ECJ says medicines in new EU member states cannot help generic applications
The European Court of Justice (ECJ) has ruled that prior national authorisations for medicines in countries recently joining the European Union (EU) are irrelevant in applications by generic manufacturers to copy such pharmaceuticals.
The European Court of Justice (ECJ) has ruled that prior national authorisations for medicines in countries recently joining the European Union (EU) are irrelevant in applications by generic manufacturers to copy such pharmaceuticals.
In a case involving Generics (UK) of Potters Bar, Hertfordshire, the ECJ said transitional protected periods for rights-holders of medicines are measured only from the date they receive formal market approvals under EU law. National authorisations under non-EU regulatory systems before a country becomes a member state are irrelevant, it said.
These medicines "cannot be considered.. a reference medicinal product" and generic manufacturers must wait until enough time has elapsed since EU authorisation, said the ECJ.
Generics (UK) had been appealing against a UK Medicines and Healthcare products Regulatory Agency refusal to allow it to manufacture a generic version of galantamine.