clist

CHECK LIST FOR SUBMISSION REQUIREMENTS FOR REGISTRATION OF PESTICIDES AND ENDORSEMENTS FOR PRELIMINARY SCRUTINY.

Table 1.CHECK LIST FOR REGISTRATION OF PESTICIDES UNDER SECTION 9(3)/ 9(3B)

Table 2.CHECK LIST FOR EXTENSION OF PROVISIONAL REGISTRATION UNDER SECTION 9(3B)

Table 3.CHECK LIST FOR 9 (4) TIM CASES UNDER INSECTICIDES ACT, 1968

Table 4.CHECK LIST FOR UNDER SECTION 9 (4 ) FIM/RSF/CBN/NF CATEGORY OF THE INSECTICIDES ACT, 1968

Table5.CHECK LIST FOR UNDER SECTION 9 (4 ) TI/FI CATEGORY OF THE INSECTICIDES ACT, 1968

Table 6.CHECK LIST FOR REGISTRATION OF PESTICIDES FOR EXPORT UNDER SECTION 9(3)/ 9(3B)/ 9(4)

Table 7.CHECKLIST FOR LABEL EXPANSION u/s 9(3)

Table 8.CHECKLIST FOR LABEL EXPANSION OF INSECTICIDE FOR HOUSEHOLD USE u/s 9(3)

Table 9.CHECK LIST FOR ENDORSEMENT OF BIOEFFICACY CLAIM ON LABEL/LEAFLET OF REGISTRATION CERTIFICATE U/S 9(4 ) OF THE INSECTICIDES ACT, 1968

Table 10. CHECKLIST FOR ENDORSEMENT OF NEW/ALTERNATE PACKAGING

Table 11.CHECKLIST FOR ENDORSEMENT OF CHANGE OF NAME OF THE COMPANY/FIRM

Table 12. CHECKLISTFOR ENDORSEMENT OF FACTORY ADDRESS FOR THE FIRST TIME/SHIFTING OF FACTORY AND ESTABLISHMENT OF SECOND FACTORY ADDRESS

Table 13.CHECKLIST FOR TRANSFER OF CERTIFICATE OF REGISTRATION OF ONE PERSON/UNDERTAKING IN THE NAME OF ANOTHER PERSON/UNDERTAKING

Table 14.CHECK LIST FOR ENDORSEMENT OF CHANGE OF NAME OF SOURCE OF IMPORT OF CHEMICALS DUE TO DISINVESTMENT.

Table 15.CHECKLIST FOR CHANGE OF NAME OF SOURCE OF IMPORT.

1.

CHECK LIST FOR REGISTRATION OF PESTICIDES UNDER SECTION 9(3)/ 9(3B) NAME OF THE APPLICANT :- M/S --------------------------------------------------------

---------------------------------------------------------

PRODUCT :- -------------------------------------------------------------------------------------

TYPE OF THE PESTICIDE & ITS USE :------------------------------------------------------

A. Administration / Legal : Complete / Deficient

i) Index

ii) Page Numbering

iii) Authentication of pages by authorized signatory

iv) Form – I duly signed

v) Demand draft as registration Fee

v) Requisite number of stamped envelops

vi) Notarized copy of BOD Resolution/Affidavit/Partnership Deed.

S.No. Parameter 9(3B)

9(3)

TIT TIM FIM TIT TIM FIT FIMTITVsTIM

TIMVsTIT

TIT(NewSource)

CBN(IM)

RSF(IM)

NF(IM)

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15A. CHEMISTRY1. Source of Supply of

TechnicalR NR R R NR R R R NR R R R R

2. Chemical Composition

R R R R R R R R R R R R R

3. Chemical Identity of technical


4. Physico - Chemical Properties of adjuvants


5.

5(a)

Technical Bulletin Copy of RTT permit

R

R

NR

NR

NR

NR

R

R

NR

NR

R

R

NR

NR

R

R

NR

NR

R

R

NR

NR

NR

NR

NR

NR6. Specification R R R R R R R R R R R R R

7. Method of Analysis R R R R R R R R R R R R R

8. Analytical Test Report


9. Identification& Quantification of identifiable Impurities

NR NR NR R R NR NR R R R NR NR NR

10a. Shelf-life claim R R R R R R R R R R R R R10b. Shelf-life Data NR NR NR R R R R R R R R R R

11. Establishment of Chemical Equivalance

NR NR NR NR NR NR NR NR NR NR NR NR NR

12a. Process of Manufacture

NR R R NR R NR R NR R NR R R R

12b. Information about Raw Materials Used


12c. Their Source of Supply.


