Executive Board of the

Health Ministers’ Council

For GCC

Registration By-Laws of Pharmaceutical

Companies and Their Products

Prepared (In Arabic) By: Central Gulf Committee for Drug Registration

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Chapter One

The first article

Executive Office

Executive Office of the Council of Health Ministers of the Gulf Cooperation Council

Committee

Gulf Central Committee for drug registration

Pharmaceutical company

It is the parent company of one or more of medicinal plants licensed to operate

according to the regulations of the countries in which it operates

Pharmaceutical factory

It is the Establishment, in which the manufacture of medicines are done according to

the Basis of good manufacturing practice pharmacotherapy

Drug

It is any material or combination of materials prepared for the treatment or prevention

of disease to humans or animals, or that are used to diagnose medical conditions, or

to return or repair, or change the physiological functions in humans and animals

Country of Origin

It is the country of the Medicines manufacturer or that has the right Of manufacturing

and / or marketing, its regulatory Controls Can Issue the free sale certificates Or the

Pharmaceutical Preparation Certificates ( CPP )

Reference country

It is the state that issues the pharmaceutical Certificate of the product ( CPP ) On

which the product registration is based

Pharmaceutical Product

It is any Medicine Manufactured on Pharmaceutical Basis

Innovative product

is the first product to be launched in the market of innovative company under

Commercial name

Preparation multi-source (generic)

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Pharmaceutical preparation is similar to the innovative pharmaceutical preparation in

the dosage and safety, concentration and quality, action, and how to use

Sources of raw materials

A. Human

Including blood and blood products

B. Animal

Including micro-organisms and the body or part of the animal's body secretions and

its derivatives and its toxic derivatives, blood its products

C. Plant

including its micro-organisms, plant body and its parts, Excretion and its Extractions

D. Chemical

whether it is Natural, semi natural OR Completely Artificial in the Nature

Biopharmaceuticals (biological):

It is the Products that can be produced using any of the Following Vital Method:

Development of microbial strains and cells Of Real Nuclei

Extraction of Substances From the biological tissues, including human or

animal or plant tissue

DNA methods

Cell hybridization methods

Microbiological development in embryos or animals

Stem cell technology

Certificate of pharmaceutical product: (CPP)

It is a certificate issued by the competent health authority of the country in which the

Pharmaceutical Preparation is Fully OR partially Manufactured

Owner of the marketing

It is the pharmaceutical company that holds the marketing of the Medicine, whether it

is the Medicine manufacturer or marketing Responsible, this company is fully

responsible for the quality of the drug and its safety, effectiveness, and post-

marketing follow-up and all legal procedures relating to the sale of drug or withdraw

from Market, damage, or follow-up side Effects symptoms….etc.

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Owner of a manufacturing license

Pharmaceutical company is a manufacturer of the product or some steps of

manufacturing of pharmaceutical Production licensed by the health authorities in

those countries, according to the rules and regulations for the production and trading

of medicines applicable in those countries

Chapter II

Article II:

The pharmaceutical company agent (or agents accredited) applies for the registration

of pharmaceutical company or one of its factories to the Executive Office of the GCC

accompanied by the following documents and information:

1 - the type and activity of the company and the date of incorporation, Company

Profile and owners of the companies in the case of Special privacy companies

2 - The number of Pharmaceutical factories owned by the company and their

addresses

3 - the company's relationship with each of these factories and the commercial and

legal Relations & responsibilities Relationships

4 - a certificate clarifies the commercial relationship between the authorized agent in

any of the GCC member and the company (certified by the competent authorities)

5 - a certificate issued by the health authorities in the State of the factory to prove its

commitment to the basics of good manufacturing practice ( GMP ) and commitment

Of health authorities' For regular inspections certified by the competent authorities

6 - Plant license issued from the health authorities in the State of the factory, allows

pharmaceutical manufacturing (explaining the production lines) to be documented

from one of the GCC embassies

7 - Provide functional structure of the plant illustrates the different sections and the

number of employees with qualifications of managers of production departments,

quality control and research and development (R&D) and technical manager of the

factory

8 – Simple Sketch diagram for the manufacturing buildings & its Working Lines

9 – List Of preparations produced by the factory, whatever By its own name or for its

own account or through contractual Manufacturing / or for other companies, its

Registration & Marketing dates in the State of the factory and other countries

10 - A letter from the company confirms that the Products that will be exported to

GCC countries Exactly Comply to that produced & Marketing in the country of origin

11 - a documented list From the company mentions the Country names in which it is

Registered, Attached with Copy of these Registration Certificates

12 - Pledge to Commit to what is agreed in the Gulf Statement Code for Marketing of

Drug

13 - list of Pharmaceutical Preparations that the company wants to Marketing in the

GCC countries

14 – Provide the Site Master File of the factory

15 – Letter Clarifies the Production Lines Needed to be Registered By the Company

16 - Provide a complete file includes the Required Registration Documents For the

first product Or Products needed to be Registered & Marketing By the Company in

the GCC countries according to the direction, as Clear in Appendix No. (1)

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Article III

Registration is Accepted ONLY For Companies or Distributing or Marketing or

Packing Organizations, that has its own pharmaceutical Factories, Except that

Companies which have the License to manufacture or Marketing some Essential

pharmaceutical Products & there are NO Equivalent Registered Products in the

Market

Article IV

A team from GCC Committee members visit the factory to make sure the application

GCC (Good Manufacturing Practice) that Approved by the executive office after

paying the fees for inspection in accordance with the text of the ministerial decisions

issued

Article V

1 - In case of failure of the factory in the application of the Approved Good

Manufacturing Practice Basis, This Factory will not be Registered and can submit a

new application for registration after ONE Year from the Failure decision date of the

