Académique Documents
Professionnel Documents
Culture Documents
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1.
2.
2.
1
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3.
33.
4.
44.
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55.
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8.
88.
Uvod
Introduction
ALIMS - organizacija koja se kontinuirano razvija i unapreuje...............................................
4
ALIMS - an organization that is continually evolving and improving.................................................
2.1. Misija i vizija ALIMS...............................................................................................................
5
2.1. Mission and Vision of ALIMS.........................................................................................................
2.2. Organizacija ALIMS...............................................................................................................
7
2.2. ALIMS Organization.........................................................................................................................
2.3. Istorijat i povereni poslovi....................................................................................................
9
2.3. Background and entrusted activities...........................................................................................
2.4. Ljudski resursi........................................................................................................................
12
2.4. Human Resources............................................................................................................................
2.5. Meunarodna saradnja i lanstvo u meunarodnim organizacijama.....................
13
2.5. International cooperation and membership in international organizations.....................
2.6. Ciljevi razvoja..........................................................................................................................
18
2.6. Development Goals ......................................................................................................................
Regulatorna performansa ALIMS......................................................................................................
20
ALIMS Regulatory Performance....................................................................................................................
3.1. Predregistracione aktivnosti................................................................................................
21
3.1. Pre-registration activities................................................................................................................
3.2. Medicinska sredstva.............................................................................................................
25
3.2. Medical devices.................................................................................................................................
3.3. Veterinarski lekovi.................................................................................................................
27
3.3. Veterinary medicines.......................................................................................................................
3.4. Postregistracione aktivnosti: farmakovigilanca, informacije o lekovima,
praenje potronje i prometa, oglaavanje..................................................................... 28
3.4. Post-registration activities: pharmacovigilance, information about medicines,
monitoring of consumption and trade, advertising.................................................................
3.5. Klinika ispitivanja.................................................................................................................
34
3.5. Clinical trials.......................................................................................................................................
Laboratorijska kontrola kvaliteta.......................................................................................................
36
Laboratory quality control...............................................................................................................................
Upravljanje kvalitetom u ALIMS.........................................................................................................
40
Quality Management in ALIMS.....................................................................................................................
Struni skupovi u organizaciji ALIMS - edukacija strune javnosti..........................................
43
Professional meetings organized by ALIMS - education of expert public.........................................
Publikacije ALIMS...................................................................................................................................
45
ALIMS Publications...........................................................................................................................................
Internet stranica ALIMS........................................................................................................................
47
ALIMS Website..................................................................................................................................................
1. Uvod
Direktor
1. Introduction
hrough time, the main orientation of man is his concern for his health and life, so in his
struggle for survival this determination was a driving force to preserve them. The result
of this is the development of medicines and medical devices, in order to treat or prevent
diseases, or preserve life in humans and animals.
Now, obligation to preserve the health and life is taken in part by Medicines and Medical Devices
Agency of Serbia - ALIMS, that in accordance with the Law on Medicines and Medical Devices
(Official Gazette of RS, no. 30/2010 and 107/2012) and regulations adopted for its execution
complies with the requirements and standards of the European Union gives decission to confirm
the quality, safety and efficacy of medicines and medical devices.
Seriousness and commitment with which all employees shall approach their work tasks in
accordance with the level of responsibility in making these decisions by the Agency. Also, in
the prescribed quality control of medicines and medical devices the Agency makes decisions
every day in order to check if the standards in relation to their quality are met and these are the
standards of most developed countries in the world, to ensure the security of the application of
these products.
The system established in the Agency was tested in some difficult circumstances and showed
that Serbian citizens can have trust in the Agencys decision in relation to medicines and medical
devices that are within its market.
A specific activity of the Agency is following the life cycle of the drug on the market and possibly
taking corrective measures as provided in our regulations in the field of pharmacovigilance, that
are also in compliance with the latest EU standards.
In carrying out its duties the Agency maintains permanent cooperation with state authorities,
universities, professional associations of doctors, pharmacists, dentists, veterinarians, patient
organizations, the media and the general and professional public.
Also, the Agency in carrying out its duties develops a high level of regional and international
cooperation, and has support in its development by reference organization in Europe and the world,
which is also reflected in a number of projects and the existence of international agreements in
the areas the Agency is in charge of.
Putting on the market medicines and medical devices for which quality, safety and efficiency are
proved by prescribed procedures are the basic principles of the Agency, in order to achieve the
objectives in relation to the preservation of health, extending life and securing its quality.
Managing Director
5
2.1. Misija i vizija ALIMS
6
Nau viziju emo ostvariti kroz efektivne i efi
kasne procese u okviru sistema menadmen
ta kvalitetom, usaglaenog sa zahtevima ISO
9001:2008, tako to emo:
uspostavljati i odravati visoke standar
de u postupku evaluacije dokumentacije,
kontoli kvaliteta i pruanju adekvatnih
informacija,
kontinuirano uiti i razvijati kompetent
nosti,
kontinuirano poboljavati sistem menad
menta kvalitetom,
izgraditi jaku organizacionu kulturu i pre
poznatljiv imid,
imati lidersku ulogu rukovodstva u ostva
renju vizije.
