Gulf Central Committee for Drug Registration

اللجنة الخليجية المركزية للتسجيل الدوائي

GULF CENTRAL COMMITTEE FOR DRUG REGISTRATION

Manufacturing Site Registration Renewal applicationform

Part II : Manufacturing site details

RENEWAL □ / (attach copy from GCC central and peripheral member states Registration certificates)
Registration Number in GCC countries and date of first registration / GCC
UAE
Bahrain:
KSA:
Oman: / Qatar:
Kuwait:
Yemen:
1.Applicant information
The authorized GCC central licensed Pharmaceutical Establishment which submits the application on behalf of the manufacturing site or a pharmaceutical company engaged with the site through a legally binding agreement (ex; contract manufacturing).
Name:
Address (street)
City / Country:
Tel: / Fax:
Website / E-Mail
Does the applicant hold registration ( valid or under process) for other sites and or pharmaceutical companies at GCC central Registration?
Yes [ ] No [ ] (If YES please attach copies of evidence documents)
2.Site Name
3.Site address
Address (street)
City / Country
Tel: / Fax
Website / E-Mail
4.Applicant – Manufacturing site relationship(s) (attach evidence documents)
□A-the applicant was directly appointed by the manufacturing site (attach the legalized appointment letter)
□B-themanufacturing site is subsidiary of another manufacturing site represented by the applicant (attach legalized relationship letter)
If yes name the mother site and the date of its registration in GCC central Registration.
□C-the manufacturing site is contracted by a pharmaceutical company(MAH) represented by the applicant(attach legalized relationship letter)
If yes for B or C, provide the following information for the company in relation to this site application.

• Name :
• Address:

City: Country:
Fax: tel.:
Postal address:

• Status of registration in GCC central (and date- attach the available evidence documents)

……………………………………………………………………………………..

• Licensure status at C.O.O (Country of Origin) (attach copies):

Licensed activity in C.O.O: □ Manufacturer □ MAH
(if manufacturer specify the manufacturing activities (manufacturing, packaging, batch release..etc) and lines per activity( licensed at C.O.O):
……………………………………………………………………………………..
……………………………………………………………………………………
Licensing authority name :
License Numbers (attach copies) & Expiry dates
……………………………………………………………………………………
……………………………………………………………………………………

• Name of the main Product(s) registered via GCC central Registration Committee and at member states (individually differentiating if they are registered via GCC central route or only peripherally registered)upon the manufacturing site registration and the exact manufacturing steps the manufacturing site (in the application) is involved in.
• Please attach a table for each product that shows the following details

1-product
2-Active ingredient
3-strength
4-pack sizes
5-GCC member states where product registered , its CIF price for each pack size
6-Mention if it was registered in the member states mentioned in 5 via central or peripheral route.
5.Manufacturing Site Details
A. COO Manufacturing License
Name & address of competent authority that issue the manufacturing license
Manufacturing License No.
Expiry date

1. COO GMP Certificate & its Expiry date

Name & address of competent authority that issue the GMP certificate
GMP certificate No.
Expiry date

1. Mention the authorities and country (other than C.O.O) where the site is approved for the product registration.

Country / **Type of Evidence / Certificate No. / Date of issue
*All data according to attached documents
** Evidence could be GMP certificate or registration certificate of the site or registration certificate of product include the site name & address.

1. specify the operations carried out in the site (tick √ which are appropriate)

Manufacture / Assembly & labeling / Storage &Handling / Analytical Testing / Batch releaser
[ ] / [ ] / [ ] / [ ] / [ ]

