How long does it take to register a generic medicine in the EU?
The registration of a generic medicine usually takes 1 to 2 years, but can sometimes take longer. Moreover, access to the market in many EU Member States is delayed for generic medicines—as for originator products—by having to wait for pricing and reimbursement status. Generic medicines manufacturers also spend considerable time and money on developing their products which are not, as sometimes alleged, mere “copies” of the originator product. It can take several years to bring a generic medicine to the market following the original commercial decision to do so.