12d. Step-wise Manufacturing Process.


12e. Chemical Equation NR R NR NR R NR NR NR R NR NR NR NR12f. Formula NR R NR NR R NR NR NR R NR NR NR NR

12g. Flow sheet diagram of process of manufacture


12h. Effluent Treatment method


13. Documents such as registration certificate / Certificate of DNA/manufacturing licence or any other approval under any Govt. regulation will be acceptable to support that manufacturer is actual producer

R NR NR R NR R NR R NR R NR NR NR

14. Certificate from manufacturer that the dealer/ trader is an authorised dealer/ trader of the manufa - cturer.

R NR NR R NR R NR R NR NR NR NR NR

15. A test report about the quality of the product from a

R NR NR R NR R NR R NR NR NR NR NR

laboratory as per GLP scheme or from a company of ISO-9000. This requirement will be provided along with first consignment. Thereafter,each consignment should have proper analytical test report of the manufacturer.

16. The applicant should provide sample alongwith standards technical sample from the principals/ authorized dealers for chemical verification. In case of techni - cal grade pesti- cidesu/s 9(3), samples of std. impurties are also to be provided for chemical verification. In process sample to be provided in case of indigenous manufacture of technical u/s 9(3) TIM & 9(4) TIM withundertaking


17. Methodology for residue estimation as per BIS format.


B. BIOEFFICACY & RESIDUES18a. Bio-effectiveness NR NR R NR R R R R R R R R R18b. Phycotoxicity NR NR R NR R R R R R R R R R

18c. Effect on parasites & predators

NR NR R NR NR R R NR NR NR R R R

19. Translocation in plants

R R NR R R NR NR NR NR NR NR NR NR

20. Metabolism in soil R R NR R R NR NR NR NR NR NR NR NR21. Metabolism in water R R NR R R NR NR NR NR NR NR NR NR

22. Metabolism in plant R R NR R R NR NR NR NR NR NR NR NR23. Persistence in soil R R R R R R R NR NR NR R NR R

24. Persistence in water R R R R R R R NR NR NR R NR R

25. Persistence in plant R R R R R R R NR NR NR R NR R

26. Compatibility with other chemicals, if claimed


27. Residues in plant NR NR R NR NR R R R R R R R R/NR

28. Residues in soil NR NR R NR NR R R NR NR NR R NR NR29. Residue tolerance

limits fixed by foreign countries

NR NR R NR NR R R NR NR NR NR R R

30. Cost benefit ratio NR NR NR NR NR NR NR NR NR NR R NR NR31. Registration status

in foreign countriesR NR R R NR NR NR NR NR NR NR R R

32. M.R.L. Performa in duplicate

NR NR NR NR NR R R NR NR NR R R R

C. TOXICITY32. Acute oral in rat &

miceR R R R R R R R R R R R R

33. Acute dermal R R R R R R R R R R R R R34. Acute inhalation R R R R R R R R R R R R R

35. Primary skin irritation


36. Irritation to mucous membrane


37. Sub-acute oral rat R R NR/R R R NR/R NR/R NR NR R NR NR NR/R38. Sub-acute oral dog R R NR/R R R NR/R NR/R NR NR R NR NR NR/R

39. Sub-acute dermal R R NR/R R R NR/R NR/R NR NR R NR NR NR/R40. Sub-acute inhalation R R NR/R R R NR/R NR/R NR NR R NR NR NR/R

