DIRECTORATE GENER.

AL OF DRUG ADMINISTR*ATION
MINISTRY OF HEALTH AND FAIVIILY WELFARE" BANGLADESH
. 1 ut h o n:e Ll P cr,'^ o rt n a i On I y

Annexure-1
j&r
%p
FORNI Title: Check list lbr Registration Application of
Pharmaceutical products.
,ffi
Fonn No. y'ersion No Efiective Date Review Date Ar"rthorized bv Date Page No.
NR\-VIA 001/F0l-01 0t OCT'18 ocT'23 01 of 03

Part-A: Administrative Information:

1. Name and address of the ilIanufacturer of the Drug:

2. Manufacturing License Number (for locally manufactured drugs):

a; Biological:
b) Non-Biological:
3. Name of the Drug:
a; Generic name (use INN name if included in INN List)
b) Name of the reference product (lnnovator Brand)
c) Meeting reference of Drug Control Committee for approval (for existing product)
d) Name under which the drug is proposed to be sold (Optional)
4. Summary of Product characteristic (SmPC) as per WHO format (Annex-l):
a) Quaiitative ancl cluantitative conrposition
b) Pharmaceutical form
c) Ciinicalparticulars
d) Pharmacological properties
e) Pharmaceutical particulars
0 MA holder name and address

5. Registration Status at USFDA, UKNIHR{ or included in BNF of the produ ct (Only

Jbrloc al\, maruy'itctured ql n eu./ unin n-o,luc ed product))

Docutnents for Registration status of the product by United Status Food & Drug
Administration (usFDA) or united Kingdom Medicine & Health product
Regulatory Authority (UKIIHRA,) or inclusion in British National Formulary (BNF).

6' Particulars and signature of qualified personnel for locally manufacturing

drugs (On l1t for locally marufact w"ed of neuy'unintro&t c ed product) )

Pafiiculars of (a) Head of Product Development/Research and Development (b) Head of

Quality Assurance (c) Head of Production (Full name, Qualifications, Date of Joining in
the applicant's company, Total experience in the pharmaceutical industries, PCB
Registration Number (If any).

Application has to bs duly signed by the above personnel.

Pagel of4
 DIRECTORATE GENIERAL OF DRUG ADMINISTRATION
]VIINISTRY OF HEALTH AND FAN,IILY WELFARE. BANGLADESH
7u th ori:e d P ars r:n rt al On lv
Annexure-1
FORII Title: Check list for Registration Application of
#,
Forn No.
Pharmaceutical products.
v'ersion No Effective Date Review Date Authonzed by Date
ffi
Page No.
NR\-I,IA 00 1 F0 1-0 1 01 ocT'i8 ocT'23 02 of 03

7. Application for importation of drug:

The fbllowing additional information are to be provided:

a) Name, address. E-mail address. Telephone number. Fax number of the authorized
local agent of exporter (Authorization document has to be appended)
b) Registration status in the country of origin: Registration stants in the country of
ori-ein (Free Sale Certificate of one of the cor.rntries has to be submitted).
c) Registration status of human products in advance countries: Registration status of
at least one of the follorving seven countries with same brand name: USA, UK,
Germanl', France, Australia, Srvitzerland, Japan, E-\A (Free Sale Certificate of
one of the countries has to be submitted)
d) Registration status of veterinary products: In case of veterinary medicine
registration stafirs of at least one of the lollowrng countries rvith same brand name.EU
countries, USA, Srvitzerland, Canada, Australia, Japan, South Korea and
Singapore (Free sale certit-icate has to be submitted from the country of origin and
fiom any ofthe above countries).

8. Nlarimum Retail Price (IIRP) or Indicative Price:

(llention the proposed maximum retail rice (N{RP) or Indicative Price)

Part-B: Oualitv- Information

9. Active Pharmaceutical Ingredient (API):

a) General Information
i) Nomenclature
ii) Stmcture
iii) General properties (Physico-chemical properties)
b; Nlanufacture
i) Name and address of llf anufhcturer
c) CharacterizationofAPl
i) Elucidation of structure and other characteristics (ii,,irr .\['l riiiLnLiirr)]ilr1":i (ir
iiliII ;itttt"ttUt"
ii) In-rpurities Profile' (ii'r:;i; -t ;'1 iirrri:"riirit',.riii)
d) Control of drug substances
i) Specification
ii) Analyical procedures , ,/ ,r 1 ^'t
iii) \':iliillrli*n.\'*r:iL:lrijrr'll rri'-1n;1ir.,ii;3] pt r,i;rLltii,i1 lk r,{.' [r-"]. vvl-o*r-/< Nt:y -:fu
iv) cerlificate of analysis bc^.64

