invited to the "Export Control Information Day" December 07, 2023.
This information day is taking place for the 15th time and was offered in a hybrid format. We did not miss the opportunity to make our way to Frankfurt am Main in order to get informed on site about the following current topics by BAFA:
Initially the validity of GMP certificates for manufacturing sites of API’s located outside the Economic European Area (EEA) was automatically extended until the end of 2023 without the need for further action from the holder of the certificate due to the pandemic crisis. The EEA authorities have now announced another extension until the end of 2024.
Here, the link to the official EMA announcement: EUDRA website.
Transo-Pharm establishes relationship with 22nd Century Group as their partner for Global Sales, Marketing, and Distribution of Pharmaceutical Grade Cannabinoid APIs
Partnership Will Provide Pharmaceutical Grade Cannabinoid Active Ingredients to the Largest Pharmaceutical and Consumer Goods Names in the Industry
22nd Century Group, Inc., a leading biotechnology company dedicated to improving health with reduced nicotine tobacco, hemp/cannabis and hops advanced plant technologies, today announced filing of a U.S. Drug Master File (DMF) to the US Food & Drug Administration (FDA) for cannabidiol (CBD) API from GVB Biopharma, a 22nd Century Group Company. The submission (DMF 037727) demonstrates 22nd Century Group’s absolute commitment to supplying high quality pharmaceutical grade API to the pharmaceutical industry and OTC markets.
The validity of GMP certificates for manufacturing sites of API’s located outside the Economic European Area (EEA) are automatically extended until the end of 2023 without the need for further action from the holder of the certificate, unless the issuing/supervisory authority takes any action that affects the validity of the certificate.
This automatic extension is applied in the same manner as for certificates of manufacturing sites located within the EU.
Please also refer to the COVID notification on the official EUDRA website.