Registration Committee. The Factory must Offer All Proofs that All the Observations

Arises By the GMP Inspection Committee Of GCC are Covered

2 – Companies Have to Respond to the Observations Of the GCC ( GMP ) Inspectors

Within maximum 6 Months From the Date Of the Registration Committee, Otherwise

the registration application shall be Cancelled after proposed to the Registration

Committee

3 - Re-visit the company if it deems observations of the Committee requires that

inspection and the final is the second visit

4 - In the case of The Committee Approval Of the Company registration, Certificate Of

Registration of that Company is issued, its Duration is 5 Years

Article VI

company must notify the Central Registration Committee in writing of any sale or

purchase or merge or any legal action related to the company or one of its factories

registered within ninety days from the procedures Completion, On Condition that the

Company must Update its Data according to the Central Registration Committee

recommendation

Article VII

The company that centrally registered, must complete the administrative procedures

for the registration of the company in all GCC countries one year from the date of its

Central registration, Otherwise the company will be applied to Registration

Requirement Of Each GCC Country

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Article VIII

1 The Company must be re-registered in any of the Following Case:

A - in the case of a radical change in the factory building or renovation of production

lines or manufacturing site transfer

B - in the case of the expiration of the registration certificate of the factory issued by

the executive office, the request is re-register must be applied before a period not

exceeding six months from the Expiry date of the Registration Certificate

2 – Local or Foreign pharmaceutical factories (or their agents / Official

representatives) Apply Re-registration Request to the Executive GCC Office, Before

not more than 6 Months of Registration Expiration Of his Principal, attached with the

Following Documents :

1-2 - Request to Re-register the Factory according to the Official Form of Factory

Registration, fulfilled, Stamped & Signed On every page by Technical Manager,

Clarifying On Authorized Document that No Change has be Executed during the Last

five Years Of Registration

2.2 Any changes in the type and activity of the previously registered company

3-2 – Reports For factories and companies contracting with registered factory,

addresses and factory relationship with each of them and the extent of legal, technical

& commercial responsibility

4-2 – Recent Certificate issued by the regulatory authorities in the State of the factory

to prove its commitment to the Basis of good manufacturing practice (GMP) issued by

the health authorities in the country of the factory and certified

5.2 - Provide manufacturing license issued & Certified by the health authorities

6.2 Products List produced by the factory, whether its own or for the account through

contractual or manufacturing for other companies, registering dates and marketing in

the State of the factory and other countries

7-2 documented list of company names recorded by the countries attached photos of

registration certificates

8-2 - A letter from the company confirms that the Products that will be exported to the

GCC countries are Matching in quality, Constituents & Manufacturing Methods as in

the country of origin & its markets

9-2 - Commitment by what is stated in the Gulf Code of Drug Marketing

10-2 – Hint About the company's activities in the field of research and development

11.2 - Provide Site Master File

3 – From the Above Data Offered from the Company, If the Gulf Committee For Central

Registration, assured that there are any Modification Happened in the Manufacturing

Steps, in this Case, this committee has the wright to Send Technical Team to Inspect

this Company to Assure that this Company applies the Basis Of GOOD

MANUFACTURING PRACTICE (GMP)

4 - These requirements provide a Hard Copy & Soft Copy (CD)

5 - Pay the fees determined by the executive office to renew the registration of

company

Article IX

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The Central Registration Committee Has the right to request any additional studies or

documents or testing in Central certain places and companies adhere to do so

Article X

Each Company that manufactures and / or owns the right of pharmaceutical product

marketing to appoint qualified person that will be responsible for monitoring and

follow-up the side effects and quality of the pharmaceutical Product and assume the

following tasks:

1 - Create a system for monitoring side effects and quality of pharmaceutical

Products, monitor and record all the cases that are sent to the company by health

practitioners or patients, which are monitored by the marketing people

2 - Continuous Evaluation Have to be done for safety, & Quality of the Pharmaceutical

Products Marketed in the GCC Countries

3 - The full and immediate response to any request from the GCC Committee of the

central registration to obtain the additional information necessary to evaluate the

benefits and risks related to pharmaceutical Product that Marketed in the Area,

including Data about Sold Quantity & the Medical Prescriptions

4 - Prepare and coordinate reports of side effects resulting from the periodic safety

studies or updated safety reports for individual cases

Article XI

Each Company that manufactures and / or owns the right of pharmaceutical product

marketing to provide the Committee with reports about the Product as follows:

1 - Report to the Committee about the qualified Person name that appointed by the

company to monitor side effects and quality of the product, as well as his alternative

person in case of his absence and all methods of their contact during the twenty-

four hours

2 - Immediately Inform the Committee about any serious side Effects Within 15 Days

Maximum From the Date Of Company Aware Of these Side Effects

3 - Inform the Commission of any Subject Related to the Safety Of the Pharmaceutical

Product, that Discussed Or Concluded during the Revision Or Analysis the Data of

monitoring the Side Effects Of the Product

4 - Inform the Committee about any decision that taken related to the Product By any

Authority as a result of any data related to the Safety of this Pharmaceutical & Clarify

the cause Of this Decision

5 - Inform the Committee about any side effects are Observed through the following:

- Scientific, medical and pharmaceutical Magazines

- Clinical Studies

- Web sites that the company Interests or is responsible

- Post-marketing studies Of the Pharmaceutical Product

- Medical Records

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- Various media

- Surveys Studies, such as studies of the effectiveness of the Pharmaceutical product

& The patient Compliance

6 - Prepare and submit periodic safety reports updated for innovative product

immediately upon the request of the Committee and also Submit routinely every six

months during the first two years after product registration and then every year for

two years and then every three years thereafter years after product registration and

then every year for two years and then every three years after that.