Osnovne vrednosti
Basic values
7
2.2. Organizacija ALIMS
Direktor
Managing director
Kancelarija direktora
Managing Director Office
Nacionalna kontrolna
laboratorija
National Control
Laboratory
Fiziko-hemijska
laboratorija
Physico-Chemical
Laboratory
Bioloka laboratorija
Biological Laboratory
Odeljenje za upravljanje
kvalitetom i podrku
Quality Managment
and Support Unit
Centar za
humane lekove
Human Medicines
Centre
Sektor za stavljanje u
promet humanih lekova
Licencing Department
Sektor za procenu
dokumentacije o leku
Assessment Department
Farmaceutski sektor
Pharmaceutical
Department
Medicinski sektor
Medical Department
Nacionalni centar
za farmakovigilancu
National
Pharmacovigilance
Centre
Centar za podrku
Centre for Support
Finansijski sektor
Financial Department
Odsek za raunovodstvo
Accounting Department
Odsek za komercijalne
poslove
Department of
Commercial Affairs
Administrativni sektor
Administrative Department
Sluba za prijem zahteva
iz nadlenosti Agencije i
poslove pisarnice
Receipt and Issuing
Affairs
Odeljenje za prave i
opte poslove
Legal and General
Affairs
Grupa za informacionu
tehnologiju
IT Group
Veterinarski sektor
Veterinary Medicines
Department
Sektor za
medicinska sredstva
Medical Devices
Department
8
Upravni organi Agencije su Upravni odbor
i direktor. Upravni odbor ima predsednika
i etiri lana, od kojih se jedan bira iz reda
zaposlenih u Agenciji.
U okviru Agencije takoe funkcioniu Komi
sije koje ine eksperti, saradnici Agencije i
to su:
Komisija za stavljanje u promet humanih
lekova
Komisija za stavljanje u promet veterinarskih
lekova
Komisija za medicinska sredstva
Komisija za procenu klinikih ispitivanja
humanih lekova
Komisija za procenu bezbednosti lekova
Komisija za farmakovigilancu veterinarskih
lekova
Komisija za procenu klinikih ispitivanja
veterinarskih lekova
Pored ovoga, ALIMS u pojedinim pitanjima
strune procene koristi i usluge spoljnih
eksperata, najeminentnijih strunjaka u
naoj zemlji za pojedine oblasti medicine i
farmacije. Konano, ALIMS je bio i domain
drugim telima kao to je Komisija Evropske
farmakopeje (na slici).
Managing bodies of the Agency are a Managing Board and managing director. The
Managing board has a chairman and four
members, one of whom is chosen among the
Agency employees.
Within the Agency also operate Commi
ssions, which are made by experts, collaborators of the Agency and these are:
Committee for Marketing Authorization of
Human Medicines
Committee for Marketing Authorization of
Veterinary Medicines
Committee for Medical Devices
Committee for Human Medicines Clinical
Trials Assessment
Committee for Medicines Safety Assessment
Committee for Veterinary Medicines Pharmacovigilance
Committee for Veterinary Medicines Clinical
Trials Assessment
In addition, in certain matters of expert evaluation ALIMS uses services of external experts,
the most eminent experts in our country in
certain areas of medicine and pharmacy. Finally, ALIMS was the host of other bodies,
such as the European Pharmacopoeia Commission (on the picture).
9
2.3. Istorijat
i povereni poslovi
2.3. Background
and entrusted activities
Already in the 1948, within the federal administrative body of Yugoslavia, responsible for
health, a Federal Bureau was established,
which in addition to medicines was dealing with
testing and control of sera and vaccines, as well
as cosmetics, dietary supplements, medical
equipment, and other materials that are used in
medical purposes. This Institute has grown into
the Republic Institute for testing and control of
medicines, which under the name of The Pharmacy Institute of Serbia operates from 1960.
Serbia develops a new national policy on medicines in accordance with the amended system
of production and distribution of medicines in
the world, and the Law on Medicinal Products
and Medical Devices (2004) is adopted, pursuant to which the manufacture and distribution
of medicines and medical devices is harmonized with directives and recommendations of
EU and ICH and on the basis of which in 2004
the Medicines and Medical Devices Agency of
Serbia is formed.
During its long history, generations of pharmacists, doctors, chemists, and other professions, specialists, masters and PhDs, as well
as hundreds of employees have become part
of the history and traditions of the Pharmacy Institute and at the same time, Medicines
and Medical Devices Agency of Serbia.
10
Agencija za lekove i medicinska sredstva
Srbije je nadlena da:
11
13. Uestvuje u planiranju i sprovoenju si
stematske kontrole lekova i medicinskih
sredstava i uzimanju sluajnih uzoraka iz
prometa;
14. D
aje miljenja za uvoz i izvoz uzoraka e
lija, odnosno tkiva za postupak klinikog
ispitivanja lekovima;
15. Vri kontrolu kvaliteta lekova i medicinskih
sredstava;
16. Priprema strune publikacije iz nadleno
sti Agencije;
17. V
ri i druge poslove, u skladu sa zakonom.
Prostorni resursi
Aktivnosti u ALIMS odvijaju se u dva objekta staroj zgradi, koja je pripadala Zavodu za far
maciju Srbije i novom objektu, ija je izgrad
nja finansirana iz projekta Evropske agencije
za rekonstrukciju. Sve laboratorije u okviru
Nacionalne kontrolne laboratorije ALIMS su
renovirane tako da odgovaraju najstroijim
svetskim zahtevima u oblasti kontrole kvali
teta, to se naroito odnosi na Mikrobioloku
laboratoriju, odnosno sterilni blok ove labo
ratorije.
