List of Abbreviations used in Regulatory Affairs.

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ADR - Adverse Drug Reaction

ADME - Absorption, Distribution, Metabolism and Excretion

ADROIT - Adverse Drug Reactions On line Information Tracking

AI - Adverse Incident

AIMDD - Active Implantable Medical Devices Directive

AITS - Adverse Incident Tracking System

ARM - Application to Reclassify a Medicine

ASPPs - Anonymised Single Patient Print Outs

ASR - Annual Safety Report

ATC - Anatomical, Therapeutic, Chemical

BAN - British Approved Names

BLA - Biological License Application

BNF - British National Formulary

BP - British Pharmacopoeia

BSE - Bovine Spongiform Encephalopathy

CA - Competent Authority

CAPLA - Computer Assisted Product Licence Application

CANDA - Computer Assisted New Drug Application

CD - Controlled Drug

CEP - Central Enquiry Point, Certificate of European Pharmacopeia (certificate of suitability)

CFC - Chlorofluorocarbons

CJD - Creutzfeldt-Jakob Disease

CMC - Chemical, Manufacture and Control

CMS - Concerned Member State

CP - Centralised Procedure

CPP - Certificate of Pharmaceutical Product

CR - Computed radiology

CRO - Contract Research Organisation

CT - Computed tomography

CTA - Clinical Trial Application

CTC - Clinical Trials Certificate

CTD - Clinical Trials Directive, Common Technical Document

CTX - Clinical Trials Exemption scheme

DB - Device Bulletin

DCP - Decentralized Procedure

DDX - Doctors and Dentist Exemptions

DIR - Diagnostic Imaging Review

DMF - Drug Master File

DMRC - Defective Medicines Report Centre

DR - Digital radiology

EC - European Community

eCTD - electronic Common Technical Document

EEA - European Economic Area

EEC - European Economic Community

EP - European Pharmacoepia

EPAR - European Public Assessment Report

EPID - Extended Public Information Document

EQA - European Quality Award

ERA - Environmental Risk Assessment

EU - European Union

EUDRA - European Union Drug Regulatory Authorities

FOI - Freedom Of Information

GCP - Good Clinical Practice

GDP - Good Distribution Practice

GHTF - Global Harmonisation Task Force

GLP - Good Laboratory Practice

GLPMA - Good Laboratory Practice Monitoring Authority

GMDN - Global Medical Device Nomenclature

GMO - Genetically Modified Organism

GMP - Good Manufacturing Practice

GMPLA - Good Manufacturing Practice Licensing Authority

GP - General Practitioner

GPRD - General Practice Research Database

GPvP - Good Pharmacovigilance Practice

GSI - Government Secure Intranet

GSL - General Sale List

I&AC - Imaging and Acute Care

IC - Information Centre

ICES - Integrating Community Equipment Services

IM - Intramuscular

IM(ER)R - Ionising Radiation (Medical Exposure) Regulations

ImPACT - Imaging Performance Assessment of CT scanners

IMPD - Investigational Medicinal Product Dossier

IMS - Information Management Strategy

IMP - Investigational Medicinal Products

IND - Investigational New DrugI

NN - International Non-proprietary Names

IRR - Ionising Radiation Regulations

IVDD - In Vitro Diagnostic Directive

ISBN - International Standard Book Number

IUCD - IntraUterine Contraceptive Device

IUD - IntraUterine Device

IVDs - In Vitro Diagnostic Medical Devices

IT - Information Technology

IV - Intravenous

MA - Marketing Authorisation

MAA - Marketing Authorisation Application

MAIL - Medicines ACT Information Letter

MAL - Medicines Act Leaflet

MDA - Medical Device Alert

MDD - Medical Devices Directive

MDR - Medical Device Reporting, Medical Device Regulation

MDLO - Medical Device Liaison Officer

MEDDRA (MedDRA) - Medical Dictionary for Drug Regulatory Affairs

ML - Manufacturer's Licence

MORE - Manufacturer's On-line Reporting Environment

MP - Member of Parliament

MRA - Mutual Recognition Agreement

MRI - Magnetic Resonance Imaging

MRP - Mutual Recognition Procedure

MTL- Medicines Testing Laboratory

MTS - Medicines Testing Scheme

NAS - New Active Substance

NB - Notified Body

NCE - New Chemical Entity

NDA - New Drug Application

NOP - Non-Orthodox Practitioner

ODD - Orphan Drug Designation

OTC - Over-The-Counter products

P (medicine) - Pharmacy medicines

PAPs - Product Analysis Prints

PCT - Primary Care Trust

PD - Pharmacodynamy

PET - Positron Emission Tomography

PET/CT - Positron Emission Tomography and Computerised Tomography

PIL - Patient Information Leaflet

PIP - Paediatric Investigation Plan

PK - Pharmacokinetic

PL - Product Licence, Package LeafletPL (PI) - Product Licence (Parallel Import)

