Appendix 15A_Checklist for MIV-1 Applications for Biologics

checklist MIV biologics

Guidance on Medicinal Product Registration in SingaporeJanuary 2009 checklist for minor variation applications (miv-1) for biologics

APPENDIX 15ACHECKLIST FOR MINOR VARIATION APPLICATIONS

(MIV-1) FOR BIOLOGICS

Applicants should be familiar with the documentary requirements for MIV submissions refer to Table A in Appendix 15 for the list.

The following documents must be submitted with each MIV submission, as given in Table A below:

Hard CopyE-Copy

PRISM application formYes N/A

Table of ContentsYes Optional*

Checklist for MIV applicationsYes Optional*

Table of Amendment DetailsYes PRISM

MIV-specific Supporting documents

Administrative (Module 1/Part 1)

Other supporting documentsYes

OptionalPRISM

PRISM/CD

Relevant CTD section(s) of the currently registered version with the proposed change(s) clearly annotatedOptionalPRISM/CD

Current and proposed product labelling (annotated and pristine copies), where applicableYes PRISM

* E-copies may be submitted via PRISM or CD-ROM.When submitting the Checklist for Minor Variation Applications for Biologic Drugs, applicants must make the following declaration:

Declaration of the applicant for MIV-1

I hereby submit an application for the concerned product to be varied in accordance with the proposals given above. I declare that(There are no other changes than those identified in Section 0.4 Amendment Summary;

(All Conditions for the change(s) concerned are fulfilled; and,

(The required documents as specified for the change(s) have been submitted.

DOSSIER REQUIREMENTS FOR BIOLOGICS MIV-1

Declaration of the applicant for MIV-1

I hereby submit an application for the concerned product to be varied in accordance with the proposals given above. I declare that (please tick the appropriate declarations)

FORMCHECKBOX

There are no other changes than those identified in Section 0.4 Amendment Summary;

FORMCHECKBOX

All Conditions for the change(s) concerned are fulfilled; and,

FORMCHECKBOX

The required documents as specified for the change(s) have been submitted.

____________________

______________________

_______________

Applicants Name

Applicants Signature

Date

B1Change of Manufacturing Site

For any change, including addition to or replacement, of currently registered manufacturing site(s) of drug substance, drug product, process intermediates, and/or primary packager. If there are any changes in the manufacturing process, include documents listed under B3.

Supporting Documents

1)Official letter authorising the proposed site to perform the related activity; FORMCHECKBOX

2)GMP certificate; FORMCHECKBOX

3)Validation study reports and/or summaries of the manufacturing process at the proposed manufacturing site; FORMCHECKBOX

4)Release and/or shelf life specifications; FORMCHECKBOX

5)Batch analysis data (in a comparative tabular format) of at least three batches manufactured at the currently registered and proposed site; FORMCHECKBOX

6)Results of appropriate stability studies of at least three batches produced at the proposed manufacturing site in accordance with the relevant stability guidelines. FORMCHECKBOX

7)Batch numbering system. FORMCHECKBOX

B2Change of Testing Laboratory

For any addition or replacement of the current registered laboratories for stability tests or any quality control (QC) tests.


1)Official letter authorising the proposed site to perform the related activity; FORMCHECKBOX

2)Analytical assays at the proposed site; FORMCHECKBOX

3)Validation study reports and/or summaries at the proposed site; FORMCHECKBOX

4)Release specification; FORMCHECKBOX

5)Batch analysis data (in a comparative tabular format) of at least two batches tested at the currently registered and proposed site. FORMCHECKBOX

B3Change of Manufacturing Process

For any change in the procedure and/or scale of the current registered manufacturing process at any stage during manufacture of drug substance and/or drug product.


