CDSCO apprises about the Continuity in validity of Written Confirmation Certificate for API consignments for Exports

New Delhi: Through a recent circular, the Central Drugs Standard Control Organisation (CDSCO) has apprised about maintaining the continuity in the validity of “Written Confirmation” Certificate (WCC), wherein, validity for the renewed WCC will be valid from the date of the expiry of the previous WCC.

European Union has mandated that every consignment of Active Pharmaceutical Ingredient (API) from Non-EU/non-listed countries must be supported by a “Written Confirmation” Certificate (WCC) issued by the Competent Authority of that Country, stating that the consignment conforms to the standards of Good Manufacturing Practices (GMP) as laid down in the EU guidelines or equivalent thereof. This is effective from 2nd July 2013.

Directorate General of Health Services, CDSCO issues Written Confirmation Certificate on the basis of recommendation received from the concerned CDSCO zonal office and the standards shall be applicable for issue of “Written Confirmation Certificate” for active substances exported to the European Union (EU) for medicinal products for the Human use.

The documents required should be as per, “Good Manufacturing Practices Guide for Active Pharmaceutical Ingredients ICH harmonized Tripartite Guideline stated as per ICH Q7".

The WCC issued by the directorate is valid for three years from the date of issue and as per the SOP “EP-INS-001” published by CDSCO, if grant of “Written Confirmation” is recommended before the expiry of valid “Written Confirmation” the renewed “Written Confirmation” shall be issued from the date of expiry of previous “Written Confirmation.

However, it has come to notice of CDSCO that the recommendations for the renewal of WCC are being received after the expiry of the previous WCC and this has caused Non- Continuity in the validity of WCC, though the firms are maintaining the compliance to the Standards referenced in paragraph 2 stated above.

Hence, in order to maintain the continuity in the validity of WCC, it has been decided that the validity for the renewed WCC shall be deemed to be valid from the date of the expiry of the previous WCC.

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