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Bahrain Pharmacy PQR 2023 V3

Pharmacy PQR 2023

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0% found this document useful (0 votes)
455 views28 pages

Bahrain Pharmacy PQR 2023 V3

Pharmacy PQR 2023

Uploaded by

Muzaffar Ali
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 28

PHARMACY

PROFESSIONALS
QUALIFICATION
REQUIREMENTS
March 2023 - version 3
Contents
Definitions: ....................................................................................................................................................................................................3
Acronyms: ...................................................................................................................................................................................................................... 6
Preface: .......................................................................................................................................................................................................................... 8
1. Licensure General Requirements ................................................................................................................................................................9
1.1Educational Qualifications .......................................................................................................................................................................9
1.2 Professional Experience ....................................................................................................................................................................... 10
1.3 Professional License and Certificate of Good Standing ............................................................................................................................ 11
1.4Primary Source Verification ................................................................................................................................................................... 11
1.5 Bahrain Pharmacy Licensure Examination (BPLE):................................................................................................................................... 12
BPLE Exemption Policy ............................................................................................................................................................................. 12
BPLE Result Validity: ................................................................................................................................................................................. 12
BPLE Attempts ......................................................................................................................................................................................... 12
1.6 Discontinuity of Practice: ................................................................................................................................................................ 13
2. Renewal of Licenses ................................................................................................................................................................................. 14
3. License Re-categorization ......................................................................................................................................................................... 15
4. License Transfer………………………………………………………………………………………………………………………………………………………………………………………….15
5. General Regulatory Items ......................................................................................................................................................................... 16
6. Qualification and Experience Requirements for Pharmacy Licensure . ……………………………………………………………………………………………………..…17
7. Licensing Process Flowchart …………………………………….…………………………………………………………………………………………………………………………………….22
7.1 professional registration for licensing flow chart….……………….…………………………………………………………………………………………………………..23
7.2 licensure exam policy flow chart ……………………….…………….…………………………………………………………………………………………………………………24
7.3 Discontinuity of Practice flow chart………………………………………………………………………………………………………………………………………………….. 25
7.4Renewal of Licenses flow chart……..……….…………………………………………………………………………………………………………………..…………………….. 26
7.5Transfer of Licenses flow chart……..………………………………………………………………………………………………………………………………………………….. 27
7.6 re-categorization of Licenses flow chart………………………………….……………………………………………………………………………………………………….. 28

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Last Update:MAR 2023


Definitions:
Authority: National Health Regulatory Authority

Continuing Professional Development (CPD): A range of learning activities through which healthcare professionals maintain and
develop/improve their knowledge and skills/professional performance throughout their career to ensure that they retain their
capacity to practice safely, effectively, and legally within their evolving scope of practice. CPD is also sometimes referred to as
Continuing Medical Education (CME).

Credentialing: A process whereby specific licensing title is assigned to a healthcare professional based on recognized and
accredited qualifications, training, experience, and current practice.

Experience: Hands on clinical experience gained by a licensed healthcare professional during a salaried employment/contractual
period and it excludes volunteer jobs, observer-ship, or clinical attachment.

Fitness to practice: A status where the healthcare professional is able to consistently demonstrate the ability to practice without any
impediments i.e. physical or others.

A gap of Practice: A defined period of discontinuation of clinical experience/ practice.

Certificate of Good Standing (CGS): A certificate showing evidence that the healthcare professional is competent to practice
the profession, has not been found guilty of unprofessional conduct, and that there are no pending or previous disciplinary
orders or criminal proceedings against the healthcare professional.

Healthcare Profession: A field of healthcare recognized by the Authority.

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Last Update:MAR 2023


License: A permission granted by the authority to practice a healthcare profession.

Licensing: A process of granting a legally protected professional title by the authority.


Pharmacy Professionals: All professionals practicing pharmacy including a pharmacist, pharmacy technicians, and medical
delegates…etc.

Pharmacist: A professional who holds bachelor’s degree in pharmacy or a Pharma D.

Pharmacy Technician: A professional who holds a diploma in pharmacy. licensed to practice the profession of a pharmacy technician
under the direct supervision of a pharmacist.

