Law

w nº 6.360,, of Septem
mber 23, 1976
1

Deals with saniitary surv veillance, to whichh

medicines, drugs,, pharmac ceutical in
nputs and
d
related products, and oth hers are henceforthh
subject and enacts
s other prov
visions.

The Presiddent of the Republic I let be know

wn that the
e National Congress
C decrees and
d I sanction
n
the followiing law:

TITLE I
Prelim
minary Provvisions

Art. 1° - Medicines,
M drugs, phaarmaceuticaal inputs an
nd related products, a as defined in Law No.
5.991, of December 17, 197 73, as well as the hygiene products,
p c
cosmetics, perfumes,,
household sanitizing products, products meant
m for aesthetic
a ennhancemen nt and othe ers defined
d
below, aree henceforth subject to
o the norm
ms of sanitary surveilla
ance institutted by this Law.

Art. 2° - Only
O companies duly authorizedd by the Ministry of Health
H and whose facilities have
e
been licen
nsed by thee sanitary organizatio
o ons of the Federal
F Units where tthey are lo
ocated may y
extract, produce, maanufacture,, transform
m, synthesizze, purify, fraction, pack, re-pac
ck, import,,
ore or remit products mentioned in Article 1.
export, sto 1

Art. 3° - For
F the purposes of th his Law, in addition to
o definitions
s set forth in numeralls I, II, III,,
IV, V and VII of Artic
cle 4 of Law
w No. 5.9911, of Decemmber 17, 19 973, the folllowing defiinitions are
e
adopted:

I. Diet Products: Products

P te
echnically prepared in order to meet
m the die
etary needs
s of people
e
enjoying special physiologica
al conditions;

II. Nutrients: Sub

bstances making
m up food with nutritional value, su
uch as protteins, fats,,
carbohyydrates, wa
ater, minera
al elements
s and vitam
mins;

giene Products: Produ

III. Hyg ucts for ex
xternal use, antiseptic
c or otherw
wise, mean nt for body
y
cleaning
g or disinfe
ecting, encompassing toilet soapps, shampo oos, toothp
paste, moutth-washes,,
antipers
spirants, deodorants,
d , shaving products
p and after-shhave produucts, astrin
ngents andd
others;

IV. Perrfumes: Prroducts witth aromatiic composiition obtain ned from natural orr synthetic c
substan
nces which,, in the appropriate concentratio
c on levels and
a vehicle
es, may hav ve as theirr
main purpose the e addition of
o pleasant odor to pe eople or en
nvironmentts, including extracts,,
perfumed waters, cream perfumes,
p bath prep parations, and roomm scenting products,,
presentted in liquid
d, gelatinou
us, paste orr solid form
m;

V. Cosmmetics: Products for external use e, meant too protect orr embellish different parts
p of the
e
body, such
s as face powder, talcum, be eauty cream ms, hand-cream and s similar prod
ducts, face
e
masks, beauty lo otions, milkky creamy and astrin ngent solutions, hand d lotions, foundationn
cream and cosme etic oils, ro
ouge, blush h, lipsticks, lip crayon
ns, sun pro otectors, tan productss
and artificial tan products, mascara, eye-shado ow, eyeliners, hair dyes, hair bleaching g
productts, hair currling or strraighteningg products, wave settting produc cts, hair sp
prays, hairr
stuff an
nd similar products,
p haair lotions, hair removving produccts, nail pro
oducts and others;

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VI. Colorants: Suubstances additional to medicin nes, diet products,
p c
cosmetics, perfumes,,
e products and similar products,, household
hygiene d sanitizing
g products and similarr products,,
having the effect of giving color to those produ ucts and, in
i the case e of certain types off
cosmetics, that of transferrin
ng such colo
or to the sk
kin surface and to skin
n annexes;

ousehold Sanitizing
VII. Ho S Products: Substance es or prep
parations m meant for household d
hygiene
e, disinfecting or pestt-control, in
n collective
e and/or pu
ublic enviro
onments, in
n places off
shared use and in water trea
atment, enc compassing g;

a) insect-killing products - meant too fight, prevent and co

ontrol insec
cts in dwellling places,,
ces and site
plac es of shared use and their
t neighborhood;

b) rat-killing
r p
products - meant to fight rats, mice
m and otther rodentts, in dwelling places,,
vessels and places
p and sites of sh
hared use, containing g active substances, isolated orr
associated, an nd not hazzardous to human he ealth or liffe or to th
hose of useeful warm--
bloooded anima als when applied
a in compliance
c with recom mmendatio ons contained in theirr
pacckaging;

c) disinfectant
d ts - meantt to destro
oy micro-orrganisms, in a selecttive or indiscriminate
e
mannner, whenn applied to
o inanimate
e objects orr to environ
nments;

d) detergents
d - meant too dissolve fats and fo
or the hygiene of can
nisters and containers
s
and
d for househ
hold applica
ations.

abels: Printted or litho

VIII. La dentification, as well as the wording paintted or fire--
ographed id
engraveed, pressuure-engrave ed, pasted or directtly applied on canistters and containers,
c ,
packagees or packaaging, cartoons or any other packkaging prote
ector;

IX. Packaging: Coontainer, ca

anister, jar or any othher type of packaging, susceptib ble of being
g
removeed or not, meant
m to coover, pack, bottle, pro
otect or ma
aintain, spe
ecifically or otherwise,,
productts mentione
ed in this Law;

X. Registration: The inscriptiion, in the appropriate

e ledger, after the decision on licensing by
y
the heaad of the relevant body within the Ministry of Hea alth, under a serial number,
n off
productts mentioneed in this Law, indica ating their name, manufacturer,, origin, pu urpose andd
other elements in their compposition;

nufacturing: All operattions neces

XI. Man ssary for ob
btaining pro
oducts cove
ered by this
s Law;

w Materials
XII. Raw s: Active orr inactive substances
s used in the
e manufactture of med
dicines and
d
other products cov
vered by thhis Law, bo oth those th
hat remain unaltered a
and those susceptible
s e
ergoing changes;
of unde

ot or Shipm
XIII. Lo ment: Amo ount of a medicine
m or product covered by y this Law,, producedd
within one
o cycle of manufactturing and the
t essentia
al characte
eristic of wh
hich is homogeneity;

ot Number: Designatio
XIV. Lo on printed in the label of a mediicine or of a product covered
c by
y
this Law
w allowing to identify
y the lot or shipmentt to which they belon ng, and, shhould it be
e
necessaary, to loca
ate and reeview all manufacturi
m ing and insspection op perations carried
c outt
during production;;

XV. Quality Contrrol: Set of measures meant to guarantee,

g at any timme, the pro
oduction off
lots of medicines and other products covered
c by this Law, satisfying the norms related to
o
purity, efficacy and innocuity
y;

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 XVI. Semi-Elaborrated Product: All su
ubstances or mixturre of substances stilll under a
acturing pro
manufa ocess;

h a given drug contain

urity: Degrree at which
XVII. Pu ns other forreign materials.