1. Activities at the Site

Please tick MA (Manufacture and Assembly) or MO (Manufacture only) as appropriate for each category of production.
Activities / MO / MA
STERILE PRODUCTS
STERILE LIQUID DOSAGE FORMS
Large Volume Parenteral (100ml or more)
Irrigation Solutions (100ml or more)
Small Volume Parenteral ( Below 100ml )
Small Volume (Eye drops)
Aseptically prepared
Terminally sterilized products
Other Sterile Liquid Dosage Forms please specify
STERILE SEMI-SOLID DOSAGE FORMS
Creams
Ointments
Aseptically prepared
Terminally sterilized products
Other Sterile Semi-Solid Dosage Forms please specify
STERILE SOLID DOSAGE FORMS
Solid fill (including powders for reconstitution)
Freeze-dried (lyophilized)
Sutures and licensable wound management devices
Other Sterile Solid Dosage Forms please specify
NON-STERILE PRODUCTS
Solid, Semi-solid and other liquid non-sterile dosage forms ( Unit and Multi-dose non-sterile liquids)
Aerosols (pressurized)
Spray
Solution
Lotion
Liquid
Suspension
Tablets, Please Tick Mark Film Coated , Enteric Coated  ,Effervescent  Or Other Specify:
Capsules, hard gelatin
Capsules, soft gelatin
Suppositories
Pessaries
Powders
Granules
Effervescent Granules
Cream
Ointment
Paste
Gel
Intra mammary preparation for veterinary use
Medical Gases
Other Non Sterile Dosage Forms please specify
ACTIVE INGREDIENTS (BIOLOGICAL) produced or handled in the site
Vaccines
Sera and other Immunologicals
Blood and other blood products
Other biological, please specify
OTHER ACTIVE INGREDIENTS produced or handled in the site
[A] Potentially hazardous
Penicillin's
Cephalosporin's
Hormones
Cytostatics
Cytotoxics
[B] Miscellaneous
Radioactive Pharmaceuticals
Veterinary Ectoparasiticides
Veterinary Feed additives & Premixes
medical devices :please specify
Herbal Medicines
Solid Dosage Form (Tablets, Capsules, Powders)
Liquid Dosage Form
Homeopathies
Solid Dosage Form (Tablet, & Pillules)
Liquid Dosage Form
ASSEMBLY ONLY
(tick √ which are appropriate)
**NOTE: Filling of sterile products is classified as manufacture, not as assembly
Primary Packaging
Filling of Primary Container
Liquid dosage forms
Semi-solid dosage forms (including creams and ointments)
Solid dosage forms (including tablets and powders)
Blister and/or strip packaging
Medical gases
Secondary Packaging
Secondary packaging of primary containers
Labeling of primary containers
Sterilizations processes used in the site (for products or components (if available) / Yes / No
Steam or steam/air
Biocidal gas/chemical
Dry heat
Irradiation/electron beam
By ethylene oxide
By Micro filtration
Declaration
We hereby declare that all the information given above are true and correct, and assume full responsibility for this declaration with all consequences which might arise from false or erroneous information
1.In accordance with article regulations for registration of manufacturing site, I hereby confirm that all existing data are related.
2.We certify that all of the information provided above is true & correct. If the information is incorrect, we are willing to accept denial of permission or termination of this case. we are willing to accept legal responsibility
3. We are committed to keep conformance with the requirements of the Drug Control Regulations with respect to the medicinal product marketing authorization.
4.We hereby agree that weconsider ourselves responsible for the medicinal productquality including obtaining the required regulatory approvalsat country of origin and GCC central Registration Committeefor any subsequent variation related to product marketing authorization or production as well as themaintenance of product registration
5.We also acknowledge responsibility in the event of any pharmaco-vigilance issue or quality defect associated with the product that may occur>
6. We Undertake and accept obligation to notify the GCC central Registration Committee of any incidents immediately that includes the following.
[a] Any malfunction or deterioration in the characteristics and/or performance of a product as well as any inadequacy in the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state or health.
[b] Any technical or medical reason connected with the characteristics or performance of a product leading, for the reasons referred to in subparagraph [a] to systematic recall of product of the same type by the manufacturer at any country where the product is marketed.
Full name of the manufacturing facility:
Address:
City:
Country:
Office Telephone Number: Office Fax Number:
E-Mail:
Contact Person Name & Tel Number
Signature:
Name and designationand of Signatory:
To be signed by the Managing Director/ of the manufacturing site or an equivalent person who has overall responsibility for the Manufacturing activities within the site
Note: 1) All information should be completely filled by the manufacturing site in-charge personnel.
2) Incomplete application form will be rejected by theGCC Central Registration Department.
LIST OF REQUIRED DOCUMENTS

1. The application form duly filled signed and stamped by the Authorized Technical (Qualified) Manager (Person) within the manufacturing site intended for registration.,(Except for the part of applicant information should be done in coordination with the applicant)

The legalized relationship letters should be submitted to clarify the relation between the applicant and the manufacturing site as described below.

1. A legalized original appointment letter issued by the company in direct relation to the applicant authorizing the applicant to submit -on its behalf- the application of the manufacturing site along with the registration file, to the GCC central Registration Committee. The said letter company headed paper, stamped and signed by the authorized person in charge in the company. (the appointed applicant will be responsible to receive the registration certificate from the GCC central Registration Committee and should commit to follow up and update GCC central Registration Committee with any licensure and / or legal changes in the status of the site at C.O.O ).
2. The legalized relationship letters as mentioned within the application part 4.
3. For the company in direct relation to the applicant (if different than the manufacturing site in application) status documents:

a- Notarized Copies of the licenses of the company at C.O.O in addition to its registration certificate copies GCC central Registration Committee and GCC member states.
b-Legalized relationship documents letters that describe the legal and technical relation between the company in direct relation with the applicant and the manufacturing site in the application given that they are issued from both companies (i.e. manufacturing site and the company in direct relation to the applicant)

1. For the manufacturing site in the application:
2. Legalized current GMP certificate issued by the competent authority in country of origin. (attested true by any country from the GCC States).
3. Legalized valid Manufacturing License issued by the competent authority in country of origin. (attested true by GCC member state Embassy)
4. list of the products registered per GCC member state(specifying trade name, scientific or INN name of active ingredients, dosage form manufactured and/or assembled by the site, the manufacturing step done by this site per product and the countries the product registered in).
5. Site Master file.
6. A notarized copy of registration certificate or GMP evidence document from other countries than country of origin of the manufacturing site.
7. Company Profile.

g. List of associated manufacturing facilities, if any.
h. Brief report on research activities (if any)

1. The original proof of having paid the required fee for registration