Formation of New Indian State Telangana Requires Update to CEPs

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 03-08-2015 18:58


The European Directorate for the Quality of Medicines and Health Care (EDQM), which is responsible for the European Pharmacopoeia and the European biological standardization program, reports that companies in the new Indian state of Telangana will have to update their certificates of suitability (CEPs) to reflect the new state in the listing of their addresses. The EDQM has an inspection program for manufacturing sites, covered by an application for a CEP to the monographs of the European Pharmacopoeia. In June 2014, India formed a new state, Telangana, which formerly was part of the Indian state, Andhra Pradesh. Many of the addresses mentioned on CEPs and in CEP applications that are currently listed as being in Andhra Pradesh are now in the new state of Telangana and need to updated, said EDQM in a statement.

Holders of CEPs and applicants for CEPs are responsible for updating their CEP applications. EDQM is requiring all companies to update this information in all applications. For on-going applications (new and revision), companies should submit an application form as soon as possible with the new address details, as well as an updated Section 3.2.S.2.1 if necessary.

If the address(es) mentioned on a CEP which is about to be granted are in the state of Telangana this will be included in the address(es) on the CEP by EDQM. Holders will then be expected to provide an updated application form and if appropriate an updated Section 3.2.S.2.1, at the next revision or by August 31, 2015. For already granted CEPs and where there is no ongoing revision, holders should submit notifications in compliance with the current EDQM procedures for all affected CEPs by August 31, 2015.

Source: EDQM


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