Information for manufacturing authorisation holders: Notification of imminent request for active substance information

Medicines regulatory news

19 December 2012

According to Directive 2001/83/EC as amended, all active substances used in medicinal products marketed in the EEA must be manufactured in accordance with the EU Good Manufacturing Practice (GMP) or, if
imported, with equivalent rules. As a result of the adoption of Directive 2011/62/EU, from 2 July 2013, the importation in the EEA of active substances is only possible if:

  • Option 1: the consignment is accompanied by a 'written confirmation' by the competent authority of the exporting third country that the plant manufacturing active substances operates in compliance with EU GMP or with equivalent rules, and is subject to equivalent rules for control and inspections; or
  • Option 2: the third country has been listed by the European Commission as a country with an equivalent system of supervision and inspection as in the EU; or
  • Option 3: exceptionally and only where necessary to ensure the availability of medicinal products, the need for the written confirmation can be waived if the specific manufacturing plant has been inspected by the competent authority of a Member State.

Nevertheless, by 2 July 2013 implementation deadline some authorities of active substance exporting countries may not be in a position either to issue the 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 this reason the MHRA, as the rapporteur for this work stream of the Heads of Medicines Agencies' Task Force for harmonised implementation of the Falsified Medicines Directive, has led the mapping of source manufacturers of active substances imported into the EU for manufacture into non-centrally authorised medicines for human use.  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 option 3 (above) and to prioritise and coordinate these inspections, together with those for centrally authorised products, on an EU-wide basis.

On this basis, the MHRA will shortly be contacting UK-based MIA holders to request data on active substance imported into the UK for manufacture as above.

Page last modified: 21 December 2012