XVIII. Brazilian Common

C D
Denominat ion (DCB) - denom mination of the pharrmaceuticall
element or of the pharmaceutically acttive principle approved by the fe
ederal body
y in charge
e
of sanittary surveillance;

XIX. Intternational Nonproprietary Name (INN) de enomination

n of the pharmaceutic
cal elementt
or of the pharmaceutically ac
ctive princip
ple recomm
mended by the World HHealth Organization;

XX. Sim milar Medicine - the e one thatt contains the same active prrinciple or principles,,
presentting the sa ame degre ee of concentration, the same pharmace eutical for, the same e
vehicle,, the same dosage and therapeutic, pre eemptive or
o diagnosis indicatio ons of the e
reference medicine registere ed at the feederal bodyy in charge
e of sanitarry surveillan
nce, apt too
differ solely in terrms of cha
aracteristics
s pertaining
g to the siz
ze and form the prod duct, of its
s
period of validity, packagingg, labeling, excipients and vehiccles, and ha aving to bee identified
d
ademark;
by a tra

XXI. Geeneric Med dicine - a medicine similar

s to a referenc ce product or to an innovative e
productt intended to
t be intercchangeablee with the la
atter, norm
mally produc ced after or foregoingg
of the patent
p prottection or of
o other exxclusivity riights, once
e its efficac
cy, safety and
a quality
y
are verified and it is given by
y DCB or in its absenc
ce, by INN;

XXII. Reference
R M
Medicine - an
a innovating productt, registere ed at the feederal bodyy in charge
e
of sanittary surveilllance and marketed in the coun ntry, the effficacy and safety of which
w have
e
been sccientifically verified at the relevant federal body,
b on th
he occasion of its regis
stration;

XXIII. Interchang
geable Pharmaceutica al Product - therapeutic equiva alent of a reference
e
ne, having the
medicin t same effects
e in te
erms of effic
cacy and sa
afety essen
ntially verified;

XXIV. Bio-equival
B lence - thee demonsttration of the pharm maceutical e equivalencee amongstt
productts presente ed under the same pharmaceut
p tical form, containing g identical qualitative
e
and quaantitative composition
c n in terms of
o active principle or principles, with comparable bio--
availabiility, when studied under the sam
me experim
mental desig gn;

XXV. Bio-availabil
B lity - it ind
dicates the
e speed annd the exttent of abssorption off an active
e
principle in a form
m of dosage, starting from its time/conc centration curb in the e systemic
c
circulation or in its
i excretio on in urine
e (items ad
dded by Laaw No. 9.7 787, of February 10,,
1999).

Art.4° - Products
P me
eant for ch
hild use maay not conntain caustiic or irritatting substa
ances, they
y
must havee packaging
g exempt frrom blunt parts
p and may
m not be presented in aerosol form.
f

Art.5° - Prroducts me
entioned in this Law may
m ave names or designations leadin
not ha ng to errorr
(Language e given by Law
L No. 6.4
480, of Dec
cember 1, 1977).
1

§ 1º - The adoption of a nam me equal or similar fo

or products having diffferent comppositions is
s
den, even iff they are from
forbidd f the sa
ame manuffacturer, annd, in cases of filing requests
r att
the relevant office
e of the Min
nistry of He
ealth.

§ 2º - The name of a produ uct having its application for reg

gistration m
made afterw
wards may
y
be appproved, prrovided tha at the prev
vious request for reg gistration has been denied forr
technic
cal or scientific reason
ns.

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 § 3º - Once the e collision of brands is verified d, the change of the e product'ss name orr
designation mustt be reques sted within 90 (ninety
y) days from
m the date e of publica
ation of the
e
on in the Offficial Journ
decisio nal of the Union, under the penalty of registtration denial.

§ 4º - Without daamage to th
he provisionns of this Article,
A and,, ad lib of tthe Ministry
y of Health,,
medicines containing a sinngle widely known ac ctive substtance and the immune-therapy y
produccts, drugs and
a pharmaaceutical in
nputs must be identifie ed by the d denominatioon listed in
n
the Bra
azilian Pharrmacopoeia
a, and in no
o case shou uld they bear fancy na ames or designations.
(Addedd by Law No. 6.480, of
o Decembe er 1, 1977)..

Art. 6° - The
T verifica
ation that a given prooduct, so fa
ar deemed useful, is h harmful to health and d
does not meet requ uirements established
e by law means
m its immediate withdrawal from the e
market an nd the req quirement that its co omposition formula and a the lannguage in its labels,,
instruction
ns for use and
a packag ging be chaanged, undder the pen nalty of reg
gistration cancellation
c n
and of seiz
zure of the product in the whole national te erritory.
Only Paraggraph - The e registratio
on and licensing for use of medic cines, as w
well as the approval
a orr
the require
ement of ch hange in th
heir compon nents belon
ng solely too the Ministry of Health.

Art. 7º - As
A a measu ure of sanittary safety and in vieww of reasons duly jus
stified by th
he relevantt
body, the Ministry off Health ma ay suspendd, at any tiime, the manufacturin
m ng and sale e of any off
the products mentio oned in this s Law whic ch, althoug
gh registereed, becomes suspectt of having g
effects harrmful for hu
uman healtth.

Art. 8º - No
N establish
hment man nufacturing or industriializing a product cove ered by this Law may
y
operate without the assistance
a and effectiv
ve responsibility of a legally certtified technician.

Art. 9º - Establishme
E ents covered by this La aw making up Public Administrat
A tion or crea
ated by the e
latter do not
n need lic censes for operating,
o although thhey are subbject to reqquirements pertaining g
to the appropriate facilities,
f eq
quipment and
a machinery and to t the tech hnical assis
stance and d
responsibility.
Only Paragraph - Fo or the purp poses of saanitary conntrol, as prrovided forr in the leg
gislation in n
mmunication
force, com n to the Minnistry of He
ealth by the
e organizattions referred to in thiis Article off
the existennce or insta
allation of establishme
e ents mentiooned in this
s Law is ma andatory.

Art. 10 - Imports
I of medicines,, drugs, pharmaceutic cal inputs and
a other p
products me
entioned in
n
this Law, for
f industrial and com mmercial pu urposes and
d without a previous a
and express
s favorable
e
opinion byy the Ministtry of Health, are forbiidden.

Sole Paragraph
P - The requ uirements provided for f in this Article include acqu
uisitions orr
donatio
ons involvin
ng personss of public and
a private
e law the ammount and quality of which may y
jeopard
dize the ex
xecution of national heealth progra
ams.

Art. 11- Drugs,

D mediicines and any related d pharmace eutical inpu
uts, hygiene
e products,, cosmetics
s
and house ehold sanitizing products, importted or not, shall only be delivereed for consumption inn
their origin
nal packagiing or in other ones, previously
p authorized
a by the Ministry of Hea
alth.

§ 1º - In order to
o fit the de
evelopmentt of Federa al Governmment plans aand progra
ams for thee
produc
ction and distribution
d to the usee of special packaging g or re-pac
ckaging allowing costt
reduction withoutt prejudice for the purrity or effica
acy of prod
ducts.

§ 2º - Imported products, the marke eting of whhich in the internal m

market does s not need
d
al prescripttion shall have
medica h clarify
ying langua age on the
eir composition, indic
cations and
d
mode of
o use, in Portuguese,
P , added to the
t labels.

