Q & a Foreign Companies-MoH 2007

7/21/2019 Q & a Foreign Companies-MoH 2007

1/23

Meeting between the Ministry of Health and Foreign Companies operating in the pharmaceutical field in Vietnam ,Hanoi, 06/1/00!

Questions & Answers

I Drug registration

1. The DAV should accept ICH format which still compl with ACT!(Sanof-Aventis)

Answer"ACCSQ/PPWG meeting already discussed and agreed to befexible regarding ACTR dossier. Vietnam also allo !or "C# numbering interms o! $C%.

#. Detailed guidelines for each $ind of %ariation is necessar( Pharma Group)

Answer" T&ere is a 'art guiding in detail !or minor and ma(or

)ariations in our dra!t o! ne drug registration regulation.

. 'C( could )e understood as new in the world or *rst+timeregistered drug in Vietnam, (Sanof-Aventis)

Answer"$e c&emical entities mean drugs containing ne acti)eingredients in)ented in t&e orld and not yet mar*eted enoug& + years int&e origin country.

-. It should )e regulated clearl on eecti%eness and appling

progress of the new regulation. If dossiers are su)mitted )eforethe eecti%e time/ whether the will )e e%aluated according tonew or pre%ious regulation ( Sanof-Aventis)

Answer" dra!t o! ne drug registration regulation included atransition article &ic& clari,es- e)aluation and granting )isa number todossiers submitted be!ore t&e eecti)e day o! ne regulation ill com'lyit& 0rug registration regulation 'romulgated in 0ecision $o. 1232/3442/Q5678T dated 29/4:/3442 o! t&e ;inister o! #ealt& and )accine andbiologicals registration regulation 'romulgated in 0ecision $o. or*ing grou's tried to s'eci!y t&isclassi,cation to t&e extent as muc& as in t&e stability guidelines.

3. The storage conditions regarding drugs stored )elow #0oCshould )e regulated clearl (Sanof-Aventis)

Answer" ?ntil no> e committed to current regulation'romulgated in 0ecision $o. 1232/3442/ Q5678T dated 29/4:/3442

"rug #dministration of Vietnam $ 1% 'i(ng V), H* +i $ -el. 0 !%66&% $ Fa. 0 &%!& 1


2/23


@ acce'ting results o! stability studies it& storage conditions belo 3+oC.W&en im'lementing AS%A$ stability guideline> beside results o! stabilitystudy> t&ere are also some !actors &ic& s&all be considered including-&et&er t&ere is any unstable '&enomenon> &et&er any data !romaccelerated conditions is 'ro)ided> &et&er more 'rotecti)e 'ac*aging isnecessary. "n t&e e)aluation 'rocess> aut&orities could reBuest com'anies

to su''lement more data !rom stability studies.4. 5hether companies which contract to manufacture drugs can$eep %isa num)er after theirs contractor ha%e other %isa num)er,( Sanof-Aventis)

Answer"According to Circular $o. 4/TT678T dated 39/+/344 onlydrugs &ic& are manu!actured one stage o! manu!acturing 'rocesses bycontract can *ee' t&e 're)ious granted )isa number. "! &olemanu!acturing 'rocesses are manu!actured by contract> drugs aregranted dierent )isa numbers !or contractors.

6. 5e would li$e to re7uest the DAV to recei%e drug registrationdossiers # das per wee$(Sanof-Aventis)

Answer"T&e 0AV is im'lementing administration re!orm so as torecei)e all coming dossiers during &ole ee* at t&e 0AVDoEce.

8. The DAV should accept e+registration and su)mitting CD+!om.9harma :roup is read to co+operate in technical support andfunds (Pharma Group)

Answer" T&e ;F# is committed to a''ly "T in administration'rocess in order to increase eecti)e 'er!ormance> sa)e &uman resourcesand re!orm administration. %6submission reBuires good in!rastructure ands'ecialists must acBuire reasonable *noledge about "T. "n t&e !uture> e6submission ill be em'loyed as soon as 'ossible based on e6go)ernment'rinci'le. Currently> t&e con)entional submission is still a''lied.Submitting C06Rom ould results in decrease o! o)erload o! storeddossiers and related or*s> T&e 0AV ill study and utilie t&is 'rocessste' by ste'. T&e 0AV &ig&ly a''reciates t&e coo'eration and su''ort!rom all com'anies in t&is issue.

1;. 9lease e


3/23


oEce. S'ecialists ill re6e)aluate t&e su''lement dossiers> i! t&ey !ul,ll allreBuirements t&en ill be named in t&e 'ro'osed drug list !or granting)isa at t&e senior board meeting. ?nsuccess!ul su''lement dossiers asell as drugs not Buali,ed !or )isa numbers are got oEcial letter 're'aredby t&e drug registration de'artment. T&e Buality o! e)aluation o! drugregistration dossiers" T&ere are + grou' o! s'ecialists or*ing !or

e)aluation- Hegal matters> Quality standards> manu!acturing 'rocess>'&armacology and clinical grou's. T&ey are all at &ig& le)el degrees> !ullo! ex'erience in t&eirs ,elds and or*ing in researc& institutes> institute o!Buality control> uni)ersities> national &os'itals. T&ey consult t&e 0AVregarding Buality o! dossiers. A!ter t&ey comment drug registrationdossiers> t&e drug registration de'artment ill collect> 'rocess andconclude to &a)e ,nal results and re'ort to t&e ;F# senior board.

11. According to current %accine and )iologics registrationregulation/ it is necessar to translate dossiers into Vietnamese

in regards with foreign dossiers Vietnamese %ersion is to )eoriginal dossier2. This is an issue as translation could )e incorrectcompared to (nglish origin/ not all meaning are translated as wellas spending on translation. 5e would li$e to re7uest the =>H toa)rogate this re7uirement and accept )oth (nglish andVietnamese dossiers applied for foreign products2 (PharmaGroup)

Answer" Translation into Vietnamese is one issue o! currentregulation. "n real> e still &a)e to read %nglis& dossiers to com'are t&econtent. "n t&e 'ast> drug registration regulation &ad t&e same

reBuirement but a!ter im'lementing !or a 'eriod> it as cancelled as itsina''ro'riateness. T&e ;F# acce't t&is reBuirement and ill consider soas to amend in t&e ne regulation.

