Official Gazette

Issue No. 3243 – Thursday 7th January 2016

Resolution No. (12) for the year 2015

Issuing the Regulations on Drugs Registration System

In the National Health Regulatory Authority

Chairman of the Supreme Council of Health,

National Health Regulatory Authority (the "Authority"):
Upon perusal of Decree Law No. (18) for the year 1997, on the regulation of pharmacy
profession and pharmacy centers, amended by Decree Law No. (20) for the year 2015,
particularly Items (63 bis, 64, 65, 66, 67 and 68) thereof,
Law No. (38) for the year 2009 establishing the National Health Regulatory Authority, as
amended by Decree Law No. (32) for the year 2015,
Decree Law No. (21) for the year 2015 on private health institutions, and

Decree No. (5) for the year 2013 establishing the Supreme Council of Health, as amended;
After the approval of the Supreme Council of Health in its meeting No. (1) held on
Thursday, 22/10/2015, and

Based on the presentation of the Chief Executive Officer,

Decided as follows:

Article I
The provisions of the Authority's Regulations on drugs registration system, annexed to this
Resolution, shall come into force.

Article II
Resolution No. (2) for the year 2014 on the formation of the Drugs Registration Committee
and determining its terms of reference shall be cancelled, as well as any provision
inconsistent with the provisions of this Resolution.
Article III
This Resolution and the attached Annex shall be published and shall be in force on the day
following the date of publication.

Chairman of the Supreme Council of Health

Lieutenant Doctor / Mohammed bin Abdulla Al Khalifa

Issued on: 2nd Raby's al-Awwal 1438 H.

Corresponding to 31st December 2015

 Regulations on Drugs Registration System

In the National Health Regulatory Authority

Definitions
Article I

In applying the provisions of this Resolution, the following words and phrases shall have the
meanings indicated against each of them:
The Kingdom: Kingdom of Bahrain.

The Authority: The National Committee to regulate the professions and health serDeputys.
The Council: The Supreme Council of Health.
CEO: The Chief Executive Officer of the Authority.
The Law: Decree Law No. (18) for the year 1997 on the regulation of the profession of
pharmacy and pharmaceutical centers.
Committee: Committee for Drugs' registration.
Registration Applications: Applications for the registration of drugs and pharmaceuticals.
Drugs used for emergencies and unregistered: Medications used to treat some emergency
and critical cases in hospitals and have no substitute registered in the Kingdom.

Committee's formation, terms of reference and sessions' organization

Article II

A Committee shall be established in the Authority under the name of the Drugs
Registration Committee", under the supervision of the CEO. The Committee shall be
chaired by the Head of the Pharmaceuticals Office in the Authority, the Head of the
Department of Pharmacology at the Ministry of Health as Deputy-Chairman and the
membership of:
1) Two Senior Pharmacists in the Authority.

2) One Pharmacist in the Authority

3) One drugs' registration specialist in the Authority, who shall also act the reporter of
the Committee.

The Deputy-Chairman shall replace the Chairman in his absence or inability and
membership term in this Committee shall be three years.
A resolution nominating the Chairman and Deputy-Chairman of the Committee shall be
issued by the CEO.

Article III
The Committee shall undertake the following tasks:
1) Deciding upon the registration applications of drugs and pharmaceutical products in
the Kingdom.
2) Recommending the restrictions on dispensing or marketing of any registered drug or
pharmaceutical product in the cases referred by the CEO. The Committee shall
present its recommendations to the CEO to take the appropriate actions.
3) Reviewing the side effects to using any drug or pharmaceutical product in the post-
marketing phase, making recommendations thereon to the CEO.

