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| Certification of Substances Division PA/PH/CEP (13) 110 Strasbourg, March 2014
Certification of suitability to the Monographs of the European Pharmacopoeia
The Policy of Two Rounds of Evaluation for Applications for Certificates of Suitability and Requests for Revision
1. Introduction
As has been previously mentioned on the EDQM web pages, to optimise the process for evaluating applications and to ensure the official timelines are met, the EDQM applies strictly the procedure described in the Resolution AP CSP (07) 1.
The assessment of new applications is handled in two phases:
the evaluation of the original application, and, if necessary, the evaluation of additional information upon request from the EDQM. Applications lacking sufficient information after evaluation of the applicant's response to the deficiency letter are definitively closed. A second request for additional information will be issued in exceptional cases only.
A similar policy is applied to the assessment of request for revisions of certificates as described in PA/PH/Exp. CEP /T (04) 18, “Procedures for management of revisions/renewals of certificates of suitability to the European Pharmacopoeia monographs”.
This document is intended to clarify the process of assessment for new applications and requests for revision of a certificate where a letter is sent by EDQM to the applicant to request additional information.
2. Outcome of the assessment of the initial submission for a new application for a certificate or a request for revision When the initial assessment of the application is complete there are four possible conclusions as described in points 2.1 to 2.4. This is applicable to all types of requests except notifications.
The four potential conclusions described in points 2.1 to 2.4 are not applicable to notifications which are either accepted or rejected. If a notification is accepted then either a revised certificate will be granted or a letter will be sent from EDQM to the applicant advising that the request has been accepted. If a notification is rejected a letter will be sent from EDQM to the applicant advising that the request has not been accepted.
2.1. The information provided is complete and the certificate can be granted or the request for revision of the certificate is accepted.
For an application for a new certificate, a certificate will be granted.
For requests for revision, either a revised certificate will be granted or a letter will be sent from EDQM to the applicant advising that the request for revision has been accepted.
2.2. The information provided is unsatisfactory and the certificate cannot be granted or the request for revision of the certificate accepted until the issues identified are resolved.
After the assessment of the initial submission for a new application for a certificate or a request for revision, if there are outstanding issues then the EDQM will communicate these issues to the applicant.
For an application for a new certificate, the EDQM sends a letter entitled “REQUEST FOR ADDITIONAL INFORMATION “ which lists the questions relating to the issues outstanding with the submission which prevent the granting of a certificate of suitability to the applicant/holder.
The applicant/holder has 6 months to reply to this request and provide the information required.
The applicant/holder should reply to this request and provide full information required by the deadline or the assessment may be stopped due to this failure to respond (see section 5).
On reception of the response by EDQM, an acknowledgement of receipt is sent to the applicant. The submitted information requires assessment and the deadline for the assessment of the response and the provision of a response to the applicant is 4 months from the issue of the acknowledgment of receipt.
For requests for revision, the EDQM sends a letter entitled “REQUEST FOR ADDITIONAL INFORMATION “ which lists the questions relating to the issues outstanding with the submission which prevent the granting of a certificate of suitability/approval of the request to the applicant/holder.
The applicant/holder has 1 month to reply to this request and provide the information required.
The applicant/holder should reply to this request and provide full information required by the deadline or the assessment may be stopped due to this failure to respond (see section 5).
On reception of the response by EDQM, an acknowledgement of receipt is sent to the applicant. The submitted information requires assessment and the deadline for the assessment of the response and the provision of a response to the applicant is as described in the acknowledgment of receipt.
2.3. The information provided is in general satisfactory but further information is required before the certificate can be granted or the request for revision approved. This refers to the situation when there are some minor remaining point(s)/needs for clarification which have to be addressed after the assessment of the response and where the subsequent information provided by the applicant/holder does not require to be fully assessed.
Following this conclusion, the EDQM sends a letter to the applicant entitled “REQUEST FOR CLARIFICATION” which lists the points in the submission which require clarification and which prevent the granting of a certificate.