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 DIRECTOR{TE GENERAL OF DRUG ADMI]\IISTRATIONI
MINISTRY OF HEALTT] AND FAMILY WELFARE. BANGLADESH
,1urh ori:ctl Parso n rt cl On it
Annexure-1

ffi FORNI Title: Check list for Registration Application of

Pharmaceutical products. ffi
Forrn No. y'ersion No tfective Date Review Date Authorized bv Date Page No.
NL{-hlA 001iFO1-01 01 ocT'i8 OCT'23 0l of 03

v) Reference of specification for compendia API / Justification of specification

tbr non-compendia API

e) Referencehvorking standards ofApI

l) Container closure s)'stem of API
g) Stabilit"v data of the API (liri-'r:r .\ill ttunlit;rcfurcr)

10. Finished Pharmaceutical Product (Fpp):

a) Description and composition
b) Product Development:
i) Components of drug producr (ApI & Excipients)
ii) Formulation development and Justificationfor overage (if any)
iii) lvlanufacturingProcessDevelopment
iv) Container closure system
v) Microbiologicalattributes
vi) ('l}n:;::ri;.t: i,.; iii.ri-.iititr,:; rji.trfi ytrr-.iilr r'rlf .;,3lj11 1l1is:r:',.::ji":.:t i\.1li::i.l;rtr-ri.,, .:r.
il{'! r:i;r.: ii. I\,'ir:ri ilil i_.,ry;,11 .1r,,r,,
c) ilIanufacture
i) Batch size w,ith formula (proposed Commercial Batch)
ii) Manuf'acturing process and process control (Process f'lorv, Manulacturing
steps, process control)
iii) Control of critical steps and intemtediates
iv) Process validation(OLtr ,;t,,1 slli::r't;lsjt-rri t,ri' ::1rIljgr1;..- :ir;tr:Lti-rillt;i. r.r I jl i:tL,et
r1 ii,flii ilt-i1. ft (;ir,J)-s i,aljdritii.,i.t ..i, i i1 h; rii:|J ii;i ii:.st ll::.;r:
i:,,)it:i:::1ii'tJ:
ci:i:ti:lcl",-tril b;tr;h;s .r,:il r ill ,rril.ilitt,;J t{) Diil,},\ ilt:ticrliirilj.,' iil:ir
q;;rr:'ll 1;' ;1 I
d) Control of excipients
i) Specification for excipients (Pharmacopeia reference has to be mentioned tbr
compendial excipients, for non-compendial it is needed)
ii) Analytical procedures used for testing excipients
iii) Excipients of human or animalorigin (Halal certificate, TSE, BSE)
iv) Novelexcipients (if any)
e) Control of FPP
i) ProductSpecification
ii) AnalyticalProcednres
iii) Validation/verification of analytical procedures
iv) Certificate of analysis
v) Characterizationofimpuritiesllmpurities profile
vi) Reference of specification for compendial productiJustification of
speci tication for uon-compendial product
f) Reference standard/ reference materials/ lvorking standard
i) Name of the Standards
Page 3 of4
 DIRECTORATE GENER-AL OF DRUG ADMI}IiSTR{TION
]VIINISTRY OF HEALTH AND FAIVIILY WELFARE, BANGLADESH
,1ut h ari-d P ersitnrt c I On lt'
Annexure-1

#, FORII Title: Check list for Registration Application of

Pharmace utical products.
6h
's-w
Form No. y'ersion No.iEffective Date Review Date Authorized by Date Page No.
NRA-VIA 001,,F01-01 0r i ocl rs OCT' 23 04 of 03

ii) Name of the lvlanufacfurer

iii) Source olthe standard
ir') Certiflcate of analysis
g) Container closure system
i) Primary packaging material
ii) Secondary packaging material
h) Stabilitv study
i)Accelerated Stability Study Data
ii)Long tenn stability data
(3 month data at the time of submission and six month before reeistration with
commitment for long-term sfudy)

Part-C: Toxicological Information(For nerv genericiunintroduced nroclucts i1: 'irrlr:*ljiil.sh

!i:r Ilt't.,' ):

ll. a) Acute, sub-acute and chronic toxicity studies in animals

b) Mutagenicity studies
c) Studies on reproductive system and teratogenicity;
d) Other studies

Part-D : Clinical Information :( For nerv generici'unintroduced products )

12. a) Clinical study reports:

i) For biologics full clinical study
ii) For generic product bio-equivalence study (if applicable)

b) Tabular listing and presentation of all clinical studies:

i) Pharmacokinetics and Phamracodynamics
ii) Studies related to intended therapeutic activity
iii) Studies related to secondary pharmacological activity
iv) Studies on side-etfectsiadverse reactions in human subjects

Please Note: Information supplied if found wrong will lead to immediate cancellation of
application the prodnct.

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