EDQM Guideline on Suspension or Cancellation of a CEP

The EDQM explains its policy on the suspension or withdrawal of a certification of suitability in a new document. The following information is taken from the new EDQM document.

According to the new document a number of reasons can result in a suspension of a CEP:

  • Inspection findings (critical and/or major deficiencies). The inspection might be carried out by the team of EDQM or by an inspectorate of a European Economical Area (EEA) member state or a country with which the EU has a Mutual Recognition Agreement on GMP inspections (MRA)
  • Refusal by a company to be inspected in the framework of the EDQM Certification scheme
  • A CEP is not in compliance with the requirements of the procedure and the holder has not submitted suitable information to maintain it.
  • The CEP holder is not able to fulfil the manufacturing commitments of the submitted CEP application and/or is not in compliance with GMP, typical examples being temporary cease of production, upgrade of the site, partial destruction

An Internal EDQM Decision Board reviews the request for suspension and any supportive information and submits proposals of actions to be taken to the Ad'Hoc Committee.

The Ad'Hoc Committee decides on the invalidation of the relevant CEP(s), as well as on the conditions for restoration and information to be forwarded to the relevant authorities. The holder of the CEP is notified and given proper justification of the decision, the length of suspension and conditions of restoration and of the possibility to appeal.

Once a CEP has been suspended or cancelled, the holder has to inform its customers of the situation to allow them to take responsibility with regard to the concerned substance and any related marketing authorisation or marketing authorisation application. In case of a suspension, whoever has initiated it, or in the case of a withdrawal by the EDQM, the relevant authorities of the member states of the Convention on the Elaboration of a European Pharmacopoeia as well as the countries with which special agreements have been made are informed by the EDQM to enable them to take appropriate actions regarding the marketing authorisations or marketing authorisation applications which make reference to the respective CEP(s). The status of the CEP (suspended or withdrawn) is published in the Certification database available on the EDQM website.

Source: EDQM Webpage: www.edqm.eu


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