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8 Jun 2013

Rx-360 Summary of EU’s Falsified Medicines Directive rule (Article 46b 2011/62/EU)

On 2 July 2013, the EU’s Falsified Medicines Directive rule (article 46b 2011/62/EU) requiring “written confirmations” to accompany each consignment of API imported into the EU for use in commercial Human Health drug product went into effect.

The Heads of Medicines Agencies (HMA) of the EU Member States have published a guideline to ensure a consistent approach is used for the release of APIs under this rule. The guideline provides a process map to follow in the case that an imported API consignment, which is not from countries listed under article 111b of te Directive, is not accompanied by a “written confirmation”.


The process asks for risk assessments to be provided to EMA (European Medicines Agency) and the European Commission by the national competent authority when no “written confirmation” is present and no waiver exists. This process is expected to be necessary only for a short interim period while these new rules are being implemented across the EU. The intention is to enable the EMA to monitor the situation, to coordinate inspections as needed and to keep the network informed.


To view or download the document, click here

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