Article XII

The company or the Product marketing Owner Carries the full responsibility for

delivery of warning messages approved by the GCC Committee of the Pharmaceutical

Products to physicians and pharmacists working in the public health & private

sectors On GCC Committee Request

Article XIII

The COMPANY Registration is Canceled or Suspended in the following cases:

- If the company did not make application for the registration for any of their products

within one year from the Date Of informing the Company Agent By its Registration

- If the Fraud Or Manipulation is proven Concerning the documents submitted

- If there is a decision By Stopping the activity & Productions Of the company

- If it is proved that the Company made Repeated Violations Or Its Products

Repeatedly Did Not Pass the Analysis Tests OR the Company Does Not Always Apply

the GMP Rules

Article XIV

The Company has the right to object to the Committee’s decision, have to submit

reasons for the objection to the GCC Executive Office within two months from the

decisions submission Date to the Company. The Committee’s Decision will be Final,

after Studying the Objection

Article XV

The Registration Canceled Company Can Offer Application for Re-registration again,

After Removing All Reasons caused its Registration Cancelation & By the

Recommendation Of Registration Committee

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Chapter III

Registration of Pharmaceutical Products

Article XVI

All pharmaceuticals Products Have to be Registered, According to the definitions

included in the Regulation list for registration of the Pharmaceutical products. The

company have to apply the Form for its Products Registration, The Registered

Pharmaceutical Company have to Complete the administrative procedures to finalize

its Products Registration in each Country of the GCC members, after ONE Year from

the Company Central GCC Registration, If NOT, the Company would be Registered

according to Each Gulf Country Registration Procedures

Article XVII

Requirements to register the pharmaceutical product:

A - All manufacturing sites involved in the Product manufacturing, have to be

Centrally registered according to the Official Rules

B - The product submitted for Central registration, Must be Registered & Marketing in

the country of origin / Reference Country for at least one year before application for

its central registration, If Not Marketing, the reasons must be Clarified and submit a

certificate of this pharmaceutical product Of the same Components From an

Approved country By the GCC Committee. For the Innovative Pharmaceutical

Products, The Committee has the wright to exclude From the Duration Condition

Article XVIII

Registration procedures are as follows:

A -The Company Or its Representative apply for registration Request of the

Pharmaceutical product to the Executive Office attached by a special file containing

Product Specifications, chemical, pharmaceutical and biological Analysis of the

product, according to the Technical Requirements of the Unified Technical File (CTD)

For registration in accordance with the procedures specified by the Committee in

Annex No. (1)

B - If the pharmaceutical product submitted for registration is contractually

manufactured or Manufactured and marketed By a license or cooperative marketing,

So the applicant must Meet the requirements mentioned in the Annex (2), in addition

to the requirements listed in the Annex (1)

C - if the Pharmaceutical Product submitted for Central registration manufactured and

marketed under license, or Share Marketing the applicant must Verify all the

Requirements mentioned in Annex No. (3) ., in addition to the Requirements

Mentioned in Annex No. (1)

D - in the case of Share Cooperative marketing, apply what is mentioned in Annex No.

(4)

E - in the case of Applying the first pharmaceutical preparation Janice to Central

registration the Executive Office address the Patent Office of the Secretariat General

of the Cooperation Council for the GCC to find out the status of the patent License Of

for

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innovated Product and in the absence of a reply within thirty (30) days is complete the

registration Procedure is Completed For that Janice pharmaceutical product

Article XIX

The applicant has the right to object the Decision of Central Gulf Committee for

Pharmaceutical Products for the Non Registration of the Pharmaceutical Product

within a maximum period of 30 days from the date of notification of the decision

Article XX

Certificate of the Pharmaceutical registration will be disbursed from the executive

office, is valid for a period of five years

Article Twenty-first

If any modification in the composition of the Non active material or specifications Of

the Pharmaceutical Product or place of manufacturing or a change in the internal and

external packaging Containers, OR the design or the contents of the Leaflet, will be

executed, the Company Agent or his representative must apply a Request By this

change (s), according to the procedures and requirements listed in Annex No. (2). and

the company's commitment does not make the change only after the issuance of the

formal approval From the Committee

Article Twenty-second

All information mentioned in the indicative guide for the requirements of the internal

leaflet and leaflet for health practitioners and External label of pharmaceuticals

Products and posted on the Internet Site of Executive Office of the internet On the

internal and external packaging of the Pharmaceutical product, and the End User

Information, On condition that the information are Clearly printed and difficult to be

removed

Article Twenty-third

The GCC Central Committee For drug registration may Exclude some of

pharmaceutical Products From mentioning the Details Of the Containers Or Leaflets &

its Translation, after the Studying the Request Offered By the Company, This is if the

Pharmaceutical Product is Specified For Governmental Therapeutic Institutions

Article Twenty-Fourth

If there is an allegation for New MEDICAL use of the registered pharmaceutical

Product, must provide the following:

1 - The approval of the regulatory authorities in the country of origin or the U.S. Food

and Drug

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Administration or the European Agency for the Evaluation of Drug

2 - pharmacological and toxicity studies

3 - clinical studies

Article Twenty-fifth

Corporate commitment to respond to the observations of the Committee within a

period not exceeding (6) months from the proposal date, otherwise the Company

Registration will be Considered Cancelled, after Offering to the Registration

Committee

Article Twenty-sixth

Clinical, pharmacological & toxicological studies must be submitted, in the case of

pharmaceutical products that contain Known ingredients, previously used, but

without any particular medical reasons ( Only used as additives & improvement the

method of Product’s manufacturing

Article Twenty-seventh

It is not allowed to use Alcohol in the pharmaceutical products manufacturing and

Registration Committee can exclude the necessary pharmaceutical Products from this

Condition within the approved ratio of Alcohol

Article Twenty-eighth

Following Points must be taken into consideration concerning the Sources Of Raw

Materials:

1 - You must indicate the source of the raw materials used in the manufacturing of

pharmaceutical Products and methods of preparation and analysis, mention the name

Of Pharmacopea - if any

2 - You must provide proof that the file of the active raw material ( DMF ) has been

Approved by pharmaceutical reference authorities, such as the certificate Of

suitability of raw material for pharmaceutical Products & Submit a letter of access

issued by the active substance Manufacturer and Directed to the Company Or the

GCC Executive Office

3 - the company must provide an updated file of the active ingredient ( DMF ), and the

documents mentioned in item (2) above If the Source Of RAW Material is Changed

after the Product Registration and get the approval of the Committee on the new

source

4 - In the case of materials extracted from human, animal or plant or blood products

as well as the Fine Bio Products, in this case the Manufacturing company must

provide Certificates that these materials free of pathogens such as viruses and

bacteria & Identify in Details the sourcing of these materials and methods Of its

collection, transportation and storage - if available

5 - In the case if the chemical and physical characteristics of the active ingredient ,

affects bioavailability, in this case, the molecular picture, solubility Rate & the

Molecular Volumes after material Crouching must be provided – if Found

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Article Twenty-ninth

Registration validity:

The Pharmaceutical Product that Centrally Registered, is valid for Five years from the

date of registration with the Central Gulf Committee for drug registration and

registration can be renewed upon application, three months before the expiry date of

the certificate and be accompanied with the requirements for re-registration

Article Thirty

Re-registration of pharmaceuticals centrally:

1 - The owner of the marketing right or his representative apply for re-registration

facility documentation and accompanied with all needed documents & the approved

requirements for re-registration, this will be at least 3 Months from the Expiry Date Of

the Registration Certificate and prior to a period of not less than three months from

the date of expiration of the certificate of registration and payment of the Registration

Fee For each Concentration & Each Size Of the Product

2 – The Product Registration will be considered as Cancelled, if the Request is not

applied within this period & Not mention the reasons For that, within maximum 6

Months Of the Certificate Expiry Date

3 - accompanied with a request for re-registration of the following requirements :

1-3 -Fulfill the form of pharmaceutical product re-registration signed and stamped by

company

2-3 – Recent Certificate of pharmaceutical formulation Of the Product ( CPP ) or a

certificate of free sales from the country of origin issued by the competent regulatory

authority in the country of origin

3-3 - A list prepared by the manufacturer with names of countries that allowed the

handling of the product and a list of other countries names, in which the Product is

applied For Registration the addition to the countries that the Product Not

Registered & the Reason for that

4-3- Approved Leaflet OR Summary Of the Product Specifications ( SPC ), in country

of origin, in English Language & Approved From the Concerning Authority

5-3 - All approved changing requests from the GCC Committee of the Executive Office

From the Registration Date or Re- registration Date, arranged in Sequence

6-3 - Commitment from the company that there is no change in the product, If there is

any Change, the company Submit these Changes requirements With the Re-

registration Request

7-3 - Update the stability Study and provide recent stability study For at Least 2

Batches of the production covers all the Product Shelf Life

8-3- provide certificate of suitability or DMF with letter of access from factory

9.3 - provide methods of analysis of the product according to the latest Approved

Pharmacopeia has been adopted in the constitutions of drugs approved for

concerning chemical, physical and Microbiological Analysis

10-3 - provide a certificate of analysis includes the Result analysis of items as

mentioned

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In item (9-3), above, including Microbial Contamination Test For Oral Solid Dosage

Form, if the Excipients are from Plant Or Animal Sources, according to the

Specifications Of USP or EURP

11-3 – Pharmaceutical Products that manufactured by Contract, the manufacturing

Company have to submit any changes may be changed in the Technical Contract

12.3 If the product contains plasma, Plasma Muster File must be Offered for the

products Or the Manufacturing Company Commits that the Source Of the Plasma or

the methods of its Extraction will not be changed as in that product Registered before

13-3 The Form of Serum, Vaccines & Biological products is Fulfilled by the Company

who Offers the Contract or Execute the Contract, Stamped & Signed by the

Responsible Person on Every Page

14-3 - The results of follow-up studies the product-marketing

15-3 - Recent Commercial Samples

16-3 – Sample Or Artwork for External Package

4 - These requirements provided as Hard Copy & Soft Copy

5 - Pay the fees determined by the executive office to renew the registration of the

product

6 - Any other requirements requested by the Committee

If the company does not apply request for re-registration their Products, this will be

proposed to the Committee, to decide Cancelling or suspend the Registration Of that

