Pharmacy Awareness Campaign May 1

Licensing Process for Pharmacies and their
Professionals
Dr. Hana I. Badran
Sheryan Project Manager
Todays Overview
1
Licensing Process for Professionals
List of DHA approved Professional Title
Licensing Process for Facility
Health Regulation Department
Application Process for

Professionals
1. For First time user:
Visit our webpage:
http://eservices.dha.gov.ae/DHAWeb/Default.aspx
Create a Sheryan account on line (user name

and password)
5/2/2013
2. Fill New Professional License application and

upload the required documents:
Latest Passport Size Photograph with white background
Valid passport copy
Education certificate
Last 2 years experience

PSV report from dataflow if available
5/2/2013
MOH license (Valid or renewed receipt) or5 MOH
Declaration Page
700
DHS
Notes
The DHA license expiry date will have the same expiry
date of MOH license
DHA License can be renewed 3 month earlier to the
expiry date, where a payment of 1010 DHS will need to
be done online via credit card.
Applicant can collect the license from HRD during
working hours
This license will be valid only for the Emirate of Dubai
List of DHA approved

Professional Title
1.
Pharmacist
2.
Pharmacy Technician (equal to Pharmacy Assistant)
3.
Pharmacy Trainee
4.
Clinical Pharmacist
Application Process for

Facilities
1. For First time user:
Visit our webpage
Create a Sheryan account online (user name

and password)
5/2/2013
11
2. Fill New Facility License application and

upload the required documents:
1. Passport photocopy with residency visa for non-locals
2. UAE identity card (National ID)
3. Initial Approval: where you need to submit the
followings:
Map
Facility layout
Blue print
DED reservation name certificate
MOH valid registration license
4. NO Payment of 1010 DHS, to email us
regulation@dha.gov.ae
with your application13reference
5/2/2013
Notes
The DHA license expiry date will have the same expiry date
of MOH license
DHA License can be renewed 3 month earlier to the expiry
date, where a payment of 7510 DHS will need to be done
online via credit card.
Facility can collect the DHA license from HRD during
working hours
Dubai
Community Pharmacy Licensure &
Pharmaceutical Practices
Guide
May 1, 2013
Alia Hani Yousef ,Bs.c in Pharmacy
Objective
To provide awareness of the new pharmacy

regulation in Dubai
To facilitate implementation
DHA Health Facility Regulations
Hospital
Diagnostic Imaging
Day Surgical Centre
Outpatient
Clinical Laboratory
Home Healthcare
Three Guidelines
Health Facility
Guidelines: Planning,
Design, Construction
and Commissioning
Health Record
Guidelines
Guidelines on Dental
Infection Prevention
&Safety
Community Pharmacy Regulation

Chapter One: Definitions & Procedures
Administrative Procedures
Chapter Two: Requirements

Dubai
Community Pharmacy
Licensure
Pharmaceutical
Practices
Guide
General Considerations
Community Pharmacy Requirements
Design Requirements
Requirements for 24 hours duty

Dubai Health Authority
Chapter Three: Pharmaceutical Practices
Section one: Medication Management
Section Two: Records Management
Section Three: Good Pharmacy Practices
Scope
This Guideline applies to every licensed

pharmacy providing pharmaceutical
services and subject to licensure under
the Dubai Health Authority establishment
law, including pharmacies private, semigovernmental, and free zone areas
Definition of Terms
Community Pharmacy - all those establishments that are
privately owned and whose function is to serve societies need for
both drug products and the pharmaceutical services
Controlled Drug -Class A - medicine that contains an active

ingredient listed in schedules 7 and 8 of the UAE Federal law
for 1995, or a medicine that has been assessed as having a
significant potential for abuse and / or could be diverted for illegal
use
Definition of Terms
Controlled Drug -Class B - medicine that is used for psychiatric

conditions or a schedule 3 medicine that avoids narcotic control
due to its formulation or any other medicine that requires stricter
control than that of prescription
Medicine/medication/pharmaceutical drug - defined as any

chemical substance intended for use in the medical diagnosis, cure,
treatment, or prevention of disease
Narcotic - a medicine containing an active ingredient listed in