41. Neuro-toxicity NR NR NR R R NR/R NR/R NR NR NR NR NR NR/R42. Synergism &

potentiationNR NR NR R R NR/R NR/R NR NR NR NR NR NR

43. Teratogenicity NR NR NR R R NR NR NR NR NR NR NR NR

44. Effect on reproduction

NR NR NR R R NR NR NR NR NR NR NR NR

45. Carcinogenicity NR NR NR R R NR NR NR NR NR NR NR NR46. Metabolism NR NR NR R R NR NR NR NR NR NR NR NR

47. Mutagenicity NR NR NR R R NR NR NR/R NR/R R NR NR NR48. Toxicity to birds R R R R R R R NR NR R R NR NR

49. Toxicity to fish R R R R R R R NR NR R R NR NR50. Toxicity to

honeybeesR R R R R R R NR NR R R NR NR

51. Toxicity to live stock

R R NR R R NR NR NR NR R NR NR NR

52. Medical data R R R R R R R R R R R NR NR

53. Human toxicity information from foreign countries

R R R R NR NR NR NR NR R NR NR NR

54. Observation in man (Health records of spray operators)

NR NR NR NR NR R R NR NR NR R NR R

55. Health records of Industrial workers.

NR NR NR R NR R NR R NR R NR NR NR

56. Toxicity to live stock (Field trial & observation)

NR NR NR NR NR R R NR NR NR R NR NR

57. International report on carcinogenicity & genotoxicity status

NR NR NR R/NR R/NR NR NR NR NR NR NR NR NR

D. PACKAGING AND LABELLING58. Labels and leaflets

as per IR-1971 existing norms (i) for size 250 ml & below (ii) for 500 & above.


59 Labels to contents R R R R R R R R R R R R R

a. Detailed Chemical composition


b. Purpose for import / manufacture.


c. Antidot R R R R R R R R R R R R Rd. Toxicity triangle R R R R R R R R R R R R R

e. Cautionary statement


f. Brief direction concerning usages


g. Restriction if any R R R R R R R R R R R R R60. Leaflets to contain a. Detailed Chemical

composition on leaflets accompanying small labels (upto 250 ml size container)

NR NR R NR NR NR R R R NR R R R

b. Introductory para about the pesticide


c. Detailed directions concerning usages


d. Time of application NR NR R NR NR R R NR NR NR R R R

e. Application NR NR R NR NR R R NR NR NR R R R

equipment

f. Waiting Period NR NR R NR NR R R NR NR NR R R Rg. Symptoms of

poisioningR R R R R R R R R R R R R

h. First aid measures R R R R R R R R R R R R R

i. Antidot & treatment R R R R R R R R R R R R Rj. Restriction, if any R R R R R R R R R R R R R

k. Instruction for storage


l. Information regarding disposal of used packages.


61. Type of packaging (pkg material + compatibility with content)


62. Manner of packaging


63. Specification for primary package


64. Specification for secondary packaging.


65. Specification for transport packaging.


66. Manner of labelling NR R R NR R NR R R R R R R R67. Performance of

container during storage stability test

NR NR NR R R R R R R R R R R

Abbreviations :

R : Required NR : Not RequiredTIM : Technical Indigenous

Manufacture TIT : Technical Import

FIT : Formulation Import FIM : Formulation Indigenous Manufacture

CBN : Combination Formulation RSF : Relatively Safer FormulationIM : Indigenous Manufacture NF : New FormulationAR : Already Registered

i. For Import of formulations under section 9(3) :

a. If the applicant does not seek registration for import of technical together with formulation, in such a case the applicant shall be required to submit complete data as per requirement of import of technical.

b. Rationale for importing formulation.

ii. Data on effect on parasites and predators is not required in case of

fungicides and herbicides.

iii. In case of relatively safer formulations two consecutive seasons data on

bioeffectiveness indicating phytotoxic effects, if any, on two representative crops at two agro-dimatic zones of the country or one season / year multilocation data generated under different agro-climatic zones is required to be submitted.

iv. In case of TIM Vs TIT and TIT Vs TIM under section 9(3), one season data

on bioeffecacy including phytotoxicity, if any, on two representative crops at two climatic zones is required to be submitted.

v. One season residue data on two representative crops particularly on fruits

and vegetables is required in case of relatively safer formulation, TIM Vs TIT and TIT Vs TIM under section 9(3).

vi. In case of herbicides data on effect on soil physico-chemical properties,

soil flora and fona and succeeding crops is required alongwith the long term residue studies.

vii. Data requirements of chemical pesticides are also applicable for

registration of chemical plant growth regulators.

viiii.

NF: In case of wettable powder, if toxicological data is generated for EC formulation applicable as per guidelines, then there is no need to generate data on wettable powder containing the same a.i.

ix.RSF : The need for additional toxicity data will be determined on case to case basis.

