Under the recently adopted Falsified Medicines Directive active pharmaceutical ingredients (APIs) exported to Europe must be accompanied by a letter proving they were produced in accordance with quality rules equivalent to those in place in Europe.
Manufacturers in such countries are exempt from this requirement if their country is deemed to have a regulatory framework – covering everything from good manufacturing practices (GMP) standards, inspection protocols and enforcement actions – that is of a sufficient standard.
The concept paper – published last month explains how the EC plans to make such assessments and features an audit checklist through which the Commission, the European Medicines Agency (EMA) and various selected member states will examine manufacturing rules in the exporting country.
Foremost among the EC’s criteria is the requirement that GMP standards in the third-party country are equivalent to those set out in Part II of Eudralex Volume 4 .
The frequency of facility inspections in the exporting country and the effectiveness of GMP enforcement will also be taken into account – with the framework set out in Article 52a (4) and Article 111(1b) of directive 2001/83/EC as the basis for the comparison.
The EC recommends that points 1-9 and 11 of the audit checklist be used as a pre assessment model.
Additionally, the Commission will consider how exporting countries respond and communicate when an API manufacturer in their territory is found to have fallen short of the required production standards.
Under the plan countries seeking the waiver will be required to contribute to a ‘community information and rapid alert system’ and communicate any suspension or withdrawal in a timely fashion.
Industry stakeholders have been invited to give their feedback on the proposal by March 23, with the EC predicting that the plan will be adopted next yearand apply to all APIs brought into Europe from July 2, 2013.