Schedules 1 to 6 of UAE Federal law 14 for 1995


Dubai
Community Pharmacy
Licensure
Pharmaceutical
Practices
Guide
Design Requirements



Design Requirements
Space Requirements
Hand Washing Area
Wall Finish & Flooring
Main area requirements (sales area,
storage, dispensing, etc..)
Cabinets (POM, Controlled
Drugs, Expired Meds, etc)
Communication
Devices
Air
Conditioning
lighting

Design Requirements
Medication Preparation Area
Power Supply
First Aid Kit
DHA Pharmacy
license
Fire
extinguishers
Ref

24 Hour Duty Pharmacies
Duty permission and Validity
24 hours operating pharmacy not allowed to close /
unless permission cancel
pharmacy access
pharmacy display board
licensed pharmacist availability
medications availability


Dubai
Community Pharmacy
Licensure
Pharmaceutical
Practices
Guide
Design Requirements

PHARMACEUTICAL PRACTICES
Section One: Medication Management
Storing Medications and

Pharmaceutical Products
Storage
Pharmacy Temperature
monitoring
Medicines
Vaccines
Pharmaceutical products
Room temperature between 15-30 c

Relatively cool area between 8-15c
Cold place temperature around 8c
Refrigerator temperature between 2-8 c
Storing Medications and Pharmaceutical Products
Precautions
Exposure to sun light

POM display and advertising
Storage conditions
Purchasing and Dispensing

Licensed Agents
or MOH
Registered
Distributors
Official Purchase
Invoice (batch/lot
no. of each item,
expiry)
Dispensing
expired
medication !
Smuggled and
Illegal Products
Free Sample
Medications
Selling Price &

Discounts
Purchasing and Dispensing

Stickers and
Labels
Selling medication
in original packs
or part packs
Medicine name,
batch number/lot
number
Expiry date
Leaflet
Trading of
Medical Products
Directing
customers to buy
other than
prescribed
Changing or
modifying
pharmaceutical
preparation
Prescription Only Medications (POM)
Prescription
Availability
Validity
Legible Contents (hand written or electronically

printed)
Name, Age,
weight, &
contact number
Generic or Trade
name
Pharmaceutical
preparation
form, dosage,
route of
administration,
duration &
instruction
Licensed
Healthcare
Professional
(Name, stamp,
signature & date)
Alterations in Prescription
Permission from
Patient & Doctor
Signature of
Pharmacist
Change product
with similar
active ingredient
Document in
writing
Doctors cannot
be contacted
Doctors refuse
to change
medication
Pharmacist is
not permitted
to dispense
medication!!!
Errors in Prescription
Controlled Drugs
Federal Law No. 4 for 1983
Controlled Prescription Psychotropic Substances
Duration of Prescription (CDA & CDB)
General Practitioner - 3days

Specialist - 2 weeks
Consultant - 4 weeks
Psychiatry Specialist or Consultant - 4 weeks
Condition for Dispensing (CDA) Medication
Prescription exceeds specified period
MOH Controlled Drug Prescription form
Validity - 3 days from the date of issuance
copy of patients UAE identity card/passport
Stamp and signature
Condition for Dispensing (CDA) Medication

record in special
register book (DHA,
MOH)
Return of damaged
stock
re-dispensing
Storage
Dispensing
medications
exceeding approved
doses
licensed physician
issuing narcotic or
psychotropic
substances for
himself
CDA(Group-A)Registration
log book
CAB (Group-B)Registration
log book
Special Requirements CDA Outpatient Prescription
Federal Law No.4 (1983)
serial number
patient's full name, age and address (given name, surname, middle
name)
permanent ink
generic & trade name of medicine
date of issuance, signature and stamp of the prescribing physician
dosage & strength of active ingredient (figures & letters) route of
administration, duration and instructions of use
Duration of supply
Special Requirements CDA Outpatient

