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NAME : Pawar Dnyaneshwar Ranjitsinh
CLASS : Final Year B. Pharmacy
ROLL No: 31
SUBJECT : Pharmacovigilance
Guided By : Mrs. Pawar R.V.
TOIPC NAME : Anatomical, Therapeutic And Chemical Classification Of Drugs
 In the Anatomical Therapeutic Chemical (ATC) classification system, the active
substances are divided into different groups according to the organ or system on
which they act and their therapeutic, pharmacological and chemical properties.
 ATC 14 main groups are:
1)A - Alimentary Tract and Metabolism
2) B - Blood and Blood Forming Organs
3) C - Cardiovascular System
4) D – Dermatologicals
5) G - Genito Urinary System and Sex Hormones
6) H - Systemic Hormonal Preparations, Excl. Sex Hormones and Insulins
7) J - Ant infectives For Systemic Use
8) L - Antineoplastic And Immunomodulating Agents
9) M - Musculo-skeletal System
10) N - Nervous System
11) P - Antiparasitic Products, Insecticides And Repellents
12) R - Respiratory System
13) S - Sensory Organs
14) V – Various
Drugs are classified in groups at five different levels:
 1st Level: The system has fourteen main anatomical or pharmacological groups
(1st level).
 2nd Level: Pharmacological or Therapeutic subgroup
 3rd& 4th Levels: Chemical, Pharmacological or Therapeutic subgroup
 5th Level: Chemical substance
Examples:
 1) The complete glibendamide classification demonstrates the structure of the code:
i) AAlimentary tract and metabolism (first level, main anatomical group).
ii) A10 Drugs used in diabetes (second level, main therapeutic group).
iii) A10B Oral blood-glucose-lowering drugs (third level, therapeutic/ pharmacological
subgroup).
iv) A10B B Sulfonamides, urea derivatives (fourth level, chemical/ therapeutic/pharmacological
subgroup)
v) A10B B01 Glibendamide (fifth level, subgroup for chemical substance)
Therefore, in the ATC system all plain glibendamide preparations are given the code A10B
B01.
 2) SIMPLE Codes:
i) Lamivudine (e.g., epivir): is used in HIV as antiviral drug: J05AF05.
ii) Sumatriptan (e.g., Imigran): is used an Antimigrain as 5HT1 agonist: N02CC01.
iii) Fromoterol (e.g., Oxis): is used in asthma as beta-2 agonist: R03AC13.
Inclusion and exclusion criteria:
 The WHO collaborating centre in Oslo establishes new entries in ATC classification
on requests from users of system.
 It includes
Manufacturers
Regulatory Agencies
Researchers.
 Active ingredients which fulfil one of following criteria will normally included in ATC
system.
➢ They are new chemical entities or biologicals proposed licensing in range of
countries. A new chemical entity is normally not included in the ATC before an
application for marketing authorization is submitted is submitted in at least one
country.
➢ They are existing well defined chemical entities used in variety of countries. An INN
should preferably be established for active ingredient. Alternatively other official name
e.g. USAN or BAN names should be available.
➢ They are herbal medicinal products assessed and approved by regulatory
authorities based on dossiers including efficacy, safety and quality data.
➢ Other medicinal products are considered on case by case basis. Complementary
homeopathic and herbal traditional medicines are in general not included in ATC
system.
Reference
A Book Of Pharmacovigilance
By Dr. Agnimitra Dinda, Monika Saxena.
Thakur Publication.
First Edition 2021
Page No. 56-57

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Anatomical, therapeutic and chemical classification of drugs.pptx

  • 1. NAME : Pawar Dnyaneshwar Ranjitsinh CLASS : Final Year B. Pharmacy ROLL No: 31 SUBJECT : Pharmacovigilance Guided By : Mrs. Pawar R.V. TOIPC NAME : Anatomical, Therapeutic And Chemical Classification Of Drugs
  • 2.  In the Anatomical Therapeutic Chemical (ATC) classification system, the active substances are divided into different groups according to the organ or system on which they act and their therapeutic, pharmacological and chemical properties.  ATC 14 main groups are: 1)A - Alimentary Tract and Metabolism 2) B - Blood and Blood Forming Organs 3) C - Cardiovascular System 4) D – Dermatologicals 5) G - Genito Urinary System and Sex Hormones 6) H - Systemic Hormonal Preparations, Excl. Sex Hormones and Insulins 7) J - Ant infectives For Systemic Use 8) L - Antineoplastic And Immunomodulating Agents 9) M - Musculo-skeletal System 10) N - Nervous System 11) P - Antiparasitic Products, Insecticides And Repellents 12) R - Respiratory System 13) S - Sensory Organs 14) V – Various
  • 3. Drugs are classified in groups at five different levels:  1st Level: The system has fourteen main anatomical or pharmacological groups (1st level).  2nd Level: Pharmacological or Therapeutic subgroup  3rd& 4th Levels: Chemical, Pharmacological or Therapeutic subgroup  5th Level: Chemical substance
  • 4. Examples:  1) The complete glibendamide classification demonstrates the structure of the code: i) AAlimentary tract and metabolism (first level, main anatomical group). ii) A10 Drugs used in diabetes (second level, main therapeutic group). iii) A10B Oral blood-glucose-lowering drugs (third level, therapeutic/ pharmacological subgroup). iv) A10B B Sulfonamides, urea derivatives (fourth level, chemical/ therapeutic/pharmacological subgroup) v) A10B B01 Glibendamide (fifth level, subgroup for chemical substance) Therefore, in the ATC system all plain glibendamide preparations are given the code A10B B01.  2) SIMPLE Codes: i) Lamivudine (e.g., epivir): is used in HIV as antiviral drug: J05AF05. ii) Sumatriptan (e.g., Imigran): is used an Antimigrain as 5HT1 agonist: N02CC01. iii) Fromoterol (e.g., Oxis): is used in asthma as beta-2 agonist: R03AC13.
  • 5. Inclusion and exclusion criteria:  The WHO collaborating centre in Oslo establishes new entries in ATC classification on requests from users of system.  It includes Manufacturers Regulatory Agencies Researchers.
  • 6.  Active ingredients which fulfil one of following criteria will normally included in ATC system. ➢ They are new chemical entities or biologicals proposed licensing in range of countries. A new chemical entity is normally not included in the ATC before an application for marketing authorization is submitted is submitted in at least one country. ➢ They are existing well defined chemical entities used in variety of countries. An INN should preferably be established for active ingredient. Alternatively other official name e.g. USAN or BAN names should be available. ➢ They are herbal medicinal products assessed and approved by regulatory authorities based on dossiers including efficacy, safety and quality data. ➢ Other medicinal products are considered on case by case basis. Complementary homeopathic and herbal traditional medicines are in general not included in ATC system.
  • 7. Reference A Book Of Pharmacovigilance By Dr. Agnimitra Dinda, Monika Saxena. Thakur Publication. First Edition 2021 Page No. 56-57