PLR - Product Licence of Righ

tPLUS - Product Licence User System

PMS - Post Marketing Surveillance

POM - Prescription Only Medicines

PPI - Patient Pack Initiative

PRRs - Proportioned Reporting Ratios

PSURs - Periodic Safety Update Reports

PUMA - Paediatric Use Marketing Authorisation

QA - Quality Assurance

QC - Quality Control

QOS - Quality Overall Summary

QP - Qualified Person

QRD - Quality Review of Documents

RAMA - Remote Access for Marketing Authorisations

R&D - Research & Development

rINN - Recommended International Non-proprietary Name

RMP - Risk Management Plan

RMS - Reference Member State

RP - Responsible Person

SABS - Safety Alert Broadcast System

SAMM - Safety Assessment of Marketed Medicines

SI - Statutory Instrument

SMF - Site Master File

SOP - Standard Operating Procedure

SPC or SmPC - Summary of Product Characteristics

SPECT - Single photon emission computed tomography

SSRIs - Selective Serotonin Reuptake Inhibitors

TCM - Traditional Chinese Medicine

THMPD - Traditional Herbal Medicinal Products Directive

THMRS - Traditional Herbal Medicines Registration Scheme

THR - Traditional Herbal Registration

TSE - Transmissible Spongiform Encephalopathy

USAN - United States Adopted Names

USP - United States Pharmacopeiav

AIC - Virtual Adverse Incident Centre

VAMF - Vaccine Antigen Master File

VMD - Veterinary Medicines Directorate

VTE - Venous ThromboEmbolism

WL - Wholesale Dealer's Licence

Coal Tar derivatives: A very Potential carcinogen used as FDC in Cosmetics.

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It is used in almost all shampoos formulated to treat dandruff and flaky scalp. It is also used in food colours for preparation of candies, lozenges.............

It is often disguised with names such as FD, FDC or DF&C colour.

It causes potentially severe allergic reactions, asthma attacks, fatigue, nervousness, headaches, nausea, lack of concentration, cancer, carcinogen, cough, redness of skin, burning sensation, can irritate nose, throat, hoarseness, nosebleeds, coughing, phlegm, changes in skin pigment and a rash.

A 2001 California study published in the International Journal of Cancer found that women who used to permanent hair dyes once a month were twice likely to develop bladder cancer!

There are many factors involved with hair colouring.

Studies in the U.S. have suggested that the chemical reaction created by hair cololuring products may be having a carcinogenic effect and have also associated hair colourings with an increased risk of Non-Hodgkin's lymphoma.

Try to avoid dark hair dyes entirely and choose products made with natural ingredients instead.

It is already Banned in EU cosmetics!

Benzaldehyde: A poisonous scenting agent.

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It is a narcotic, sensitizer, local anesthetic and CNS depressant.

It causes irritation to the mouth, throat, eyes, skin, lungs and GI tract, causing nausea and abdominal pain.

It may cause kidney damage.

Do not use it with contact lenses.

It is commonly found in perfume, cologne, hairspray, laundry bleach, deodorants, detergents, Vaseline lotion, shaving cream, shampoo, bar soap, dishwasher detergent.

It can also be smelt in the Appy Fizz drink, which is a soft drink.

Alpha-Terpineol: A Poisonous Scent in Soaps.

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It is highly irritating to mucous membranes.

Aspiration into the lungs can produce pneumonitis or even fatal edema.

It can also cause excitement, ataxia (loss of muscular coordination), hypothermia, CNS respiratory depression, headache.

It is advisable to prevent repeated or prolonged skin contact.

It is found in perfume, cologne, laundry detergent, bleach powder, laundry bleach, fabric softener, stickup air freshener, Vaseline lotion, soap, hairspray, after shave, roll-on deodorant.

Acetone: A chemical solvent used in cosmetics.

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Acetone features on EPA, RCRA, CERCLA hazardous waste list.

Inhalation of acetone can cause dryness of the mouth and throats, dizziness, nausea, in coordination, slurred speech, drowsiness, and, in severe exposures, coma.

It acts primarily as a central nervous system (CNS) depressant.

It is found in cologne, dishwashing liquid, detergent, nail enamel remover.
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