Products of the Company

Article Thirty-first

Pharmaceutical product registration is canceled in the following cases:

1 – Its Toxicity is approved , or serious side effects are happened or it is Suspended in the

Market as a Request Of World Health Organization (WHO) or International health organizations

2 - If the Gulf Central Committee for drug registration has reports from Specialist

health authorities assure that this Product has harmful side effects to any technical

reasons evaluated by the Committee

3 - if its registration is canceled or its Production is suspended in the country of

origin

4 - If the Product is not marketed or imported within two years from the date its

central registration in at least two Gulf countries

5 - If assured that the Data related to the Pharmaceutical Product in its Registration

File are Not True

Article Thirty-second

The Offered Pharmaceutical Products to Central Registration, are Analyzed in

laboratories designated by the Central Registration Committee to make sure its

Specifications conform the specifications and information in its Offered registry file

and the company's agent in any state must deliver the needed Standard Samples &

any requirements needed for the Product analysis, within 6 Months

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In the case of pharmaceutical product did not pass the analysis tests, During Stages

of its Registration, its Re- analysis will not be started except by the Approval Of the

central Gulf Committee for drug registration

Article Thirty-fourth

1 - Gulf Central Committee for drug registration has the right to postpone or reject

registration of any product mentioning justifications and reasons

2 - The applicant, Whose Product needed to be Registered (company or its

representative) can object to the Committee's decision, proving reasons for his

objection to the Executive Office within two months from the date of notification of

the Committee decision, after studying the objection; the Committee Decision is Final

& the Company cannot Offer the Product For Re-registration before One year from

the Date Of the Committee’s Final Decision

3 - The Company can Withdraw its file before presenting to the Registration

Committee and has the right to Ask For Registration at any time

Article Thirty-fifth

Pricing Of Pharmaceutical Products:

Pharmaceutical Products are priced according to the Approved Gulf Pricing Rules

Article Thirty-sixth

The pharmaceutical Products that manufactured By Licensed Manufacturing Or

sharing manufacturing Or Contractor Manufacturing are Registered according to the

Approved Rules in Annex No: ( 2, 3 & 4 )

Chapter IV

ALL the Pharmaceutical Product’s Approved data From the Committee Must be

mentioned On Inner & Outer Packaging, on the Product Leaflet & End User

Information

All the Data must be Clearly Printed & difficult to be Removed, according to the

Directorate for the Requirements Of: Internal Leaflet and Users information & the

External Labels of the Pharmaceutical Products

Article Thirty-seventh

The Certificate of Pharmaceutical Product (CPP) issued by the competent health

authorities should contain the following information:

1 - Number and date of the certificate in the Original country

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2 - the name of the State issued the certificate

3 - Name of the Gulf region, the Gulf state that has the right of import

4 - Name and address of the Factory of the Pharmaceutical Products

5 – Commercial & Scientific Name Of the pharmaceutical Product , If Not Available,

the Scientific Name Of the Pharmaceutical Product is Enough, With the name of the

Manufacturer & its Trade Name

6 - Qualitative and quantitative composition of the Active & Non- Active Constituents

Of the pharmaceutical product in detail

7 - Name and address of the manufacturer of the final form of the pharmaceutical

Product & Ready for marketing

8 - A commitment Of health authorities signed this certificate to inspect the

manufacturer to assure its commitment to good Manufacturing Practice Rules and

duration of Each periodic inspection

9 - (If the Leaflet is not attached By the CPP, The Approval Of the Leaflet By

authorities in the country Of origin is Enough )

10 – Mention If the pharmaceutical product is marketed in the country that Initiate the

Registration Certificate Or Not

11 - Number and date of pharmaceutical product Registration in the country of

issuance of the certificate - if any - and if Not, Mentioning of the Reason is a must

12 - Name and address Of the marketing Authorization Holder Of the pharmaceutical

product

13 - The name and address of the Authority that Approved & Stamped the certificate

Article Thirty-eighth

The Summery Of the Product Characteristic (SPC) must include the following

information:

A - The trade name of the pharmaceutical Product and the company's Trade Mark

B - The Pharmaceutical shape (or shapes) and Pharmaceutical concentration (or

concentrations)

C - The qualitative and quantitative composition of the Active & Non Active

Constituents, and it is advisable to use names adopted by the World Health

Organization - if available

D – The Proposed Scientific name by the World Health Organization - if any - or the

Known scientific name or the Known described chemical name

E - Pharmacological properties Of the Product, and its Relation to its Medical

Treatment, to the Product Pharmacokinetics & Pharmacodynamics

F- Clinical Properties include the following:

1 - Reasons of Indications

2 - Contraindications

3 - side effects according to its statistical arise and shape

4 - Warnings and precautions to be taken

5 - Use during Pregnancy and Brest lactation

6 – Interference with other drugs, food, and alcohol

7 - How to use for Adults, Children, and Kids - if available

8 - Overdose, its symptoms, hold and treatment Of the resulting Symptoms that may

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Happen as poison & Antidote if available

9 – Special warnings

10 - Effect on driving and the use of Heavy Hazardous Equipment’s

G - Pharmaceutical Properties & include the following:

1 - the Shelf life of the product after mixing - if any - or after open the Product’s

package for the first time

2 - The necessary precautions for storage

3 - The Properties Of the First & Secondary Package Of the Pharmaceutical Product

