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Drug Regulatory Affairs
Institute of Drug Regulatory AffairsFaculty of PharmacyUniversity of Szeged
§§
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Introduction• Tamás ! Paál" Professor • for #$ years% &ead of the &ungarian national com'etent drug
(human) regulatory authority• no* retired" +ut President of the Scientific ,oard of the
same authority• Also President of the &ungarian Pharmaco'oeia-ommission• .orld &ealth /rganization (.&/) e0'ert (1uality assurance"
drug regulatory affairs" her+al medicines" drug side effectsignal assessment)
• Drug Regulatory Affair field 'ro2ect e0'ertise (.&/ or 3U)%4icaragua" Uganda" Uz+e5istan" 6aza5hstan" Tur5menistan",osnia and &erzegovina
• /fficially visited 78 countries until no*
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.here are you from9
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Technical details
• The slides of the lectures *ill a''ear on theUniversity A4***!'harm!u:szeged!hu;gyfi;
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(
30am to'ics
• *ill +e 'resented at the end of anylecture to'ic
•4ot only to'ic titles> The Students *ill+e 'rovided also *ith the +ullet 'oints(su+to'ics they should deal *ith)
• An e0am'le is 'rovided on the ne0tslide
• As a rule" the e0am covers $:? to'ics
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E*a+&le ,$% the e*a+ t$&ics,asic elements of la*
S'ea5 a+out the definitions in a la*" then discuss thefollo*ing%
• la*• la*:ma5er (discuss various 'ossi+ilities in different
countries)• la* enforcing +odies;'ersons (name some of them)• sources of la* (+oth meanings)• different 'ieces of la*! as a rule" the ty'e of their
content" their hierarchy" *here are they 'roclaimed• *hat is @soft la*• *hat is @co:authority• @1uasi authorities (*hat is the @rigth for veto 9)
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.arning" B
In my lectures• drug• drug 'roduct• medicine• medicinal 'roduct• 'harmaceutical ('roduct)• are used as synonyms> (As a rule" @drug
a''ears on the slide for it is the shortest*ord>)
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.arning" #
In my lectures• drug" drug 'roduct" medicine" medicinal
'roduct" 'harmaceutical ('roduct)• means the one that is ready to ta5e +y or
administered to humans> (C Dosage:forms)• .hen I s'ea5 a+out drug su+stances " I use
the term active 'harmaceutical ingredient (API )
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F$%
0En lish is a , nn lan a e and di,,e%entc$ nt%ies and $% anisati$ns se di,,e%entte%+in$l$ ies s$+eti+es deli5e%atel '6
E7 7• D% 8 +edicinal &%$d ct
8 &ha%+ace tical &%$d ct9S FDA
WH!
E9 ,$%+e%EFTA
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Drug Regulatory Affairs.hat the hellthey are9
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Drug regulatory affairs
Any activity *ith drugs
,y *hom9 (the authority)
no (Cdoes not +elong todrug regulatory affairs)
yes
Prior authorisation needed9
,ased on *hich (o+2ectiveand su+2ective) criteria9
Su+2ect to regular control(1uality" ins'ection)9
,y *hom9 (the authority),ased on *hich (o+2ectiveand su+2ective) criteria9
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Activities *ith drugs=
• research (chemical" +iological)• clinical trials on human +eings
• manufacture• registration
; evaluation
; authorisation• (*holesale) distri+ution
c$ntin ed
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Activities *ith drugs (cont d)
• (retail) distri+ution• 'ricing• 'rescri+ing
• reim+ursement;su+sidy• advertising (if any)• s'ecial control (e!g! narcotics)
• 'ost:mar5eting surveillance ; national drug 1uality control la+ ; adverse effect re'orting system
• etc!