Prescription
Federal Law No.4 (1983)
Controlled Drugs
Management of expired controlled drugs

separated from the active stock
labelled
removed as soon as possible
may be returned or destroyed as per the Narcotics
and Controlled Drugs Guide
Record in the controlled drug register
Section Two: Record Management
Documents & Records

Dedicated area
UAE Pharmacy Professional law
Pharmacist Professional Code of Conduct
Guidelines and minimum standards for Good Pharmacy
Practice (GPP) in UAE Pharmacies issued by MOH
DHA and MOH circulars and relevant documents
Forms reporting adverse reactions used by
Pharmacological vigilance program
Documents & Records

List of registered medication in UAE
approved price list issued by MOH amendments
List of controlled drugs and classifications and
amendments
pharmacy license DHA and DED
staff valid DHA licenses (including trainees)
Staff list
Continuous Professional Development (CPD)
Contact data
Contact Numbers
Pharmaceutical Vigilance Committee in MOH (MOH
website www.moh.gov.ae)
Poison Information Centres in the UAE
http://www.haad.ae/haaddeps/pdic/tabid/194/default.aspx
Directory of all health facilities contact details
Registers Records and Reports

Daily Temperature Record (12 months)
Records of controlled drug registers
CDA
CDB
numbered and stamped by MOH
Invoices
Registers Records and Reports

Commercial transactions
Controlled Drugs prescriptions (5 years) (CDA and
CDB)
Reports of Controlled Drugs (CDA and CDB)
Prescriptions of medication preparation
Violations and fines - pharmacy & staff
Scientific References
British National Formulary (BNF)

British Pharmacopoeia (BP)
United States Pharmacopeia (USP)
European Pharmacopoeia (Ph. Eur.)
Martindale: The Complete Drug Reference
Goodman and Gilman: The Pharmacological Basis of Therapeutics
A book for clinical pharmacy or clinical pharmacology
Section three : Good Pharmacy Practices
Legal and Ethical framework

Abide with UAE Pharmacy federal laws, related
legislations and circulars
Comply with Pharmacists Professional Code of
Conduct by MOH
Pharmacy staff is not allowed to offend or criticize any
healthcare professional
Continuing professional development
Up to date knowledge and skills
Personnel
Valid DHA license; Training permission

Availability during duty hours
Scope of Practice
Technicians & Trainees under supervision
Professional Staff Uniform and ID card
Confidentiality
First Aid Activities not allowed
Annual leave not exceeding 60 days
Substitute Pharmacist Pre-approved by HRD
Waste Management
Disposal of wastes in accordance
with UAE laws and regulation
Disposal via approved companies
must be recorded
Medication Management
Classification of Medications in UAE
Federal law 14 (1995)

Schedules
Abbreviation
Older UAE
descriptions
Narcotic
Narcotics
Controlled Drug - Class A
CDA
Registered
Prescription (RP)
Controlled Drug - Class B
CDB
Semi-Controlled,
prescription (CP)
Prescription Only
Medicine
POM
Prescription Drug
(P)
Over the Counter
OTC
General Sale List
GSL
MOH assigned Mode of

Dispensing
1-6 (Narcotics) Controlled Drug - Narcotic
7-6 (Psychotropics)
Not scheduled according

to Federal Law 14 (1995)
Healthcare Professionals
Registration & Licensing
Ms. Khawla Al Mansoori