Clinical Pharmacist: A professional who holds a Pharma D or a bachelor’s degree in pharmacy & a postgraduate degree in Clinical
Pharmacy Sciences and has relevant experience in this field. work directly with physicians, other health professionals, and patients to
ensure that the medications prescribed for patients contribute to the best possible health outcomes.

Specialist clinical pharmacists: - health professionals that work & train for many years to become specialists in a specific clinical
area such as ophthalmology, geriatrics, oncology, and more. The role is usually patient facing, involving attending consultant ward
rounds, multidisciplinary meetings, and providing support and training to nursing staff, pharmacy technicians, and junior pharmacists.

Ayurvedic Pharmacist: a professional who holds a bachelor’s degree in Ayurveda pharmacy or a bachelor’s degree in pharmacy or
a Pharma D and a postgraduate degree or accredited courses in Ayurveda Pharmacy Sciences and has relevant experience in this field.

Ayurvedic pharmacy technician: a professional who holds Diploma in Ayurvedic Pharmacy or Diploma in Pharmacy & a post-
graduate qualification related to Ayurveda study or course and has relevant experience in this field.

Nuclear Pharmacist: a professional who holds a bachelor’s degree in pharmacy or a Pharma D and holds an accredited postgraduate
qualification in the field of "Nuclear Pharmacy", a professional who is specially trained to handle, prepare and distribute radioactive
materials that radiologists use for certain imaging procedures and treatments.

Industrial pharmacist: a professional who holds a bachelor’s degree in pharmacy or a Pharma D or accredited postgraduate
qualification in the field of " Industrial pharmacy " and has relevant experience in this field., a professional who conducts research,
testing, and analysis in Drug development and production of drugs and related supplies. They use the latest methods, technologies, and
processes for the development of new drugs.

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Last Update:MAR 2023


Medical delegate: A professional who holds a degree in pharmacy (bachelor’s degree in pharmacy or diploma in pharmacy) and is
responsible for the promotion of medicines and pharmaceutical products.

Primary Source Verification: A process of validating documents required for licensure from the issuing organization.
Negative Verification Report: A verification result indicating negative feedback on the submitted credentials.
Positive Verification Report: A verification result indicating that all submitted credentials have been verified successfully and genuine.
Unable to verify report: A verification result indicating an incomplete verification process related to failure in providing all necessary
credentials, and/or applicant is not responding to the verification agency, and/or certain issues related to the issuing body.

Qualification: Educational evidence granted by universities, colleges, academic institutes, or schools that are nationally accredited
or formally recognized.

Residency Program: Advanced clinical training in an accredited health facility that provides clinical training in a specialty
recognized by the regulatory authorities in the country. Qualify the graduate to work in the field of specialization.

Internship: -: A minimum of one year of supervised clinical practice completed by graduates from Pharm D programs to
consolidate the knowledge gained during their study according to applied legislation in the country

Re-Categorization: The process of application and assessment for the issuing of a license from one license category to another
category.

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Last Update:MAR 2023


Acronyms:
• BPLE: Bahrain Pharmacy Licensing Examination

• CPD: Continuing Professional Development

• CGS: Certificate of Good Standing

• NHRA: National health regulatory authority

• PQR: Professional Qualification Requirement

• PHARM. D: Doctor of Pharmacy

• PH D: Doctor of Philosophy

• D PHARM: Diploma in Pharmacy

• MPharm: Master of Pharmacy

• DClinPharm :- Doctor of Clinical Pharmacy

• ASHP: American Society of Health-System Pharmacists

• BPS: - Board of Pharmacy Specialties

• PGY1: Postgraduate year one of pharmacy residency program

• PGY2: Postgraduate Year Two Pharmacy Residency Programs

• CPS: Clinical pharmacist specialist

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Last Update:MAR 2023


• GPhC :- general pharmaceutical council

• BCNP: - Board-Certified Nuclear Pharmacist

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Last Update:MAR 2023


Preface:
The Supreme Council of Health (SCH) in the Kingdom of Bahrain is pleased to present the revised PQR. The first PQR was issued in 2017. This
revision was necessary to keep up with the advancements in the healthcare professions to ensure the quality of services provided for the
healthcare recipients.