4 - Compatibility or incompatibility with other products - if any

H - Additional Information: and include the following:

1 - Name and address of the Marketing Authorization Holder

2 - Special Precautions how to deal with the Unused Drug Solution or its Secondary

Package

3 - Packages available for marketing and measurements (as Volumes……etc)

4 - special instructions to deal with the product - if any

Article Thirty-ninth

Specifications Of product pharmaceutical Outer Label:

The pharmaceutical product Outer Label, must contain the following information, With

clear writing and in Arabic and / or English:

1 - Commercial product name, followed by the scientific name (with the Pharmacopeia

name, on which base the Product is Manufactured)

2 - Active Constituents Contents ( Quantity & Quality) in each Dose Or in The

Pharmaceutical Shape , in Weight Or Volume, Using the Scientific Name

3 - Pharmaceutical Shape and Package in weight OR Volume or in Dosages number

4 - The list of the additives that had limited pharmaceutical actions. In case Of

Injectable Solutions, Eye Drops & topical Drugs, it is important to mention the

additives

5 - How to use

6 - Warning for keeping medicine out reach of children

7 - Special Warnings for the Pharmaceutical Product-If any

8 - Batch number, Production date and the Expiry (in Month & Year)

9 - Add storage conditions in Degree Centigrade On Outer & Inner Packages

10 - Precautions necessary to get rid of the Unused Potion Of the pharmaceutical

Product or Outer package

11 - Name and address of the marketing Authorization Holder of the Pharmaceutical

Product

12 – pharmaceutical Products that can sail Without prescription must:

- Mention How to Use

- Symbols or logos used to illustrate certain information so this information will be

compatible with what is mentioned in the summary of the Product Properties (SPC)

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Blisters:

Must contain the following data:

1 - Commercial Product Name

2 - Scientific name of the product

3 - Concentration

4 - Batch number and expiry date

098

5 – Name of marketing Authorization Holder

Small packages:

In the case of small packages on which cannot write all the information mentioned

Before, it must clearly show the following Data:

1 - The name of the pharmaceutical product, and its concentration and method of its

usage - if necessary

2 – Production Date (whenever possible)

3 - How to use

4 - Expiration date

5 - Batch No.

6 - content by weight or size or the number of units

7 - You can add any other information required by the importing country

Article - Forty

- The need to commitment the Use Of Child Resistant Caps & use in all Liquid & Syrup

Containers

- All Containers must be carried by Tamper Proof (Opening Protector)

- It is necessary to issue identity Code for Tablets

- Safety sticker must be applied on the outer packaging Of the Registered Product so

that not to be imitated or easily opened

Article forty-first

Gulf Central Committee for drug registration may exclude some the Pharmaceutical

Products From the details of packaging as mentioned, after studying the application

submitted by the Company and that only be Applied on the pharmaceutical products

that are only Used in Therapeutic institutions

Article Forty-second

Internal leaflet Data:

All the contents of the internal leaflet and its Artwork, must be according to the

general guidance of Registration that published On the Web Site of the Executive

Office: www.sgh.org.sa

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Article Forty-third For Registration Of blood products, vaccines and similar vital products must meet the

requirements as mentioned in the common technical file (CTD), as well as in

accordance with the requirements of Appendix No. (6) Of the innovative Products

Appendix (1)

Requirements Of the FILE for Pharmaceutical Product Registration

Fill the registration application form described in the Electronic pharmaceutical

registration system, By the company or its agent inside a FILE, its Components have

to be arranged according to the Technical File Of the World Conference adapt &

according to what is specified in the guiding structure of the Registration, Published

on the Executive Office Web Site www.sgh.org.sa

Appendix (2)

Register Drugs that manufactured By contractual or cooperative

manufacturing Contractual or Cooperative Manufacturing:

The registered pharmaceutical company, that has the right to manufacture, marketing

or Owns the Pharmaceutical Product patency contracts with another pharmaceutical

company to manufacture the product partially or completely

The Contractual Manufacturing Product Donor must commit to the Following:

First: If the company that executing the contract is registered in Gulf Countries

1 - Determine the basic steps of the manufacturing process and the location Of Each

Step

2 - Copy of the contract Signed By Contract’s donor & the Contract Execution, the

Following Items must be included in the Technical Contract:

A) commitment of the Contract Donor to inspect the production, control& storage

Areas, Manufacturing, Analysis Methods, Batch Records and all the Technical

Facilities

B) The manufacturing and Control steps are the responsibility of both the Contractor

Donor & Contractor Execution, it is necessary to define who is the Responsible For

Products Release..? The Contractor Donor Or The Contractor Execution

C) Specify the name of the person, who is in charge of the Batches Release, His

Position & Signature, the Central Gulf Committee for Drug Registration must be

informed about the name of his Alternative, if the Person in Charge is changed

D) Determining the duration of the Contract

3 - A letter from the company Awarding contract stating their responsibility for the

quality and safety of the drug

4 -The technical manager Of the Company Executing the Awarding Contract, Have to

undertake to notifying in advance the Central Gulf Committee For Drug Registration,

For any Change in the information mentioned in items 1 and 2

5 - Make a statement of the countries names and a copy of products marketing

Certificates that its manufacturing conditions are the same as mentioned above &

Mention the Marketing Date in Each Country

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6 – The Manufacturing by Others must Not Restrict On Gulf Countries only, Except the

