IN FORCE SEZ / EOU / FTWZ ·? undated

6 Streamlining the procedure for disposal of applications for 'Written Confirmation' (WC) for Active Substances Exported to the EU for Human Use in accordance with Article 46(2)(b) of Directive 2001/8

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File No.: I C-21011/41/2026-eoffice/34688 Government of India Directorate General of Health Services Central Drugs Standard Control Organization (International Cell)

FDA Bhawan, Kotla Road, New Delhi-110002 Date 2 7 MAR 2026

CIRCULAR

Subject: Streamlining the procedure for disposal of applications for “Written Confirmation” (WC) for Active Substances Exported to the EU for Human Use in accordance with Article 46(2)(b) of Directive 2001/83/EC received in CDSCO SUGAM Portal — Reg.

In order to streamline the processing and ensure time-bound disposal of applications pertaining to written confirmations received on SUGAM Portal of CDSCO, it has been decided that following procedures to be followed which simplify the existing process by eliminating the double layer of review:-

1. Upon receipt of applications on said portal, the Zonal/Sub-zonal offices of CDSCO shall verify appropriateness of document submitted by the applicant. The inspection report (IR), compliance verification report (CVR) and recommendation letter shall be uploaded and thereafter application shall be forwarded to Head Quarter (HQ) within three (03) weeks of receipt of application.
1. International Cell, CDSCO HQ shall review the adequacy of documents for its disposal within three (03) weeks of receipt of application. Query will be issued by HQ based on the input from the Zonal/Sub-Zonal offices of CDSCO.

Encl.: SOPs

a Singh(Raghuvanshi) Drtgs-Contrefler General (India)

To,

1. All Zonal/Sub-zonal offices/International Cell of CDSCO
1. All Stakeholders through CDSCO Website

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----- Start of picture text ----- MINISTRY OF HEALTH AND FAMILY WELFARE, GOVT. OF INDIA CENTRAL DRUGS STANDARD CONTROL ORGANIZATION, DGHS DRUGS STANDARD CONTROL ORGANIZATION, DGHS STANDARD CONTROL ORGANIZATION, DGHS ORGANIZATION, DGHS DGHS ----- End of picture text -----

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----- Start of picture text ----- CENTRAL DRUGS STANDARD CONTROL ORGANIZATION, DGHS DRUGS STANDARD CONTROL ORGANIZATION, DGHS STANDARD CONTROL ORGANIZATION, DGHS ORGANIZATION, DGHS DGHS Authorized Personnel Only E cnscal‘ertilensca4 Procedure; for: review. and‘ processingiu ; of 24103) 20 26 5, GOR: online application for issue of “Written 26] 03] apa9 "Ween saat Confirmation” for active substances [Supersedes | 00~—=*' See eee peas goa International Cell, CDSCO(HQ) products for human use, in accordance ; ; with Article 46(2)(b) of Directives No. 2001/83/EC at International Cell, Head | Page No. lof Quarter of CDSCO [Name [Bhavani [Name [SidhwAaCHdName [Slitv Kamar[Name [dw © Chandos Ish Date | SHloalag [Date ["a7fosfab [Date [O#1¢72026 [Date | “rlo sll Control Status 1.0 Background CONTROLLED COPY ----- End of picture text -----

121 European Union has mandated through directives No. 2001/83/EC dated 08th June, 2011 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 Purpose.
lee CDSCO issues Written Confirmation Certificate on the basis of recommendation received from the concerned CDSCO zonal/sub-zonal office and the standards shall be applicable for issue of "Written Confirmation Certificate" for active substances exported to the EU for medicinal products for Human use, in accordance with Article 46 (2)(b) of Directives No. 2001/83/EC.
2.0 Purpose To lay down a procedure for review and processing of online application made through SUGAM portal (https://cdscoonline.gov.in) at International Cell, Head Quarter of CDSCO for issue of “Written Confirmation” for active substances exported to the EU for medicinal products for human use, in accordance with Article 46(2)(b) of Directives No. 2001/83/EC.
3.0 Scope This document is applicable to all online applications made through SUGAM portal (https://cdscoonline.gov.in) for issue of “Written Confirmation” for active substances exported to the EU for medicinal products for human use, in accordance with Article 46(2)(b) of Directives No. 2001/83/EC.