.
Licensing Titles
Title
Qualifications
Experience
Route 1:
BSc or Doctor of Pharmacy (Pharm. D) degree from an
accredited college of pharmacy
OR
Post baccalaureate Pharm. D degree or MSc Clinical
Pharmacy
AND
Current National License
Minimum of one year experience as a

clinical pharmacist with clinical
responsibilities providing Pharmaceutical
care
Pharmacist
Bachelor degree in Pharmacy from an accredited college of

pharmacy recognized in home country AND
Active License/Registration to practice pharmacy
Minimum of two years experience as Pharmacist.
Pharmacy Technician

Graduate of an accredited diploma in Pharmacy program

Minimum of two years experience as Pharmacy
(minimum of two 2 years course duration) recognized in home Technician.
country.
Clinical Pharmacist
(New)
Renewal of Professional License

Continuous Professional Development (CPD)
Category
CPD requirements
Doctors and Dentists
30 hours
Nursing
15 hours
Pharmacists
15 hours
Allied Health
10 hours
General Rules for Inspection
Alia Hani Sharif, BS.c in Pharmacy
Objectives
To promote awareness on the general rules of
Quality Assurance Section, Facility Monitoring
Unit Inspections
Specifically,
emphasize the scope of inspection
accentuate the purpose of inspection
highlight expectations from Licensure Surveyors
Definition
Inspection
is the onsite survey of health facility including all
aspects of the facility (physical structure, Medical,
Engineering, nursing etc)
Initial Inspection
is an inspection conducted in order to review and
compare the architectural floor-plan submitted and
Health facility Guidelines of a new applicant
Definition
Final Inspection
is an on-site inspection by surveyors and/or relevant
others to determine compliance with the DHA
regulatory standards of a new applicant for licensure
Random Inspection
is an unannounced onsite visit to an established and
licensed health facility in order to identify compliance
to DHA standards
Definition
Inspection Committee
A group of qualified professional working
together to review and evaluate the services
of the facility and compliance to DHA
Standards
Scope
All Health Care Facilities Located in
Dubai
Hospitals
Day care surgery centers
Specialty clinics
Polyclinics
General clinics
Physiotherapy centers
Diagnostic centers
Optical shops
Pharmacies
General Rules
Purpose of Inspection
Inspection makes an important contribution to
the
improvement of delivering health services
provides assurance to the public on the safety of
services in the Emirate of Dubai
General Rules
DHA Authorized Surveyors
QAS-FMU Licensure Surveyors are given the
right to conduct various inspections
through Delegation of Authority by the
Director General of Dubai Health Authority
and the Ministry of Justice
Legal Seizer Bailiffs
General Rules
The Inspection Team
Minimum of two licensure surveyors
Committee consisting of multi-sector
specialist
Frequency of Inspection
minimum of two inspections per year
surveyors shall decide upon the time interval
between visits
General Rules
Planned Inspections
Initial
Final
Unannounced Inspection
Random Inspection
General Rules
Expectations
Surveyors approach shall be one of
Transparency
High degree of professionalism
Surveyors shall make objective judgments

Surveyors shall provide constructive
recommendations after inspection process
General Rules
Licensure surveyors authorities
Use of digital cameras when deemed
necessary
Request the reproduction of any relevant
document
Field Inspection Report Form
Thank you.
Executive Council Resolution No. (32)

Regulating
Practice of Medical Professions in
Dubai
Dr Layla Al-Marzouqi
28 articles--Summary
Practising healthcare profession

Medical Practice Committee & its function
Process of Application for License
Penalties for Ethical & Technical Violations
&Administrative Violations
Law Enforcement Officers
Penalties
Appeal
Reinstatement of License to Practise a Profession
Accrual of Fees and Fines
Medical Practice Committee

Develop / review
Rules & Conditions for licensing Professionals /
Healthcare Facilities
standards for equivalence of academic &
professional medical qualifications
Consider license applications of Professionals/
Healthcare Facilities
Medical Practice Committee

Set exemption standards from initial assessment
required for granting licenses
Impose appropriate penalties on violating
Professionals / Healthcare Facilities
Perform any other duties assigned by Director
General
Fees for Healthcare Facilities Licenses

