LEGISLASI

& REGULASI PROFESI FARMASI

Aspek Umum Regulasi Obat dan

Peraturan Kefarmasian
Oleh: Tutus Gusdinar Kartawinata
Sekolah Farmasi ITB
gusdinar@fa.itb.ac.id

Keahlian dan Kewenangan Apoteker

UU Nomor 36 Th 2009 tentang Kesehatan, ps 108 ayat 1:

Apoteker memiliki keahlian dan kewenangan untuk

melaksanakan praktik kefarmasian yang mencakup
5 bidang berikut:
a. Pembuatan termasuk pengendalian mutu sediaan
farmasi;
b. Pengamanan, pengadaan, penyimpanan dan
pendistribusian obat;
c. Pelayanan obat atas resep dokter;
d. Pelayanan informasi obat;
e. Pengembangan obat, bahan obat dan obat tradisional.

CREW TENAGA KEFARMASIAN

APOTEKER
TENAGA TEKNIS KEFARMASIAN
SAINTIFIK
VOKASIONAL

-----------------------------------------------------------ASISTEN TENAGA KESEHATAN/KEFARMASIAN

MAKNA PROFESI FARMASI

BAGI SUATU BANGSA

Profesi farmasi memberikan jaminan keamanan,

khasiat dan mutu serta pelayanan bagi setiap
pengguna produk farmasi atau bahan eksogenik
lain yang dimanfaatkan untuk tujuan modifikasi/
eksplorasi terhadap sistem fisiologi atau kondisi
patologi.

Fungsi esensial negara

dalam bidang kefarmasian

Essential means that if the public sector is unable to perform

these functions, public health goals cannot be achieved and the
least privileged part of the population will suffer.
Policy making, priority setting: what are the problems?
how do we address them?
how do we know what we have
achieved?
Regulation & control: what are the rules?
are the rules respected?
do we need to change rules?
Professional standards: who is allowed to do what?
Access to drugs: can people use the drugs they need?
Information: can people use drugs properly?

Legislasi dan regulasi obat merupakan

bagian dari sistem pelayanan kesehatan
Drugs are a public good and not simply just another
commodity: first for their high social value, and then
because consumers and prescribers are unable to
assess their quality, safety and efficacy.
Dr. Gro Harlem Brundtland
Director General of WHO EDM

LEGISLASI OBAT
Setiap produk yang wajib mendapat legislasi harus
jelas, tidak meragukan, serta mencakup definisi yang
komprehensif.
MEDICAL PRODUCT:
Any substance or pharmaceutical product for human or
veterinary use that is intended to modify or explore physiological
systems or pathological states for the benefit of the recipient.

REGULASI OBAT
Regulasi obat mencakup seluruh aturan legal,
administratif dan teknis dengan tujuan untuk menjamin:
Semua alasan dasar (premise), orang (people) dan praktek
(practice) yang terkait dengan pengembangan, pembuatan,
impor, ekspor, perdagangan besar, pasokan, dispensing dan
promosi obat harus mematuhi standar, norma, prosedur dan
persyaratan yang sah.
Produk obat harus aman, efektif dan bermutu.
Informasi produk tidak boleh bias, harus akurat dan tepat
guna.
Obat harus selalu tersedia.
Obat harus digunakan secara rasional.

Regulasi obat merupakan sentral dari interaksi

berbagai kegiatan multifaset dan sangat kompleks
Government
Manufacturers

Products

Regulatory
authority

Experts

Prescribers
Medicines
Patients/Consumers

Importers/Wholesalers/Retailers

Apotek

satu-satunya tempat
yang secara legal diberi
kewenangan untuk menyimpan
dan
menyerahkan obat & racun

Apothecary

apo = terpisah secara esensial

thec = tempat simpan, gudang
Greek:
apotheke = barn, storehouse
a place where things are put away, from apo- "away" + tithenai "to put

Meningkatnya kompleksitas permasalahan terkait obat telah

menyebabkan pemakaian obat tidak lagi hanya didasarkan pada
pilihan atau pengalaman pribadi (testimonial).
Dibutuhkan pembuktian berbasis logika keilmuan melalui
riset bermutu untuk menjamin keberhasilan terapi.
Apoteker harus mampu untuk menjamin ketersediaan data dan
informasi terkait obat, yang dibutuhkan untuk menetapkan
pilihan obat dalam upaya menjamin keamanan, ketepatan dan
kerasionalan penggunaan obat (evidence-based pharmacy).
Tenaga kefarmasian makin dituntut untuk mampu menjadi
researcher dalam hal mencari obat baru dan pengembangan
bentuk sediaan baru (drug delivery system),