This document applies to all healthcare facilities both in the governmental and private sector to assess the documents submitted by applicants
within their geographical jurisdiction to ensure safe and competent delivery of services. Moreover, it places an emphasis on educational standards,
experience, and licensure requirements for healthcare professionals to be licensed to practice safely in the Kingdom of Bahrain and in accordance
with Bahrain laws and benchmarked international best practices.

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Last Update:MAR 2023


1. Licensure General Requirements
• All applicants must fulfill all the following requirements in order to qualify for licensure.
• Non-Bahraini pharmacy professionals applying for a license must be no more than 65 years of age.

1.1 Educational Qualifications


• Academic qualifications will be evaluated by NHRA

• Qualifications must be issued by institutions/colleges recognized in home country

• At the entry level, minimum qualification requirement is high school certificate as per country specific education

• Professional qualifications are evaluated in accordance with the following criteria:

O The country and institution from which the qualification was awarded
O The level of national recognition of the qualification
O The duration and curriculum of study, and the presence of clinical practice\practice training
O Qualifications acquired through honorary nature, correspondence, or online distance learning are not counted towards the
PQR
• Qualifications not mentioned in this document may be evaluated and reviewed by NHRA Committee, to determine the eligibility for an
appropriate professional title.

• NHRA Committee will be responsible for evaluating the academic qualifications and all specialized certificates issued by universities
outside the Kingdom of Bahrain while preserving its right to reject any certificate that violates the regulations and standards approved by
SCH. The Committee may also change as it deems appropriate whenever the need arises.

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Last Update:MAR 2023


1.2 Professional Experience
• The applicant’s experience must be relevant to the category applied for (except medical delegates who may have
experience as pharmacists) and must have been accomplished in an appropriate setting licensed by the professional
regulatory and licensing authority in the country of practice.
• Bahraini nationals are exempted from experience requirements for the basic entry level.
• All other applicants are required to fulfill experience as per their relevant titles according to the PQR.
• The applicant must provide evidence of meeting the minimum required experiences for the applied category.
• The applicant's experience must be practical clinical experience gained by a licensed healthcare professional.
• Non-clinical practice ex. (administrative, academic, and research) is not fulfilled for the NHRA license requirements.
• practitioner who has experience in more than one country and this experience is considered the minimum
experience required for the applied category must provide evidence of the registration and have a valid professional
license to practice in all these countries as well as with a verification report for those licenses & experiences.
• Experience with Pharmaceutical Marketing Agencies or sales representatives is not acceptable for all categories.

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Last Update:MAR 2023


1.3 Professional License and Certificate of Good Standing
• The applicant must be registered and have a valid professional license to practice, or registration from their home country
and/or country of last employment.

• Licensing/Registration validity (where applicable) must cover the minimum experience required for the applied category.
• Certificate of Good Standing (CGS) must meet the following requirements:

o Valid and not older than six (6) months at the time of application for licensure

o Issued by the professional regulatory and licensing authority in the country(s) of last employment.

• NHRA may request more evidence or conduct investigations if deemed necessary to prove the status of good conduct of
the healthcare professional.
• The applicant must declare that he/she has never been convicted of any legal cases, or medical malpractice during
his/her practice in the healthcare profession, or that he/she is currently under investigation.

1.4Primary Source Verification


• The documents required for licensing shall be verified directly from the original or primary source.
• These documents include: -
o educational qualification(s)
o experience certificate(s)
o professional license(s)
o Good Standing certificate (CGS)
o any other documents deemed necessary by NHRA

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Last Update:MAR 2023


1.5 Bahrain Pharmacy Licensure Examination (BPLE):
• All pharmacy professional applicants must pass NHRA’s BPLE in order to obtain a professional license in the
Kingdom of Bahrain

BPLE Exemption Policy:


Only Bahraini or GCC nationals holding a valid GCC license will be exempted from the licensure examination.

BPLE Result Validity:


The validity of the licensure examination is five years only. If the applicant did not practice within five years, he/ she
need to repeat the exam.

BPLE Attempts
Pharmacy professionals have a total of four examination attempts provided following conditions are adhered to:

1. Each applicant may attempt the examination four consecutive times provided the attempts are done within a
maximum of three years from the date of the first attempt.

2 Only Bahraini applicants who do not pass the exam after the fourth attempt, he/she is required to go through a
period of training in a Licensed Health Care Facilities accredited by NHRA for a minimum of six months.

