News

29.11.2018

[Translate to english:] Die HWI development GmbH hat Geburtstag!

[Translate to english:] Die HWI development GmbH hat Geburtstag! Am Freitag, den 16.11.2018 wurden 10 Jahre Entwicklung am Standort Appenweier mit der Belegschaft und einigen Wegbegleitern gefeiert.[more]

02.05.2018

HWI Campus – Your gate to Europe for EU batch release and pharmacovigilance activities

Following the Brexit, the United Kingdom (U.K.) will become a “Third country”. From March 30th 2019 marketing authorisation holders based in the U.K. will need to have a registered office and/or a manufactu¬ring site with a corresponding manufacturing authori¬sation in the EU/EEA. For EU batch release and pharmacovigilance activities the QP and QPPV will also have to be resident here. This is clarified by the European Commission and EMA in their “Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use“, published in May 2017. We provide solutions for your (re-)entry to business in the EU![more]

17.10.2017

TradReg2017

On 14th and 15th September the "TradReg" conference, organised by BfArM, took place in Bonn for the second time. It was a conference widely attended by international representatives from authorities and industry. The event served to compare the possibilities concerning the marketing authorisation and registration of herbal medicinal products worldwide. Furthermore it was intended to evaluate opportunities to continue harmonising the rules and regulations existing in the individual countries and to eliminate constraints.[more]

07.08.2017

CPhI 2017 in Frankfurt

Finally the time has come: CPhI worldwide will open its doors in Frankfurt from 24th to 26th October 2017, an event that you shouldn’t miss under any circumstances![more]

18.07.2017

Brexit will Turn U.K. into a “Third Country“ from 30th March 2019

Following the Brexit, the United Kingdom (U.K.) will become a “third country”. From 30th March 2019 marketing authorisation holders of medicinal products based in the U.K. will need to have a registered office and/or a manufacturing site with a corresponding manufacturing authorisation in the EU and/or the EEA. [more]

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