2.CHECK LIST FOR EXTENSION OF PROVISIONAL REGISTRATION

UNDER SECTION 9(3B)

NAME OF THE APPLICANT: M/s……………………………………………………..

…………………………………………………………….

NAME OF THE PRODUCT: ………………………………………………………...

A. Administration/legal

i) Index

ii) Page numbering


iv) Authorization for the signatory (Notarized copy of BOD

resolution/affidavit/partnership deed)

v) Form-I duly signed

vi) Demand draft as registration fee

vii) Requisite number of stamped envelops

viii) Justification for extension

ix) Copy of all earlier CRs for the product

x) Details of data generated to fulfill the conditions of provisional

registration.

a. Chemistry

b. Bioefficacy

c. Toxicity

d. Packaging

3.CHECK LIST FOR 9 (4) TIM CASES UNDER INSECTICIDES ACT, 1968

NAME OF THE APPLICANT: M/S……………………………………………………..

…………………………………………………………….

PRODUCT : ………………………………………………………………………

Administration/Legal:-

1. Index2. Page numbering3. Authentication of pages by authorized signatory.4. Demand draft.5. Requisite number of stamped envelopes6. Form-I duly signed 7. Authorization for the signatory (Notarized copy of BOD

resolution/affidavit/partnership deed)

Chemistry:-1. Chemical Composition

2. Chemical Identity/Structural formula

3. Physico-Chemical properties

4. Specification

5. Method of analysis

6. Analytical Test Report from an independent laboratory

7. Identification and quantification of associated standard identifiable

8. Shelf- life claim and Products Quality undertakings

9. Establishment of chemical equivalence

10. Process of manufacture

11. Information about raw material

12 Source of supply

13. Step-wise manufacturing process

14. Step-wise chemical equations

15. Flow –sheet diagram of manufacturing process

16. Effluent treatment method/flow – sheet diagram, and

17. Drawl of in-process sample and its Analysis Test Report (ATR) from CIL

Toxicology

1. Acute oral in rat & mice

2. Acute dermal

3. Primary skin irritation

4. Irritation to mucous membrane

Packaging

1. Seven copies Label/leaflets as per IR 1971 existing norms

2. Manner of packaging

3. Manner of Labeling

4. CHECK LIST FOR UNDER SECTION 9 (4 ) FIM/RSF/CBN/NF CATEGORY OF THE INSECTICIDES ACT, 1968


…………………………………………………………….

NAME OF THE PRODUCT :……………………………………

1. Index

2. Page numbering

3. Authentication of pages by authorized signatory.

4. Demand draft.

5. Requisite number of stamped envelopes

6. Form-I duly signed

Notarized copies of the following:-

1. BOD Resolution/Partnership Deed/Affidavit

2. SSI Certificate, if SSI Unit

3. PAN NO.

4. Incorporation Certificate

5.CHECK LIST FOR UNDER SECTION 9 (4 ) TI/FI CATEGORY OF THE INSECTICIDES ACT, 1968


…………………………………………………………….

PRODUCT : ………………………………………………………………………

1. Index2. Page numbering3. Authentication of pages by authorized signatory.4. Demand draft.5. Requisite number of stamped envelopes6. Form-I duly signed

Notarized copies of the following:-

1. BOD Resolution/Partnership Deed/Affidavit2. SSI Certificate, if SSI Unit 3. PAN NO.4. Incorporation Certificate5. Letter of consent, duly legalized from Indian Embassy/High Commission/ Consulate in the Country of origin.

6.

CHECK LIST FOR REGISTRATION OF PESTICIDES FOR EXPORT UNDER SECTION 9(3)/ 9(3B)/ 9(4)

NAME OF THE APPLICANT: - M/s.--------------------------------------------------------

---------------------------------------------------------

PRODUCT AND ITS CATEGORY: - ---------------------------------------------------------

A. Administration / Legal :i) Indexii) Page Numberingiii) Authentication of pages by authorized signatoryiv) Demand draft as registration Feev) Requisite number of stamped envelopsvi) Authorization for the signatory.

