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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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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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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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()


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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(-


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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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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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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• 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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• "%$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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).


• "%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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-2

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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-/

T &ical &ieces $, la@

Act $, "a%lia+ent 0Bill 5e,$%e6• %eated 5 the "a%lia+ent Acc$%din t$ itsacce&ted &lans7 $di,icati$n: Cis this Act $&en ,$% it<

• What is c$ntained in an Act< Whatc$nce%ns e>e% citiQen#

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