'o''y
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.here to find regulations9
• The so called @hard la* (Acts of Parliament"
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What t$ teach<
• It is so sim'le for" e!g! chemistry andtechnology they are the sameevery*here= (la* love9)
• It is also sim'le for the &ungarianundergraduates% the to'ic is the&ungarian;3U regulatory affairs
• ,ut you have come from (and return to)different countries *ith e1uallydifferent drug regulatory affairs=
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"%inci&les $, this c$ %se
• Teaching .orld &ealth /rganization(.&/ ) advised rules" they are universal
• Al*ays call the attention of thestudents to @that is *hat you shouldclarify *hen returning home
• Sho* 3uro'ean Union ( 3U ) and
&ungarian rules as e0am'les only
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Regulatory affairs=
/ur life is @regulated in manydifferent *ays continuously=
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= les $>e%nin $ % li,e'
c st$+?,ashi$nc$++$n c$ %tes
Ethical % les
&%$,essi$nal% les
ha%d la@
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= les $>e%nin $ % li,e'
• -ostum;fashion" common courtesy not al*ays*ritten" varies *ith the cultures greeting" (not) ta5ing man shat off" cutlery" rolls left:hand:side= +ut may+e serious% 'osition ofchildren;*omen is certain cultures
• 3thical rules in a given 'rofessional circle mainly*ritten 'artly sanctioned C @you are e0'ected to doyou are e0'ected to dothisthis 3thical -odes of Professional -ham+ers" of IndustryAssociations (e!g! on medical advertising)" &elsin5i Declarationof Physicians other*ise you are not acce'ted in the
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= les $>e%nin $ % li,e' $nt d
• = les $, the &%$,essi$n 0Cs$,t la@ 6as a % le: @%itten Cthis &%$,essi$nal 0e7 7&ha%+acist6 is e*&ected t$ d$ this 0in a i>ensit ati$n6 ; in case the $ %t tends t$,$ll$@ it in its decisi$ns
• 0Ha%d6 La@:en,$%cea5le# Ne ati>ea th$%it decisi$ns &$lice +eas %es $ %t s
d e+ent
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Ethical % les
"%$,essi$nal % les0s$,t la@6
0ha%d6 la@
st$+ ,ashi$n c$++$n c$ %tes
Hie%a%ch $, the % les'
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Hie%a%ch $, the +$st i+&$%tant&%$,essi$nal % les in H n a%
• Ha%d la@
• S$,t la@
• $nstit ti$n• Acts $, "a%lia+ent• G$>e%n+ental Dec%ee
• iniste% s Dec%ee• 0 nici&alit Dec%ee6
• +iniste%ial idelines
• +eth$d$l$ ical lette%s $, Nati$nal B$a%ds?Instit tes• scienti,ic lite%at %e
H I E = A = B H I
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A%e the%e $the% % les in $ %c$ nt% <
• Presidential Decree9• Royal Decree9
• -ommon ('recedent) la*9• Any other ty'e of @soft la* 9
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Royal ruling
• In some countries% traditional" insteadof @State 'resident (dinasties versuselected 'residents)! Also
• @*ea5 (only ceremonies)• @strong (admitted or hidden ruling)
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-ommon la*
• Anglo:sa0oon system% @ the 'recedentis +inding
• If a -ourt delivered a decision in acase% ; another (same level) -ourt ; in a similar case
; must deliver the same decision>• Thus" -ourt decisions are ta5en as
@la* (Ccommon la*)
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Drug regulatory affairs
-an +e taught in various *ays!!!
Simply thecontent of
the rule…
As for law
graduates...
/r=
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E>e% 5$d n$@s the ,$$t5all a+e 0at leastin H n a% 6 0e*ce&t the nati$nal c$ach#6
• Imagine a very good foot+all 'layer=• &is only 'ro+lem is that he does not
5no* the rules e!g! @ hands:off "@offside " etc!
• .hat is your o'inion" can he +e
successful as a team mem+er9
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The sa+e is >alid ,$% D%=e lat$% A,,ai%s#
It is more than sim'le @administration >The Art of Pharmacy +elongs to the Regulated
Field > Thus" to 5no* the relevant regulationsis the 'rofessional life itself>
This is the to'ic you must 5no*" if anything>The 'ro+lem is% you can not sim'ly learn it" the rather
+ecause the details may +e different in yourhomelands> Instead" you must understand the logic +ehind it>
This is *hen I try to hel' you>
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$ +a thin $ a%e e*&e%iencedal%ead 7 Is it t% e<
• .ho is la*:ma5er 9 .ho is enforcing the la*9• Is a 'am'hlet of a drug *holesaler" descri+ing regulations a
source or inter'retation of the la*;regulations9 (Eust youo+ey it9)
• .hat is G co:authority 9 e!g! corresponding authority 9• .hat is the ans*er to the 1uestion @*hy so many similar
drug 'roducts are registered9• .hat to do" *hen a 'atient : ma5es a com'laint in the 'harmacy9 : +rings the medicine +ac5" for" according to him;her" it had no
efficacy9
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D$ $ n$@ the %i ht ans@e%<
• It is n$t >e% &%$5a5le alth$ h the @e%es$ si+&le J esti$ns'
• At the end $, this se+este% h$@e>e% n$t$nl these 5 t + ch +$%e di,,ic ltJ esti$ns can 5e ans@e%ed and @hat is
+$%e:
$ @ill n$@ @hat t$ d$#
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Th s this is n$t Cla@ $%
Cthe$% 5 t:h$@ the"ha%+ac a,,ai%s 0in thei%5%$adest +eanin 6 a%e
@$% in #?