4) Reviewing the reports from the competent authorities, in the Kingdom or abroad,
on drugs and pharmaceutical products, as well as their side effects, making
recommendations thereon to the CEO.
5) Issuing recommendations issued on cancelling the registration of any drugs and
pharmaceutical products in case reports are submitted to the Committee from
competent authorities, in the Kingdom or abroad, that prove that their having
harmful side effects or for any technical reasons determined by the Committee.
Recommendations shall be submitted to the CEO for decision.
All in accordance with the provisions of Decree Law No. (18) for the year 1997 on
regulating the profession of pharmacy and pharmaceutical centers and taking into account
the terms, conditions and the procedures set forth in this Resolution.

Article IV
The Committee shall undertake its terms of reference as of the issuance date of the
members' nomination resolution. It shall be located in the Authority and shall convene at
the invitation of the CEO or its Chairman once per month or whenever needed. The
invitation to the meeting shall enclose the agenda to be discussed and the meetings of the
Committee shall be valid only with the presence of the Chairman or his Deputy and the
majority of the members. Resolutions of the Committee shall be issued by a majority of
the members present, and in case of a tie the Chairman of the meeting shall have a casting
vote.

Article V
The Committee's Reporter shall undertake the following tasks:

1) Preparing meetings' agenda in coordination with the Chairman.

2) Inviting to the meetings of the Committee in coordination with the Chairman.
3) Recording, arranging, numbering and keeping minutes of the meetings.
4) Any other tasks assigned by the Chairman of the Committee.

Article VI
In performing its terms of reference stipulated in Article (III) of this Resolution, the
Committee may delegate one or more members to carry out specific tasks and, through the
CEO, may ask the ministries, the government agencies and other competent bodies for the
information, data or documents it deems necessary to perform its functions.

General Requirements for Registration

Article VII

The registration of any drug or a pharmaceutical product, in all its forms, concentrations
and packages, shall require submitting a registration application for each to get the
approval of the Committee.

Article VIII
The drug or a pharmaceutical product shall be registered and marketed in the country of
origin for at least one year before it is registered in the Kingdom. In case it is not
marketed in the country of origin, the reasons shall be clarified along with submitting a
certificate document for marketing the drug or the pharmaceutical product with the same
composition in one of the countries accepted by the Authority. The Committee may
exempt certain important and necessary drugs or innovative lotions from the condition of
duration.

Article IX
Registration applications shall be accepted only after approving the manufacturing sites of
the drugs or pharmaceutical products according to the foundations adopted in the Gulf
Cooperation Council, not precluding the Committee's assessment of the drugs or the
pharmaceuticals.

Submission of Registration Applications

Article X
The factories of drugs or pharmaceuticals, their commercial agents inside the Kingdom, or
the government pharmacy agencies shall submit the registration applications, whether
they are for the drugs or pharmaceuticals prepared locally or imported. The application
shall be submitted on the form provided for this purpose, attaching the documents and
samples provided for in Article purpose (64) of the Law.

Article XI
A special register shall be established in the Pharmaceuticals Organization Office at the
Authority to record the serialized registration applications according to their submission
dates, indicating the fulfillment of requirements and documents that must be attached to
the registration application and giving the applicant a receipt against recording his
application in the said register after fulfilling the documents and samples provided for by
the Law.

Article XII

Registration applications that fulfilled the requirements and documents shall be presented
to the Committee in its first meeting after the registration to be reviewed, studied and
evaluated according to the order of enrollment in the applications' register record or
according to the urgency justifications estimated by the Committee based on a reasoned
decision.

Article VIII
The drugs and pharmaceutical products included in the registration application shall be
analyzed at the expense of the applicant in the laboratories specified by the Authority to
ensure their compliance with the regulations and technical information stipulated in the
registration record. The applicant shall provide the samples and supplies required for
completing that analysis.

Article XIV
In case of registering a drug or a pharmaceutical product, it shall be recorded under a
serial number, providing the applicant with an official extract thereof to work as a license
for trading in the said drug or a pharmaceutical product, to be valid for five years from the
issuance date.
In case of the Committee's rejection of the registration application, it shall be a reasoned
decision, and must be reported to the applicant by a registered letter with
acknowledgment of receipt within fifteen days from the date of rejection.