1#. The issue on amendment of list of %accine/ treatment)iologics/ diagnostic )iologics and semi+*nished productspromulgated in the Decision 'o. 1?#;;3?Q@+BT dated #1??#;;3(Pharma Group)

Answer" T&e ;F# are re)ising t&e current )accine and biologics

regulation. Accordingly> t&ere ill be no list o! must6register )accine andbiologics> instead all )accine and biologics &ic& matc& t&e de,nition&a)e to register com'lied it& regulation.

1. Treatment )iologics/ pre%ention )iologics ha%e to )eregistered )ased on drug registration regulation or %accine and)iologics regulation, there are a lots of treatment )iologicsmar$eted widel and used ) man patients )ut not et listedsuch as hormones Insulin/ growth hormones/ gonadotropin2/)lood produced factors (rthropoietin2/ monoclon and

multiclon anti)od2,(Pharma Group)Answer" 7ased on current regulation- 7iologics registration need to

con!orm to )accine and biologics registration regulation 'romulgated in

"rug #dministration of Vietnam $ 1% 'i(ng V), H* +i $ -el. 0 !%66&% $ Fa. 0 &%!& %


4/23


0ecision $o. &en releasing ne 0rugregistration regulation> biologics @ exce't diagnostics ill com'ly it&drug registration regulation.

1-. Vietnam proposed to appl ACTD?ACT! from 1?1?#;;6 to showdetermination to upgrade the 7ualit of Vietnampharmaceuticals. Howe%er/ 9harma :roup re7uest the deadlineof 1?1?#;;8 which mentioned in the pre%ious ACCQ+995:meetings there) we ha%e enough time for preparing. (PharmaGroup)

Answer" Vietnam illa''ly t&e '&ase6in 'rocess o! ACT0/ACTR assame as ot&er AS%A$ countries li*e agreement in t&e 21t& ACCSQ

meeting- @exce't administration data e ill &a)e to im'lement t&eado'ted AS%A$ Common Tec&nical ReBuirements and AS%A$ Tec&nicalGuidelines including AS%A$ stability reBuirement on storage conditions@one "Vb i.e 14IC/:+J R# not later t&an 2 stKanuary 344L a''lying !or all,rst/ ne submissions o! 'roduct dossiers. "n case> t&e AS%A$ Tec&nicalGuidelines are not a)ailable to be used to demonstrate t&e com'lianceit& t&e s'eci,c 'arameter suc& as im'urity> t&e res'ecti)e $0RAs canexercise t&eir on met&odologies or reBuirements based oninternationally acce'ted standards/ guidelines. Starting !rom 2st Kanuary344L> submission o! dossiers !or reneal &as to be based on t&e ACT0Mormat and t&e com'liance it& t&e AS%A$ Tec&nical Guidelines is needed

exce't !or Buality data &ic& is le!t to indi)idual countries to decide t&etime!rame but not be later t&an 2stKanuary 3423.

10. During drug registration processes/ I9 matters )ecome moreand more important e%en the =>H do not administer all I9 relatedmatters. Howe%er/ we would li$e to clarif our plan andinterdisciplinar mechanism to implement I9 in pharmaceutical in%ention/ commercial )rand name/ industrial design/ dataprotection2 as well as all mechanisms and procedures to ensurenot granting %isa for I9 %iolated drugs (Pharma Group)

Answer"T&e 0AV already &ad some oEcial meetings it& t&e $F"Pto clari!y aut&orities and res'onsibilities beteen to oEces anddiscussed solutions to resol)e "P matters in '&armaceutical. Accordingly>T&e go)ernment assigns "P administration to ;inistry o! in!ormation andcommunications @national oEce o! Co'yrig&ts and ;inistry o! science andtec&nology @ national oEce o! intellectual 'ro'erty o! Vietnam

6 0ra!t o! ne drug registration regulation regulated com'aniesneed to ta*e res'onsibilities t&emsel)es in related it& "P @industrialdesign> brand name> in)ention. W&en dis'utes occur> T&e 0AV ill 'unis&)iolations based on our res'onsibilities a!ter &a)ing conclusions !rom

aut&orities suc& as it&draal o! )isa numbers> mar*et sus'ending ect.6 0ra!t o! ne drug registration regulation could be re)ised to not

reBuire c&ec*ing o! industrial design/brand name/in)ention. Com'anies

"rug #dministration of Vietnam $ 1% 'i(ng V), H* +i $ -el. 0 !%66&% $ Fa. 0 &%!&


5/23


can submit c&ec*ing document (ust !or in!ormation so as to su''ort t&e0AV in monitoring and coo'erating it& t&e $F"P and related aut&orities i!needed.

T&e ;F# encourage '&armaceutical com'anies to study t&oroug&lyall "P regulations be!ore mar*eting t&eirs 'roducts so as to a)oid damage&en !ound to be criminals.

13. Decision 'o. ;?#;;3? Q@+BT regulates procedures related todata protection in drug registration dossiers are completeldierent from practices and procedures in other countriesappling this regulation America/ (2. In the future/ whether the=>H?the DAV will re%ise this law to match with internationalregulation and when, ( Pharma Group)

Answer" 0ata 'rotection regulation in drug registration dossiers isone o! com'ulsory conditions t&at &el' Vietnam to settle multilateral

negotiation &en (oining WTF. W&en dra!ting t&is regulation> t&e ;F#already consulted many s'ecialists in related ,elds and negotiatorsagreed it& t&e regulationDs content.

America and %? are de)elo'ed countries. T&eirs la and data'rotection regulation in drug registration dossiers are suitable it&economic conditions and societies. T&e ;F# is illing to learn use!ul'oints and a''ly t&em in Vietnam> &oe)er not all articles are a''ro'riateit& VietnamDs s'eci,c conditions.

"n accordance it& social de)elo'ment and Vietnam'&armaceutical> data 'rotection regulation in drug registration dossiers

must be amended to be a''ro'riate during eac& 'eriod.

14. 9lease inform in details all procedures applied and to )eapplied to ensure the DAV do not grant %isa num)ers for genericproducts which %iolate data protection and e t&e 0AV ill build u' andissue t&e 'rocedures o! e)aluating drug registration dossiers it& data'rotection and generic dossiers containing 'rotected acti)e ingredients

Regarding exclusi)e in)ention> Please re!er to Buestion $o. 2.