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 TITLE II
Registration
R n

Art. 12 - No productt mentione ed in this Law,

L including importe
ed ones, mmay be industrialized,,
displayed for sale or delivered for
f consumption beforre registratiion at the M
Ministry of Health.

§ 1º - Registratio
on referred
d to in this Article sha e) years, and may be
all be valid for 5 (five e
revalid
dated for equal
e and successive e periods, the initial number of registra ation being
g
maintaained.

§ 2º - The validity of regis

stration an
nd of registtration re-v
validation of diet pro
oducts, the
e
period of which is of 2 (twwo) years, is an exc ception to the provis sions of the previouss
paragrraph.

§ 3º - Registratio on shall be granted

g witthin at mos
st 90 (ninetty) days, co
ounting from the date
e
requesst is filed, except
e in ca
ases of non compliance with this Law or with its regula ations.

§ 4º - Deeds perrtaining to registration and regis stration re--validation shall produce effects
s
only sttarting from
m the date of
o publication in the Official
O Jourrnal of the U
Union.

§ 5º - Granting of
o registration and its re-validatio
on, and the
e previous and contro ol analyses,,
if appropriate, are
e subject to
o the paym
ment of public prices, referred
r to in Article 82.
8

§ 6º - Re-validattion of registration sh hould be re

equested inn the first semester of the lastt
year of the five-yyear periodd of validitty, and re-v
validation of registrattion shall be
b deemed d
automa atically gra
anted, irres
spective of decision, should the ere be no p pronouncem ment up to
o
the datte of termin
nation of th
he validity in
i force.

§ 7º - The registration of a product whose re-validation has s not been requested within the
e
period of time refferred to in Paragraph
h 6 of this Article
A shall be declare
ed expired.

§ 8º - Registratio
on of a pro
oduct that is not indu
ustrialized within
w its ffirst period of validity
y
shall not be re-va
alidated.

§ 9º - The registration men ntioned in this

t Article must contaain the form
mula of the
e product's
s
compoosition, indic
cating ingre
edients utilized and thhe respectiv
ve dosage.

Art. 13 - Any
A change
es in the formula, change of commposition elements or of their quantity, any
y
addition, subtraction
s or innovation introduced in the
e preparatiion of the product sh
hall dependd
upon prev vious and express authorization by the Ministry of Health, and ssuch changes shall bee
immediate ely added to
o registration.

Art. 14 - Fancy
F names and den nominations of produc d and industrialized prior
cts licensed p to the
e
entry into force of th
his Law are excluded from
f requirrements provided for in this La. (Language e
given by Law
L No. 6.4480, of Dec
cember 1, 1977).
1

Art. 15 - Registration
R n of produc
cts mentionned in this Law shall be denied whenever conditions,,
requiremeents and prrocedures fo
or this purpose providded for in law, regula
ation or issued by the
e
relevant bodies are not
n complieed with.

TITLE III
Reg
gistration of
o Drugs, Medicines an
nd Pharmac
ceutical Inp
puts

on of drugs, medicines and pharmaceutic

Art. 16 - Registratio cal inputs, given their sanitary,,
medicinal or prophy ylactic, currative, atte
enuating orr diagnosis
s characterristics, is subject,
s in
n

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addition to
t meeting
g the app
propriate regulatory
r requireme
ents, to th
he followin
ng specific
c
requiremeents:

uct complies with the provisions of Article 5 and its pa

I. Thatt the produ aragraphs; (language
e
given by
b law No. 6.480, of December
D 1 1977).
1,

at the produ
II. Tha uct, by means of scie
entific verification and analysis, bbe recognizzed as safe
e
and efffective for the intended use and
d possess thet necessa
ary, activity, quality, purity and
d
innocuity;

III. In cases of new productts, that exttensive info

ormation be provided on their composition n
and us se, so that their nature be assess
sed and theeir necessa
ary degree of safety and efficacy
y
be dete ermined;

esentation,, when req

IV. Pre quested, of samples for analys sis and ex
xperimentin
ng deemed
d
necess
sary by the relevant bodies of the
e Ministry of
o Health;

en there be
V. Whe e new substances in the compossition of me
edicines, the delivery of samples
s
accompanied by chemical
c an
nd physic-c
chemical da
ata identifying them;

VI. Whhen it is a drug or a medicine e whose preparation requires ttechnical and specific c
machin
nery, evideence as to the
t fact that the esta ablishment is duly equuipped and d maintains
s
people able to handle such machinery
m or as to thee out-sourc
cing of such
h activities;;

aragraph - (Language
Sole Pa e given by Law
L No. 6.4
480, of Dec
cember 1, 1
1977).

Art. 17 - Registration y of products mentioned

m in this Tiitle shall b
be denied wheneverr
conditions, requirements and procedures
p urposes pro
for such pu ovided for in law, regulations orr
ns issued by
instruction y relevant body
b are no
ot complied
d with.

Art. 18 - Registratioon of drugss, medicine es and pha armaceuticaal inputs oof foreign provenance
p e
shall depend, in addition to on the
t conditioons, requireements andd procedure es provided
d for in this
s
Law and inn its regula
ation, on th
he verificatiion that such productts are alrea
ady registerred in theirr
countries of
o origin.

Art. 19 - Registratiion of druugs, medicines and pharmaceu utical inputts shall be

e canceledd
whenever non auth horized chhanges in their form mula, dosaage manufacturing conditions,,
indications
s for use and
a specifications announced in
n prospectu
uses, labells and advvertisementt
material are introduc
ced.

aragraph - Should it become

Sole Pa b neccessary to change
c the
e compositioon, the dos
sage or thee
therapeutic indications of a technically produceed pharma aceutical prroduct, the
e company y
would request the appropriaate permiss
sion to the
e Ministry of
o Health, aas providedd for in the
e
regulattion of this Law.

Art. 20 - Medicines whose preparation re equires speecial care in

n terms off purificatio
on, dosage,,
on or conservation sha
sterilizatio all only be registered
r when:
w

omposition contains new

I. its co n substan
nce or subs
stances;

II. its composition contain ns known substance or substa ances for to which a new orr
advanttageous application in therapeutiics may be given;

ey present improveme
III. the ents in theiir formulae or forms, from the p
pharmaceuttical and/orr
therapeutic points
s of view.

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 Sole Paragraph- Medicines whose com mposition does
d not co
ontain subsstance or substances
s s
eficial from the clinical or therapeutic points
known to be bene s of view m
may not be registered.
uage given by Law No. 9.782, of January 26
(Langu 6, 1999).

Art. 21 - The rightt to registe nes similar to others already rregistered is granted
er medicin d
provided that
t they meet
m the req
quirements set forth in this Law.

§ 1º - Similar me edicines to be manufa actured in the

t Countryy are deem
med registered after a
period of time of o one hundred and twenty day ys countedd from thee date the respectivee
requesst is filed ha
as elapsed, if so far a denial has not been is
ssued.

§ 2º - Counting g of the period

p of time
t egistration shall be interrupted
for re d until the
e
concerrned compaany satisfies the requirement of the sanitary authority
y, and such period off
time may
m not exc
ceed one hu undred andd eighty day
ys.

