CENTER FOR DRUG REGULATION AND RESEARCHDRUGSTORE ( ) / HOSPITAL PHARMACY ( ) / INSTITUTIONAL PHARMACY ( )SELF-ASSESSMENT TOOLKIT FORMINITIAL APPLICATION OF LICENSE TO OPERATECOMPANY NAME :COMPANY ADDRESS :ACTIVITY/IES :NON-STERILE COMPLEX COMPOUNDING ( )STERILE COMPOUNDING ( )ONLINE ORDERING AND DELIVERY ( )Direci!"#:Fi$$ !% &e '!r( )* ic+i", &e -..$ic-)$e c!$%("/Pr!0i1e re(-r+# !" &e c$ie"2# c!$%(" 3&e" "ece##-r*/Acc!(.$i#& i" 1%.$ic-e c!.ie#/DOCUMENTARY RE4UIREMENTS:Yes NoREMARKSCLIENT FDA5/ A..$ic-i!" F!r( Is the application properly filled out? Is it duly notarized? Arethesignatoriesintheapplicationformtheauthorizedpersons as required under the following circumstances?(a) If single proprietorship the owner as registered in DTI(unless there is a different authorized person) (b) If partnership/corporation one of the incorporators or authorized person as indicated in the board resolution orSecretarys !ertificate (c) If cooperati"e authorized person indicated in the board resolution or Secretarys !ertificate of the cooperati"e If the signatory is not the owner or one of the incorporators# as the case $ay be% Is the board resolution or Secretarys Certificate notarized and clearly identify the person authorized to sign for and in behalf of the owner or corporation? Is the person identified in the said document the same person who signed the Application Form and/or Contract/ Agreement? 6/ Pr!!' !' 7%#i"e## N-(e Re,i#r-i!" (a) &or single proprietorship# !ertificate of 'usiness(egistration issuedbythe Depart$ent of Trade andIndustry (DTI) Is the business name applied for !" the same with that of#!I registration certificate? Is the #!I certificate still $alid? Is the owner appearing in the application form the same withthat of the #!I certificate? Is the address of the establishment applying for !" withinthe territorial co$erage?If the business address indicated in#!I isdifferent fromthee%act addressasdeclaredintheapplication form& is there a clear copy ofBusiness/MayorsPermit or Barangay clearanceindicating the complete )(epublic of the *hilippinesDepart$ent of +ealthFOOD AND DRUG ADMINISTRATIONaddress of drug establishment?(b) &or corporation# partnership and other ,uridical person#!ertificate of (egistration issued by the Securities and-.change !o$$ission (S-!) and /rticles ofIncorporation Is the business name applied for !" the same with that ofthe S'C registration certificate? If the company uses anotherbusiness name style different from its corporate name& is anamended S'C registration reflecting the same submitted? Is the address indicated in the S'C the same with the addressof the establishment applied for !"? o If the address in S'C is still occupied but the businessoperation applied for !" is located in a separate area&is a clear scanned copy of (usiness /)ayors *ermit or(arangay clearance indicating the complete address ofdrug establishment submitted? o If the address inS'Cis nolonger occupied& is anamended S'C registration reflecting the currentbusiness address submitted? Is the type of acti$ity and product applied for !" indicatedin the Articles of Incorporation +Article II,? (c) &or cooperati"e# !ertificate of (egistration issued by the!ooperati"e De"elop$ent /uthority and the appro"ed by0laws Is the business name applied for !" the same with that ofthe C#A registration certificate? Is the address indicated in the C#A the same with the addressof the establishment applied for !"? Is the type of acti$ity and product applied for !" indicatedin the appro$ed articles and by-laws of the cooperati$e? (d) &or go"ern$ent0owned or controlled corporation Is there a copy of the law creating the same? +if with originalcharter, 3. Cre1e"i-$# !' P&-r(-ci# -"1 Re#.!"#i)$e P&-r(-c* A##i#-" Are the responsible pharmacist and pharmacy assistant+where applicable, identified? Is the *.C I# of the responsible pharmacist still $alid? If not$alid& is there a proof of renewal attached? Istheresignationletterof theresponsiblepharmacist frompre$ious company signed/ conformed by theowner/authorized representati$e of the establishment? +whereapplicable, o Is the !" number of the pre$ious company indicated? Is the name of pharmacist in the certificate of attendance to F#A seminar on licensing of establishment the same with application form for !"? Is the seminar attended corresponds to the type of !" applied by the establishment? If not yet attended& is proof of registration of the scheduled licensing seminar included? If a responsible pharmacy assistant is employed& is a copy of the Certificate of !raining of *harmacy Assistants submitted? 8/ Ri#+ M-"-,e(e" P$-" Are the ris/s for the establishment properly identified? Are there plans of action for these identified ris/s? Is there an established S"* for pharmaco$igilance?1 Is there an established S"* for handling regulatory mandatesfrom F#A& such as product recall& withdrawal& suspension ofacti$ities& etc? 9/ L!c-i!" P$-" Is the s/etch submitted indicates certain landmar/? Is the 0*S Coordinates included?:/ Pic%re !' Dr%,#!re 3i& Di#.$-* !' Si,"-,e #oes the picture clearly show the signage bearing the e%act business name of the establishment as registered in #!I/S'C +e%cept for franchise drugstore, ;/ Pr!!' !' P-*(e" Is the payment made according to the required fee2ADDITIONAL RE4UIREMENTS(