3. Bahraini applicants After proofing of completion of training, two more consecutive exam attempts may be
permitted provided that the attempts are within two years from the date of completion of training

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Last Update:MAR 2023


1.6 Discontinuity (GAP)of Practice
This section applies to Bahrainis ONLY
• pharmacy professionals who discontinue their practice for at least three (3) years and opt to be licensed in the Kingdom of
Bahrain are required to pass the NHRA licensure assessment as the first step to obtain the license to practice and must undertake the
following actions: -
1- Apply directly to take the NHRA licensing exam if passed the first exam attempt Pharmacist will obtain a license
to practice and work under the supervision of a licensed professional same specialty for one year
2- A pharmacist who fails in the first exam attempt will be required to go through CPD credits and a clinical
training program and must follow the requirements below: -
A- All training programs & CPD credits shall be carried out in an approved practice setting by NHRA in: -
❖ (6) months of training on a full-time basis (7 hours a day/ 5 days a week)
❖ 100 CME/CPD credits
B- All CPD credits must be related to the practice specialty of the healthcare professional, and according
to the CPD-specific requirements of NHRA.
C- All applicants are required to complete a training program which shall be determined by NHRA in the
specialty field.
3- applicants after completion of CPD credits, and the clinical training required to re-attempt the NHRA licensure exam
(according to the number of attempts NHRA exam policy) if passed the re-attempt exam professional will obtain a
license to practice and work under the supervision of a licensed professional same specialty for one year.
• Non-Bahraini nationals will not be able to apply for a license (as a new profession license) or renew a license if they have a
gap of clinical practice of three (3) years and above, they need to provide at least 6 months of work experience with a valid
license in the home country.
• Applicants are required to provide a Health fitness certificate to the practice and a certificate of good conduct.
• Bahraini national Clinical pharmacists or Specialist clinical Pharmacists who Discontinued practice, must provide 12 months of
training in the same field, or present an additional approved qualification in Clinical Pharmacy Practice to break the GAP
period.

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Last Update:MAR 2023


2. Renewal of Licenses
2.1. All pharmacy professionals must submit a minimum of 25 CPD hours annually.
2.2. CPD must be relevant to the field of the specialty/area of practice of the healthcare professional.
Furthermore, please note the following:
2.2.1 For CPD events inside the kingdom, only those activities recognized and accredited by NHRA will be accepted.
2.2.2 For CPD events outside the Kingdom of Bahrain will be accepted only if they are issued by the concerned
recognized bodies in that country /or accredited by the Authority in that country.
2.2.3 No CPD activities performed by pharmaceutical companies will be recognized.
2.3. CPD hours should be submitted annually to NHRA even if the license is renewed for two years or more.
2.4. Bahraini pharmacy professionals who are issued licenses without the specification of a facility must:
2.4.1 renew their license for two years at a time.
2.4.2 Prove the continuity of their practice (must provide proof of a minimum of one full year of practice) during the
three years.
2.4.3 Failure to provide continuity of practice will lead to the pharmacy professional being considered in a gap of
practice and will need to fulfill the discontinuity of practice requirements as per the requirements of this PQR prior to
their license being renewed.
2.5. License can be renewed up to a maximum of four years each time.
2.6. A health fitness certificate is required every three years & not done more than SIX months from
the date of the renewal application.

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Last Update:MAR 2023


2.7. Applicants Can submit a license renewal application two months prior to the expiry date of their current licenses.
2.8. If the professional does not achieve the required CPD target for each year, the renewal application will be pending for 6 months
from the date of the requirements until the CPD target is completed and the application will be rejected after 6 months, and the
professional must submit a new renewal application.

3. License Re-categorization
3.1 Pharmacy professionals may apply for a re-categorization of their license supported by the following documents:
3.1.1 A formal competency letter from the Pharmacy Manager /Supervisor
3.1.2 Additional qualification obtained.
3.1.3 Verification of the qualification and experience if obtained from outside of the Kingdome of Bahrain
3.2 All re-categorization applications must fulfill the years of experience required post qualification as per this PQR
3.3 In compliance with the Discontinuity of Practice (Gap of Practice) criteria for the new re-categorized category.