16. 9harma :roup highl appreciates the go%ernmentEs decisions

and eorts of the =>H/ the DAV in o%erall proFects andde%elopment strategies as well as impro%e capacit of thepharmaceutical industr. ased on related legal documents/is

"rug #dministration of Vietnam $ 1% 'i(ng V), H* +i $ -el. 0 !%66&% $ Fa. 0 &%!&


6/23


there speci*c plan of the =>H?the DAV to administer and ensurehigh 7ualit of generic products through some mechanismincluding )io+e7ui%elence data re7uirement in drug registrationdossiers , ( Pharma Group)

Answer"T&e ;F# are 'lanning to build u' and issue list o! acti)eingredients and dosage !orms &ic& are com'ulsory to test 7A/7% be!oregranting )isa numbers and t&e '&ase6in 'rocesses. T&e 'rinci'le to buildu' t&is list is included in t&e meeting documents> 'lease ma*e yourcomments.

18. 'ew Chemical (ntities 'C(Gs2 allowed to mar$et ) drugadministrations li$e DA or (=(A usuall possess enoughdocuments/ %ariet of research and clinical data Hence/ we worra)out clinical trial re7uirement in Vietnam in regards with newdrug which not et mar$eted enough 0 ears in origin countries.

9lease e t&ey are still e)aluated based on're)ious la and are normally 'rocessed more t&an 23 mont&s. Mor t&at!orm submitted !rom 42/4:/344 e)aluated in accordance it& ne "P la



7/23


are mostly 'rocessed it&in 23 mont&s=. T&e 0AV ill consider drugregistration dossiers based on letter $o. 2 training courses onACT0 and Guidelines on drug stability studies ere organied and early344:> training courses on 7A/7% studies ere also &eld. "t is 'laned t&at assoon as t&e ne regulation on drug registration is issued> t&e 0AV s&all

&old a series o! training courses to instruct enter'rises &o to com'ly it&ACT0 and AS%A$ tec&nical guidelines.

##. hall the DAV accept )rac$eting and matriexem'tion cases and exem'tion o! some '&ases a''lied it& ne drugs.

T&ese agencies s&all or* out a co6ordination sc&eme and 'rocedures tore)ie clinical trial reBuirements in Vietnam !or registration o! ne drugsand s&all submit t&e ;o#Ds leaders !or a''ro)al.

"rug #dministration of Vietnam $ 1% 'i(ng V), H* +i $ -el. 0 !%66&% $ Fa. 0 &%!& !


8/23


#-. hall the =oH impro%e the consistenc in terms of technicalrecommendations and re7uirements of Drug !e%iewCommittee?Drug (%aluation Committee to drug registrationapplications, (Pf"er).

Answer"T&e 0AV s&all issue t&e ;anual on 0rug Registration &ic&contains all s'eci,c instruction to assist com'anies to 're'are t&eir drugregistration dossiers 'ro'erly and to enable drug e)aluators maintain t&eirconsistency in t&eir tec&nical recommendations. T&e 0AV also s&all &old aconsultation it& drug e)aluators to discuss t&is issue.

#0. There should )e a clear stipulation on Kdrug 7ualit controlre7uirementL during the drug registration process. It is proposedthat this re7uirement is either limited or replaced ) increaseddrug 7ualit inspections while drugs are in circulation process

(Pf"er).Answer"T&e 0AV does not reBuire t&e submission o! t&e result o!

drug Buality control tests to t&e ;o#Ds designated 0QC institutes &endrug registration dossiers are being e)aluated. #oe)er> in case any drugBuality control met&ods are !ound not !easible> t&e 0AV may 'ro'oset&ose institutes to e)aluate t&em. At 'resent> t&e 0AV is de)elo'ing SFP!or reBuirement o! drug Buality s'eci,cations e)aluation a''lied it& drugregistration a''lications ,led at t&e 0AV.

#3. or some specialied drugs such as anti+cancer drugs/ thecost for such e%aluation including the pro%ision of -; )ottles ofdrugs to the designated DQC institute ma amount to V'D 10;million. This high e 0ecree :3/344/$56CP 'ro)iding detailedinstructions on Ha o! Commerce sti'ulates t&e o'eration o!

re'resentati)e oEces> aEliates o! !oreign legal entities in Vietnam as!ollos- "n case an aEliate o'erating in t&e ,elds reBuired to meet certainconditions as set by las> t&at aEliate s&all be entitled to o'erate only

"rug #dministration of Vietnam $ 1% 'i(ng V), H* +i $ -el. 0 !%66&% $ Fa. 0 &%!& &


9/23


&en all t&ose conditions are !ully met. "n addition> according to Article29> t&e P&armaceutical la- %nter'rises engaging in t&e im'ort6ex'ort o!drugs s&all com'ly it& GSPs.

"n accordance it& Resolution $o :/344/Q#22 o! $ationalAssembly dated $o)ember 3Lt&> 344 rati!ying Protocol on VietnamDsaccession to WTF and t&e 0ecision $o 24/344:/Q567T; dated ;ay 32st>

344: o! t&e Commerce ;inister declaring t&e roadma' !or goods tradingand acti)ities directly related to goods trading> in '&armaceutical ,eld>!rom 42/42/344L> 244J oned !oreign com'anies> (oint6)enturesbeteen a !oreign in)estor and a local in)estor s&all be entitled to im'ortdrugs @exce't Clusters 1443> 144+ and 144 "m'ort6%x'ort Tax "ndex.

#oe)er> in all cases> drugs s&all &a)e to be stored in a 'ro'erconditions. T&ere!ore> t&e ;o# s&all 'ro)ide s'eci,c instructions later toensure t&e 'ractical im'lementation !easible.

#. 5hen shall the =oH issue regulations guiding the

esta)lishment of aJliates of foreign companies operating inpharmaceutical *eld in Vietnam, (#ue$$i! Pharma.

Answer"T&e establis&ment and registration o! aEliates o! !oreigncom'anies o'erating in '&armaceutical ,eld in Vietnam s&all com'ly it&0ecree :3/344/$56CP dated Kuly 3+t&> 344: o! t&e Go)ernment 'ro)idingdetailed instructions on Ha o! Commerce sti'ulates t&e o'eration o!re'resentati)e oEces> aEliates o! !oreign legal entities in Vietnam0ecree 99/344/$06CP dated 3L/9/344 concerning business registrationand tec&nical conditions !olloing t&e P&armaceutical la 0ecree:L/344/$56CP dated 4L/9/344 and ot&er '&armaceutical regulations. "n

3449> t&e ;o# s&all issue s'eci,c guidelines on business conditionsreBuired !or aEliates o! !oreign entities in Vietnam corres'onding it&business !orms Vietnam &as committed to o'en.