Article XV
The applicant may appeal the Committee's decision to reject the registration application
to the CEO to submit the same to the Council within one month from the date of notifying
him with the rejection decision. The Council shall rule on the appeal within one month
from its submission

Registered drug package data

Article XVI
The producing factory shall mention the commercial and scientific name of the registered
drug or pharmaceutical, indicating the way to keep it, its lot number, expiration date and
the date of its registration in the Kingdom, on the outer packaging, in both Arabic and
English languages, in addition to any other data that may be required by the Authority.

The Authority may exclude some drugs or pharmaceutical products from the packages data
as referred to, at the request of the manufacturer, whenever using the drugs or
pharmaceutical products is relevant to one of the government health care institutions.

Registration Renewal
Article XVII
The registration of the drug or pharmaceutical product shall be renewed based on an
application to be submitted within six months from the expiry date of the registration
period, enclosing the documents and samples provided for in Article (64) of the Law.

The expiration of the registration period without submitting a renewal application as

above-mentioned shall entail the cancellation of the registration automatically.

Provisional Registration
Article XVIII
1) Drugs or pharmaceutical products are considered registered at the Authority if they
are registered at the Gulf Central Committee for Drug Registration (GCC-DR).
2) Drugs or pharmaceutical products that are not registered at the GCC-DR may be
temporarily registered at the Authority in accordance with procedures established
by a resolution by the CEP for one year in the following cases:
A) Registering them at one of the GCC reference states (Saudi Arabia - UAE -
Oman - Kuwait).
B) Registration for one year at one of the following agencies:
- Food and Drug Administration Authority (FDA).
- HEALTH CANADA
- European Medicine Authority (EMA)
- SWISSMEDIC
 - Therapeutic Goods Administration (TGA) - Australia.
Provided that during the year the registration procedures at the Authority shall be
taken in accordance with procedures set forth in these Regulations, unless the
provisional registration shall be cancelled.
3) In all cases, the price of the drugs or pharmaceutical products shall be determined
based on the standard price lists approved by the Executive Board of the GCC
Health Ministers or at the cost, insurance and freight price (CIF).

Article XIX

Article (58) of the Law shall apply on drugs imported personally for certain patient cases.

Article XX

Licensing the importation of drugs used for emergencies in hospitals and not registered
in the Kingdom of Bahrain
1) License to import drugs used for emergencies in hospitals and not registered in the
Kingdom of Bahrain shall be limited to the list attached to this Resolution, prepared
by the Committee and approved by the Council.
2) The Authority, upon the approval of the Council, may amend the approved list
either by adding new drugs or deleting any of them, in case such drugs are
registered any of the stated approved by the Authority or for the reasons
considered by the Authority.

3) Pricing mechanism does not apply to the drugs approved in the attached list.

Article XXI
Only hospitals shall be authorized to request to import drugs used for emergencies, which
usage shall be limited to these hospitals and are not allowed to be marketed or traded in
the local market.

Article XXII
Requesting the drugs contained in the attached list and used for the following emergencies
shall be subject to:
1) To be registered in the country of origin.
2) TO have alternatives registered in any of the states or bodies approved by the
Authority.
Article XXIII
1) The hospital requesting the importation of drugs used for emergencies shall take
the following into consideration:
A) The requesting hospital shall apply to the Authority with a prior request for
the entry of the drugs, including the quantity of the drugs to be imported,
sufficient for at least three months.
B) The hospital shall complete the application form approved by the Authority,
to be attached with the purchase order.

C) The pharmacy assigned to undertake the purchase by the hospital shall

submit the purchase order and the application form enclosing a copy of:
- Good Manufacturing Practice (GMP) of the producing company

- Product certificate of registration in the country of origin.

2) Customs clearance may be undertaken only by the Authority.

The attached list is already in English