4. License Transfer
4.1License transfer is a process of re-issuing a professional license under a different facility
4.2 The following are required for the transfer of a license:
o Valid NHRA License (at least two months before the expiry date of the license)
o Offer letter or Invitation of employment from the new facility.
o NOC from the previous healthcare facility, proof of cancellation of work permit, mobility application from
LMRA, or end service certificate. (This point is not mandatory for Bahrainis)
4.3 Legal Accountability is essential for practitioners and owners of a new facility in the case started practicing in the new
facility without approval from NHRA to transfer the professional license.

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Last Update:MAR 2023


5. General Regulatory Items
• Professional licensure and registration titles are independent of employment grade and titles.
• Healthcare facilities should not employ a pharmacy professional at a higher category than that given by NHRA.
• All Professional categories should practice within their specified scope framework.
• NHRA reserves the right to re-evaluate any healthcare professionals should the need arise.
• practice the profession of pharmacy in the Kingdom of Bahrain with an expired license It is considered an illegal practice.
• Bahrainis who have been issued licenses without the specification of a facility, must:
o Apply for transfer of their license as soon as they obtain an offer letter.
o They should not start their practice in the prospective facility except after the transfer of the license.
• All pharmacy professionals holding administrative or academic positions will not be licensed by NHRA unless they prove the
continuity of clinical practice.
• Non-Bahraini wives married to Bahraini husbands' nationals will be treated as Bahraini regarding the policies of experience,
number of examination attempts, and discontinuity of practice.
• For recategorization requests for Bahrainis and Bahrain residents who started educational programs before this PQR was
approved, the old PQR will be applied for their recategorization.
• This PQR shall be reviewed once every three years.
• A practitioner is practicing the profession of pharmacy illegally if he describes to himself a specialized title from among the
titles of practicing the profession of pharmacy other than the licensed title and registered in the records of NHRA.

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Last Update:MAR 2023


6-Qualification and Experience Requirements for Pharmacy Licensure
Professional Academic Qualifications Experience Qualifying Remark
title Examination
Pharmacist Bachelor (BSc) in pharmacy five years of experiences
post certification as a (Prometric)
pharmacist with a valid
license for non-Bahraini
PharmD with a Six-year degree inclusive Two years of experiences PharmD qualification with an
of (Five years of academic study and post certification as a internship in (pharmaceuticals
One year of internship or residence pharmacist with a valid companies or community
in a hospital as part of the license for non-Bahraini pharmacies) will be treated as the
curriculum) criteria for a Bachelor of Pharmacy
degree (need 5 years’ experience)
Clinical PharmD Six-year degree inclusive of two years of experience post-
Pharmacist (Five years of academic study and certification as a clinical
One year of internship or residence pharmacist in a hospital
in a hospital as part of the setting with a valid license for
curriculum) non-Bahraini
DClinPharm degree issued from (accredited Australian
universities)
MPharm degree two years of experience post-
certification as a clinical (Prometric) MPharm degrees from UK or Europe
pharmacist in a hospital countries must be from GPhC-
setting with a valid license for accredited universities
non-Bahraini
BSc of Pharmacy And post-graduate Two years of experience post-
qualification in PharmD (Doctor of certification as a clinical
Pharmacy) pharmacist in a hospital
BSc of Pharmacy & post-graduate setting with a valid license for master’s (must be two (2) years of
non-Bahraini (Prometric)
qualification master’s in clinical studies including 6 months of
pharmacy training)

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Last Update:MAR 2023


BSc of Pharmacy and PGY-1 (Clinical (Minimum two (2) years duration of
Pharmacy Residency program) the program and accredited by ASHP)
BSc of Pharmacy and PGY-2 (Clinical PGY-2 must be an accredited
Pharmacy Residency program) Not required experience (Prometric) program that builds upon the
competencies established
& completion of PGY-1
BSc of Pharmacy and PH.D. (in
clinical Pharmacy)