. Timeline for e%aluation of import orders of unregistered drugsshould )e shortened to ; das in cases where there isac$nowledgement note of *ling drug registration dossiersM thereis urgent needs from hospitals (Sanof Aventis% &urocham% PharmaGroup).

Answer- T&e current sti'ulation on re)ie and !eedbac* to im'ortorders o! unregistered drugs is not more t&an 34 or*ing days. "n s'ecial

cases suc& as drug im'ort !or e'idemics and calamities> t&e ;o# s&all'rioritie to s&orten t&e re)ie.

-. The =oH should consider to re%ise or amend stipulations onimport/ e


10/23


Answer" T&e ;o# s&all &old consultation it& t&e Tec&nicalCommittee and s&all consider t&is sti'ulation into t&e coming re)isedCircular on im'ort> ex'ort o! drugs.

0. It is proposed that the =oH consider pressing issues related to

licensing of foreign companies operating in pharmaceutical *eldin Vietnam &urocham% Pharma Group).

Answer" T&e ;o# s&all consider t&ese issues &en re)ising t&eCircular guiding t&e registration o! !oreign com'anies o'erating in'&armaceutical ,eld in Vietnam.

3. rom ;1?;1?#;;8/ is .raun Hanoi 9harmaceutical NimitedCompan is entitled to import and distri)ute drugs ,

Answer- According to t&e 0ecision $o 24/344:/Q567T; dated32/4+/344: o! t&e Commerce ;inister> !rom 42/42/344L> 244J !oreign

oned com'anies> (oint6)entures beteen a !oreign in)estor and a localin)estor are entitled to im'ort drugs @exce't Cluster 1443> 144+ and1446 "m'ort %x'ort Tax "ndex but not entitled to distribute drugs.

7.7raun #anoi P&armaceutical Himited Com'any is !oreign in)estedcom'any t&us it is not entitled to distribute drugs exce't t&e &olesale o!t&eir 'roducts and entitled to im'ort drugs &en !ully meeting conditionslaid don in t&e related existing regulations.

III+ Drug Qualit management

1. or fa$e drugs/ drugs %iolating intellectual propert rights/smuggled drugs/ it is proposed that there should )e trainingcourses organied for pharmacies/ medical doctors and patientsso as to impro%e their awareness on these products. There shouldalso )e a more se%ere punishment on %iolators and the co+operation )etween competent authorities and manufacturers soas to enforce the decisions related to recall/ disposal andreporting re7uirements of these productsM inspections intosources of %iolations etc. (#ue$$i! Pharma).

Answer" T&e 0AV ac*noledges t&is recommendation and s&allinitiate )arious measures to im'ro)e &ealt&care 'ro!essionalsD *noledge

on !a*e> smuggled drugs and drugs )iolating intellectual 'ro'erty rig&ts>including t&e direct instructions gi)en to 'eo'le or*ing at 'ro)incial&ealt& bureaus.

Any acts concerning trading !a*e> smuggled drugs> 'ro&ibited drugsi! !allen into t&e categories o! criminal acts s&all be sub(ect to Article 2+62+: o! t&e Criminal Ha> ot&erise> t&ey ill be treated according to t&e0ecree


11/23


com'etent aut&orities in t&is regard> a mec&anism to collect in!ormation!rom enter'rises> &ealt&care 'ro!essionals and t&e 'eo'le. "t is 'lannedt&at a regulation s'eci!ying t&e or*ing rules o! Committee s&all be soonissued.

A concerted solution in &ic& t&e collaboration among ministries>sectors and t&e com'letion o! related legal !rameor* are needed. At'resent> t&e ;o# &as been initiating consistently GPs > mamu!acture>Buality control> storage> distribution o! drugs to end6users so as to ensurea com're&ensi)e Buality management i.e. drugs are 'urc&ased !romaut&oried dealers> Buality o! drugs are assured by using t&e Bualitymanagement system drug in!ormation is 'ro)ided timely to managersand drug users etc.

#a)ing im'lemented t&e anti6!a*e drug 'rogram initiated by W#Ft&roug& ";PACT establis&ment> t&e 0AV &as de)elo'ed a co6ordinatingand re'orting mec&anism it& local com'etent aut&orities suc& as 'olice>borderline army guards> mar*et control !orces and customs as ell as

international organiation @W#F> "nter'ol.. to en&ance t&e anti6!a*e>smuggled drug acti)ities.

#. 9ls. $indl e


12/23


statements not refecting true nature o! drugs> unclear> &a)ing intent tocom'are it& ot&er drugs s&all not be alloed !or ad)ertisement.

#. !ecentl/ it ta$es longer time to e%aluate an application ofdrug promotion and companies then recei%e onl an

ac$nowledgement note after ha%ing *nal appro%al from the DAV.5e propose the DAV to re%iew these e%aluation andac$nowledgment procedures (&urocham).

Answer"?nder t&e regulation on drug in!ormation and 'romotion>it&in 2+ days since t&e date o! rece'tion o! !ull a''lication @incld. t&e'ayment o! !ee> t&e 0AV &as to gi)e !eedbac* to t&e a''licants. #oe)er>in many cases> a''lications are not 'ro'erly submitted> !or instances> lac*o! a''ro)ed 'ac*age insert> o! aut&oriation letter or !ee is not 'aid etc..t&en t&e 0AV &as to ait !or com'anies to 'ro)ide su''lement documentsuntil it is !ully acce'ted. Mor t&ose a''lications &ic& are correctly

submitted> t&e 0AV alays 'ro)ide !eedbac*s it&in 2+ or*ing days.So as to 're)ent t&e cases in &ic& com'anies may abuse t&e

ac*noledgement note to conduct t&e ad)ertisement acti)ities it&out'ro)iding su''lementary documents as reBuired> t&e 0AV do notimmediately issue t&at ac*noledgement note at t&e time o! a''licationrece'tion but only a!ter t&e su''lementation is com'leted. #oe)er> t&edate on t&e ac*noledgement note remains t&e date o! !ull and correcta''lication submission.