§ 3º - Registra ation, when granted under th he conditio ons set fo orth in the e previouss
paragrraphs, shalll lose its vaalidity, irres
spective off notification or summ mons, if the product is
s
not ma arketed witthin a one--year perio od after thee date regiistration is granted. This
T periodd
may be e extendedd for six mo ore months, ad lib of the
t sanitary y authority, by meanss of written
n
justific
cation at the
e initiative of the com mpany conce erned.

§ 4º - Request foor a new re

egistration of
o a produc ct may be done
d two y
years after verification
v n
of the fact that gave
g cause
e for the lo
oss of validdity of the previously granted reegistration,,
exceptt if the company conceerned is not liable for it.

s of this Arrticle apply

§ 5º - Provisions y to produc
cts registerred and maanufacturedd in State--
Party making up p the Soutth Common n Market - MERCOSUL, for the purposes s of beingg
marketted in the Country, if they co orrespond to
t a nation nal, alread
dy registere
ed, similarr
produc
ct. (Language given by y Law No. 9.782,
9 Janu
uary 26,199 99).

Art. 22 - Drugs, meedicines and d pharmacceutical inputs contain

ning stupeffacient subbstances orr
ng psychica
determinin al dependence and th hat are subbject to the
e special coontrol prov
vided for in
n
Decree-Law No. 753 3, of Augu ust 11th , 1969,as well
w as othher acts, reegulations and otherr
relevant norms,
n and medicines s in genera
al, shall only be regis
stered if, in
n addition to
t meeting g
conditions, requirem
ments and procedures s set forthh in this Laaw and in its regula ation, theirr
packaging and labelin
ng fit stand
dards appro
oved by thee Ministry of
o Health.

Art. 23 - The
T followin
ng are regis
stration exe
empt:

ducts whos
I. prod se formulaee are listed azilian Pharmacopoeia
d in the Bra a, in the Codex
C or in
n
forms accepted by the Minis
stry of Health;

omeopathic preparations made

II. ho e of simple associations of ttinctures or
o by the
e
incorpo
oration of solid
s substa
ances;

III. concentrated solutes ussed for the extemporaaneous obttainment of pharmace

eutical and
d
industrrial prepara
ations deem
med workshhop productts,

IV. products dee

emed equa al to workkshop oness, whose formulae
f a
are not listted in thee
Pharmacopoeia or in the forms, but are
e approved
d and autho
orized by th
he Ministry of Health.

Sole Paaragraph - provisions of this Article do not preclude the mandatory charactter, for thee
purposse of marke eting products therein referred to
o, the needd for the company to refer
r to the
e
Ministrry of Health
h the inform
mation and clarifying data
d on inje
ectable solu
utes.

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Art. 24 - New medic cines excluusively mea
ant for exp
perimental use, under medical control
c are
e
equally exxempt of registratio on, and caan even beb importe ed, by me eans of an
a express s
authorization by the Ministry of Health.

aragraph - The exemp

Sole Pa ption provid
ded for in this
t Article shall be va
alid solely for a period
d
of up to 3 (three) years, after
a expiry
y of whichh products must be rregistered, under the e
y of seizure
penalty e determine
ed by the Ministry
M of Health.
H

TITLE IV
Registratio
on of Relate
ed Products
s

Art. 25 - Appliances s, instrumeents and accessories

a used in medicine,
m d
dentistry and
a related
d
activities, as well as
a in the activities of physica al educatio
on, embelliishment off aesthetic c
correction,, may onlyy be manu ufactured, or importe
ed, for delivery for co
onsumption n and salee
display aftter the Minnistry of Health
H issue
es an opinion on the
e mandatorry or non mandatory y
character of registrattion.

§ 1º - Instrumen nts or acces ntioned in this Article and contained in listts prepared
ssories men d
by thee Ministry ofo Health for this puurpose are exempt frrom registrration. Forr the otherr
purposses of this Law and off its regula
ation, howe
ever, they remain
r sub
bject to thee regime off
sanitarry surveillance.

§ 2º - Regulationn of this La
aw shall prescribe the
e conditionss, requirem
ments and procedures s
concerrning registration of machinery,
m i
instruments
s or accesssories menttioned in this Article.

TITLE V
Registration of Co
osmetics, H
Hygiene Pro
oducts, Perffumes and Others

Art. 26 - Only prod ducts mea ant for extternal use in environ nments sh hall be reggistered as
s
cosmetics,, products for persoonal hygien ne, perfum mes and others
o with
h similar nature
n and
d
purpose, in consonannce with th
heir aesthettic, protectiing, hygien
nic or odor--related purposes and
d
provided that
t they do
o not bring about skin
n rashes or harm to he ealth.

Art. 27 - In addition to being subjectt its own regulatory y requirem

ments, regis stration off
cosmetics,, products meant for personal hyygiene, perrfumes and
d others having simila
ar purposess
shall depend upon meeting the following rrequirements:

I. to fiit the list of

o substanc ces declareed innocuous, prepare ed by the relevant body of the e
Ministrry of Health h and publiished in the Official Jo
ournal of the Union, tthat shall contain
c the
e
pertineent specificcations for each categgory, as we ell as for medicines,
m inputs, raw materials,,
colorannts, solventts and otheer products allowed to o be used in
n their mannufacturing;;

II. if they
t do noot fit the list referred
d to in the previous numeral, tthe innocuiity of theirr
respective formulae must be b recogniz zed, by me eans of connclusive op
pinions issu
ued by the
e
relevannt analysis and technical bodies of the Ministry of Hea
alth.

Sole Paragraph
P - The list of
o substancces referre
ed to in nu
umeral I off this Artic
cle may be e
altered
d in order to exclude substances
s s that may be deemed d harmful to health orr to include
e
others that may be
b approved.

on of cosmetics, products mean

Art. 28 - Registratio nt for perso
onal hygienne and others havingg
identical purposes,
p containing medicinal
m s
substances,, although in does below therapeeutic level,,
shall follow
w the norm
ms containeed in articlles 16 and its numerrals, 17,18 and 19 annd its Sole
e
Paragraph, 20 and 21 and of the regulation of this La
aw.

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Art. 29 - Products referred
r to in Article 26 shall only
o be reggistered if they contaain in theirr
on raw materials, solvents, colo
compositio orants or pharmaceut
p tical inputs contained in the listt
prepared by
b the relev vant body of the Ministry of Heaalth, publish
hed in the Official Jou
urnal of the
e
Union, pro
ovided that restrictions to their use
u be expressly highhlighted in llabels and packaging,,
when apprropriate, ac
ccording to the area of the body on which they are to be applied.

Sole Paaragraph - When pres sented in the form off aerosol, products
p refferred to in
n Article 26
6
shall only
o be registered if they follow the technical standarrds approvved by the Ministry off
Health and other specific reqquirementss and norms.

Art. 30 - Cosmetics s for personal hygien

s, products ne for adullts and chiildren, perffumes andd
oducts may
related pro y have their formulaee of composition alterred, provide
ed that suc
ch changes
s
be approved by the ministry
m of Health, bas
sed upon th
he relevantt technical a
awards.