Praktik kefarmasian

Pasal 108 Undang- Undang Nomor 30 Tahun 2009 tentang Kesehatan

Praktik kefarmasian di Indonesia meliputi pembuatan

termasuk pengendalian mutu sediaan farmasi,
pengamanan, pengadaan, penyimpanan dan
pendistribusian/ penyaluran obat, pengelolaan obat,
pelayanan obat atas resep dokter, pelayanan informasi
obat, serta pengembangan obat dan obat tradisional.
Secara implisit ketentuan perundang-undangan tersebut
menuntut peran dan tanggungjawab tenaga apoteker
dalam menjaga mutu pelayanan kesehatan.

Dalam bidang produksi tanggungjawab apoteker

adalah menjamin kesesuaian proses produksi
dan mutu produk terhadap ketentuan dan
standar yang berlaku.
Sejauh ini industri farmasi Indonesia telah dapat
memenuhi seluruh kebutuhan obat nasional,
namun belum mampu menyediakan sendiri
bahan baku obat.

Dalam bidang distribusi atau penyaluran sediaan farmasi,

tanggungjawab apoteker mencakup jaminan kesesuaian
proses distribusi dan mutu produk terhadap ketentuan
dan standar yang berlaku, jaminan keamanan dan
ketersediaan produk.
Pemerintah telah memberlakukan Cara Distribusi Obat
yang Baik sebagai implementasi GDP (Good Distribution
Practice), untuk menghindari praktik kefarmasian dalam
bidang distribusi, supaya obat keras dan psikotropika,
tidak dapat dibeli dengan mudah tanpa resep dokter
dan tidak dijual di toko obat maupun pedagang kaki
lima; serta mencegah peredaran obat palsu, obat
kadaluarsa dan obat impor ilegal masih sering
ditemukan.

Beberapa kutipan:
REGULASI FARMASI
DI NEGARA EROPA

The profession was established over 150 years

ago with the purpose of representing the
interests of practising pharmacists and
protection of the public. Its roles evolved over
time into a joint professional and regulatory
organisation.
Many of the titles associated with the profession,
such as pharmacist and chemist, are restricted.
This means that it is illegal for the titles to be
used if not legally entitled to do so.

Peran Konsil Farmasi

The General Pharmaceutical Council (GPhC)
replaces the regulatory functions of the Royal
Pharmaceutical Society of Great Britain (RPSGB)
from 2010. This change was brought about in
line with government policy in relation to safety
and standards of all healthcare professions.

Pharmacists interests continue to be supported

by the RPSGB as a professional representative
body.
It provides a voice for pharmacy, publications
and opportunities for continuing professional
development, amongst other services and
functions.

As a professional practitioner, pharmacists and

pharmacy technicians are both accountable and
responsible for their working practices.
Fitness to practise procedures are the
responsibility of the professional regulatory
body. They operate through a number of formal
committees that have various sanctions
available to them.
The Commission for Healthcare Regulatory
Excellence (CHRE) oversees this process.

Fungsi Konsil Farmasi

The main functions of the GPhC include:
The registration of competent, qualified practitioners,
including arrangements for temporary registration in
emergencies
Setting and securing standards of practice, education
and training, continuing professional development and
conduct & setting up and maintaining fitness to
practise procedures
registration, regulation and inspection of pharmacy
premises.
(Reproduced from Department of Health, 2008)

According to the Pharmacy and Pharmacy

Technicians Order 2007, a persons fitness to practise
may be impaired by reason of any of following:
1. Misconduct & deficient professional performance
2. Adverse physical or mental health
3. Failure to comply with reasonable requirement by
assessor
4. A conviction for a criminal offence
5. A police caution
6. Finding impaired fitness to practise by health or
social care regulatory body.

LANDASAN HUKUM
The Europe Union is the highest legal authority for
such law in the UK. Law emanating from the EU has
then to be enacted into domestic legislation to take
effect in the UK. Domestic legislation in the UK
operates at two levels: primary law, that is, Acts of
Parliament, and secondary law, that is, detailed
provisions implementing the broad provisions of an
Act.
Public bodies are also subject to further Directions
made under the authority of primary and secondary
law. This hierarchy is reflected in the processes by
which law is made, how it is enforced and interpreted
and how it may be challenged.