. It is )etter that the DAV pro%ides speci*c and clear instructionson what to a%oid when comparing one drug with another insteadof prohi)ition. (Eurocham).

Answer- According to t&e 0ecree $o 3 3441 o! t&e Go)ernment 'ro)iding detailed sti'ulations on t&eim'lementation o! t&e Ad)ertisement Frdinance> any ad)ertisement it&intent to disgrace> com'are or cause con!usions it& 'roducts or ser)iceso! ot&er manu!acturers> traders s&all be 'ro&ibited.

-. The %alidit of an ad%ertisement permit should )e longer than

the current stipulation. In case the content of an ad%ertisementremains unchanged/ the %alidit of an ad%ertisement permitshould )e as long as the %isa of drug registration or tillcompanies appl for an updating of the pac$age insert or whencompanies wish to change the appro%ed ad%ertisement content.&urocham)

A- T&e 0AV s&all consider t&is 'ro'osal.

0. rgent reports should onl )e applied in cases of local

occurrence of se%ere ad%erse e%ents/ not applied for unintended/not se%ere ad%erse e%ents happening outside Vietnam



13/23


Answer"T&e A0R re'orting reBuired !or '&armaceutical com'anies&as been initiated in Vietnam since 344. A!ter 2 year o! im'lementation>t&e 0AV s&all re)ie and correct related 'roblems so t&at t&ese acti)itiescan be eecti)ely conducted. ?nder t&e current regulation> t&e sco'e o!urgent re'orts are se)ere ad)erse e)ents occur in t&e territory o! Vietnamunintended ad)erse e)ents &a''ening eit&er in Vietnam or o)erseas.

3. Annual AD! reporting should onl )e applied with new

chemical entities 'C(2 whose circulating period in Vietnam is

less than 0 ears. or drugs whose circulating period is o%er 0

ears/ the AD! reporting should )e done in e%er +0 ears.

Answer- Com'anies may not !ully undertand t&e 0AV reBuirementsconcerning A0R re'orting. "t s&ould be a summaried ad)erse rections o!drugs 'roduced or registered or distributed by com'anies> not a PS?R.PS?R s&ould be a''lied it& ne drugs introduced into t&e mar*et lesst&an + years. According to t&e current regulation> regular re'orting isa''lied !or any A0Rs &ic& do not !all into t&e category o! urgentre'orting @recorded !rom 2/2 to 12/23 o! t&e year. Com'anies arereBuired to re'ort once a year> latest on Kanuary 3+t& o! t&e coming year.

4. The DAV should ha%e annual reports on num)ers and sourcesof AD! reports collected from medical doctors/ manufacturersetc..2 so as to encourge medical doctors and manufacturers toreport. At the same time/ there should )e studies on reasons wh

more reports collected from one place than the other so thattimel and necessar inter%entions can )e ta$en.

Answer- Molloing t&e 0ecision 2+ t&e 0AV is de)elo'ingto 'ro(ects in &ic& to national drug in!ormation and A0R monitoringcenters s&all be establs&ed. T&e 0AV t&en can ta*e t&is recommendationsinto consideration.

6. How do the DAV manage and analse information collectedfrom AD! reports,

Answer"T&e 0AV de)elo'ed SFP on t&e collection and 'roceedingod A0R re'orts . Mor !urt&er in!ormation> com'anies may )isit t&is SFP ont&e 0AVDs ebsite.

8. 9harmaco%igilance" There are cases in which companies ha%einformed the DAV/ through sending KDear Doctor NetterLcirculated in America/ with the aim to help medical doctors $nowa)out the new warnings/ precautions and contraindications of acertain drug. In response to this/ the DAV re7uired companies toappl for a updating of pac$age insert at the Drug registration

di%ision as well as to su)mit a new pac$age insert. It is proposedthat information to medical doctors through KDear Doctor NetterL)e accepted for the sa$e of patientEs safet.

"rug #dministration of Vietnam $ 1% 'i(ng V), H* +i $ -el. 0 !%66&% $ Fa. 0 &%!& 1%


14/23


Answer" A!ter &a)ing recei)ed 0ear 0octor Hetter= !romcom'anies> t&e 0AV are alays illing to allo com'anies to !orardt&ese letter to medical doctors and at t&e same time 'roceed to oEciallyu'date t&eir 'ac*age insert !or t&e 'roduct. T&e 0AV do not reBuestcom'anies to get a''ro)al !rom t&e 0rug registration di)ision !orc&anging 'ac*age insert be!ore !orarding t&e letter to medical doctors.

V+ D!: 9!IC( =A'A:(=('T

('he uestions raised y participants ho attended the *orei!n+ompanies +onerence on ,/00,,1 and the to Seminars on

promu$!atin! the 2oint +ircu$ar No. //0,,1''L'- 34'- 3'+- 3+' he$d in5anoi and in 5o +hi 6inh city and its ansers)

1. Are the intended wholesale prices reported ) enterprises thedirect wholesale prices of its enterprises or the wholesale pricefor the entire wholesale sstem,

In case of the wholesale price for the entire wholesale sstem/ onwhat )asis can the importing enterprises determine the intendedwholesale price,. (7ietnam 6edica$ Import 8 &9port 2oint Stoc:+ompany% the ;a:n


15/23


report of drug price must )e implemented ) importingcompanies,. 7ietnam 6edica$ Import 8 &9port 2oint Stoc: +ompany)

Answers" "n case o! increase in t&e C"M 'rice @according to Vietnamdong due to c&ange in t&e !oreign currency rate resulting in increasing int&e &olesale 'rice com'ared to t&e re'orted 'rice> im'orting !acilitiesare res'onsible !or t&eir re6re'orting 'rice.

-. It is not clear in the point .1/ item / column I of the Circularas it is stipulated that drug trading companies themsel%esdetermine their productsE prices and compete for price,. (5anoi5ea$th 3ureau)

Answer" Trading com'anies &o determine t&emsel)es t&eir'roductsD 'rices and com'ete !or 'rice ex'ressed trans'arency indetermining t&emsel)es t&eir'roductsD 'rices in t&e !orm o! re'orting/re6re'orting and 'osting u' 'rices.

