European Marketing Authorisations & Regulatory Affairs
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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.



PSUR Repository
Haan, 01.02.2015 Kohne Pharma has been approved for the pilot phase of the PSUR Repository of the... 

Change of General Manager
Haan, 12.01.2015 With effect from 1 January 2015, Judith Jech hands over her leadership role to... 

Haan, 16.12.2014 There is a need to submit a PSUR for the API 5-Fluorouracil  according to... 

Latest Products

Azelastine eye drops multi dose, MAs in DE and PL available.

Cinnarizin/Dimenhydrinate tablets, Dossier expected 1Q/2015.

Olopatadin eye drops, DCP ongoing.

Sunitinib capsules, Dossier expected 1Q/2016