Facility capacities
Activities in ALIMS are carried out in two
objects the old building, which belonged to
the Pharmacy Institute of Serbia and the new
facility the construction of which was financed
from the project of the European Agency for
Reconstruction. All the laboratories within the
National Control Laboratory of the Agency
have been renovated so as to comply with
the strictest world demands in the domain of
quality control, particularly the Microbiological
Laboratory, i.e. its sterile block.
Oprema
ALIMS raspolae najsavremenijom opre
mom, neophodnom kako za kontrolu kvalite
ta lekova i medicinskih sredstava, tako i za
informatiku podrku svim procesima koji se
u ALIMSU obavljaju. Neophodne kvalifikaci
je i kalibracije opreme, kao i procesi zatite
podataka na raunaru se redovno obavljaju,
prema definisanim planovima.
Equipment
The Agency disposes with the latest equipment necessary for the quality control of
medicines and medical devices, as well as
for the informatics support for all processes
conducted in the Agency. Necessary equipment qualification and calibration, as well as
computer data protection processes are performed on a regular basis, according to the
plans defined.
12
2.4. Ljudski resursi
13
2.5. Meunarodna
saradnja i lanstvo u
meunarodnim
organizacijama
2.5. International
cooperation and
membership
in international
organizations
14
narske lekove (Agence Franaise de Securit
Sanitair e des Alments ANSES - ANMV).
U okviru meunarodne saradnje koju Agen
cija trenutno vodi, najpre treba istai aktiv
nosti u okviru IPA projekta (The Instrument
of Preaccession Assistance) koji se realizuje
u periodu od 2009. godine. U pitanju je sa
radnja sa Evropskom agencijom za lekove
(EMA) u okviru pridruivanja Srbije Evrop
skoj uniji.
and the French Agency for veterinary medicines (Agence Franaise de Scurit Sanitaire
des Alments - ANSES - ANMV).
In the framework of international cooperation
that the Agency is currently running, we should
first point out activities under the IPA project
(The Instrument of Pre-Accession Assistance),
which is realized in the period since 2009. It
is cooperation with the European Medicines
Agency (EMA) within Serbias EU accession.
CALIMS
Agence Nationale du Mdicament Vtrinaire (ANMV)
Agencija za lijekove
i medicinska sredstva Crne Gore
Agency for Medicines and
Medical Devices of Montenegro
15
16
ju i reviziji monografija Evropske farmako
peje koje predstavljaju standarde kvaliteta
za supstance koje se koriste u farmaceut
skoj industriji. U okviru drugih tela EDQM
Agencija kroz uee svojih eksperata ta
koe ostvaruje meunarodnu saradnju u
oblastima seruma i vakcina i borb
e protiv
falsifikovanih lekova, kao i evaluaciju CEP-a
i sterilnosti.
Agencija za lekove
i medicinska sredstva Srbije
Medicines and Medical Devices
Agency of Serbia
17
Nacionalna kontrolna laboratorija (NKL) je
lan Evropske mree zvaninih kontrolnih
laboratorija (OMCL mrea) a dugogodinji
izuzetni rezultati studija u kojima NKL
uestvuje u OMCL mrei potvruju kvalitet
rada i strunost zaposlenih u ALIMS.
Najnoviji sporazum koji je Agencija potpisala
u junu 2014. godine je Memorandum o
razumevanju i saradnji izmeu regulatornih
tela Srbije, Hrvatske, Bosne i Hercegovine,
Makedonije i Crne Gore.
National Control Laboratory (NCL) is a member of the European Official Medicines Control Laboratories Network (OMCL Network)
and long-time exceptional results of studies
in which NKL participates in OMCL network
confirm the quality of the work and expertise
of employees in ALIMS.
The latest agreement the Agency has signed
in June 2014 is a Memorandum of understanding and cooperation between regulatory bodies of Serbia, Croatia, Bosnia and Herzegovina, Macedonia and Montenegro.
CALIMS
Agencija za lijekove
i medicinska sredstva Crne Gore
Agency for Medicines and
Medical Devices of Montenegro
18
2.6. Ciljevi razvoja
19
primena standarda Dobre klinike prakse,
odobrenje onih klinikih ispitivanja u Srbiji,
koja su u skladu sa principima Dobre kli
nike prakse, kao i jaa kontrola njihovog
sprovoenja;
unapreenje nacionalnog sistema far
makovigilance humanih i veterinarskih
lekova;
razvoj sistema vigilance medicinskih sred
stava i uspostavljanje i razvoj sistema
vigilance vakcina i biljnih lekova;
dalji razvoj sistema redovnog pruanja in
formacija o lekovima i medicinskim sred
stvima strunoj i optoj javnosti;
unapreenje meunarodne saradnje i po
vezivanje sa drugim agencijama i meuna
rodnim asocijacijama;
jaanje kadrovskih kapaciteta Agencije po
veavanjem ukupnog broja zaposlenih, kao
i jaanjem kompetentnosti strunjaka na
ekspertskim poslovima procene dokumen
tacije kontinuiranom edukacijom;
unapreenje prostornih kapaciteta Agenci
je, u smislu obezbeenja osnovnih uslova
rada;
borba protiv falsifikovanih lekova i medicin
skih sredstava;
dalje aktivnosti na polju edukacije javnosti
i zdravstvenih radnika.