Art. 31 - Changes
C in
n formulae shall be incorporated to the pro
oduct's registration, as
a provided
d
for in regu
ulations.

Art. 32 - The
T Ministry
y of Health shall cause
e to publish
h in the Offficial Journa
al of the Un
nion the listt
of natural organic, artificial an
nd synthettic colorantts, includin
ng their sla ats and lacquers, as s
e manufactturing of prroducts mentioned in articles
allowed for use in the a 29,, Only Paragraph, and d
30.

§ 1º - Any colora ant presenting active

e or potential toxicity shall be e
excluded fro
om the listt
referre
ed to in this
s Article.

§ 2º - Inclusion or exclusioon of colorrants and of

o their derivations shall follow provisions
s
ned in the regulation.
contain r

TITLE VI
Registration of Ho
ousehold Sanitizing Prroducts

Art. 33 - Registratio
on of house ehold sanitizing produ ucts, of dis
sinfectants and deterg
gents shalll
follow the provisions of regulations and of specific complementa ary norms.

Art. 34 - Insect killerrs may only

y be registe
ered if:

y may be properly
I. they p ap
pplied, in sttrict compliance with instruction
ns containe
ed in labels
s
and other explana
atory elemeents;

epresent any possibility of hazard for hum

II. they do not re man health and for the
e health off
domes stic warm-b
blood animaals in the fo
orecast conditions of use;
u

ey are not corrosive

III. the c or harmful for s on which they are ap
f surfaces pplied.

Art. 35 - Insect killerrs shall be registered

r o
only if:

y are presen
I. they nted accord
ding to norm
ms provided for in the
e regulation
n of this Law
w;

II. if in their co
omposition the insectt-killing an
nd the syn ubstances, natural orr
nergetic su
syntheetic, comply
y with the appropriate
a e concentration indexe
es as established by the Ministry
y
of Health;

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 III. if their compposition formulae obse erve the necessary caution,
c aim
med at their handlingg
and att the therrapeutic measures in n cases off accident, in view of the ind dispensable
e
preserv vation of human life, according to
t the instructions of the
t ministry
y of Health.

Sole Paragraph - Regulation of this LawL shall set

s forth th
he requirem
ments cond
ditions and
d
dures pertaiining to reg
proced gistration of insect killers.

Art. 36 - For the puurposes of insect-kille

er registration, substa
ances making up the respective
e
formulae shall
s be con
nsidered:

vents and thinners, those used

I. solv d as vehic
cles in the
e preparatiion of inse
ect killers;

he propulsio
II. propellants, th on agents used
u in preparations under
u press
sure.

Art. 37 - The
T Ministrry of Health
h shall prep ause to be published in the Offic
pare and ca cial Journall
of the Unio
on the list of solventss, thinners and propellants allowed, with th
he respectiv
ve maximall
concentrattion levels.

Art. 38 - Association
A of insect killers
k shall be allowe
ed, and these must haave the conncentration
n
levels of active eleme
ents proporrtionally redduced, wheen belongin
ng to the sa
ame class.

Art. 39 - Insect kille

er associatiions shouldd satisfy th
he requiremments provided for in Article 35
5
nly Paragrap
and its On ph, as to to
oxicity for animals
a sub
bject to the efficiency test.

Art. 40 - Registration
R n of insect killers
k shall be permittted only wh
hen meant for:

I. the prompt
p app
plication by
y any person for dome
estic purpos
ses;

II. application and

a handlin ecialized persons or organizatiions for professional
ng by spe p l
purposses.

Art. 41 - preparationns whose compositio

c n formulaee include active substtances, isolated or in
n
n, in diffe
association erent levels of conc centration and underr certain forms and d types off
presentation shall be
e registered
d as rat kille
ers.
Only Paragraph - As ssociations of rat killing substaances of a same clas ss should be
b reduced d
nally to the concentrattion levels of
proportion o their active principles.

Art. 42 - Provisions s of this Law

L apply to the reegistration of rat-killing prepara
ations andd
substances, further specific
s req
quirements pertaining to this cla
ass of prod
ducts remaiining to be
e
established in regulattions and by
b the Minis
stry of Health.

Art. 43 - Registration of disinfectants shaall be carriied out acc

cording to the provisiions of the
e
regulation to this Law
w and to ins
structions issued
i by the Ministryy of Health.

Art. 44 - For
F the purp
poses of this Law, dettergents and disinfecta
ants and th
heir respecttive related
d
products are
a deemed
d equal to household d sanitizing products, when mea ant for appplication onn
inanimate objects and on env vironments,, remaining g subject to
t the sam me requirem ments and d
conditions in what regards registration n, industrialization, delivery foor consum mption and d
inspection.

Art. 45 - Sale of rat r killers and their delivery for

f consum
mption shaall remain restricted,,
exclusively
y, to prod ducts class sified as having
h low
w and ave erage toxiccity, and it belongs s
exclusively
y to specialized com mpanies or to organizations or bodies w within the Direct and d
Indirect Pu
ublic Admin nistration to
o supply prroducts clas
ssified as having
h high levels of toxicity and
d
to control their applic
cation.

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 TITLE VII
Registrattion of Diett Products

Art. 46 - Products meant

m for oral
o on that, though not fitting
ingestio f the provisions of Decree--
Law No. 986, of Octo ober 21, 19969,and its respectivee regulation
ns have the
eir use or sale subjectt
to medicaal prescripttion, shall be registered as die et productss, provided
d that mea ant for thee
purposes below:
b

I. to meet
m speciall dietary ne
eeds;

II. to supplemen
s t and enric
ch the usua
al nourishm
ment with vitamins,
v a
amino-acids
s, minerals
s
and other elemen
nts;

III. to disguise thet sensations of hun

nger, of ap
ppetite and
d taste, rep
placing usu
ual food in
n
restricttion diets.

Art. 47 - Only prod

ducts made
e up of th
he following
g substanc
ces shall b
be registered as diett
products:

ural food mo
I. natu odified in itts composittion or charracteristics;

II. nattural food, though no

ot deemed usual food
d, containin
ng nutrients
s or having
g nutrients
s
added to it;

III. miineral or organic prod

ducts, pure
e or associated, apt to contribu
ute for the
e design off
speciall diets;

IV. isolated or as
ssociated su
ubstances, without nu
utritional va
alue, meantt for restric
ction diets;

d compleme
V. food ents containing vitamins, minera
als or otherr nutrients;

her productts that, isollatedly or in association, may be

VI. oth e characterrized as die
et products
s
by the Ministry off Health.

Art. 48 - Diet produ ucts mentiooned in thiis Law may y be prese

ented undeer the usuaal forms off
pharmaceu utical produ
ucts, in com
mpliance with their na
ames and th
heir own ch
haracteristic
cs.

Art. 49 - In order too ensure thhe minimal dietary effficiency ne

ecessary and preventt confusion
n
with theraapeutic prroducts, thhe amountt of components of diet prod ducts justiffying theirr
indication for special diets sho
ould meet the standa ards internationally a
accepted, as
a per lists s
prepared by
b the Ministry of Heaalth.

