EU NORTH ZONE

EU NORTH ZONE

The EU North zone consists of Denmark, Estonia, Finland, Latvia, Lithuania, Sweden and Norway. The main areas of expertise for Manna Regulatory are Denmark, Sweden and Norway. Norway is not an EU member state, but follows EU Regulation No. 1107/2009.

Manna Regulatory offers services related to all areas of regulatory affairs in the Nordic countries, Denmark, Finland, Sweden and Norway and the Baltic countries, Estonia, Latvia and Lithuania, including preparation of dossiers, writing study summaries, mutual recognition applications, preparation of labels in local languages,  article 43 renewals, risk asessments and liaison with local authorities etc.

Manna Regulatory has personal contact with consultants in Sweden, Finland, Estonia, Latvia and Lithuania who can assist in the national language and legislation.

EU project Management is another area of expertise at Manna Regulatory. As examples,  organising an Article 43 renewal in EU or coordinating and facilitate the change of authorisation holder of a new portfolio.