3. Regulatorna
performansa ALIMS
3. ALIMS Regulatory
performance
21
3.1. Predregistracione
aktivnosti
3.1. Pre-registration
activities
22
23
leka. Primarna uloga teksta pakovanja je ja
sna i nedvosmislena identifikacija leka i uslo
va za njegovu bezbednu primenu.
Kroz definisanje i unos matinih podataka o
leku u centralnu bazu podataka Agencije se
u informacionom sistemu Agencije moe pra
titi ivotni ciklus leka, odnosno sve promene
u okviru njegovog kvaliteta, bezbednosti i efi
kasnosti. Takoe, to omoguava da podaci na
izlaznim dokumentima Agencije budu preci
zni i tani, kao i da se poveu slini lekovi i na
taj nain identifikuju terapijske paralele.
Agencija na osnovu procenjene dokumenta
cije odobrava uvoz neregistrovanih lekova
i medicinskih sredstava neophodnih za hit
nu, specifinu terapiju pojedinih pacijenata
ili grupe pacijenata, na zahtev zdravstvenih
ustanova. Takoe se odobrava uvoz lekova i
medicinskih sredstava namenjenih za klini
ka i nauna istraivanja kao i u svrhu dobija
nja dozvole za stavljanje u promet.
Procena bezbednosti leka podrazumeva eva
luaciju dokumentacije o bezbednosti leka u
postupku dobijanja dozvole za njegovo sta
vljanje u promet, njenih obnova, izmena i do
puna (varijacije) i izradu ekspertskog izveta
ja o bezbednosti leka, kao i procena period
i
nog izvetaja o bezbednosti leka (PSUR) do
24
stavljenih od strane farmaceutske industrije
nakon dobijanja dozvole za stavljanje leka u
promet.
to se tie procene efikasnosti leka, vri se
procena dokumentacije o efikasnosti leka u
postupku dobijanja dozvole za njegovo sta
vljanje u promet, njenih obnova, izmena i
dopuna (varijacije) i izradu ekspertskog iz
vetaja o efikasnosti leka, a zatim procena
dokumentacije o bioe kvivalenciji u postupku
dobijanja dozvole za njegovo stavljanje u pro
met i izradu ekspertskog izvetaja o bioekvi
valenciji.
U okviru Administrativnog sektora koji u svom
sastavu ima Slubu za prijem zahteva iz nad
lenosti Agencije i poslove pisarnice i Ode
ljenje za pravne i opte poslove pored optih
pravnih poslova, obavljaju se i regulatorni po
slovi. Naim
e, izvrioc i na ovim radnim mesti
ma izdaju pravna miljenja u oblasti lekova i
medicinskih sredstava, kao i pravna miljenja
u postupku formalne procene dokumentacije
o leku.
Pored Zakona o lekovima i medicinskim sred
stvima, u okviru regulatornih poslova u Agen
ciji se primenjuje i Zakon o optem upravnom
postupku u odnosu na sve poverene poslove.
Agencija odobrava izdavanje kontrolnih ma
rkica, kao i tampanje dodatnih markica za
lekove na stranom pakovanju, kao dodatnu
identifikaciju i zatitu od falsifikovanja.
Agencija postupa i po zahtevima za slobodan
pristup informacijama od javnog znaaja ko
jima raspolae ovaj organ javne vlasti, a koje
su nastale u radu ili u vezi sa njenim radom.
Primenjujui navedene propise, pored brige o
lekovima i medicinskim sredstvima, Agencija
se stara da se ostvari slobodni demokratski
poredak i informie javnost o svom radu.
0123456789
25
3.2. Medicinska sredstva
26
a set of activities related to the collection, assessment, understanding and responding to
new information about the risks arising from
the use or application of medical devices, and
in particular its harmful effects, interactions
with other substances or products, contraindications, abuse, reduced activity, failure and
technically invalidity. The Agency organizes
and monitors the vigilance of medical devices,
collects information on the quality, safety and
efficacy of medical devices after they are placed
on the market, as well as the rate of discovery
of known and new adverse reactions.
On all matters within the jurisdiction of the
Medical Devices Department, the cooperation
with manufacturers of medical devices or their
authorized representatives (representative offices, agents, distributors, etc.) is achieved.
Significant acceleration and simplification
of procedures for resolving clients requests
within the jurisdiction of the Medical Devices
Department, is of great importance and beneficial for both the customers and for patients
and other users of medical devices, which will
promptly and adequately have available high
quality, safe and effective medical devices in
the Serbian market.
644
700
600
500
338
400
300
200
100
69
0
2011
2012
2013
27
3.3. Veterinarski lekovi
Within the Agency exists a Veterinary Medicines Department is organized which is responsible for the marketing of veterinary medicines,
renewal and variation, then also for clinical trials, pharmacovigilance of veterinary medicines
and expert opinions while laboratory quality
control of veterinary medicines is performed in
the National Control Laboratory of the Agency.
The prescribed structure of registration dossiers
for veterinary medicine is divided into two sections according to the type of medicines: pharmaceutical and immunological medicines.
The registration dossier for each section
consists of administrative records and data
necessary to prove the quality, safety and efficacy of veterinary medicines.
However, due to the extremely complex subject, with which the quality, safety and efficacy of veterinary medicines is proved, as well
as with a diverse range of products there is
a need for additional laws in order to specifically regulate certain segments in this area.