The legislation implementing the Treaty is formulated by

the Council of Ministers in four basic forms:
Regulations. These have a direct effect and are binding
on all member states and on individuals in every
respect.
Directives. These are binding as to their objectives but
leave to member states the method of
implementation. Such implementation may be
legislative or administrative. Most directives include
derogations a form of exception which member
states may claim if they feel that their particular
circumstances require it.
Decisions. These are binding on those to whom they
are addressed and are often of an administrative
nature.
Recommendations. These are self-evident and are
persuasive.

1. Free movement of pharmacists

Registration as a pharmacist in the UK is
recognised. The competent authorities within the
member states deal with the procedure and
those authorities in the UK are the Royal
Pharmaceutical Society of Great Britain (RPSGB)
and its equivalent in Northern Ireland.
The new Directive 2005/36/EC also recognises a
new category of registrant, namely a visiting
practitioner who wants to provide services in the
UK on a temporary or occasional basis.

In order for a pharmacist to move freely throughout the Community s/he

must produce evidence from his/her own competent authority to the
corresponding one in the host member state that s/he:
1) is a national of a member state of the Community or treated as such;
2) a) possesses a university degree (or equivalent) which was obtained
following a course of study of not less than five years, at least four
years of which comprised theoretical and practical training in a
university, together with at least six months in-service training in a
community or hospital pharmacy; or
b) has for at least three consecutive years during the previous five
years been effectively and lawfully engaged in regulated
pharmaceutical activity, e.g. a community pharmacy, hospital
pharmacy, etc. This is known as the acquired rights provision for
those who cannot comply with point 2a above;
3) is in good physical and mental health; and
4) is of good character.

2. Production and distribution of medicinal

products for human use
Council Regulation 2309/93/EEC lays down Community procedures for the
authorisation and supervision of medicinal products for human and veterinary use and established the European Agency for the Evaluation of
Medicinal Products.
Directive 2001/83/EC, which in 2001 consolidated all the earlier Council
Directives, states that the primary purpose of controls on the production
and distribution of medicinal products is to safeguard public health.
The Directive defines a medicinal product and establishes that before a
medicine can be put on the market it must possess a licence or marketing
authorisation which had been granted on the basis of safety, quality and
efficacy. In addition, the Directive covers the labelling of medicines.
Good Manufacturing Practice means the part of quality assurance which
ensures that products are consistently produced and controlled in
accordance with the quality of standards appropriate to their intended
use, the principles and guidelines of which are specified in Commission
Directive 2003/94/EC.

3. Analytical, toxicological and clinical

standards for medicines for human use
Council Directive 2001/83/EC set up standards
and protocols for the analysis, and
toxicological and pharmacological tests which
had to be applied to medicinal products.
Clinical trials are now controlled under Council
Directive 2000/21/EC.

4. High-technology medicinal products for

human and animal use
Directive 93/41/EEC set up procedures to deal
with applications for marketing authorisations
involving high-technology medicinal products,
in particular those derived from biotechnology

5. Homoeopathic medicinal products

Council Directive 2001/83/EC is concerned with the
authorisation for marketing and the labelling of
homoeopathic medicinal products for human use. It also
provides for a special simplified registration procedure for
those traditional homoeopathic medicinal products which are
placed on the market without therapeutic indications in a
pharmaceutical form and dosage which do not present a risk
to the public. Directive 92/74/EEC relates to homoeopathic
medicinal products for veterinary use.
In March 2004, the European Union issued the Directive on
Traditional Herbal Medicinal Products (Council Directive
2004/24/EC) to regulate herbal products. Member states
were required to have a simplified registration scheme in
force by October 2005. Directive 2004/24/EC is based on longstanding use of the product and no clinical trial evidence will
be required. All herbal products already on the market can
remain so for seven years.

6. Advertising, labelling and leaflets

Council Directive 2001/83/EC deals with the
labelling of medicinal products and the
availability of package leaflets aimed at the
public. It requires that information supplied to
users should provide a high degree of consumer
protection in order that medicinal products may
be used correctly on the basis of full and
comprehensible information.
Council Directive 2001/83/EC deals with the
advertising of medicinal products for human use
both to the general public and to health
professionals. It also deals with the question of
hospitality related to sales promotion, samples,
medical representatives, etc.

7. Wholesale distribution
Council Directive 2001/83/EC covers the
control of wholesale distribution of medicinal
products for human use in the EC. It requires
that such distribution should be subject to the
possession of an authorisation to engage in
the activity as a wholesaler in medicinal
products and lays down the conditions for
such an authorisation. Such activity is subject
to licensing in the UK.

