Reactions to thePolish Transposition The Polish approach to economic operators ultimately serves

Reactions to thePolish Transposition

The Polish approach to economic operators ultimately serves as a model for the broader European approach. At a May 6 meeting in Warsaw of the Polish Competent Authority with European Association of Authorized Representatives members including Emergo Europe, reactions to the Polish law’s treatment of importers and distributors seemed appropriate in relation to the activities performed by importers and distributors.

The responsibilities the Polish law places upon importers and distributors have no precedent among other member states, where regulators to date typically have focused on manufacturers and authorized representatives.

In the United Kingdom, for example, there are no requirements for the United Kingdom-based distributor or importer to be licensed or registered with MHRA. The Irish Competent Authority, Irish Medicines Board (IMB), also does not place requirements on Irish importers or distributors. The IMB did recently survey individuals about the licensing of Irish distributors and importers, but no further steps have been taken yet. In Italy, France and Spain, notification requirements exist for Class IIa, IIb and III products, but importers and distributors are under no obligation to provide those notifications.

The Belgian Competent Authority has taken a slightly more hands-on approach in this area. For IVDs, the authority requires information on Belgian distributors of those products.