MHRA Notification of Imminent Request for Active Substance Information

The MHRA will shortly be contacting UK-based MA holders to request data on active substance imported into the UK for manufacture, as part of their role as rapporteur for the work stream of the Heads of Medicines Agencies’ task force for harmonised implementation of the Falsified Medicines Directive.

As a result of the adoption of Directive 2011/62/EU, which amends Directive 2001/83/EC from 2 July 2013, the importation of active substances into the EEA is only permitted if the supplier of the substance is certified to be operating to EU GMP standards according to criteria defined in the Directive.

However, by 2 July 2013 implementation deadline some national authorities in countries from which active substance is exported may not be in a position either to issue appropriate written statements or to apply for and be assessed as having an equivalent system of supervision to be included on the Commission’s list for exemption from providing written statements.

The aim is to minimise the risk of potential shortages of human medicines by identifying high risk suppliers which may need to be inspected in accordance with ongoing supply in exceptional circumstances and to prioritise and coordinate these inspections, together with those for centrally authorised products, on an EU-wide basis.