§ 1º - If there are
a no esta andards for the purposes of thiis Article, the
ablished sta t rate off
nts of diet products
nutrien p sh
hall depend upon decis
sion by the
e Ministry of Health.

§ 2º - The proporrtion of vita

amins to be
e added to products sh
hall co-resp
pond to the
e standards
s
established by the Ministry of
o Health.

TITLE VIIII
Autthorization of Compan
nies and Lic
censing of Establishme
E ents

Art. 50 - Operation
O o companie
of
Ministry off Health, in
n view of in
es mentioneed in this Law
L shall de
epend upon n authorization by the
e
ndication of the respeective indusstrial activity, of the nature and
d

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kind of the products and of the verifiication of the technical, scientific and operational o l
capability, and of othher requireements provided for in regulations and adm ministrativee deeds by y
the same Ministry.
Only Paragraph - The authorization men ntioned in this Article shall be valid for the whole e
erritory, and should be
national te e renewed whenever theret are changes
c or inclusion of activities,,
or changes s of partners or directtors in charrge of the le
egal repres
sentation off the compaany.

Art. 51 - Licensing,
L b the loca
by al authority, of industrrial or commercial esttablishments carrying
g
out activities mention ned in this Law, shall depend up pon operation of the ccompany haaving beenn
authorized d by the Ministry of Heealth and upon
u being met, by eaach establis
shment, the technicall
and sanita ary requirements set forth in re egulations and instrucctions issue
ed by the Ministry off
Health, inc cluding in what
w conceerns the efffective assistance of accredited technical responsible
r e
officials to the differe
ent sectors of activity.

aragraph - Each estab

Sole Pa blishment shall
s have a specific an
nd independent licens
se although
h
there be
b more thaan one esta
ablishment in the sam
me town, be elonging to the same company.
c

Art. 52 - Supplemen ntary local legislation shall set forth the requiremen
r ts and connditions forr
licensing establishme
e ents referre
ed to in this
s Law, in co
ompliance with
w the following prov
visions:

en a single establishment industrrializes or markets

I. Whe m pro
oducts head ding differe
ent natures
s
or purrposes, it shall be mandatory
m to have separate
s fa
acilities forr manufactturing and d
packag
ging materials, substa
ances and fiinished goo ods;

propriate lo
II. App ocation of facilities
f and the interrdiction of residences or dwelling
g places in
n
the buildings allocated to o the above mentioned actiivities and d in nearrby areas;

proval, by the State health orrganization,, of projec

III. Prrevious app cts and blu
ueprints off
buildings and insp
pection of c
compliance with same
e.

TITLE IX
Technical Respon
nsibility

Art. 53 - Companies s carrying out activitiies provide ed for in thhis Law are
e obliged to maintain n
credited tec
legally acc chnical resp
ponsible offficials in an amount an nd with qua
alifications enough forr
the approppriate coverage of thee different types
t of pro
oduction, in
n each esta
ablishment.

Art. 54 - It will be elong to th he technica al responsible official to prepa are the rep port to bee
presented to the Min nistry of Health, for th
he purposess of producct registration, as well as to lend
d
effective te
echnical as
ssistance to
o the sectorr under his or her proffessional re
esponsibility
y.

Art. 55 - Although h the deliv very of teechnical asssistance tot the esttablishment may be e
discontinued, or sh hould the latter cea ase operatting, the responsibility of the e technicall
professional for activ
vities carrie
ed out so fa
ar shall rem
main in forc
ce for a one
e-year perio
od counted
d
ermination of
as from te o activities
s.

Art. 56 - Irrespective of other legal typiffications, in

ncluding criiminal ones
s, for which technicall
and adminnistrative re
esponsible officials ma ay be made e accountable, the co
ompany sha all be liable
e
both from the admin nistrative and
a civil po
oints of vie
ews for sannitary misconduct derriving from m
non-compliance with this Law and its regu ulations as well
w as with h other com
mplementarry.

TITLE IX
Labelin
ng and Advertising

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Art. 57 - The
T Executive Branch shall decidde by mean ns of regula ation, on la
abeling, pro
ospectuses,,
printed maaterial, labe
els and other informattion materiial pertainin
ng to produucts mentiooned in this
s
Law.

Sole paragraph - In addition to the co ommercial name or brand, medicine must display, in n
the items referred to in the heading of this Article, in packa
aging and promotiona al material,,
the Brazilian
B C
Common Denomination or, when ap ppropriate,, the Internationall
Nonpro oprietary Name,
N in letters and characters
c never smaller than thhe size of letters and
d
characcters appeaaring in thee commerc cial". (Para
agraph addded by provisional Me easure No.
1912-77,of Augustt 27, 1999)).

Article 58 - Advertis sement, un nder any foorm of pub blicizing an

nd means o
of commun
nication, off
products under
u the regime of this Law may only be carried out after authorization by the e
Ministry off Health, as
s to be prov
vided for in
n regulation
n.

§ 1º - In cases of drugs, medicines

m o any other productt under the
or e requiremeent of sale
e
according to medical
m or dental prescription,, advertise ement sha all be res
stricted too
ations exclu
publica usively mea
ant for distrribution to physicians,, dentists a
and chemistts.

§ 2º - Advertisem
ment of fre
ee-sale med et products, household
dicines, die d sanitizing
g products,,
cosmettics and hy
ygiene products shalll be subjec
ct to speciffic norms tto be provided for in
n
regulattions.

Art. 59 - Geographic cal names,, symbols, images, drawings orr any indica ation leadin
ng to false
e
interpretattion, error or confusion as to origin, pro ovenance, nature, composition or quality,,
attributing
g to the prooduct purpo
oses or chaaracteristics
s other tha
an those it really poss
sesses mayy
not appear either in labeling
l or in advertis
sing of prod
ducts mentioned in this Law.

TITLE XI
Packaging

Art. 60 - Approval by the Miinistry of Health, as may be provided ffor in regu ulations, off
packaging, equipment and ute ensils prep pared or in nternally co
oated with substance es that, inn
duct, may alter
contact with the prod a its effe
ects or brin
ng about haarm to health, is mand
datory.

§ 1º - Packaging
g meant for containin ng drugs, medicines,
m pharmaceu utical inputts, hygiene
e
cts, cosme
produc etics, perfuumes and related products
p th
hat do no ot internally contain n
substances capab
ble of alterring the pu
urity and effficacy conditions of tthe producct shall nott
dependd upon app
proval.

§ 2º - The use of packag ging meant for conta aining or packaging

p drugs, me edicines orr
pharmaceutical in
nputs shall not be autthorized if apt
a to bringg about direct or indirrect hazard
d
to health.

§ 3º - Approval of types of packag

ging shall be precede
ed by prev
vious analy
ysis, when
n
approp
priate.

TITLE XII
Means of Transpo
ortation

Art. 61 - In cases of
o products requiring special storage and safekeeping
s g conditions, vehicles
s
used for their transp
portation sh
hould countt on equipm ment allowwing packagging and prreservation
n
conditions apt to ens
sure the purity, safety and efficac
cy condition
ns of produ
ucts.