B. Chemistry Already registered molecule

a) Chemexcil certificateb) Form – I duly signed 6(i)-Chemical composition 10(i)- BIS no/specification & method of analysis.c) 7 copies of Labels/leafletsd) For category I and VI- “Source of Import.”e) “Process of manufacture” (Indigenous manufacture) for category I and II

New molecule, not registered for use in the country. a) Chemistry-information as in (B) above.

b) Toxicity information (i) Acute oral in rat

(ii) Acute dermal (iii) Acute inhalation (iv) Primary skin irritation

(v) Irritation to mucous membrane

For Technical Additional Requirement(vi) Effect on reproduction(vii) Carcinogenicity(viii) Mutagenicity.

Bt. & Neem: As per guidelines for export-Chemistry + Toxicity information

7.

CHECKLIST FOR LABEL EXPANSION u/s 9(3)

Name of the Applicant: M/s……………………………………………….

Product :

1. Index2. Page Numbering. 3. Authentication of pages by authorized signatory

4. Requisite number of stamped envelop 5. Copy of Registration Certificate 6. Authorization for the signatory(Notarized copy of BOD resolution/affidavit/partnership deed) 7. Affidavit duly notarized regarding label expansion made earlier in respect of certificate for which the present request is being made.

Bioefficacy1. Bioeffectiveness2. Phytotoxicity3. Residue in plant4. Persistence in plant5. Residue tolerance limits fixed by foreign countries6. MRL proforma in duplicate7. Registration status in foreign countries8. Effect on parasites and predators ( applicable in case of insecticides only)9. Seven copies of revised labels/leaflets in English & Hindi

8.

CHECKLIST FOR LABEL EXPANSION OF INSECTICIDE FOR HOUSEHOLD USE u/s 9(3)


Name of the product :

1. Index

2. Page Numbering.

3. Authentication of pages by authorized signatory

4. Requisite no. of stamped envelopes

5. Authorization for the signatory (Notarized copy of BOD resolution/affidavit/partnership deed)

6. Bioeffectiveness data of minimum two repeated trials from three National Laboratories

7. Information on secondary pest outbreaks particularly of ticks & mites where residual pyrethroids are being used.

8. Data on persistence on different type of surfaces generated under Indian conditions from three laboratories (except coil/mats/liquid vaporizer).

9. Data on concentration in air in case of coil/mats/liquid vaporizer.

10. Seven copies of Label/leaflets in Hindi and English.

11. Affidavit duly notarized regarding label expansion made earlier in respect of certificate for which the present request is being made.

9.

CHECK LIST FOR ENDORSEMENT OF BIOEFFICACY CLAIM ON LABEL/LEAFLET OF REGISTRATION CERTIFICATE U/S 9(4 ) OF THE INSECTICIDES ACT, 1968

NAME OF THE APPLICANT: M/s.……………………………………………………..

…………………………………………………………….

PRODUCT: ………………………………………………………………………

1. Index

2. Page numbering


4. Notarized copy of BOD Resolution/Affidavit/Partnership Deed

5. Notarized copy of Registration Certificate of the product with approved label/leaflet.

6. If Registration Certificate is more than 2 years old, a certificate from the concerned State/UT Govt. as a proof of commencement of actual production of the pesticide.

7. Affidavit duly notarized regarding endorsement made earlier in respect of certificate for which the present request is being made.

10.

CHECKLIST FOR ENDORSEMENT OF NEW/ALTERNATE PACKAGING


1. Index

2. Page Numbering.



5. Justification for change

6. Copy of Certificate of Registration

7. Details of system of packaging w.r.t. Primary, secondary and transport packaging

8. Data supporting the suitability of the content with the container

10. Affidavit duly notarized regarding endorsement made earlier in respect of

Certificate for which the present request is being made.

11.CHECKLIST FOR ENDORSEMENT OF CHANGE OF NAME OF THE

COMPANY/FIRM


1. Index

2. Page Numbering.



5. Affidavit duly notarized regarding endorsement made earlier in respect of

certificates for which present request is being made.

6. Copy of Certificate of registration

7. In case of shifting of factory premises, a No Objection Certificate from the

Director of Agriculture of the State/UT for setting of the factory at the newly

proposed site. In case of shifting of office premises, full and complete address of

the Head Office including the branch office

8. In case of firm, copy of the Partnership Deed/ in case of Company, (a)

Memorandum of Articles & Association (b) fresh Certificate of Incorporation

consequent on change of Name, approved by Registrar of the Company, Ministry

of Law, Justice & Company Affairs.