8. Colouring of medicinal products

Directive 78/25/EEC controls the colouring
agents which can, and those which cannot, be
added to medicinal products.

9. Production of medicinal products for animal

use
Directive 2001/82/ECC as amended by 2004/28/EC
provides that no veterinary medicinal product may be
placed on the market of a member state unless a
marketing authorisation has been granted by the
competent authorities of that member state in
accordance with these directives or in accordance with
Regulation EC/726/2004.
Directive 91/412/EEC introduced a legal requirement
for a manufacturer of medicinal products for animal
use to comply with the principles and guide- lines of
Good Manufacturing Practice.
Regulation 90/2377/EEC lays down procedures to
establish maximum residue limits for animal medicines
in foodstuffs of animal origin.

10. Controlled drugs

Council Directive 92/109/EEC applies to the manufacture and
trade in scheduled substances within the EU and is implemented
in the UK by the Controlled Drugs (Substances Useful for
Manufacture) (Intra-Community Trade) Regulations 1993 as
amended. It requires the person who manufactures or trades in
these substances to be licensed and restricts the persons to
whom supplies may be made.
Council Regulation 90/3677/EEC controls the import, export,
recording and labelling of scheduled substances and the power
to enter business premises to obtain evidence of irregularities.
Records must be kept for two years. It also requires member
states to adopt measures to enable them to obtain information
on any orders for, or activities in, scheduled substances.

11. Data protection

Council Directive 95/46/EEC extends data
protection to all data maintained manually
and affects the way in which patient
medication records are stored. This Directive
was implemented in the UK by way of the
Data Protection Act 1998, which came into
force on 1 March 2000. All data, both
electronic and manual, are now controlled
under the 1998 Act.

Hak Azasi Manusia

Human rights go beyond common law, for example they recognise
a right to privacy that does not exist in the common law.
Human rights law departs from legal convention in the UK in
three main ways:
1) Precedent will not necessarily bind judgments in human rights
cases. The courts are expected to reflect concepts of human
rights at the time of consideration rather than at the time of the
complaint and thus will reflect present day attitudes and
conditions.
2) Statutes will be interpreted as to intention rather than as
written. This is a major departure from UK conventions on
interpretation of statutes.
3) The UK courts can challenge and over-rule statute if not
compatible with human rights; in other words, the judges may
challenge Parliament in this area.

Key human rights in relation to

healthcare practice
Article 2 `right to life
The right to life is really a right not to be deprived of life save in very special
circumstances. The judicial sanction of capital punishment is not a special
circumstance. It should be noted that this right is not a right to unlimited
healthcare in an effort to preserve life nor a right to death. Such rights may be
cited in cases of assisted suicide or euthanasia and there are debates regarding
issues such as assisted conception, contraception and abortion. Debate can also
arise over resource allocation and equity in availability of treatment to all
patients.
Article 3 `Right to prohibition of torture or inhuman or degrading treatment or
punishment'
Article 3 does not cover issues that have obvious relevance for healthcare but
some cases have asserted that aggressive treatment in terminal care or in some
treatments of the mentally handicapped are close to being inhuman.

Article 5 `right to liberty'

The right to liberty is particularly relevant to the treatment of those
with mental disorder, and the use of sectioning and compulsory
treatment is very relevant to consent to treatment.
Article 6 `right to a fair trial'
The right to a fair trial is mostly relevant to disciplinary processes and
such principles as the right to know what one is charged with, time to
prepare defence, right to a defence, etc. In addition any hearing has to
be within a reasonable time, without delay, and there is a right not to
incriminate oneself. Pharmacys processes (e.g. the Disciplinary
Committee procedures) do not appear yet to be fully compliant.

Article 8 `right for respect for private and family life'

Human rights issues may arise in the treatment of trans-sexuals and
the right to practise particular forms of sexuality. This right has also
been cited in relation to use of medical records in court. Article 8 is
very relevant to issues of privacy in medical care, restrictions on
disclosure of confidential informa- tion, and so on.
Article 9 `right to freedom of thought, conscience and religion'
Issues may arise where treatment is contrary to religious or cultural
beliefs and practices. There also may be an issue for a 24-hour health
service and religious restrictions on working at certain times or days.