For an application for a new certificate, the applicant/holder has 1 month to reply to this letter and provide the information required.
For requests for revision of a certificate, the applicant/holder has 1 month to reply to this letter and provide the information required.
The applicant/holder should reply to this request and provide full information required by the deadline or the assessment may be stopped due to a failure to respond (see section 5).
On reception of the response by EDQM, an acknowledgement of receipt is sent to the applicant. The submitted information will require to be checked and the deadline for the checking of the response and the provision of a response to the applicant is 1 month from the issue of the acknowledgment of receipt.
2.4. The information provided is in general satisfactory but sections of module 3 require to be updated to reflect the approved dossier before the certificate can be granted or the request for revision approved.
This refers to the situation when there must be an update of the information provided in module 3 to reflect the approved data.
For example:
Where information provided in the module 1 response has not been incorporated into the appropriate section of module 3.
To update section 3.2.S.2.1 Manufacturers to include all the sites involved in the manufacturing process from the introduction of the starting materials onwards.
To remove the information included in module 3 in the event that not all the changes described in a request for revision are accepted.
Following this conclusion, the EDQM sends a letter entitled “REQUEST FOR DOSSIER UPDATE” to the applicant requesting update of the sections of module 3 to reflect the approved dossier.
For an application for a new certificate, the applicant has 1 month to provide the appropriately updated module 3.
For requests for revision of a certificate, the applicant has 1 month to provide the appropriately updated module 3.
The applicant/holder should reply to this request and provide full information required by the deadline or the assessment may be stopped due to a failure to respond (see section 5).
There is no assessment of the response received for a request to update a dossier. There is no acknowledgement of receipt issued. The module 3 is reviewed to ensure it has been updated as required and if so, then the process to prepare the issue of the certificate or to confirm approval of a request for revision begins. It is anticipated that the certificate of suitability/letter of approval will be granted within 1 month of the receipt of the updated dossier.
3. Outcome of the assessment of the response to the request for additional information.
When the assessment of the response provided by the applicant to the request for additional information is complete there are four possible conclusions:
3.1. The information provided is complete and the certificate can be granted or the request for revision of the certificate is accepted.
For an application for a new certificate, a certificate will be granted.
For requests for revision, either a revised certificate will be granted or a letter will be sent from EDQM to the applicant advising that the request for revision has been accepted.
3.2. The information provided is complete and the conclusion is that no certificate can be granted or the request for revision is rejected.
For an application for a new certificate, the outstanding points are identified and the EDQM sends a letter, entitled “CLOSURE OF CEP APPLICATION AFTER EVALUATION” to the applicant informing them of all the outstanding issues which prevent the granting of a certificate.
The applicant may submit a new application for the same substance. It is expected that the outstanding issues from the assessment of the original closed dossier will be addressed in the new submission.
For requests for revision, the outstanding points are identified and the EDQM sends a letter to the applicant informing them of all the issues outstanding which prevent the approval of the request for revision* described in this document.
*Occasionally, where multiple changes are described in the same request for revision, it is possible that some changes may be approved and others rejected as described above. This will be made clear in the letter sent to the holder and may result in a request to update the dossier as described later in this document (see section 3.4).
The applicant may submit another revision request for the certificate for the same changes. It is expected that the outstanding issues from the assessment of the original request for revision will be addressed in the new request.
3.3. The information provided is in general satisfactory but further information is required before the certificate can be granted or the request for revision approved.
This refers to the situation when there are some minor remaining point(s)/needs for clarification which have to be addressed after the assessment of the response and where the subsequent information provided by the applicant/holder does not require to be fully assessed.
This refers to the situation when there are some minor remaining point(s)/needs for clarification which have to be addressed after the assessment of the response and where the subsequent information provided by the applicant/holder does not require to be fully assessed.
Following this conclusion, the EDQM sends a letter to the applicant entitled “REQUEST FOR CLARIFICATION” which lists the points in the submission which require clarification and which prevent the issue of a certificate.
For an application for a new certificate, the applicant/holder has 1 month to reply to this letter and provide the information required.