9. An affidavit regarding no court case is pending under any provisions of the

Insecticides Act and Rules framed there under.

12. CHECKLISTFOR ENDORSEMENT OF FACTORY ADDRESS FOR THE FIRST

TIME/SHIFTING OF FACTORY AND ESTABLISHMENT OF SECOND FACTORY ADDRESS


…………………………………………………………….

I Factory Address for the first time:-1. Index

2. Page numbering



5. Affidavit, duly notarized, regarding endorsement made earlier in respect of

Certificate for which present request is made.

6. Copy of Certificate of Registration

7. Copy of approved labels and leaflets or 7 copies of labels and leaflets

(If not approved earlier)

II Shifting of Factory and endorsement of second Factory Address:-

(A) All above from 1-6

(B) ‘No Objection Certificate’ from the State Director of Agriculture for

shifting of the factory/endorsement of second address.

13.CHECKLIST FOR TRANSFER OF CERTIFICATE OF REGISTRATION OF ONE

PERSON/UNDERTAKING IN THE NAME OF ANOTHER PERSON/UNDERTAKING


1. Index2. Page Numbering.3. Authentication of pages by authorized signatory4. Authorization for the signatory (Notarized copy of BOD

resolution/affidavit/partnership deed)5. Affidavit duly notarized regarding endorsement made earlier in respect of

certificates for which present request is being made6. Joint application signed by both the parties in respect of each registration

certificate on a non-judicial stamp paper duly Notarized with the following details:

(i) Date of commissioning the unit/Accepted date of commissioning of unit

(ii) Complete address of the manufacturing unit(iii) Details of production of different products for last one year

2. Attested copy of the manufacturing licence issued by the State Licensing Authority containing the name of products for which a requests for transfer of certificate have been made.

3. Certificate of incorporation issued by the Registrar of Companies in case of Private/Public Ltd. Companies together with copies of Memorandum and articles of association.

4. Attested copies of the Deed for dissolution of partnership or deed of partnership as the case may be.

5. Attested copies of the registered sale deed/gift/inheritance

6. No Objection Certificate from the competent court towards its transfer, in case of any Court case is pending under any provisions of the Insecticides Act and Rules framed there under against the transfer.

14. CHECK LIST FOR ENDORSEMENT OF CHANGE OF NAME OF SOURCE OF IMPORT OF CHEMICALS DUE TO DISINVESTMENT.

Name of the applicant: - M/s --------------------------------------------------------

Name of the product: - -------------------------------------------------------------------

i) Index

ii) Page Numbering


iv) Authorization for the signatory (Notarized copy of BOD resolution/affidavit/partnership deed)

v) Formal request letter by the disinvestor

vi) Copy of Certificate of Registration

vii) Certificate with reference to disinvestments along with other relevant

supporting documents.

viii) Undertaking from the buyer with reference to maintenance of same

quality, specification, process of manufacture of technical product

ix) Analytical test report of the technical product being manufactured by the

buyer with reference to quality specification as well as purity, impurity

profile of these batch samples.

x) Consent letter to supply the product to India

xi) Affidavit with reference to earlier endorsement being made.

15.CHECK LIST FOR CHANGE OF NAME OF SOURCE OF IMPORT

NAME OF THE APPLICANT: M/s.……………………………………………………..

…………………………………………………………….

Name of the Product :…………………………………………………………..

Administration/Legal1. Index

2. Page numbering

3. Notarized copy of BOD Resolution/Affidavit/Partnership Deed

4 Authentication of pages by authorized signatory.

5. Affidavit duly notarized regarding endorsement made earlier in respect of Certificate for which the present request is being made

6. Documentary proof of change of name applicable in respect of country duly authenticated by Consulate/Embassy/High Commission

i. Documentary proof as per change of manufacturing premises duly authenticated by Consulate/Embassy/High Commission.

ii. Copy of certificate of Registration

CHEMISTRY

1. Reason/justification for the change in name clarifying whether it is a case of merger/taking over of company/internal rearrangement/shifting of manufacturing unit.

2. Analytical test repot from the approved source as well as from the newly named source alongwith undertaking w.r.t. quality specification and process of manufacture

3. Supportive document from the designated National Authority/Registration Document

4. Letter of consent, duly legalized from Indian Embassy/High Commission /Consulate in the country of origin5. Any other additional relevant document/information.