Format No. QA-GNL-001/F01-00

MINISTRY OF HEALTH AND FAMILY WELFARE, GOVT. OF INDIA

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----- Start of picture text ----- » CENTRAL DRUGS STANDARD CONTROL ORGANIZATION, DGHS Authorized Personnel Only é DI me Procedure for review and processing of 27)03 )202 a) ae online application for issue of “Written me} 3 | awr9 "en acael Confirmation” for active substances |Supersedes [| 00——=*" aor sis dipeleoueaee ney le international products for human use, in accordance ; Cell, CDSCO(HQ) | with Article 46(2)(b) of Directives No. 2001/83/ECQuarter of CDSCOat International Cell, Head | Page No. 2 of4 [Name [K:Bhovarw [Name [Sidhat&SHalhfwame [<Luv KumapName [pi 2 OCT DDeU 4.0 Responsibility: 4.1 The RO/SRO/DA at International Cell, Head Quarter of CDSCO, shall review the online application submitted through SUGAM portal (https://cdscoonline.gov.in.). 4.2 Concerned Head of International Cell, CDSCO, HQ shall be responsible for the implementation and regular monitoring of compliance of this SOP. 4.3 JDC((I) shall be the “Licensing Authority” to issue “Written Confirmation” for active substances exported to the EU for medicinal products for human use, in accordance with Article 46(2)(b) of Directives No. 2001/83/EC. ----- End of picture text -----

5.0 Accountability Head of International Cell (CDSCO-HQ).

6.0 Procedure

6.1 The online application received from the Zonal/Sub-Zonal Office shall be allotted to the concerned Reviewing Officer (RO).
6.2 The Reviewing Officer (RO) shall verify the availability of the Inspection Report, Compliance Report, clear Recommendation Letter of zonal/ sub-zonal head, and the list of drug substances recommended to be considered, in accordance with SOP No. INC-WCC-001. In the event that any of these documents are incomplete or unavailable, the RO may recommend that the file be returned to the concerned Zonal/Sub-zonal Office for submission of the required documents.
6.3 After verifying the availability of documents as per para 6.2 above, the Reviewing Officer (RO) shall review the application for the adequacy of the documents submitted. If any inadequacy is observed, the RO shall raise an appropriate query and forward the application to the Senior Reviewing Officer (SRO).

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----- Start of picture text ----- MINISTRY OF HEALTH AND FAMILY WELFARE, GOVT. OF INDIA CENTRAL DRUGS STANDARD CONTROL ORGANIZATION, DGHS Authorized Personnel Only fae Procedure for review and processing of 97103 1% . cen online application for issue of “Written "ennai Confirmation” for active substances [Supersedes | 00 _—~*«| ego na ee esas : products for human use, in accordance ; intemational Cell, CPSCO) | with Article 46(2)(b) of Directives No. 2001/83/ECQuarter of CDSCOat International Cell, Head | Page No. 3 of4 Name [K-Bhavont [Name [Goh ¢7ilbame [Stew KaywaName [poh (havolastak DBctr 1oe(1 ) at loss [Dae [57/02/26 [Date [2% |a]raaé|Dae | Alo 6.4 The Senior Reviewing Officer shall review the queries raised and the completeness of the application and shall forward the application to the Decision Authority (DA). ----- End of picture text -----

6.5 The Decision Authority shall review the queries and the completeness of the application and shall return the file to the applicant for submission of replies to the raised queries.
6.6 Upon receipt of the query reply from the applicant, the Reviewing Officer shall reassess the completeness and adequacy of the application. If the reply is found to be unsatisfactory, Steps 6.3 to 6.5 shall be repeated. If the application is found complete and adequate in all aspects, the Reviewing Officer shall write recommendations in the SUGAM note sheet and forward the application to the Senior Reviewing Officer.
6.7 During the review of the query reply, the RO shall ensure that no new query is raised unless it is an outcome to the reply furnished by the applicant.
6.8 The Senior Reviewing Officer shall verify the adequacy of the application and forward it, along with recommendations written in the SUGAM note sheet, to the Decision Authority.
6.9 The Decision Authority shall verify the adequacy of the application and forward it, along with recommendations written in the SUGAM note sheet, to the Licensing Authority.
6.10 The Licensing Authority shall verify the completeness and adequacy of the application and, based on the recommendations of the Reviewing Officer, Senior Reviewing Officer, and Decision Authority, and Zonal/Sub-zonal Office recommendations either approve or reject the Written Confirmation application.
6.11 Upon approval of the Written Confirmation application, the concerned Reviewing Officer shall prepare the electronic file (e-File) for issuance of the Written

