20/21 April 2021
The European Directorate for the Quality of Medicines & Healthcare (EDQM) has published new information about the CEP procedure and its related inspections.
1) Costs of inspections
The EDQM has published a new document which describes the inspection costs. The EDQM document PA/PH/CEP (12) 28 1R refers to a table of fees and inspection costs. The costs for the inspection as well as for the travel will be invoiced prior to the inspection. For a three day inspection, for example, the fee is 5000,- Euro. If the facility is located in Asia a flat rate of 6000,- Euro will be charged to cover the travel costs, food and accommodation for the inspector. The travel costs are less when the facility is located in Europe (800,- Euro) and elsewhere (4500,- Euro). The CEP inspection fee table can be found here.
2) New Indian State has impact on CEP holders
The Indian government created a new state on 2nd June 2014 which is called Telangana. The EDQM reminds holders of CEPs and applicants for CEPs that it is their responsibility to update their CEP applications. Many of the addresses mentioned on CEPs and in CEP applications which are currently listed as being in Andhra Pradesh are now in this new state of Telangana. The new address details, as well as an updated section 3.2.S.2.1 should be submitted to EDQM. This should be done until 31 August 2015.