1)Validation study reports and summaries of the proposed manufacturing process; FORMCHECKBOX

2)Release and/or shelf life specifications; FORMCHECKBOX

3)Batch analysis data (in a comparative tabular format) of at least two batches manufactured according to the currently registered and proposed process; FORMCHECKBOX

4)Results of appropriate stability studies of at least three batches produced with the proposed manufacturing process in accordance with the relevant stability guidelines; FORMCHECKBOX

5)A declaration from the applicant that no new impurities have been introduced at or above the accepted threshold for qualification of impurities or that there is no increase in the level of impurities, which require further safety studies. FORMCHECKBOX

B4Change of Test Procedure

For any change of test procedure of drug substance, drug product, in-process tests, product release tests, and/or stability tests.


1)Validation study reports and summaries of the proposed test procedure. FORMCHECKBOX

B5Change of Specifications

For any change of release and/or shelf life specifications of drug substance, drug product, in-process tests, product release tests, and/or stability tests.


1)Scientific and/or historical data used to support the change; FORMCHECKBOX

2)Currently registered version of the release and/or shelf life specifications with the proposed change(s) clearly highlighted, underscored, or otherwise indicated. FORMCHECKBOX

B6Change of Container Closure System

For any change of the container closure system that is in immediate contact with the drug substance, drug product, process intermediates, and/or diluent used for reconstitution.


1)Information on construction materials and design features of the proposed container closure system; FORMCHECKBOX

2)Study reports and/or summaries on compatibility, leaching materials, leak tests, etc. for demonstrating the suitability of using the proposed container closure system; FORMCHECKBOX

3)Release and shelf life specifications; FORMCHECKBOX

4)Results of appropriate stability studies of at least three batches produced with the proposed container closure system in accordance with the relevant stability guidelines. FORMCHECKBOX

B7Change of Shelf Life and/or Storage Condition

For any change of shelf life and/or storage condition of drug substance, drug product, and/or process intermediates after initial opening or after reconstitution.



2)Results of appropriate stability studies of at least three batches covering the duration of the proposed shelf life under the proposed storage conditions in accordance with the relevant stability guidelines. FORMCHECKBOX

B8Change of Excipient

For any change of the qualitative or quantitative formulation of excipients of drug substance and/or drug product.



2)Batch analysis data (in a comparative tabular format) of at least two batches manufactured according to the currently registered and proposed formulation; FORMCHECKBOX

3)Results of appropriate stability studies of at least three batches with the proposed formulation in accordance with the relevant stability guidelines. FORMCHECKBOX

B9Change of Product Label

For any change of product labelling of the package insert (PI), patient information leaflet (PIL), unit carton label, inner label, and/or blister strips which cannot be classified as an MAV or an MIV-2.


1)Justification for the proposed change(s) and supporting clinical documents, where applicable; FORMCHECKBOX

2)Currently registered product label with the proposed change(s) clearly highlighted, underscored, or otherwise indicated; FORMCHECKBOX

3)Proposed product label with all change(s) incorporated; FORMCHECKBOX

B10Seasonal Variation of Influenza Strains for Vaccine

Change of only influenza strains for the formulation of an influenza vaccine according to WHO Recommendations for Influenza Vaccine Composition may be expedited. Additional changes other than strain changes will require additional supporting documents, and may delay the evaluation timeline.

Document Required In Addition to MIV-1 Compulsory Documents:

1)CTD Module 2 - Section 2.3 Quality Overall Summary; FORMCHECKBOX

2)CTD Module 3 - Section 3.2.P.8 Stability (Summary & Conclusion) of at least 6 months of the vaccine from the preceding year or season; FORMCHECKBOX

3)Currently registered product label with the proposed change(s) clearly highlighted, underscored, or otherwise indicated; FORMCHECKBOX

4)Proposed product label with all change(s) incorporated. FORMCHECKBOX

5)A commitment from the applicant to perform stability studies up to the proposed shelf-life of the product. FORMCHECKBOX

NOTE: When submitting the Checklist, please delete the MIV-1 checklist category(ies) that do not relate to the MIV application.

PAGE HEALTH SCIENCES AUTHORITY HEALTH PRODUCTS REGULATION GROUP Appendix 15A - Page 1 of 4

Appendix 15A_Checklist for MIV-1 Applications for Biologics

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