State regulatory aut&orities in drug 'rices @t&e 0AV or #ealt& 7ureausdo not carry out t&e a''ro)al !or 'rices re'orted or re6re'orted by!acilities> &en re'orted and re6re'orted drug 'rices are !ound to beina''ro'riate> t&e 0AV or #ealt& 7ureaus s&all send !eedbac* in ritingand as*ed t&em to clari!y it& regard to t&e re6re'orted drug 'rices.

0. Are drug prices re+reported ) locall manufacturingcompanies at Health ureaus applied nationwide, 5hen re+reported drug prices are found to )e appropriate/ do Healthureaus con*rm this in writing, (5anoi 5ea$th 3ureau% 3inh =inh

medica$ euipment and pharmaceutica$ >oint-stoc: company% #ue$$i!Pharma)

Answer"#ealt& 7ureaus are res'onsible !or re6re'orted drug 'riceso! manu!acturing com'anies located in t&eir areas and a''ro'riately re6re'orted drug 'rices are a''lied nationide.

According to t&e sti'ulations at t&e section b> 'oint 1.3> item 1>column "" o! t&e Koint Circular $o. 22/344:/TTHT6 78T67TC6 7CT- it&in 2:or*ing days since t&e date o! recei)ing dossiers o! re6re'orting drug'rices> i! it is !ound t&at re'orted drug 'rices are ina''ro'riate t&e 0AV or#ealt& 7ureaus s&all send !eedbac* in riting and as*ed t&em to clari!y

it& regard to t&e re6re'orted drug 'rices=."n case o! a''ro'riate drug 'rice re6re'orting> t&ere is no !eedbac*

in riting according to t&e sti'ulations at t&e 'oint 1. item 1> column ""-State regulatory aut&orities in drug 'rices @t&e 0AV and #ealt& 7ureauss&all be res'onsible !or e)aluating a''ro'riateness o! drug 'rices ands&all not carry out a''ro)al !or drug 'rices re'orted and re6re'orted bycom'anies=.

3. Are drug trading companies or regulator authoritiesresponsi)le for announcing reported drug prices. The forms of

announcement, (5ea$th 3ureaus o 5anoi% An Gian!% Phu 4en and Lon!An)



16/23


Answer"According to t&e section c> 'oint 1.+> item 1> column "" o!t&e Circular $o.22/344:/TTHT6 78T67TC6 7CT> it is sti'ulated t&at im'ortingcom'anies> locally manu!acturing com'anies must 'ro)ide t&eircustomers it& in!ormation on )alid intended &olesale 'rices &ic& arere'orted and re6re'orted in t&e !orm o! ritten announcement or recei't=

According to t&e 'oint 1.3> item 1> column V" o! t&e Circular $o.

22/344:/TTHT6 78T67TC6 7CT> it is sti'ulated t&at T&e 0AV is aut&oried byt&e ;inistry o! #ealt& to u'date and 'ublis& drug 'rices re'orted and re6re'orted by com'anies on t&e 0AV s ebsite> in t&e s'ecialist magainesand ot&er a''ro'riate mass media=.

"n order to enable t&e 0AV to u'date drug 'rices o! locallymanu!acturing com'anies> it is sti'ulated in t&e 'oint 1.> item 1> Column"" o! t&e Koint Circular $o. 22/344:/TTHT6 78T67TC6 7CT t&at Prior to t&e24t&o! eac& mont&> #ealt& 7ureaus s&all re'ort t&e situation o! drug 'ricere6re'orting o! locally manu!acturing com'anies located in t&eir areas tot&e ;inistry o! #ealt& @t&e 0AV in riting and by email @email-

Buanlygiat&uocmo&.go).)n=

4. 5h isnEt the document 'o. #01-?BT+ QND dated 18?-?#;;4 onguiding temporaril drug price re+reporting a)olished in the PointCircular 'o. 11?#;;4?TTNT+ BT+TC+ C, (5anoi 5ea$th 3ureau)

Answer" According to t&e item 2> t&e column V"" o! t&e Koint Circular$o. 22/344:/TTHT6 78T67TC6 7CT> it is sti'ulated t&at T&is Circular s&allta*e eect a!ter 2+ days since t&e day o! 'ublication in t&e Gaette andre'lace t&e Koint Circular $o. 49/3441/TTHT/78T6 7TC dated 3+/:/3441 onguiding t&e 'rice re'orting o! 're)enti)e and curati)e drugs used on&umans. All 're)ious 'ro)isions on state management o! drug 'rice &ic&are inconsistent it& t&is Circular are re'ealed=.

According to t&e document $o. 3+2 ect.> com'anies s&all be as*ed to ex'lain and'ro)ide rele)ant documents concerning t&is c&ange.

"n case com'anies do not 'ro)ide t&e Koint or*ing grou' it&rele)ant documents to enble t&em to examine drug 'rices at locals andt&ey unilaterally ad(ust an increase in drug 'rices in t&e mar*et> #ealt&7ureaus s&all reBuest t&e ;inistry o! #ealt& @0AV to deal it& case in

com'liance it& t&e section d> 'oint 1.3> item 1> column "" o! t&e KointCircular $o.22/344:/TTHT6 78T67TC6 7CT.

mailto:[email protected]:[email protected]


17/23


8. The update of reported wholesale/ retail and successfull )iddrug prices within 1# months in the DAV s we)site remains not to)e timel causing diJcult in )uilding )idding pac$age prices of)idding plans in pro%inces,. ('he 5ea$th 3ureaus o 5anoi% Phu 4enand Gia Lai)

Answer"To date> t&e 0AV &as 'ublis&ed 'rices o! success!ully bid

drugs !or t&e year 344 o! &os'itals/ institutes it& beds directly undert&e ;F# and it is sti'ulated in t&e 'oint b> item 3> column "" o! t&e KointCircular $o. 24/344:/TTHT6 78T6 7TC6 7CT &en establis&ments set u'bidding 'lans> t&ey s&all re!er to success!ully bid drug 'rices it&in're)ious 23 mont&s o! 'ublic &ealt& com'anies u'dated by t&e 0AV in t&e&ealt&care s ebsite @t&e 0AV s ebsite .

"n Kanuary 3449> t&e 0AV ill 'ublis& success!ully bid drug 'rices in344: o! &os'itals a!ter recei)ing all success!ully bid drug 'rice re'orts o!344: !rom &os'itals/institutes it& beds directly under t&e ;F# and'ro)incial &os'itals.

