European Marketing Authorisations & Regulatory Affairs


Welcome to Kohne Pharma!

With Kohne Pharma you choose a reliable partner who possesses specific experience and capabilities in the field of regulatory affairs. As a full-service-provider we pursue German application procedures as well as MR- and DC procedures within the EEA on your behalf.

We process the whole planning and realisation of the longwinded and labour-intensive application procedures on your request. Additionally, we support you in maintaining your marketing authorisations in a permanently altering regulatory environment.

The growing demand for perfect solutions has prompted us to enlarge our offer of proprietary marketing authorisations. Our portfolio of marketing authorisations covers a broad spectrum nowadays.

Besides our proprietary marketing authorisations with an emphasis on oncological, hospital, and ophthalmic products we also offer pharmaceutical dossiers and marketing authorisations of our cooperation partners and customers from both the domestic area and abroad.

You can obtain additional information about our business segments here.



Haan, 28.03.2017 Q3D Elementary impurities The ICH Q3D guideline on elemental metallic impurities... 

eCTD preparation
Haan, 25.01.2017 Since 1 January 2017 applications for marketing authorisation within mutual... 

Blue hand - New symbol
Haan, 01.12.2016 The „blue hand“ is a new symbol in Germany which indicates Educational... 

Latest Products

Chlortalidone 12,5/25/50mg Tablets, Dossier ready.

Ezetimibe 10 mg FCT, Dossier ready.

Moxifloxacin 400 mg Tabletts, German MA available.

Rasagilin Tablets 1 mg, German MA available.

Rosuvastatin 5/10/20/40 mg FCT, German MA available.

Tenofovir 300 mg Tablets, DCP ongoing.