Authorized Personnel Only

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----- Start of picture text ----- MINISTRY OF HEALTH AND FAMILY WELFARE, GOVT. OF INDIA ----- End of picture text -----

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----- Start of picture text ----- CENTRAL DRUGS STANDARD CONTROL ORGANIZATION, DGHS ----- End of picture text -----

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----- Start of picture text ----- © ac zee! Procedure for review and processing of a) ar online application for issue of “Written Ul 92] MA "Seana Confirmation” for active substances [Supersedes | 00——=*/f ee oe aa eens International Cell, CDSCO(HQ) products for human use, in accordance = ° with Article 46(2)(b) of Directives No. 2001/83/EC at International Cell, Head | Page No. 4 of 4 Quarter of CDSCO Name [KBhavont[Name [iho RalName [Slav KunonName [ot éCandui) DD<cU) 7qe(t) (4 ----- End of picture text -----

Confirmation Certificate along with the covering letter and forward the hard copy for the signature of the Licensing Authority.
6.12 After signature of the Written Confirmation Certificate, the concerned Reviewing Officer shall upload the signed certificate to the application portal as well as to take necessary steps to upload in the CDSCO website.
6.13 The officers of Head Quarter dealing with the application shall ensure that the application is approved within three weeks (03) of the receipt of complete and adequate application.

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----- Start of picture text ----- 7.0 Abbreviation Senior Reviewing Officer Standard Operating Procedure JDC(l) Joint Drugs Controller (India) 8.0 Revision History Reason(s) for Revision a: se Implementation of New Format ----- End of picture text -----

8.0 Revision History

’

MINISTRY OF HEALTH AND FAMILY WELFARE, GOVT. OF INDIA CENTRAL DRUGS DRUGS STANDARD CONTROL CONTROL ORGANIZATION, DGHS DGHS

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----- Start of picture text ----- CENTRAL DRUGS DRUGS STANDARD CONTROL CONTROL ORGANIZATION, DGHS DGHS Authorized Personnel Only fepscal‘i li Ensen( Procedure: for= review5 andc processingrn . of ~ Od = online application for issue of “Written ab los /w2r4 a Confirmation” for active substances | Supersedes | 00 _—i| Steg go) tes EL tae pedicle ee products for human use, in accordance International Cell, CDSCO(HQ) | With Article 46(2)(b) of Directives No. 2001/83/EC at Zonal/Subzonal offices | Page No. Lofs of CDSCO [Designation Drugs Inspector| Designation | CCD) _|Designation| DDC CI Date dloslag [Date |Saforfog[Date | aytqfQore|Dae| ~ | Control Status 1.0 Background CONTRA: Nyw CADVUT | 1.1 European Union has mandated through directives No. 2001/83/EC dated O8th June, 2011 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 Purpose. 1-2 CDSCO issues Written Confirmation Certificate on the basis of recommendation received from the concerned CDSCO zonal/sub-zonal office and the standards shall be applicable for issue of "Written Confirmation Certificate" for active substances exported to the EU for medicinal products for Human use, in accordance with Article 46 (2)(b) of Directives No. 2001/83/EC. ----- End of picture text -----

2.0 Purpose

To lay down a procedure for review and processing of online application made through SUGAM portal (https://cdscoonline.gov.in) at Zonal/Sub-Zonal offices of CDSCO for issue of “Written Confirmation” for active substances exported to the EU for medicinal products for human use, in accordance with Article 46(2)(b) of Directives No. 2001/83/EC.

3.0 Scope This document is applicable to online applications made through SUGAM portal (https://cdscoonline.gov.in) for issue of “Written Confirmation” for active substances exported to the EU for medicinal products for human use, in accordance with Article 46(2)(b) of Directives No. 2001/83/EC.

