The EU North zone consists of the Nordic countries Denmark, Finland, Sweden and Norway; and the Baltic countries Estonia, Latvia and Lithuania. Norway is not an EU member state but follows EU Regulation No. 1107/2009.

The Member States in the EU North Zone have established a very good cooperation and provides a well-prepared guidance document making the applicant able to adapt their data to the Northern zone requirements.

Manna Regulatory offers services related to all areas of regulatory affairs in the Nordics and Baltics.  

Whether you need a dossier to be prepared, studies to be summarised, an application for mutual recognition, a label to be in a local language, an application for label extension, adaption of a Central/South zone dossier to Northern zone requirements, an article 43 renewal, or liaison with local authorities, Manna Regulatory is ready to help!

The Nordic and Baltic countries have their own Guidance Document and Manna Regulatory can perform the risk assessments necessary to fulfil the requirements of the Northern zone Guidance Document. This includes environmental fate modelling (FOCUS, SWASH, PELMO, MACRO, SWAN) and ecotoxicological calculations according to the current EFSA guidelines and the Northern zone guidance on higher tier assessments.