Pre)iously> t&e 0AV did not u'date &olesale and retail 'ricesre'orted/re6re'orted by trading com'anies due to lac* o! legal basis ont&e a''ro'riateness o! re'orted/re6re'orted drug 'rices. W&en t&e KointCircular $o.22/344:/TTHT6 78T67TC6 7CT ta*es eect !rom 2+/24/344:>&olesale and retail 'rices re'orted/re6re'orted/ re'orted su''lementaryby trading com'anies ill be u'dated in t&e 0AV s ebsite a!ter t&eira''ro'riateness is examined.

1;. Why isnt retail surplus provisioned? (Phu 4en 5ea$th 3ureau)

Answer"According to t&e 'oint 1> Article 22> C&a'ter """ o! t&e

0ecree $o. :L/344/$56 CP 'rescribing t&e execution o! t&eP&armaceutical Ha> it is sti'ulated t&at retail com'anies only 'ost u'retail 'rices and do not sell it& 'rices &ig&er t&an t&eir 'osted 'rices.

"n reality> retail 'rices remain com'etiti)e among +44 retailcom'anies nationide> t&e Koint Circular $o 22/344:/TTHT6 78T67TC6 7CTdoes not 'rescribe retail 'rice sur'lus.

T&e retail 'rice is constituted o! &olesale 'rices N costsN 'ro,t in&ic& &olesale 'rices are considered it& regard to t&e a''ro'riatenessand consistency !or t&e entire &olesale system.

11. The update of reported wholesale and retail prices in the DAVs we)site is not timel resulting in diJculties in inspecting drugprice management at locals, ( Phu 4en 5ea$th 3ureau)

Answer" According to t&e section c> 'oint 1.+> item 1> column "" o!t&e Circular $o. 22/344:/TTHT6 78T67TC6 7CT> it is sti'ulated t&at 0rugim'orting com'anies> locally manu!acturing !acilities must 'ro)ide t&eircustomers it& in!ormation on )alid intended &olesale 'rices re'orted> re6re'orted by com'anies in t&e !orm o! ritten announcement or recei'tDD>&ic& based on t&at #ealt& 7ureaus may carry out ins'ection o! drug'rices in t&eir areas besides re'orted &olesale and retail 'rices u'datedin t&e 0AV s ebsite.

"rug #dministration of Vietnam $ 1% 'i(ng V), H* +i $ -el. 0 !%66&% $ Fa. 0 &%!& 1!


18/23


1#. The )asis to e #ealt& 7ureaus are entitled to as* tradingcom'anies to 'ro)ide as according to t&e 'oint 3.3> item 3> column "" o!t&e Koint Circular $o. 22/344:/TTHT6 78T67TC6 7CT it is sti'ulated t&at t&edossier o! re'orting drug 'rices s&all be set u' in to sets- 42 set is ,ledat t&e 0AV and anot&er is ,led at its trading !acility.

"n addition> anot&er is to base on t&e guidance as sti'ulated at t&esection c> 'oint 1.3> item 1> column "" o! t&e Koint Circular $o.22/344:/TTHT6 78T67TC6 7CT- @2 Mluctuation o! in'ut costs suc& asmaterials @3 costs o! drug circulation and 'roduction is s'eci,ed

according to t&e !olloing documents-0ecision $o.4/3441/Q56 7TC dated 29/2/344+ on t&e issuance o!

t&e regulation on 'ricing assets> goods and ser)ice.

0ecree $o.22/344+/$56 CP dated 2L/+/344+ on s'eci!ying t&eim'lementation o! some articles o! t&e Ha on Com'etition.

Circular $o.21


19/23


Mor 'rices to be ad(usted &ig&er t&an t&eir initial 'rices- to re6re'ortdrug 'rices.

Wit& regard to domestic drugs> in case o! su''lementary re'ortingand increase in 'rices> *ee' noted t&at locally manu!acturing com'aniesonly submit 0ossiers o! re6re'orting to #ealt& 7ureaus not t&e 0AV.

10. How does the DAV carry out inspection of dru prices? (?a$e*arma)

Answer" 0ug 'rice management is t&e res'onsibility o! dierent;inistries and sectors in &ic& t&e Koint ;inistry o! #ealt& Minance Commerce "ndustry are t&e *ey.

According to t&e guidance on ins'ecting drug 'rices o! t&e Circular$o. 22/344:/TTHT6 78T6 7TC6 7CT

Trading com'anies t&emsel)es re'ort and re6re'ort drug 'ricesbased on 'roduction> im'ort and trans'ort costs> ect... and t&e Kointor*ing grou' including t&e ;inistry o! #ealt& and t&e ;inistry o! Minanceconsiders t&is drug 'rice re'orting and re6re'orting.

;anagement o! &olesale 'rices !or t&e entire &olesale system

"n coordination it& rele)ant units to carry out ins'ection o! t&eim'lementation o! state management o! drug 'rices at trading com'aniesand treatment and examination !acilities.

13. In case a dossier is su)mitted %ia email/ another cop must )esent in hardcop ( #ue$$i! Pharma)

Answer"According to t&e Koint Circular $o.22/344:/TTHT6 78T67TC67CT> trading com'anies submit dossiers o! re'orting and re6re'orting drug'rices in &ard co'y.

A'art !rom 42 dossier sent in &ardco'y trading com'anies mustsubmit anot&er co'y by email !or 'ro'er examination o! re'orting and re6re'orting drug 'rices to a)oid infuence on trading acti)ities o! trading!acilities.

14. How can trading companies $now when the DAV recei%edossiers of re+reporting drug prices in case of su)mitting in hardcop and %ia email so as to ena)le facilities adFust prices after 14das , ( #ue$$i! Pharma)

Answer" "n case o! direct submission t&e 0AV ill 'ro)ide recei'ts!or dossiers o! re'orting and re6re'orting drug 'rices.

"n case o! submitting by 'ost> trading com'anies contact t&e 0AV to*no t&e date o! recei)ing dossiers or t&e a''ro'riateness o! dossiers.