MINISTRY OF HEALTH AND FAMILY WELFARE, GOVT. OF INDIA CENTRAL DRUGS STANDARD CONTROL ORGANIZATION, DGHS

Authorized Personnel Only

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----- Start of picture text ----- Ge: Procedure for review and processing of cpscal Hifensco . . . A . % Od 5 online application for issue of “Written 26 | 02/29 eens Confirmation” for active substances | Supersedes | 00——=*T International Cell, CDSCO(HQ) sireproducts for human use,oelcin accordancehal = ° with Article 46(2)(b) of Directives No. 2001/83/EC at Zonal/Subzonal offices | Page No. 2 of5 of CDSCO grloslag [Dae [+ [o3[p0 [Date [247942026 |Dae | Aloo” | 4.0 Responsibility: 4.1 The RO/NO/DDA at Zonal/Sub-Zonal offices of CDSCO shall verify the completeness of online application submitted through SUGAM portal (https://cdscoonline.gov.in) 4.2 Concerned Head of Zonal/Sub-Zonal offices shall be responsible for the implementation and regular monitoring of compliance of this SOP. ----- End of picture text -----

5.0 Accountability Concerned Head of Zonal/Sub-Zonal offices of CDSCO.
6.0 Procedure
- 6.1 Application for issuance/renewal/endorsement of “Written Confirmation” for active substances exported to EU for medicinal products for human use, in accordance with Article 46b (2) (b) of Directive 2001/83/EC shall be submitted by manufacturer through online mode via SUGAM portal (https://cdscoonline.gov.in).
- 6.2 Upon receipt of the online application, the concerned Nodal Officer of the Zonal/Sub-Zonal Office shall allocate the application to their Reviewing Officer.
- 6.3 The Reviewing Officer shall verify whether documents against each checklist points are correctly and legibly uploaded by the applicant. Adequacy of documents may not be required to be verified at Zonal/sub-zonal level.
- 6.4 For the applications made for the Grant/Renewal/Endorsement, no site inspection shall be required, provided the firm has been inspected within two years by the zonal/sub-zonal office to verify the compliance to the requirements of GMP as required as per Directives No. 2001/83/EC latest amended vide Directive 2011/62/EU or WHO Good Manufacturing Practices (GMP) for active

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----- Start of picture text ----- MINISTRY OF HEALTH AND FAMILY WELFARE, GOVT. OF INDIA CENTRAL DRUGS STANDARD CONTROL ORGANIZATION, DGHS ----- End of picture text -----

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----- Start of picture text ----- Authorized Personnel Only ----- End of picture text -----

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----- Start of picture text ----- § ‘Ge i Procedure for review and processing of epscal Alensca . . : ff . 5 €O8 5 online application for issue of “Written 4) 03) 2029 "en anus Confirmation” for active substances [Supersedes | —00——=*” Intemational; seeproducts foree human rouse, in a ccordancetlas ae = Cell, CDSCO(HQ) | with Article 46(2)(b) of Directives No. 2001/83/EC at Zonal/Subzonal offices | Page No. 3 of 5 of CDSCO Name [K-Bhavow’ [Name [Sidbo Royiwame — [STiv VumadName [dr chawalashake DD¢cU Salosbe [Dae [pJospe [Date [azyafrare [Dae | AY as per Annex 2- WHO Technical report Series(TRS), No. 957, 2010 or Good Manufacturing Practice guide for Active Pharmaceutical Ingredients ICH Harmonised Triplicate Guideline stated as per ICH Q7, for the category of drug substances applied. 6.5 In case, the firm does not fulfill the criteria of para 6.4, the Zonal/Sub-zonal Head shall depute an officer(s) to conduct an onsite Inspection to verify compliance with Good Manufacturing Practices as stated in para 6.4 above. ----- End of picture text -----

6.6 If deficiencies are identified in inspection, the same shall be communicated to the applicant for submission of compliance. The concerned Zonal/Sub-Zonal office shall be responsible for verification of compliance after receipt of the compliance report from the applicant.
6.7 Based on the nature and severity of the deficiencies reported, if required, appropriate regulatory action shall be initiated, as detailed below:6.7.1 Based on the reply received from the applicant, and if deemed necessary, suitable regulatory action may be recommended to the State Licensing Authority (SLA).
- 6.7.2 Shall inform the Head Quarter for the findings of the inspection and update further on the action taken, so as that the Written Confirmation issued for active substances exported to the European Union for medicinal products for human use, in accordance with Article 46b(2)(b) of Directive 2001/83/EC, may be suspended or cancelled.
6.8 Where the applicant submits compliance to the deficiencies and informs the concerned Zonal/Sub-Zonal Office, the compliance report shall be scrutinized. Based on the adequacy of the compliance, a further inspection may be conducted, if required.