(CPS)Clinical BSc of Pharmacy or PharmD


pharmacist And post-graduate qualification in
specialist (Listed one of the BPS specialties two years experience post
in Diagram A) BSc in Pharmacy or PharmD and certifications in the same field (Prometric) Residency program accredited by
Completion of (PGY-2) Specialty Specialization in a hospital ASHP
Pharmacy Residency. setting with a valid license for
BSc in Pharmacy or PharmD & post- non-Bahrainis post-graduate qualification (minimum
graduate qualification in one of the master’s degree)
specialties (Listed in Diagram A)

nuclear BSc of Pharmacy or PharmD Three years experience post


pharmacist / And post-graduate qualification in certifications as a nuclear
radio- BCNP. pharmacist with a valid
pharmacist BSc of Pharmacy & post-graduate license for non-Bahrainis (Prometric) master’s degree in Nuclear Pharmacy or
qualification master’s degree Radiopharmaceutics & PET
Radiochemistry MSc
BSc of Pharmacy or PharmD Two years' experience post Residency program accredited by
And completion of PGY-1 followed certifications as a nuclear ASHP
by PGY-2 in Nuclear Pharmacy or pharmacist with a valid
radiopharmacy residency. license for non-Bahrainis

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Last Update:MAR 2023


industrial Bachelor of Pharmacy or PharmD five years of experience
Required Experience must be in
pharmacist post-certification as an
Pharmaceutical Factories, Pharmaceutical
industrial pharmacist with a manufacturing companies &
valid license for non- Pharmaceutical research organizations
Bahrainis.
GMP
Bachelor of Pharmacy or PharmD & Three years of experience exam
post-graduate qualification master’s post-certification as an
degrees in (Industrial Pharmacy) Or industrial pharmacist with
post-graduate qualification related to a valid license for non-
the specialty field of industrial Bahrainis.
pharmacist
Pharmacy Diploma in Pharmacy Minimum of three years of (Prometric) two- or three-year course duration
Technician experience post certification program
as Pharmacy Technician with
a valid license for non-
Bahrainis

Ayurvedic Bachelor of Ayurvedic Pharmacy five years of post-certification Ayurveda minimum four- or five-year course
pharmacist as an Ayurvedic pharmacist Pharmacy duration program
with a valid license for non- Exam
Bahrainis.
BSc in Pharmacy or PharmD &post- two years of experience post Ayurveda study or course (minimum
graduate qualification related certification as an Ayurvedic one year's course duration) issued
to Ayurveda study or course pharmacist with a valid from an Accredited university or
license for non-Bahrainis. college in the country of study

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Last Update:MAR 2023


Ayurvedic Diploma in Ayurvedic Pharmacy Minimum of three years of Not minimum two- or three-year course
pharmacy experience post certification required duration program
technician as an Ayurvedic pharmacy
technician with a valid license
for non-Bahrainis
Diploma in Pharmacy & post-graduate Minimum of two years of Ayurveda study or course (one- or
qualification related to Ayurveda study experience post certification two-year course duration) issued
or course as an Ayurvedic pharmacy from an Accredited university or
technician with a valid license college in the country of study
for non-Bahrainis
Medical Diploma in Pharmacy or BSc in No experience required Not for non-Bahraini may have
Delegate Pharmacy required experience as pharmacists or
pharmacy technicians and need to
provide

• qualifications not listed in the table, would be reviewed & evaluated after providing the required documents.
• In compliance with the Discontinuity of Practice (Gap of Practice) criteria

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Last Update:MAR 2023


Clinical pharmacist specialist licensing

Ambulatory Care
Geriatric

Cardiology Infectious Diseases

Nutrition Support
Clinical pharmacogenomics
Internal Medicine

Critical Care (Adults \Neonates\Pediatrics)


Oncology

Emergency Medicine Pediatric

Medication -Use Safety and policy


Pharmaco-therapy

Palliative Care\ pain management


Psychiatric
Nephrology

Pharmacy information Endocrinology

Thrombosis and Hemostasis management


Solid Organ Transplantation

Neurology/Neurosurgery
clinical toxicology

Page | 21
Listed diagram A
Last Update:MAR 2023
7. Licensing Process
Flowchart

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7.1professional registration for licensing flow chart

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Last Update:MAR 2023


7.2 licensure exam policy flow chart

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Last Update:MAR 2023


7.3 Discontinuity of Practice flow chart

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Last Update:MAR 2023


7.4Renewal of Licenses flow chart

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Last Update:MAR 2023


7.5Transfer of Licenses flow chart

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Last Update:MAR 2023


7.6 re-categorization of Licenses flow chart

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Last Update:MAR 2023

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