Product(s) are related to National Companies

Second: If the company executing the contract is Not registered in the Gulf Countries:

1 - Achieve All the Items Mentioned in the paragraph (First)

2 - Provide the certificate Of pharmaceutical manufacturing license of the Company

that executes the contract issued by the concerned authorities in the country of the

Product manufacturing

3 – Submit GMP Certificate For the Executing Company , issued from the concerning

authority in the Manufacturing Country & Certificate States that the Factory if

Inspected Periodically

4 - Companies authorized to manufacture Pharmaceutical Products for Others, .are

subjected to periodical Inspections, By technical Teams, Appointed by Gulf

Committee for Drug Registration to assure that Company Well Apply the GMP Rules

Third: The secondary packaging:

1 – The Central registered companies may Execute the secondary packaging for their

products That registered in National Pharmaceutical Products factories without any

other change on the product

2 – This Kind Of Products Treatment in the Same way as the Products Registered For

the Company awarded the contract

Fourth: The generic products which provide for registration From national Factories

and are manufactured in a country outside the Kingdom:

The generic products that Applied for registration By National Factories and are

manufactured in a country outside of the GCC countries Except Only Filling And / Or

Secondary Packaging the Following Conditions must be fulfilled:

1 - if the company is one of the Leading Companies

2 – It must be Verified that the Producer Company applies Well the GMP for

Pharmaceutical Manufacturing

3 – The manufacturing of this Product Needs a High Technology, So cannot be

Manufactured Locally

Appendix (3)

Registration Of Pharmaceutical Products that are Manufactured & Marketed By

Licence

First: The Local Pharmaceutical Product Manufacturing Under License from

International Companies:

A- If the Donor Company & the Pharmaceutical Product, needed to be Manufactured &

Marketed are Centrally Registered

1 -The Donor company has the Patent License & the Manufacturing License of this

Product

2 - Written Agreement From the Donor Company's to the Local Factory For

Manufacturing & Marketing its Product in GCC

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3 - After Approval for Registering of the Product that Manufactured By License, the

Registration & Pricing of this Product Of the Donor Company, will be Suspended,

after six months of the Registration Date of the Product By the Local Company. The

Agent Of This Product has to be Informed

4 - The Donor Company and the local company should inform the Central Gulf

Committee for Drug Registration within a period of not less than six months from the

end of the manufacturing license agreement in case of the agreement is not renewed

with the company which awarded the license

5 – Cancel the Registration Suspension Of the Donor company's innovative product, (

Renew its Registration) and cancel the Registration Of the same Product Produced By

the Local Company, in case the manufacturing agreement is Cancelled between the

Donor Company & Local Manufacturer

6 - the Active & the Non active Constituents Of the Product, its Sources, the

Manufacturing Methods, the Pharmaceutical Formula, concentration, containers,

Labels & All the Product Specifications, must be the same as used By the Donor

company

7 -The factory / Local Company must be responsible in Front of the Central Gulf

Committee For Drug Registration for the Product Quality & All Problems may arise

after its Marketing

8 –The factory / Local Company must have All the Facilities & Equipment’s necessary

for Producing & analysis of the Registered Product

9 - The trade name of the Product Manufactured By Central License, must be the same

Trade name Of the Product manufactured by the Donor Company’s License & by the

Centrally Registered Name & On the Container must write :

Manufactured By (Local Factory name), under License Of (Donor Company name)

10 - It is permissible to the factory / local company; to get in agreement with the

Donor Company awarded its Product manufacturing License, to manufacture another

Product (Second Brand) by Trade Name Special For the Local Company, beside the

First Awarded Product. All the registration Requirements are like that Of Generic

Products Registration

11 - The product that manufactured under License by Factory / Local Company must

pass all the Procedures of Registration & the Analysis Required By the Central GCC

Committee For Drug Registration

12 – The Registered Products that need Bioequivalence Studies are Exempt from

these Studies, If it is manufactured By Factory / Local Company, under License Of

International; Company, On Condition that:

a- The Product is registered by the company that granted the Manufacturing license

and that the parent company provided bioavailability or bioequivalence required

Studies

b- The Product locally Manufactured has the same specifications and

manufacturing Procedures Followed by the Company that granted its Manufacturing

license

c - The source of the active Constituents and additives is the company granted the

Manufacturing license or from an authorized source under its own responsibility

regarding the bioequivalence

d – The Product must not sustained Release Pharmaceutical Product

e - Providing Comparative Dissolution studies

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13 – The Shelf Life Of the Product manufactured under license By Factory / local

company based on stability studies provided by the company which granted the

license. The Factory / Local Company must Offer Accelerated Stability studies and

stability studies at the storage conditions specified in the stability studies guide

14 - The Factory / Local Company should do all Required Quality Control Tests

conducted by the company that granted the Product License to assure the Product

Good Quality, These procedures have to apply on All the Manufactured Batches

15 - The company that granted the Product Manufacturing License should make All

the Required Quality Control Analysis on the Manufacturing Licensed Product By

means of the Factory / Local Company to be sure of conforming the steps of

manufacturing to that Of the Donor Company Approved

All the Analysis Results have to be Sent to the GCC Committee for Drug

Registration, Attached with All the Test Analysis Results Done By the Factory / Local

Company

a - In case if the Company license donor is registered centrally and required

Pharmaceutical product to be manufactured is not registered centrally, the following

must be Considered:

1 - The product must be registered according to the approved registration basis

2 - The application of what is mentioned in the first paragraph

b - In the event If the donor company is not centrally registered, the following must

be Conceder:

1 – The Donor Company must be registered , according to the Rules Of Companies

Registration in the GCC Executive Office:

2 - Application of what was mentioned in paragraph II

Second: the External manufacturing Of pharmaceutical Product under license of

Innovative Companies or Generic:

It is not allowed to register of products manufactured under license Of Innovative

Companies or Generic before generic companies outside the GCC countries. And the

Registration Committee to consider the necessary exception of some Essential

Products according to the following conditions:

1 - Fulfill the conditions mentioned in paragraph (a)

2 - Cannot be manufactured locally

3 - Its manufacturing in not Only For the Gulf Market

Third: The Local manufacturing of the Generic Product Under other Commercial

names Of identical Registered Product:

It is Permissible Only For the Local Company to Manufacture Generic Product Under

other Commercial names Of the identical Registered Product, that has the same

Specifications Of the Generic Product, On condition that:

1 – The File is provided for Registration by the Company who has the Marketing Right

of the Product

2 - The technical and legal responsibility are shared between manufacturers

according to the contract agreement

3 - pricing according to pricing rules

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Fourth: The Local pharmaceutical Manufacturing for export:

The Local company / factory is Allowed to manufacture& Register the pharmaceutical

product for the purpose of exportation & to be priced Only For exportation Purpose

Appendix (4)

Cooperative / shared Marketing Of pharmaceutical Products

Means a Registered pharmaceutical company which has the right of manufacturing

and / or marketing of innovative Centrally registered Or Not registered product , this

Company get in agreement with Other Pharmaceutical Company Centrally Registered

For Marketing Or Share in the Marketing Of this Product

Requirements of the Cooperative/Sharing Marketing For pharmaceutical Product

Centrally Registered:

1 - Provide a certificate from the Company Authorized to market the product in the

GCC countries to assure the Product Quality and it is responsible for all technical /

financial and legal Aspects, This Certificate is Approved by the competent authorities

in the country of the marketing Company

2 - Apply a pharmaceutical product certificate or a certificate of free sale of the

product from a country marketing company, mention the name of the manufacturer

and marketing company

3 - Apply a statement of the states names and a copy of marketing Certificates Of the

product under the same Manufacturing Conditions processing conditions, mention

the Marketing Date in Each Country

4 - If the product is registered in the agency contract between the Manufacturing

company and its agent in the Kingdom, approval Letter From the manufacturing

Company must offered to the Marketing Company Or Apply Proof that this Product is

Not Mentioned in the Agency Contract

5 - If the product is not registered Complete the following:

A - Provide Full Documents For product registration file by the pharmaceutical

company, which will Marketing the product, by the company or its official agent

B - Approved letter from the competent authorities in the country of origin, shows the

relationship between the company who has the right to manufacture and / or

marketing & the Marketing Pharmaceutical Company Or the Share Marketing

Company and the duration of their contract

C - Provide a certificate to prove ownership of the product patent issued From the

Country of origin

D - If the company Owns the Product Patency wishes to be Secured in any Gulf

Country, it have to submit a request to the Patent Office of the Secretariat of the

Cooperation Council, for the patent registration

E – The Manufacturer Name must be written on the inner & outer packaging, internal

and on the Internal Leaflet

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General Provisions

1 -The manufacturer and the Marketing company must Spontaneously inform the Gulf

Committee For Central Registration about termination or expiration of the marketing /

manufacturing Contract

2 - should not be co-marketing or manufacturing by others Should not be limited to only

GCC Except if Concerning National Companies

Appendix (5)

Transfer of registered drug manufacturing site for the same company

Requirements:

A – Apply Request for the transfer of the registered drug manufacturing site by the

company or its agent, accompanied by the following:

1 - The basic steps of the manufacturing process and the location For Each

manufacturing Step

2 – Define specifications, composition and sources of raw materials for the products you

want to move its Manufacturing location

3 – Commitment From the company not to make in Change in the Specifications or

Composition or Manufacturing Method of the Product in the New

4 – Commitment For Application Of real stability studies of the drug in the new location in

accordance with the instructions issued for this purpose

5 - Pharmaceutical Product Registration Certificate or Free Sale Certificate From the

Authorities Of the New Location

6 - Provide an accelerated stability studies of the drug from the new location by the

instructions issued in this regard

7 – Commitment to Offer Real stability studies covering the Shelf Life Of the Product

according to the instructions issued for this regard

8 – Providing comparative dissolution studies, according to the instructions issued in this

regard Serums, Vaccines and Biological products, are Excluded

9 - GCC Committee of the Central Registration, has the right to suspend trading or

suspend the import medicine in case of failure to submit the studies mentioned in item (7)

10 - If the product contains plasma Derivatives, PLASMA Master File Of the Product must

be Submitted & Commitment From the Manufacturing Company Not to Change the GCC

Approved Plasma products source

11 - Fulfill the form of serums and vaccines and biological products, Approved by the

donor Company for the contract or the contract Executive, Each page have to be Stamped

& signed by the Responsible Person

12 - Clarify the reasons for the transfer of the manufacturing site

B - The technical committee inspects the New Manufacturing site to make sure new

Manufacturing Site Applies the GMP of Drugs Manufacturing product, if it was not

registered

C - The GCC central registration Committee may allow agent of the company to import

the registered amount of medication from another source, if necessary, this is Before

the Registration Of the New manufacturing Site

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