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----- Start of picture text ----- MINISTRY OF HEALTH AND FAMILY WELFARE, GOVT. OF INDIA CENTRAL DRUGS STANDARD CONTROL ORGANIZATION, DGHS Authorized Personnel Only § cpsca}‘reMiicosca‘ Procedure. for. review: and: processingPe . of > * 66d = online application for issue of “Written 26 Io3 |r02 "emanate Confirmation” for active substances Supersedes | 00 —~«Y| Sapa 1). ithe) EU. for mediniia International Cell, CDSCO(HQ) products for human use, in accordance 5 ‘ with Article 46(2)(b) of Directives No. 2001/83/EC at Zonal/Subzonal offices | Page No. 4 ofS of CDSCO KipmatName FOIA (Ufiame [SlewDpc(t [ork duwiadewlds atloslag [Date [27/03/26 [Date | D#Iqyaane [Date | oF 6.9 Upon receipt of the compliance report, the concerned Zonal/Sub-Zonal Office shall verify the completeness and adequacy of the compliance either through causing an on-site inspection or by desktop review by officer. A compliance verification report shall be prepared, clearly indicating the status of each observations for their complete compliance and providing clear recommendations by the compliance verification officer. 6.10 Applications with partial or open compliance to the observations made during inspections shall not be considered for the recommendation of Written Confirmation by the zonal/sub-zonal head. 6.11. The inspection report, compliance verification report, and clear recommendation letter of the Head of the Zonal/Sub-Zonal Office of CDSCO, along with the list of drug substances to be considered for Written Confirmation, shall be uploaded in the relevant dropdown section of the corresponding SUGAM online application. The Zonal/Sub-zonal offices shall ensure that all the applications are forwarded to Head Quarter within three weeks of the receipt of complete application. ----- End of picture text -----

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----- Start of picture text ----- 7.0 References ia [nr] 1 GMP requirements as per DirectiveseeNo. 2001/83/ECTTlatest amended vide Directive 2011/62/EU 2 WHO Good Manufacturing Practices (GMP) for active pharmaceutical ingredients stated as per Annex 2- WHO Technical report Series(TRS), No. 957, 2010 3 Good Manufacturing Practice guide for Active Pharmaceutical Ingredients stated as per ICH Q7 of ICH Harmonised Triplicate Guideline ----- End of picture text -----

MINISTRY OF HEALTH AND FAMILY WELFARE, GOVT. OF INDIA CENTRAL DRUGS DRUGS STANDARD CONTROL ORGANIZATION, CONTROL ORGANIZATION, ORGANIZATION, DGHS

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----- Start of picture text ----- CENTRAL DRUGS DRUGS STANDARD CONTROL ORGANIZATION, CONTROL ORGANIZATION, ORGANIZATION, DGHS Authorized Personnel Only an TITLE SOP No. INC-WCC-001 © ac lboxce! Procedure for review and processing of | Effective Date 5, 668 ¢ online application for issue of “Written 26] 03 | 2024 ee tt Confirmation” for active substances |Supersedes | | 00—S—=*'f ; cilielcead ogee gig a agpgs Internationalseams Cell, CDSCO(HQ)_| Phroductsé for human use,aein accordanceee tD Nie (HQ) with Article 46(2)(b) of Directives No. 2001/83/ECof CDSCO at Zonal/Subzonal offices | Page No. 5 of5 Prepared By Checked By Approved By Authorized By Name [K:Bhavant [Name SidbelQnalhpName | Ch’ WuwaiName [ork dhaDagua Drugs Inspector|Designation | A\e (}) — [Designaiion] DDELt galosiné [Date [“o7lgfo6 [Date lax pgfecae [Dae | “no 8.0 Abbreviation Deputy Decision Authority Standard Operating Procedure 9.0 Revision History Pk Se Implementation of New Format ----- End of picture text -----

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