Agency is paying special attention to veterinary
medicines that may indirectly affect the food,
and to a large extent the safety of veterinary
medicines also relates to security of people.
In cooperation with the Ministry of Agriculture and Enviromental Protection of the Republik of Serbia, that is, the Veterinary Directorate we have made significant progress in
the area of checking the quality of medicines
on the market that has resulted in appropriate regulatory actions.
In addition, the Agency will contribute to the
safety of animals through intensive monitoring and providing information on the adverse
medicines reactions by developing pharmacovigilance system, as is already done for
medicines for human use.
28
3.4. Postregistracion
e
aktivnosti
3.4. Post-registration
activities
Farmakovigilanca
Pharmacovigilance
The EU regulation volume 9 is fully implemented within the Agency, which relates to pharmacovigilance of medicines for human and also on
Pharmacovigilance for veterinary medicines, as
well as the guidelines of the International Conference on Harmonization (ICH).
National Pharmacovigilance Centre (NPC) also
has continuous collaboration and connection
through vigibase with the World Health Organization Collaborating Center for International Drug Monitoring in Uppsala, Sweden (The
Uppsala Monitoring Centre - UMC). Experts
of the NPC regularly attend and contribute to
informational and educational events in the
area, as well as the annual meetings of the
member countries of the International Centre
in Uppsala and others.
Assessment of medicine safety profile is a
valid precondition for the implementation of
a rational (efficient, safe and cost-effective)
pharmacotherapy.
29
Implementacija principa savremene klinike
farm
akologije, klinike farmacije, farmakoki
netike, farm
akoterapije i farmakoepidemiolo
gije predstavlja imperativ za postizanje raci
onalne primene lekova.
NCF, evidencijom i procenom svih prijavlje
nih neeljenih reakcija na lekove, procenom
uzrono-posledine povezanosti izmeu pri
mene leka/medicinskog sredstva i neelje
nih reakcija, identifikacijom potencijalnih sig
nala, utvrivanjem faktora rizika, procenom
incidencije, kao i izradom drugih znaajnih
periodinih analiza prijavljenih neeljenih re
akcija, doprinosi da primenjena farmakotera
pija obezbedi postizanje eljenog terapijskog
efekta uz minimalan rizik od neeljenih reak
cija lekova.
Implementation of principles of modern clinical pharmacology, clinical pharmacy, pharmacokinetics, pharmacotherapy and pharmacoepidemiology is imperative to achieve
the rational use of medicines.
NPC, through recording and evaluating all
reported adverse reactions to medicines, by
assessment of the relationships between
the use of medicines / medical devices and
adverse reactions, identification of potential signals, identifying risk factors, estimate
the incidence, as well as making other significant periodic analysis of reported adverse
reactions, contributes that applied medicine
therapy ensures the achievement of the desired therapeutic benefit with minimal risk of
adverse drug reactions.
Godina / Year
2005.
2006.
2007.
2008.
2009.
2010.
2011.
2012.
2013.
Broj prijava /
Numbers of
reports
102
206
337
423
572
781
962
1179
1173
Informacije o lekovima,
praenje potronje
i prometa i lani lekovi
Information about
medicines, monitoring of
consumption and marketing
and counterfeit medicines
30
Strunjaci Agencije na osnovu pristupa savre
menim bazama podataka pruaju pouzdane i
bezbedne informacije o lekovima i medicin
skim sredstvima, kao i savete pacijentima i
zdravstvenim strunjacima za njihovu upotre
bu na racionalan i ekonomian nain.
U cilju promocije bezbedne upotrebe lekova i
medicinskih sredstava prikupljaju se i proce
njuju informacije za bazu podataka u okviru
integralnog informacion
og sistema, i pripre
maju publikacije (registar, farmakoterapijski
vodi i dr.).
U cilju farmakoepidemiolokih i farmakoeko
nomskih istraivanja Agencija prati promet i
potronju lekova i medicinskih sredstava.
Agencija redovno daje informacije o potro
nji lekova, izdatim dozvolama za klinika
ispitivanja, dozvolama za stavljanje u pro
met, obnovama i varijacijama dozvola za
stavljanje u promet, kao i povlaenju iz pro
meta lekova i medicinskih sredstava, o ne
eljenim dejstvima lekova, racionalnoj upo
trebi lekova i druge.
Novi globalni nain trgovanja i uslovi slobod
ne trgovine doveli su do ukupnog poveanja
proizvodnje svih lekova na svetskom tritu,
to je stvorilo povoljnije uslove i za proizvod
nju substandardnih i lanih lekova (counter
feit drugs).
Substandardni lek je originalni proizvod koji
ne odgovara postavljenoj specifikaciji kvalite
ta, to ima za posledicu neefikasnost leka i
dovodi u opasnost pacijenta. Substandardni
lek moe da bude posledica nemarnosti, ljud
ske greke, nedovoljnih ljudskih i finansijskih
sredstava ili falsifikovanja.
Lani lekovi predstavljaju deo ireg fenomena
substandardnih lekova. Nastali su kao posle
dica namernog i lanog oznaavanja obeleja
njegovog identiteta i/ili porekla.
Falsifik ovanje lekova oznaava namerno po
greno obeleavanje gotovih lekova ili sasto
jaka koji se koriste u njihovoj proizvodnji u smi
slu njihovog identiteta, sastava i/ili porekla.