?
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3)
edicines %e lat$% a,,ai%s
• It is 5 n$ +eans 5$%in # It has inte%estinst$%ies and an inhe%ent l$ ic
• It can 5e ta ht >e% 5$%in 5 t it is n$tthe ,a lt $, the %e lat$% a,,ai%s777
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.hy do *e teach @regulatory
affairs ==for 'harmacy undergraduates9
The +est ans*er is given +y the3uro'ean Union>
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Th s: @hat is the idance $,
the E %$&ean 9ni$n ,$% the&ha%+ac nde% %ad atec %%ic la<
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The .(?432?EE $ ncilDi%ecti>e777
• =concerning the coordination of'rovisions laid do*n +y a*" Regulation orAdministrative Action in res'ect of certain
activities in the field of 'harmacy• Article # summarises in seven
'aragra'hs *hat should +e covered
during the under:graduate courses(not listing the disci'lines" rather stressingtheir content)
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The t%ainin shall ens %e adeJ ate n$@led e $, B! medicines and su+stances used in their manufacture
#! 'harm! technology and 'hysical" chemical"(micro)+iological testing of medicines
$! effect" meta+olism and 'ro'er use of medicines"action of to0ic su+stances
?! evaluation of scientific 5no*ledge concerningmedicines (to su''ly a''ro'riate info on them)
7! legal and other re1uirements of the 'ractice of'harmacy
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Let s ha>e a cl$se% l$$ '
$ $
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The t%ainin shall ens %e adeJ ate n$@led e $, B! medicines and su+stances used in their manufacture#! 'harm! technology and 'hysical" chemical"
(micro)+iological testing of medicines$! effect" meta+olism and 'ro'er use of medicines"
action of to0ic su+stances
?! evaluation of scientific 5no*ledge concerningmedicines (to su''ly a''ro'riate info on them)7! legal and other re1uirements of the 'ractice of
'harmacy
clear:cut Drug Regulatory Affairs>
'artly +elong to Drug Regulatory Affairs(drug assessment for registration)>
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Ne@ ha&te% :Wh is the n$@led e $, % les
s$ i+&$%tant in the ,ield $,Drug a,,ai%s<
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C=e lated andCstanda%dised ,ields
T*o distinct fields of 'roducts and
services can +e identified! They can*ell +e distinguished although" in thereal .orld" they may +e overla''ing
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4(
Standa%d< =e lati$n<
Standa%dised ,ield• =e lated 5 the +a% et• 5ased $n Standa%ds 0e7 7
IS!6
• A %ee+ents
• Acc%editati$n 05 n$n&%$,it6 and ce%ti,icati$n05 &%i>ate ,$% &%$,it5$dies6
=e lated ,ield• =e lated 5 a th$%ities• 5ased $n La@s
"ha%+ac$&$eia• A th$%isati$n%e ist%ati$n
• e%ti,icati$n 5
a th$%ities
Detailed’
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4)
Standa%ds 0e7 7 IS!6: as a % le
$nl an a %ee+ent $, thesta eh$lde%s in the +a% et777
11 M 22 M
9
9&l s
=ece&tacles 0s$c ets6
A >$lta e
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4.