Medicinal Products
The term used is not medicine but relevant medicinal
product, which means a medicinal product for human use
to which provisions of the 2001 Directive and Directive
2004/27/EC applies. It is newly defined in Council Directive
2004/27/EC as:
1) Any substance or combination of substances presented
as having properties for treating or preventing disease in
human beings.
2) Any substance or combination of substances which may
be used in or administered to human beings either with a
view to restoring, correcting, or modifying physiological
functions by exerting a pharmacological, immunological or
metabolic action or to making a medical diagnosis.

Taken together these provisions are intended to ensure that

where doubt exists over whether a product those on the
borderline between, for example, medicines and medical
devices, medicines and cosmetics, medicines and food
supplements, etc. should be regulated under medicines or
other sectoral legislation, the stricter medicines regulatory
regime should apply. This is a broader definition than that in the
Medicines Act and can be defined as being a medicinal product
(a) by presentation and (b) by function.
The term a medicinal product to which Chapters of the 2001
Directive apply includes all medicinal products for human use
except those prepared on the basis of a magistral or official
formula, medicinal products intended for research, or
intermediate products intended for further processing by an
authorised manufacturer (Council Directive 2001/83/EC, as
amended).

 Magistral means any medicinal product prepared in a

pharmacy in accordance with a prescription for an
individual patient.
Official formula means any medicinal product which is
prepared in accordance with the prescriptions of a
pharmacopoeia and is intended to be supplied directly to
the patients served by the pharmacy in question.
Ingredient may be the sole active ingredient present in a
medicinal product.
Hospital includes a clinic, nursing home or similar
institution.
Animal includes any bird, fish or reptile.

Medicinal purpose means one or more of the following:

(a) treating or preventing disease;
(b) diagnosing disease or ascertaining the existence,
degree or extent of a physiological condition;
(c) contraception;
(d) inducing anaesthesia;
(e) otherwise preventing or interfering with the normal
operation of a physiological function.
Administer means administer to a human being or an
animal, whether orally, by injection or by introduction
into the body in any other way, or by external application,
a substance or article either in its existing state or after it
has been dissolved or dispersed in, or diluted or mixed
with, some other substance used as a vehicle.

Certain things are specifically declared not to be

medicinal products. These include:
1. Substances or articles manufactured for
administration to human beings or animals in the course
of the manufacturers business, or in a laboratory on
behalf of the manufacturer, solely by way of a test for
ascertaining what effects they have, and in circumstances
where the manufacturer has no knowledge that the
effects are likely to be beneficial.
2. Substances and articles as may be specified in a
ministerial order. Chemical substances used to sterilise
animals which are neither domestic nor held in captivity
are not medicinal products.

 Breathing gases for human use in conditions in

which respiration is adversely affected by
abnormal atmospheric pressure or otherwise are
not medicinal products when they are not
administered for the treatment or diagnosis of
disease. This exemption applies to oxygen, air or
any mixture of both, or of either or both with any
inert gas or gases or with nitrogen.
An animal feeding stuff into which a medicinal
product has been incorporated is also classed as a
medicinal product. Special provisions relate to
such feeding stuffs.

Generic Products
A product is defined as a generic medicinal
product when it has:
the same qualitative and quantitative
composition in active substances; and
the same pharmaceutical form as the
reference medicinal product; and
whose bioequivalence with the reference
product has been demonstrated by
appropriate bioavailability studies.

 There has to be a balance struck between allowing a

person applying for a marketing authorisation for a
follow-on product (e.g. a generic product) to be able to
use the safety and efficacy data which has been used
by the original innovator against the need for such an
applicant being forced to repeat that data for the
product when that information is already with the
licensing authority.
This balance is achieved by allowing a follow-on
competitor to rely on the data for the original product
only after the passage of a data exclusivity period. The
procedure under which a generic product can rely on
the innovators data after the end of data exclusivity
period is known as an abridged procedure.

Registration of
traditional herbal medicinal products
The Directive on Traditional Herbal Medicines (Directive
2004/24/EC) required each member state to put in place a
simplified national registration scheme for traditional herbal
medicinal products This simplified scheme consists of certain
regulatory features which are specific to these products and also
bring such medicines within the scope of Directive 2001/83/EC
and makes changes relating to applications for registration and
renewals, patient leaflets and labelling (including the Braille
requirement within five years), advertising pharmacovigilance,
importation and distribution, and enforcement. These provisions together with obligations imposed upon the holders of
traditional herbal medicinal products registration, are laid down
in the Medicines (Traditional Herbal Medicinal Products for
Human Use) Regulations.

Sekian