Mogu se falsifikovati i zatieni i generiki pro
izvodi, a falsifikat moe da bude proizvod sa:
ispravnim sastojcima;
pogrenim sastojcima;
31
bez aktivnih supstanci;
sa aktivnim supstancama u nedovoljnim
koliinama ili proizvod upakovan u lano
pakovanje.
S tim u vezi zdravstveni radnici u svim obla
stima prakse treba da:
potuju principe Dobre apotekarske prak
se, Dobre proizvoake prakse (GMP),
Dobre distributivne prakse (GDP), itd.;
kupuju lekove samo iz pouzdanih izvora,
obraajui pri tom panju na njihove uslove
uvanja pre kupovine, kao i u lancu snabde
vanja;
alarmiraju razlike u kvalitetu pakovanja,
obeleavanja ili uputstva za upotrebu, kao
i u fizikom izgledu lekova;
dravnim merodavnim telima prijave svaki
sluaj sumnje, bilo da je u pitanju odsustvo
oekivanog terapijskog efekta ili da je lani
lek ponuen ili dostavljen i izoluju i ne iz
daju svaki lek za koji se sumnja da je laan
i da sarauju sa istraiteljima kako bi se
pronaao izvor snabdevanja.
Zatita stanovnitva od upotrebe substan
dardnih i lekova loeg kvaliteta, kao i lanih
lekova, a u skladu sa preporukama Svetske
zdravstvene organizacije, jedan od ciljeva
ALIMS i u tom pogledu ostvarujemo blisku
saradnju sa nadlenim institucijama u Srbiji
ali i na meunarodnom planu.
Oglaavanje lekova
i medicinskih sredstava
Oglaavanje lekova i medicinskih sredstava
je svaki oblik davanja istinitih informacija o
ovim proizvodima optoj i strunoj javnosti
Protected and generic products can be counterfeited and counterfeit products may have:
Right ingredients;
Wrong ingredients;
No active ingredients;
Active ingredients in insufficient quantities or product packed in fake packaging.
In relation to this, health care professionals in
all areas of practice should:
Respect principles of Good Pharmacy
Practice, Good Manufacturing Practice
(GMP), Good Distribution Practice (GDP),
etc.;
Buy medicines from trusted sources only,
paying at the same attention to their storage conditions before buying, as well as in
the supply chain;
Alarming about the differences in quality
packaging, labeling or Patient information
leaflet, as well as the physical appearance
of medicines;
Report any case of doubt to authoritative
state bodies, whether it is an absence of
expected therapeutic effect or that a false
medicine is offered or delivered and isolate
and not issue every medicine that is suspected to be false, and to cooperate with
investigators to find the source of supply.
Protection of the population from the use of
substandard and poor quality medicines and
fake medicines, according to the recommendations of the World Health Organization,
is one of ALIMS goals and in this regard we
have close cooperation with other institutions
in charge of this in Serbia, but also on international level.
Advertising of medicines
and medical devices
Medicines and medical devices advertising is
every form of providing general and professional public with the accurate information
about these products in order to encourage
32
radi podsticanja propisivanja i prometa leko
va i medicinskih sredstava, njihovog snabde
vanja, prodaje i potronje. Od 2010. godine,
Agencija je dobila nadlenost u odobravanju
oglaavanja lekova i medicinskih sredstava.
Agencija daje odobrenja za:
1) r eklamiranje medicinskih proizvoda putem
sredstava javnog informisanja, ukljuujui
i internet, reklamiranje na javnim mestima
i druge oblike reklamiranja leka (potom,
posetama i sl.);
2) promociju medicinskih proizvoda zdrav
stvenim i veterinarskim radnicima koji
propisuju lekove, i to obavetavanjem na
strunim skupovima, u strunim asopisi
ma i drugim oblicima promocije.
Agencija odobrava materijal koji je namenjen
kako strunoj javnosti (zdravstveni i veteri
narski radnici koji propisuju lekove, diplomi
rani farmaceuti i druga struna lica u oblasti
proizvodnje i prometa lekova na veliko i malo,
kao i u organizaciji obaveznog zdravstvenog
osiguranja) tako i optoj javnosti (graani
Republike Srbije).
33
Takoe, zabranjeno je reklamiranja leka op
toj javnosti:
- koji se izdaju uz recept;
- k oji se izdaju na teret sredstava zdravstve
nog osiguranja;
- koji sadre opojne droge ili psihotropne
supstance, lekova za tuberkulozu, infektiv
ne bolesti...
Promotivni materijal namenjen strunoj jav
nosti mora da sadri osnovne podatke o le
ku iz dozvole za lek, odnosno podatke koji su
usklaeni sa Saetkom karakteristika leka,
kao i podatke koji se odnose na reim izda
vanja leka. Ovi podaci moraju biti tani, au
rirani, proverljivi i u dovoljnoj meri potpuni da
primalac na osnovu njih moe da form
ira svo
je miljenje o terapijskoj vrednosti odreenog
leka, kao i da imaju datum kada su sainjeni
ili kada su poslednji put revidirani.