Standa%ds
• as a rule" are not +inding• (only e0'ress the interest of the ma2ority of
the sta5eholders" if you ignore it% can not sell
your 'roduct)• may +e ta5en mandatory +y a la* (the la*:ma5er needs rules" there is a standard"instead of ela+orating similar rules refers to
the standard C the standard +ecomes la*)• In some countries every standard is at thelevel of la* (former Soviet Union>)
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Th s +is nde%standin 777
• the "ha%+ac$&$eia is the standard $,the J alit $, +edicines
• Standa%d 0set $, %eJ i%e+ents6 5 t n$tin the IS! +eanin 777
• the @$%d standard has 5%$ade% andna%%$@e% +eanin s in En lish'
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(
4e* -ha'ter &o* drug affairs have +een
'laced on the regulated field9
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(3
S$+e hist$% $, D% =e lati$n
• And from the late B th -entury% industrialdrug 'roduction" trade C gross adulteration'ossi+le C social 'ressure for regulation and
control (C regulated field )• To:day% 'roliferation of 'roducts"manufacturers" su''liers" 'romotionactivities" also drugs *ith serious sideeffects (the thalidomide affair% fetaldeformities)" etc!% even more 'ressure andmore develo'ed regulation
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((
F %the% a% +ents ,$% d% %e lati$n 1
Eany interested intermediaries• In ancient times% the com'etent healer (also
'roducing medicines) K the 'atient
• To:day% researchers" manufacturers"distri+utors" 'romoters and medical salesre'resentatives" 'rivate insurers" dis'ensersC variety of third 'arty interactions
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()
F %the% a% +ents ,$% d% %e lati$n 2
InformationDrugs are not selected +y 'atients +ut
mostly 'rescri+ed +y 'hysicians" *hode'end mostly onmanufacturers ;sellers information! Inunregulated mar5ets this info *erecom'letely influenced +y 'rofit motives
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(-
F %the% a% +ents ,$% d% %e lati$n 3
Financial considerations• If there are no or inade1uate rules" the
'rescri+er is com'letely nonsensitive totreatment e0'enses % resources *asted (itmay also ha''en if the drug costs are totally'aid +y the )
• If 'harmacists income is sim'ly lin5ed to the
'rice of non:'rescri'tion drugs sold%financial interest to advise the moree0'ensive one
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(.
F %the% a% +ents ,$% d% %e lati$n 4
Drug testing and outcomesFor registration" drug manufacturers are
re1uired to 'erform various (incl! animal)
studies to demonstrate thera'eutic +enefits!If no such regulation e0ists" e0'ensive orlengthy studies *ere omitted that *ould giverise to mar5eting of drugs of 'oor safetyand;or efficacy (+ut *ith higher 'rofit)
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(/
F %the% a% +ents ,$% d% %e lati$n (
Eisuse of drugs and drug shortagesThey may have serious im'act on the health of
+oth the individual and the entire 'o'ulation!30am'le% anti+iotic misuse (lo* or not enough
doses" e!g! for shortages) micro+ialresistance other 'atients in danger
30am'le% curing a communica+le disease'atients 'revents further transmissions
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)2
Regulatory affairs and the4ational Drug Policy
Wh t i th $ t t $ CD%
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)3
What is the c$ntent $, CD%=e lat$% A,,ai%s <
According to .&/" it is 'art of the 4ational4ationalDrug PolicyDrug Policy
.hy a Drug Policy9
Practically in all countries (from the Third.orld to USA)" 'ro+lems %• ensuring availa+ility of safe" efficacious and
good 1uality drugs to the *hole 'o'ulation (C
afforda+ility and;or distri+ution)"• rational drug use
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)4
$+&$nents $, the D% "$lic$+&$nents $, the D% "$lic
• Le islati$n %e lati$ns and idelines• Selecti$n $, d% s• S &&l
• "ha%+ace tical O alit Ass %ance• =ati$nal se $, d% s• Ec$n$+ic st%ate ies ,$% d% s• =esea%ch• H +an %es$ %ces de>el$&+ent• $nit$%in $, the d% &$lic
D% =e lat$% A,,ai%s the+sel>es ? Cha%d and Cs$,t la@ $n
$+&$ t $ D% l t$%
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)(
$+&$nents $, D% =e lat$% A,,ai%s 1
• =esea%ch $n ani+als <h +an clinical t%ials
• an ,act %e a th$%ised< L$cal heale%s<
• =e ist%ati$n assessed $% si+&l %e iste%ed<• "%$c %e+ent State< " 5lic se%>ice $5li ati$n<• Dist%i5 ti$n @h$lesale c$++ nit &ha%+acies h$s&ital &ha%+acies d$ct$%s $the%
$+&$nents $ D% e l t$%
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))
$+&$nents $, D% =e lat$% A,,ai%s 2
• Na%c$tic d% s• "s ch$t%$&ic s 5stances
• "%ec %s$% s 5stances• =e lat$% c$nt%$l
nati$nal la5< J alit de,ect %e&$%tin < AD= +$nit$%in < ins&ecti$ns<
$+&$nents $ D% =e lat$%
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)-
$+&$nents $, D% =e lat$% A,,ai%s 3
• "%$d ct P se%>ice lia5ilit• "atients %i hts
• D% ad>e%tisin ?&%$+$ti$n ,$% health &%$,essi$nals ,$% the ene%al & 5lic
• "%esc%i5in % les• Wastin d% s• "%$,essi$nal ha+5e%s S$cieties
$+&$nents $ D% =e lat$%
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).