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 Sole Paragraph - vehicles used
u in the
e transporta
ation of drrugs, medic
cines, pharrmaceuticall
inputs and related
d products,, diet, hygieene produc
cts, perfumes and sim
milar produccts must bee
granted the necesssary disinffection andd hygiene conditions necessary
n fo
or the pres
servation off
human n health.

TITLE XIIII
Infracttions and Peenalties

Art. 62 - A medicine, drug or ph

harmaceutical input is
s deemed altered, adu
ulterated orr unfit:

s been mix
I. If it has xed or pack ubstances apt to mod
ked with su dify its therapeutic va
alue or the
e
purpose it is meant for,
f

a integral element off its normal compositiion has bee

II. When an en withdraw wn or falsiffied, wholly
y
or partly, or
o when suuch elementt has been replaced by b another one
o of lowe
er quality or
o when the e
dosage ha as been modified, or iff a substance foreign to its comp
position hass been added to it, so o
that it bec
comes different from the
t formula
a contained in the regiistration;

III. en
Whe its volume does not corres
spond to
o the approved amount;

IV. When its purity

y, quality and
a authenticity do not meet the requirements of
o Brazilian
n
Pharmacop
poeia or of other code
e adopted by
b the Minis
stry of Health.

graph - sho
Sole Parag ould there occur chan nges due too the passa age of time
e or to caus
ses beyondd
the responsibility off the techn nician or ofo the com mpany the latter would be com mpelled too
immediateely withdraaw the prroduct from m the ma arket, for the appro opriate corrrection orr
replacemeent, under the
t risk of incurring
i in
n sanitary in
nfraction.

Art. 63 - A hygiene product,

p co
osmetic, pe
erfumes or similar pro
oduct is dee
emed forge
ed, falsified
d
or adultera
ated when::

s presente
I. it is ed with ind dications leading to error, dec
ception or confusion as to its
s
provennance origin
n, composittion or purp
pose;

II. it does not meeet the sta

andards and d paradigmms set forth
h in this Law and in regulations,,
or the specificatio
ons contained in registtration;

III. its nature, composition, properties or characteristics insttrumental ffor its regis
stration are
e
modifie ed due to addition,
a reduction or withdrawall of raw maaterials or c
components s.

aragraph - Inputs made up of ac

Sole Pa ctive, addittional or co
omplementaary raw ma aterial, of a
chemiccal, bio-che
emical or biological
b n
nature, of natural orr synthetic origin, or any otherr
material meant for
f manufaacturing, haandling and processin ng hygiene
e products,, perfumes s
milar produ
and sim ucts are included in the provisionns of this Arrticle.

Art. 64 - It is forbidden to re eutilize con

ntainers traaditionally used for ffood, beverrages, softt
et products
drinks, die s, mediciness, drugs, chemicals, hygiene
h pro
oducts, cos
smetics and d perfumes s
for packagging sanitiz
zing and sim
milar produucts. must be granted d the necesssary disinffection and
d
hygiene coonditions neecessary fo
or the preseervation of human hea alth.

Art. 65 - It is forbid
dden to entter new da
ates or to re-pack
r in new packaaging produucts whose
e
period of validity has expired, except forr therapeuttic serums susceptible
e of being red-dosed
d
ered.
and re-filte

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Art. 66 - Non-compl
N iance with provisions of this Law w, of its re
egulation and of comp plementaryy
norms imp plies sanita
ary infractio
on, infracto
ors being subject to prosecution
p and to the
e penalties
s
provided for
f in decrree-Law No o. 785, of August 25, 1969, without
w pre
ejudice for the otherr
applicable civil and criminal
c typ
pifications.((Note: Decrree-Law No o. 785, of A
August 25, 1969, was s
revoked byy Law No. 6.437,
6 of August
A 20, 1977).

Sole Pa aragraph - The lawsuuit referred to in this Article

A may
y be initiate
ed and judged by the e
Ministrry of Health
h or by thee sanitary authorities
a of the Stattes, the Federal District and the
e
Territo
ories, as appropriate.

Art. 67 - Irrespective of infractions provided for in Decree-Law No. 785, of Augus st 25,1969,,
wing practices susce
the follow eptible of punishmen nt by sanctions indicated in that legall
instrument constitutee serious or most serious infracttions: (Dec
cree-Law No
o. 785, of August
A 25,,
1969, wass revoked by
b Law No. 6.437, of August
A 20, 1977).

abel products under tthe regime

I. To la e of this Law or to advertise the
em without complying g
with prrovisions off this Law and of its regulations
r or in a ma
anner contrrary to the terms and
d
conditions of Health;

II. To alter the manufacturi

m ng process
s of produc
cts without previous a
assent by th
he Ministry
y
of Health;

III. To sell or disp

play for sale
e a productt whose period of valid
dity has ex
xpired;

IV. To enter new dates in products wh hose period of validity

y has expire
ed or to pack them in
n
new coontainers, except
e for therapeutic
t serums ap
pt to be re-dosed and re-filtered;;

V. To industrialiize produc
cts withoutt the assis
stance of a legally accredited
d technicall
respon
nsible officia
al;

VI. To use ,in th

he prepara ation of ho
ormones, organs
o of animals
a thaat are not sound, orr
nting signs of decay the
presen t momennt they are to be manipulated, or coming from ill orr
exhaussted animals, or from animals ha
aving underrgone loss of weight;

o re-sell a biological
VII. To b prroduct thatt has not be
een kept un
nder refrige
eration, in compliance
c e
with in
ndications determined
d by the manufacturer and approv ved by the Ministry off Health;

VIII. To
T use rat killers wh hose actionn be performed throu ugh gas or steam inn galleries,,
drainpiipes, basem
ments, cella
ars or place
es having possible
p communicatio
on with res
sidences orr
places frequentedd by humann beings or useful anim
mals.

TITLE XIV
n
Inspection

Art. 68 - Sanitary
S surveillance activities
a hall encompass all and any prod
sh duct mentio oned in this
s
Law, incluuding thosee for which h registratiion is waiv
ved and re elated prodducts, manufacturing,,
distribution, storage and sale esstablishments and the e vehicles meant
m for ttransportation of such
h
products.

Sole Paragraph
P - Advertise ement of products
p and brand names, through any means off
commuunication, publicity,
p la
abeling and labels are also subjec
ct to surveiillance activ
vities.

Art. 69 - Inspection activities

a be
elong to:

I. The federal hea

alth organiz
zation;

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 a) when the product is in transit from one federal uniit to anoth
her, by road, through
h
ers, lakes
rive s, sea o or air, under th he control of fed deral organizations;

b) when
w it is an
a imported
d or exportted productt;

c) when
w it is the case of sample collection for control, pre
evious and fiscal analy
ysis.

e State, Terrritory or Fe
II. The ederal Distrrict health organizatio
o ons:

a) when it ann industrialized produ

uct, or when it is de
elivered forr consumpttion in the
e
respective are
ea of jurisdiction;

b) as to industrial or comm
mercial es
stablishmen
nts, facilitties or equipment;
e

nsport through roads, rivers an

c) as to tran nd lakes within
w their jurisdictio
onal areas;

d) when
w it is the
t case of sample collection for fiscal analy
ysis.