Lekovi koji se izdaju bez recepta se mogu re
klamirati u sredstvima javnog informisanja
itd., ali mogu se davati informacije o njihovom
delovanju samo u skladu sa Saetkom karak
teristika leka koji je sastavni deo dozvole za
lek. Reklamiranje lekova koji se izdaju bez re
cepta mora biti objektivno i ne sme dovoditi u
zabludu a Agencija utvruje listu lekova koji
se mogu reklamirati na ovaj nain.
34
3.5. Klinika ispitivanja
35
kolom klinikog ispitivanja i Smernicama Do
bre klinike prakse.
Ako doe do ozbiljne i neoekivane neelje
ne reakcije ili ozbiljnog neeljenog dogaa
ja u toku sprovoenja klinikog ispitivanja
leka sponzor je duan da odmah obavesti
Agenciju i etiki odbor pravnog lica, odno
sno zdravstene ustanove u kojoj se sprovo
di kliniko ispitivanje. U ovakvim sluajevi
ma, Agencija moe da predloi Ministarstvu
zdravlja da obustavi ili zabrani sprovoenje
klinikog ispitivanja leka, posebno ukoliko je
utvreno da je postojalo nepotovanje pro
tokola klinikog ispitivanja ili Smernica Do
bre klinike prakse.
Agencija aktivno radi na edukaciji strune i
opte javnosti o znaaju klinikih ispitivanja
i u tu svrhu je sprovodila informativne kam
panje u medijima i publikovala brouru za
uesnike i potencijalne uesnike u klinikim
ispitivanjima.
Godina / Year
2008.
2009.
2010.
2011.
2012.
2013.
36
4. Laboratorijska
kontrola kvaliteta
4. Laboratory quality
control
National Control Laboratory (NCL) is an organizational unit of ALIMS that performs quality
control of medicines and medical devices.
Quality control is performed by highly trained
professionals, of whom a significant number underwent planned continuous training
in accredited European laboratories of EU
countries. The training was organized in collaboration with the European Directorate for
the Quality of Medicines and Health Care of
Council of Europe (EDQM).
Laboratory control is carried out in accordance with the requirements of the European
Pharmacopoeia, national pharmacopoeia or
in accordance to other recognized pharmacopoeias or validated methods of analysis.
NCL is equipped with the most modern
equipment that is fully qualified, calibrated
and validated in accordance with up to date
requirements.
Within the NCL there are Physico-chemical
laboratory, Biological Laboratory (in which
there are Microbiological laboratory and Laboratory for pharmacological control) and the
Quality Management and Support Unit.
Fiziko-hemijska laboratorija
Physico-chemical laboratory
37
HPTLC denzitometar; Dissolution aparat; Si
stem za ispitivanje raspadljivosti; Sistemi za
titraciju; Kjeldahl sistem i drugi.
Bioloka laboratorija
Biological Laboratory
38
Odeljenje za upravljanjem
kvalitetom i podrku
39
Commission of Reference Substances) - od
2006. godine;
40
5. Upravljanje
kvalitetom u ALIMS
5. Quality Management
in ALIMS
41
Takoe, aktivnosti upravljanja kvalitetom
znaajno su usmerene ka meunarodnoj
saradnji i usaglaavanju sistema menad
menta Agencije sa zahtevima Evropske
agencije za lekove koji se odnose na regu
latornu performansu nacionalnih agencija
za lekove. Od navedenih aktivnosti naroi
to je znaajno formiranje Strategije pripre
me i razvoja unutranjih kapaciteta Agenci
je za sprovoenje Benmarking procedure
(BEMA), koja obuhvata sledee oblasti:
organizacija, procena dokumentacije o le
kovima, farmakovigilanca i interakcija sa
inspekcijskim organima.
Budui da su aktivnosti upravljanja kvalite
tom involvirane u sve segmente rada Agen
cije, njegovo odravanje i kontinuirani razvoj
direktno doprinose uspostavljanju i odra
vanju visokih standarda u strunom radu
Agencije.
42
rtifikovan sistem upravljanja zatitom ivotne
sredine, Agencija je demonstrirala svoju po
sveenost zatiti ivotne sredine na taj nain
to je opasan otpad koji nastaje u procesima
rada, zbrinjavala na siguran nain. Upravlja
nje otpadom regulisano je standardnim pro
cedurama i uputstvima sistema upravljanja
zatitom ivotne sredine i sistema upravlja
nja kvalitetom.
Farm
aceutski i hemijski otpad se od 2005.
godine izvoze u zemlje EU koje poseduju insi
neratore, u kojima se otpad unitava na tem
peraturama veim od 800C. Izvoz se obavlja
u skladu sa principima Bazelske konvencije o
kontroli prekograninog kretanja opasnih ot
pada i njihovom odlaganju i Agencija dobija
sertifikat da je otpad uniten u ovlaenom
postrojenju. Agencija od 2008. godine saku
plja i alje na reciklau upotrebljeni papir i
karton kao i staklo.
Pomak koji je nainjen u zatiti ivotne
sredine u naoj zemlji poslednjih godina
zahvaljujui veoj angaovanosti resor
nog Ministarstva ohrabruje i podstie da i
Agencija stalno tei unapreivanju posto
jeih postupaka.