$+&$nents $, D% =e lat$% A,,ai%s 4
• "%icin %ei+5 %se+ent?s 5sid• In %elati$n t$ that:
• The 5asic "HA= A !E !N!
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)/
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Gettin sta%ted: ce%tain, nda+ental c$nce&ti$ns
• La@La@ 8 stat t$% %e lati$n• La@ +a e% La@ +a e% : c$%&$%ate 5$d $% &e%s$n
a th$%ised t$ iss e a &iece $, la@• "e%s$n a&&l in ?en,$%cin la@"e%s$n a&&l in ?en,$%cin la@: an $,,icial
@h$ $n the 5asis $, la@ +a +a e 0ci>ilse%>ice6 decisi$ns
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-1
La@ +a e% 1
• $ + st c$ns lt the le al s ste+ in $ %c$ nt% #
• Is it a Fede%al c$ nt% < I, es @hatle islati>e tas s ha>e the lands0te%%it$%iese%ed 5 theFede%al and @hat 5 the Lands
le islati$n<E7 7 +edicines %e ist%ati$n is ,ede%al in the 9SA and
S@itQe%land se+i ,ede%al in Ge%+an
§
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La@ +a e% 2
• D$ $ ha>e =e& 5lic Kin d$+ etc7<• I, "a%lia+enta% =e& 5lic a%e the%e t@$
H$ ses< E7 7 H$ se $, $++$n and H$ se $,L$%ds in the 9K $n %ess and Senate in the9SA
• An la@ +a in &$@e% $, the ,$%+e%<
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-3
T &ical la@ +a e%s
• 0"%esident $, the State?Kin e%n+ent• iniste% • 0!the% Nati$nal B$d 6
• nici&alities the B$d <
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-4
a*:enforcement organs
• 0Head $, an6 A th$%it $% his?he%a th$%ised c$llea e0s6
"a%t $, the inist% $% inde&endent A enc <
• 0Head $,6 an$the% B$d a th$%ised ,$%ce%tain la@ en,$%ce+ent tas s
• R d e 0 $ %t R % 6• 0 nici&alit 6 cle%
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$ l
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-)
In ce%tain c$ nt%ies 0li eH n a% 6 the la@ en,$%ce+ent
a th$%it is i>en777• 't$ sin le &e%s$ns# 0E>en i, +$%e s ch
&e%s$ns a%e actin #6• Th s ci>il se%>ice la@ en,$%ce+ent is
5$ nd t$ a th$%ised &e%s$ns he%e#
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--
"ieces $, la@ 1
S$ %ces $, la@S$ %ces $, la@ 0t@$ +eanin s: 5$th thela@ +a e% and @he%e the la@ is& 5lished6
• "a%lia+ent• G$>e%n+ent• iniste%
• 0 nici&alit "%esident Kin '6
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-.
"ieces $, la@ 2
• $ sh$ ld identi, @hat ind $, &ieces $,la@ d$ and did e*ist 0s$+e $ tdated ,$%+s+i ht %e+ain in ,$%ce6
• S$,t la@ e7 7 idelines +eth$d$l$ icallette%s etc7 $, a th$%ities $% &%$,essi$nalB$dies' N!T &ieces $, la@#
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