Fees for License of Professionals
Penalties for Administrative Violations
Suspended/revoked
HCP may not work, even in
administrative positions, in HCF without
prior approval from HRD.
Fines
Practicing without license
Opening facility without getting final approval
Being uncooperative with Law Enforcement
Officers
Not submitting required date to DHA within time
limit
Not issuing sick leave electronically
Not issuing medical report to patient
For technical and ethical violation
Administrative Measures for

Violating Legislation
close section or whole HCF for a period not > 6 M
at a time
suspend the HCP for 12 M
revoke License of HCP/HCF
Investigation :
temporary partial or complete closure/
suspension of HCF/HCP for a period not >3 M
Extension of the closure for the same period.
Violation constitutes a criminal refereed to judicial
body
Ethical & Technical violations

Running unnecessary medical tests for patients to
make financial profits
Treatment of a patient without prior consent,
except in emergency
Determining treatment by a Professional without
conducting clinical examination of the patient.
Infection control measures
Use of unauthorised or illegal means to treat
patients
Penalties for Ethical & Technical

Violations
Warning
Fine 2,000- 10,000 dirhams HCP
Fine 5,000- 25,000dirhams - HCF
Grievance
written grievance to be submitted within 30 days
Will be referred to grievance committee
decision shall be final
10
Reinstatement of License to
Practise a Profession
HCF/HCP can apply for reinstatement of License
after 2 years
Committee shall decide on the application
according
Law Enforcement Officers

Function
prove acts committed in violation of this
resolution
have access to inspect HCF
audit Professionals
issue violation reports
seek assistance from government entities
concerned, including police officers
Thank you

Pharmacy Awareness Campaign May 1

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Licensing Process for Pharmacies and their

Licensing Process for Professionals

List of DHA approved Professional Title

Licensing Process for Facility

Health Regulation Department

Application Process for

Create a Sheryan account on line (user name

2. Fill New Professional License application and

Last 2 years experience

List of DHA approved

Pharmacy Technician (equal to Pharmacy Assistant)

Application Process for

Create a Sheryan account online (user name

2. Fill New Facility License application and

Alia Hani Yousef ,Bs.c in Pharmacy

To provide awareness of the new pharmacy

DHA Health Facility Regulations

Day Surgical Centre

Community Pharmacy Regulation

Chapter Two: Requirements

Community Pharmacy Requirements

Requirements for 24 hours duty

Health Regulation Department

Chapter Three: Pharmaceutical Practices

Section one: Medication Management

Section Two: Records Management

Section Three: Good Pharmacy Practices

This Guideline applies to every licensed

Controlled Drug -Class A - medicine that contains an active

Controlled Drug -Class B - medicine that is used for psychiatric

Medicine/medication/pharmaceutical drug - defined as any

Narcotic - a medicine containing an active ingredient listed in

Community Pharmacy Regulation

Chapter Two: Requirements

Community Pharmacy Requirements

Requirements for 24 hours duty

Health Regulation Department

Chapter Three: Pharmaceutical Practices

Section one: Medication Management

Section Two: Records Management

Section Three: Good Pharmacy Practices

Community Pharmacy Requirements

Community Pharmacy Requirements

Community Pharmacy Requirements

Community Pharmacy Requirements

Community Pharmacy Regulation

Chapter Two: Requirements

Community Pharmacy Requirements

Requirements for 24 hours duty

Health Regulation Department

Chapter Three: Pharmaceutical Practices

Section one: Medication Management

Section Two: Records Management

Section Three: Good Pharmacy Practices

Storing Medications and

Room temperature between 15-30 c

Storing Medications and Pharmaceutical Products

Exposure to sun light

Purchasing and Dispensing

Selling Price &

Purchasing and Dispensing

Prescription Only Medications (POM)

Legible Contents (hand written or electronically

General Practitioner - 3days