16. If price adFustment is caused ) the change in import ta< orVAT which companies onl $now when the perform customsprocedures to recei%e their goods2 companies can carr outimmediate sale with reported?re+reported prices plus new ta< ratewithout waiting for 14 das after su)mission of price re+reportingdossiers. The reasons" increase in prices caused ) a change in

ta< rate/ in case of waiting for 14 das after su)missioncompanies will )e incurred losses caused ) e


20/23


Answer""n 'rinci'le> &en re'orted or re6re'orted &olesale 'ricesare ad(usted im'orting com'anies 'er!orm re6re'orting according to t&eguidance at t&e item 3> column "" o! t&e Koint Circular $o.22/344:/TTHT678T67TC6 7CT.

T&e ad(ustment is caused by state 'olicies on tax> im'ortingcom'anies need to announce t&e 0AV soon

T&e 0AV ill deal it& t&is as !ollos-

Wor*ing it& rele)ant aut&orities @Tax and Customs aut&orities toassist com'anies in case o! incorrect a''lication o! tax rate.

T&e 0AV ill as* t&e (oint or*ing grou' to consider drug 'ricere'orting and re6re'orting.

#oe)er &en tax rate decreases trading com'anies need to ad(usta decrease in 'rices and announce t&e 0AV.

18. 5e would li$e to as$ the DAV to let us $now when the list of

regional countries will )e pu)lished for price reference in case ofsupplementar reporting or re+reporting. If companies do not selldrugs in the mar$et of countries in that list/ are the a)le todeclare prices of other countries, (#ue$$i! Pharma% =iethei$m 7i@tNam)

Answer" W&ile t&e (oint ;inistry o! #ealt&6Minance6Commerce"ndustry is ,naliing t&e list !or 'rice re!erence. Trading com'anies carryout re'orting and re6re'orting o! drug 'rices as usual. A!ter issuance>trading !acilities ill add in!ormation on C"M 'rices in t&eir dossiers o!re'orting/re6re'orting drug 'rices.

"n case com'anies do not sell drugs in some regional countries int&e list> t&ey ill &a)e to commit to be res'onsible !or lac* o! realin!ormation on C"M 'rices o! t&eir drugs.

Com'anies can announce C"M 'rices o! t&eir drugs in ot&er countries!or 0AV s re!erence.

#;. Can companies use wholesale prices used for distri)utors ofcountries in the list instead of CI prices, The reasons"multinational pharmaceutical companies in man countries ha%e)ranches and are allowed to trade drugs/ so the import price is

their internal price/ ma)e > price/ not commercial CI price. InVietnam/ CI prices consist of mar$eting e


21/23


T&e C"M 'rice U MF7 'rice N t&e trans'ort costs !rom t&e ex'ortingcountry to a Vietnam s 'ort N t&e insurance c&arges

T&e re'orting o! C"M 'rices according to t&e guidance o! t&e KointCircular $o.22/344:/TTHT6 78T67TC6 7CT is 'rescribed at t&e Article 24 o!0ecree $o.:L/344/$56 CP dated L/9/344: s'eci!ying t&e execution o!some Articles o! t&e P&armaceutical Ha.

W&olesale 'rices o! countries !or 'rice re!erence sometimes do notrefect t&e actual )alue o! drugs because &olesale 'rices are aected byt&eir &ealt&care and commercial conditions suc& as t&e 'olicy o! 'ricesu''ort and im'ort tax> ect.

;oreo)er> !oreign manu!acturing com'anies are not alloed to carryout direct drug distribution in Vietnam> t&ere!ore> drug 'rice re'orting isres'onsibility o! Vietnamese im'orting com'anies.

#1. According to the Point Circular 'o. 11?#;;4?TTNT+ BT+TC+ CT/

the orm 'o. 1+ :T Drug !eporting heet2 and the form 'o.3+ :TDrug !e+reeporting heet2 used ) foreign manufacturingcompanies or companies authoried to register drugs/manufacturing companies and drug registering companies areas$ed to sign and stamp. In case manufactures carr outprocessing and contracting and are not in%ol%ed in trading/ is itenough if companies are as$ed to register with their name,(&urocham% Pharma!roup))

Answer" Com'anies aut&oried to register drugs> re'resentati)eoEces in Vietnam can sign !or !oreign manu!acturing !acilities i! t&ey areaut&oried to decide 'rice used in t&e Vietnam s mar*et.

. Questions as regards drug price management in the PointCircular 'o. 1;?#;;4?TTNT+ BT+ TC

1. etting up prices for )idding to purchase chemicals/ consumedmaterials )elongs to the scope of adFustment of the Point Circular'o.1;?#;;4?TTNT+ BT+ TC, (5ea$th 3ureau o 5 NBi% ;C:n


22/23


Answer" At 'resent> t&e 0AV &as u'dated success!ully bid 'rices o!&os'itals/institutes it& central beds in t&e 0AV s Website@&tt'-//.da).go).)n

"n case o! no 'rices o! drugs used in &os'itals at t&e 'ro)incial anddistrict le)el in t&e ebsite> during t&e time aiting !or 'ublication o!success!ully bid 'rices o! 'ro)incial/munici'al &os'itals> a'art !romin!ormation on success!ully bid 'rices at 'ublic medical !acilities u'datedby t&e 0AV at t&e latest ot&er c&annels on 'rices may be used to consult@2. T&e a)erage 'rices o! success!ully bid drugs in medical com'anies inits 'ro)inces and ot&er 'ro)inces @3. T&e a)erage drug 'rices in t&emar*et to set u' 'lanned 'rices to 'urc&ase drugs .

W&en trading com'anies 'artici'ate in drug bidding at &os'itals and'rices o! bidding drugs are not a)ailable in t&e 0AV s ebsite> tradingcom'anies are as*ed to commit t&at drug 'rices !or 'rocurement are not&ig&er t&an t&ose re'orted/re6re'orted at t&e 0AV or #ealt& 7ureau.

. Do traditional medicines/ her)al medicines sliced medicines/ali%e raw materials2 need )idding , ('he 5ea$th 3ureaus o An Gian!%Gia Lai% 'in Gian!% ?hnh 5o% SOc 'rCn! and Ninh 'huFn)

Answer" 0rugs sourced !rom &erbal materials @remedies> ect. needbidding.

-. How to deal with in case of no presence of contractors in a)idding pac$age or no proposal of )idding, ( 5ea$th 3ureau o;C:n


23/23


list o! main drugs used in examination and treatment com'anies issuedattac&ed it& 0ecision $o. 41/344+/Q56 78T dated 3

Documents

Q & a Foreign Companies-MoH 2007