Sole Paragraph
P - Competence mentio oned in thiis Article may
m be devolved, by y means off
agreemment, in a reciprocal manner, by the Unio on, the States and Fe ederal Distrrict, exceptt
for the
e hypothese
es of non-trransferable powers, as
s expresslyy provided ffor in law.

Art. 70 - Sanitary surveillance activities shall be ca

arried out on a perm
manent basis, being a
routine acttivity of health organizations.

Art. 71 - Functions
F a
and preroga
atives of inspection ag
gents shall be establis
shed in reg
gulations to
o
this Law.

Art. 72 - Assessmen nt of infracctions, und

der this Laww, shall be
e done by means of seizure off
samples and interdicttion of the product or of the esta
ablishment,, as provide
ed for regulation.

§ 1º - Verrification off infraction shall give grounds, as

a appropriiate, for se eizure and destruction
d n
of the prod
duct, all ovver the natiional territo
ory, for can
ncellation of registratio
on and cashiering the
e
establishm
ments licen nse, steps that shalll only be ecome effe ective afterr publication of the e
condemnin ng decision in the Official Journal of the Union.

anges due to
§ 2º - Cha t unpredic
ctable causes, circums stances or natural eveents apt to determinee
damage, deterioratio
d on or conta
amination of
o products, rendering g them inefffective or harmful to
o
health sha
all also prov
vide ground
ds for seizure, interdic
ction and de
estruction.

Art. 73 - For the purposes

p o sanitary surveillance, experim
of ments mea ant for verifying the e
efficiency of formulae
e shall be carried
c out in compliance with no
orms set fo
orth by the Ministry off
Health.

Art. 74 - Civil
C servan
nts who arre partners,, shareholdders of, or have an in
nterest of any
a kind in
n
companies s carrying out
o activitie es subject to the regime of this Law, or who deliver services to
o
such organnizations orr in control laboratorie
es.

TITLE XV
Quality C
Control of Medicines
M

Art. 75 - The
T Ministrry of Health
h shall enact norms and
a improve mechanis sms meantt to ensure e
consumers s the qualitty of mediccines, bearing in mind
d the identity, activity
y, purity, efficacy and
d
innocuity of
o products s, and encompassing quality
q spec
cifications and
a produc ction inspec
ction.

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 aragraph - Norms refe
Sole Pa erred to in this Article
e shall, dete
ermine the quality speecifications
s
of raw materials and of sem mi-processeed products s used in th
he manufac cture of meedicines, ass
well as
s the qualitty specifications of the
e latter, annd shall acccurately de
escribe the criteria forr
the res
spective acc ceptance.

Art. 76 -N No raw ma aterial or semi-proce essed product may be b used in the manu ufacture off
medicines without th he verificattion that th
hey posses acceptable e quality, a
according to evidence
e
that shall be dealt with in norms issued by y the Ministtry of Health.

Art. 77 - Inspection
I of the prod
duction of medicines
m shall
s bear in mind, on
n a priority
y basis, the
e
following aspects:
a

I. mannufacturing,, bearing in
n mind unffavorable in
ntrinsic and
d extrinsic factors, inc
cluding the
e
possibiility of con
ntaminationn of raw materials, of semi-p processed products and a of the
e
finished product;

II. the finished prroduct, in order

o to check whethe er in meets
s requireme
ents pertaining to the
e
techniccal officials
s in charge of manufaacturing an nd inspectio
on of produ
ucts, to the
e sites and
d
equipmment, to th he sanitatio
on of the environmen
e t, to raw materials
m a
and to insppection and
d
self-ins
spection sy ystems and to the regiistration of medicines.

Art. 78 -WWithout preejudice for control annd inspectio

on carried out by the e public poowers, anyy
establishmment meantt for the production ofo medicine es shall possses a tech
hnical depaartment forr
quality ins
spection, op
perating in an autonom mous mann ner within its sphere o
of competence, aimed d
at checkinng the qua ality of raw
w materials
s or substa ances, at surveying
s q
qualitative aspects off
manufactu uring operaations and the stabilitty of medic
cines produuced, as weell as at ca
arrying outt
other neceessary tests
s.

Sole Paragraph - Industrial pharmace eutical labooratories arre allowed to carry out controls
s
ed for in th
provide his Article in official in
nstitutes orr laboratories, by mea
ans of agreeements orr
contrac
cts.

Art. 79 - All
A reports ono accidentts or harmfful reactions s caused byy mediciness shall be transmitted
t d
to the rele
evant sanitaary authoritty.
Only Para agraph - Changes
C in the quality of med dicines andd any chan nge in the eir physicall
characterisstics shall be investig
gated in alll details, and
a once verified,
v sh
hall be subjject to the
e
appropriatte correctiv
ve measures.

TITLE XVI
Sanitary Surrveillance Organizatio
O ns

Art. 80 - Sanitary
S surveillance activities
a n this Article shall be c
mentioned in carried out:

ederal level, by the Ministry

I. at fe M of Health,
H as provided
p fo
or in legisla
ation and re
egulations;

II. in the
t States, Territories and in thee Federal District,
D ough their own organizations, in
thro n
compliance with the
t relevannt federal no
orms and with
w the loccal supplem
mentary legislation.

TITLE XVIII
Final and Transitory Provisions

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Art. 81 - Companies
s already exploiting
e a
activities mentioned in
n this Law shall havee a twelve--
month period to carrry out the
e changes and adapttations nec cessary forr complianc
ce with its
s
provisions.

Art. 82 - (Revoked by
y Provisional Measure
e No. 1912--7, of August27, 1999
9).

Art. 83 - Drugs,
D micals and workshop products shall be sold
chem d in their original pack
kaging and
d
may only y be fractionated fo or re-sale, in comm
mercial esta ablishmentts, under the directt
responsibility off the respective technical official in charge.

Art. 84 - Provisions of this Laaw do not preclude the

t enforceement of o other norm
ms covering
g
activities mentioned
m herein as to
t aspects mentioned
m in specific legislation.

Art. 85 - Provisions
P of this law apply to products
p mentioned
m in
n Article 1,, governed by speciall
norms, as appropriatte.

Art. 86 - Sanitizing
S phyto-sanittary and zo
oo-sanitary
y products, those of eexclusive veterinarian
n
use and thhose meant for fighting rats andd other rod
dents in ag
griculture are excluded from the e
regime of this Law, since
s they are meant for use for purposes s different ffrom those herein sett
forth.

Art. 87 - The Execuutive Branc ch shall enaact the reggulation an

nd the dee eds necessa ary for the
e
accurate compliance
c with this la
aw.
Only Paraggraph - Whhile regulatiion and othher deeds provided
p for in this Arrticle are no
ot enacted,,
the curren
nt ones thatt do not conflict with provisions
p of
o this Law shall rema ain in force..

Art. 88 - This
T Law enters into force 95 (n
ninety-five)) days afte
er its public
cation, and provisions
s
contrary to
o it are herreby revoke
ed.

B
Brasilia, Sep
ptember 23
3, 1976; 15
55 of Independence an
nd 88 of the
e Republic.

Ernesto Geisell
Paulo
o de Almeid
da Machadoo

Font: Offic
cial Gazette
e, Septemb
ber 24, 1976

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