For requests for revision of a certificate, the applicant/holder has 1 month to reply to this letter and provide the information required.
The applicant/holder should reply to this request and provide full information required by the deadline or the assessment may be stopped due to a failure to respond (see section 5).
On reception of the response by EDQM, an acknowledgement of receipt is sent to the applicant. The submitted information will require to be checked and the deadline for the checking of the information provided and the provision of a response to the applicant is 1 month from the issue of the acknowledgment of receipt.
3.4. The information provided is in general satisfactory but sections of module 3 require to be updated to reflect the approved dossier before the certificate can be granted or the request for revision approved.
This refers to the situation when there must be an update of the information provided in module 3 to reflect the approved data.
For example:
Where information provided in the module 1 response has not been incorporated into the appropriate section of module 3.
To update section 3.2.S.2.1 Manufacturers to include all the sites involved in the manufacturing process from the introduction of the starting materials onwards.
To remove the information included in module 3 in the event that not all the changes described in a request for revision are accepted.
Following this conclusion, the EDQM sends a letter entitled “REQUEST FOR DOSSIER UPDATE” to the applicant requesting update of the sections of module 3 to reflect the approved dossier.
For an application for a new certificate, the applicant has 1 month to provide the appropriately updated module 3.
For requests for revision of a certificate, the applicant has 1 month to provide the appropriately updated module 3.
The applicant/holder should reply to this request and provide full information required by the deadline or the assessment may be stopped due to a failure to respond (see section 5).
There is no assessment of the response received for a request to update a dossier. There is no acknowledgement of receipt issued. The module 3 is reviewed to ensure it has been updated as required and if so, then the process to prepare the issue of the certificate or to confirm approval of a request for revision begins. It is anticipated that the certificate of suitability/letter of approval will be granted within 1 month of the receipt of the updated
dossier.
4. Sending a subsequent request for additional information.
Exceptionally, after assessment of the response to the request for information foreseen by the procedure, there may be a second request for additional information sent to the applicant.
For an application for a new certificate, the EDQM sends a letter entitled “REQUEST FOR ADDITIONAL INFORMATION “ which lists the questions relating to the issues outstanding with the submission which prevent the granting of a certificate of suitability to the applicant/holder.
The applicant/holder has 3 months to reply to this request and provide the information required.
The applicant/holder should reply to this request and provide full information required by the deadline or the assessment may be stopped due to this failure to respond (see section 5).
On reception of the response by EDQM, an acknowledgement of receipt is sent to the applicant. The submitted information requires assessment and the deadline for the assessment of the response and the provision of a response to the applicant is 4 months from the issue of the acknowledgment of receipt.
For requests for revision, the EDQM sends a letter entitled “REQUEST FOR ADDITIONAL INFORMATION “ which lists the questions relating to the issues outstanding with the submission which prevent the granting of a certificate of suitability/approval of the request to the applicant/holder.
The applicant/holder has 1 month to reply to this request and provide the information required.
The applicant/holder should reply to this request and provide full information required by the deadline or the assessment may be stopped due to this failure to respond (see section 5).
On reception of the response by EDQM, an acknowledgement of receipt is sent to the applicant. The submitted information requires assessment and the deadline for the assessment of the response and the provision of a response to the applicant is as described in the acknowledgment of receipt.
5. Administrative closure of an application due to lack of response in required time.
At each point in the assessment process, where a letter of request for information is sent to the applicant/holder, the time by which the response should be received is clearly indicated in the letter.
For an application for a new certificate, if no response is provided by the applicant within the time allocated then the dossier will be closed.
The applicant may submit a new application for the same substance. It is expected that the outstanding issues from the assessment of the original closed dossier will be addressed in the new submission.
For requests for revision, the EDQM sends a letter to the applicant informing them that the lack of response has prevented the approval of the request for revision, which is therefore closed.
The applicant may submit another revision request for the certificate for the same changes. It is expected that the outstanding issues from the assessment of the original request for revision will be addressed in the new request.
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