43
6. Struni skupovi u
organizaciji ALIMS edukacija
strune javnosti
6. Professional
meetings organized
by ALIMS - education of
expert public
icinska
ve i med
a za leko je organizuje
Agencij
Srbi
sredstva
ices
ical Dev
ng
es and Med
Medicin Serbia is organisi
of
Agency
jum
Simpozi
um
Symposi
lekovim
ilar
on Biosim
cts
al Produ
Medicin
el M
stern Hot bar 200
Best We
24. novem
Beograd
8.
el M
stern Hot ember 2008
Best We
24th Nov
Belgrade,
44
Pored ovoga, strunjaci Agencije su lanovi
velikog broja meunarodnih udruenja i aso
cijacija i redovno uestvuju na relevantnim
sastancima, skupovima i kongresima na ko
jima izlau radove, dre predavanja i predsta
vljaju nau zemlju.
U budunosti, Agencija e se fokusirati na
edukaciju zdravstvenih profesionalaca u
oblasti farmakovigilance sa ciljem poveanja
broja prijava neeljenih dejstava i ovi skupo
vi e biti akreditovani od strane Zdravstvenog
saveta Srbije.
13:00-14:00 Lunc
ion
networking
the decisions:
y Assessment
Assessment of
Health Technolog
International
rde
illance
Caroline Labo illance, consumption surve
g surve
rtisin
Adve
14:30-15:10
broucq
Georges Haze
14:00 -14:30
15:10-15:25
15:25- 16:25
16:25-17:00
Coffee break
py
diabetes thera
Concrete case:
rde
Caroline Labo
D1-D2
cq
Debriefing of
ges Hazebrou
rde and Geor
Caroline Labo
th
Third day, 11
February 2009
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prospective...
ent situation,
cq
situation (curr
The Serbian
ges Hazebrou
rde and Geor
Caroline Labo
broucq
Georges Haze
nuctio
Introd
Stefanovic
10:00-10:10
ntation-Danka
ALIMS prese
h
10:10-10:25
Ministry of Healt Health Insurance
10:25-10:40
ute of
Serbian Instit
10:40-10:55
10:55-11:15
Coffee break
11:15-14:00
14:00
i
Agencia za lekove rbie
medicinska sredstva
Medicines and
Agency of Serbia
Medical Devices
ruacia domai
roizvoaa lekova Manufacturers
Local
Association of
of Medicinal Products
stvom
rbie
od okrovitel
a eublike
Ministarstva zdravlof
Under the Auspices the Republic of Serbia
of
Ministry of Health
Discussion and
conclusions
g
Certificate issuin
uz odrku
a
druena roizvoa
VA
inovativni lekova
unareivane
i druena za
a - K
kliniki isitivan
With support of
the Manufacturers
Association of
INOVIA
Drugs
e
of Innovativ
for Advancement
and Association
of Serbia - KLINIS
of Clinical Research
simpozijum
9. tradicionalni
Symposium
9th Traditional
Programme
Vrac
bra
15 - 16. novem
15
2013. godin e
ka
Kongresno- muzi a
dvora na Centr
Millen nium AD
Vrsac
ber 2013
t
15t -16 ovem
Music all
Congress and
Millen nium AD
o t e Centre
45
7. Publikacije ALIMS
7. ALIMS Publications
NRL i NRVL
Nacionalni registri lekova (NRL) odnosno
Nacionalni registar veterinarskih lekova
(NRVL) su prirunici za farmaceute i lekare,
odnosno veterinare koji sadre farmakoinfor
matike podatke neophodne za propisivanje
i izdavanje lekova i druge korisne informaci
je za sprovoenje farmaceutske zdravstvene
zatite, odnosno za pruanje farmaceutskih
zdravstvenih usluga.
46
Promet i potronja lekova
U skladu sa Zakonom o lekovima medicinskim
sredstvima, ALIMS prikuplja i obrauje po
datke o prometu i potronji lekova u Srbiji i
publikuje ih na godinjem nivou. U ovim knji
gama se nalaze zdravstveno-ekonomski i
statistiki pokazatelji kao i farm
ako-epidemi
oloki pokazatelji upotrebe lekova iz kojih se
mogu izvoditi analize a sve sa ciljem da bu
du od koristi dravnim institucijama ali i svim
uesnicima u prometu lekova u Srbiji.
Farmakoterapijski vodi
Farm
akoterapijski vodi je publikacija koja
sadri informacije o profilima lekova, organi
zovana u skladu sa ATC klasifikacijom o me
dicinskim proizvodima sa brojnim farmakoin
formatikim podacima u vezi sa bezbednom
primenom lekova.
Pharmacotherapy Guide
Pharmacotherapy Guide is a publication
which contains information on the profiles of
medicines, organized according to the ATC
classification of medical devices with numerous pharmakoinformatical data related to the
safe use of medicines.
Ostale publikacije
Agencija je objavila ili podrala objavljivanje
velikog broja strunih publikacija, meu koji
ma treba izdvojiti Magistralne form
ule (2008).
Other publications
Agency published or supported the publication of a large number of expert publications,
among which Magisterial formulas (2008)
should be pointed out.
47
8. Internet stranica
ALIMS
8. ALIMS Website
48
Agencija za lekove i medicinska sredstva
Srbije - ALIMS
Vojvode Stepe 458,
11221 Beograd, Srbija
www.alims.gov.rs
i-mejl: hygia@alims.gov.rs
Direktor
Spec. dr. med. Saa Jaovi
Urednik
Mag. farm. Pavle Zeli
Izdava
Helicon Publishing, Panevo
Za izdavaa
Velimir ivkovi
tampa
Helicon Publishing, Panevo
Tira
500