DC/TA/F001

APPLICATION FOR REGISTRATION OF A MEDICINAL PRODUCT

1. Detail of local Distributor Authorized Distributor Contact person Address /Street City: Email:: Detail of Drug Store License No. Of License Date of Renewal Tel:

2. Detail of the Manufacturing site responsible for batch release of finished product Name of Manufacturing Site Name & Date of Latest GMP certification issued: Address /Street City Postal Code Country:

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Email:

Tel:

NOTE: 1. The site should be the batch releaser and corresponded to the site mentioned in CPP 2. Manufacturing site registration is required for the site (s) involved in the manufacturing process of finished product and is /are mentioned in CPP other than batch releaser.

3. Detail of the Marketing Authorization Holder responsible for the products in UAE. Name of Marketing Authorization Holder Address/Street City Country Website: Qualify person Details 1. Authorized to negotiate/sign documents on behalf of company during the registration procedure: 2. Authorized for negotiations between holder of registration certificate and Drug Control Department after the registration 3. Acting on behalf of the company for conducting pharmacovigilance: Authorized for product defects and recalls. ( Please attach letter of attorney for qualified person and if different persons please attach letter of attorney for each). Qualify person Qualification: mention briefly Postal Code

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City: Tel/Fax International Code: Email:

Country: P.O Box:

4. Detail of Manufacture (s) of API (s) (Active Pharmaceutical Ingredient) Name of API: NOTE: Only one name should be given in the following order of priority: INN*, European Pharmacopoeia, common name, scientific name. * The active substance should be indicated by its recommended INN International non-proprietary name, accompanied by its salt or hydrate form (if any) Manufacturer of API
Only final manufacturer should be specified.

Address of site of Manufacture City GMP certification issued by:

Attach copy of valid GMP certificate

Country

Date of Issue

Expiry

Where an API manufacture has been inspected by reference country - name of competent authority which carried out the inspection, date of inspection & type of inspection (pre/post-authorization/special/re-inspection) 1

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Notarized copy of the Ph. EU. Certificate of suitability, FDA approval, UK-MHRA approval, or Japan Ph., for the API & letter of access are available: (applicable for Generic medicinal product only) Yes { } No { } Open part of the Drug Master File, & letter of access are available: (applicable for a new chemical entity of
a medicinal product only)

Yes { } No { }

5. Details of Product Trade Name Dosage Form Active Ingredients (INN or Scientific name) Strength Route of Administration
Pharmacotherapeutic group & sub-group (use British Normal Formulary classification preferably)

Group:

Sub-group: prescription only medicine General Sales Medicine

Mode of dispensing in country of origin

Narcotic

Controlled Drug

Pharmacy only

6. Product Packaging, Patient Information, Storage conditions, & Shelf Life Describe the packaging of primary and/or secondary material & Color of pack
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Pack Size (s) to be registered in UAE A patient information leaflet is to be supplied with the product Yes { } No { } Is the Arabic leaflet provided (Bilingual) Yes { } No { } if No please write the reasons of that Shelf Life of the product Unopened : Use which is appreciated Storage condition (same as in outer pack label & leaflet) Special Proposed storage conditions after first opening container (if available)

Opened:

Reconstituted:

7. Product composition Only one name for each active substance should be given in the following order of priority: International non-proprietary name (INN, European Pharmacopoeia, common name, scientific name.
S.N. Name of Active ingredient Quantity/Unit Quality standard
[Ph Eur / BP / US / House]

1 2 3 4

S.N.

Name of Excipient (s)

Quantity/Unit

Function

Quality standard
[Ph Eur / BP / US / House]

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1 2 3 4 5 6 7

8. Ingredients of Animal Origin

List of materials of animal origin contained or used in the manufacturing process of the medicinal product
Animal origin susceptible to TSE Other animal origin TSE Declaration By Applicant The product contains no ingredients derived from animals. If applicable, is any stearate or stearic acid in the product is derived from a vegetable source? The product contains (or comes into contact during its manufacture) with animalderived materials that are potential sources of TSE agents but appropriate precautions are taken in accordance with the European Commission and US Food and Drug Administration requirements to minimize the risk of contamination with TSE agents.
(tick one) Signature Stamp

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NOTE: If a product contains an ingredient (active or excipient, e.g. magnesium or calcium stearate, stearic acid, gelatin, lactose) that is, or potentially is, of animal origin, or comes into contact with material of animal origin during manufacture, the source of the material (or contact) must be declared, and evidence must be provided that the product is free from viruses, other micro-organisms transmissible spongiform encephalopathy (TSE) agents.. (e.g. a European Pharmacopoeial Commission Certificate of Suitability is acceptable as evidence of Freedom from TSE agents.)

9. Regulatory status Overseas applications and approvals (list 2 countries at least, if available) Name of regulatory authority Country Data of Approval

10. Leaflet Information Write the important information according to attached SPC

Therapeutic indications

Posology and method of administration

Contraindications

Special warnings and precautions for use

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Interactions with other medicinal products and other forms of interaction

Pregnancy and lactation

Effects on ability to drive and use machines

Undesirable effects

Overdose

11. Pharmacological Properties Pharmacodynamic properties

Pharmacokinetic properties Preclinical safety data

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12. Bioequivalence Details for Generic Product Full Detail of study should be submitted according to GCC or ICH Guidelines

Is the Bioequivalence study required?

Yes { } No { } If yes, provide the following information: Contract companies (Research Center/ Hospital) used for bioavailability or bioequivalence trials. For each contract company, state where analytical tests are performed and where clinical data are collected: (Name , location, country, telephone/ fax, -mail)

Is the authenticated GLP certificate or other Accreditation certificate for the center attached to the Bioequivalence File? Yes { } No { } Is there an original declaration by the center indicating that study done according to Good Clinical Practice? Yes { } No { } Is the comparator was innovator and is register in UAE? Practice? Yes { } No { }

Ex-factory Price

13. Price Details Attached the authenticated original price certificate Price to Public Price Proposed CIF price pharmacy in in country of to UAE port country of origin origin

Remark

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14. Declaration

In accordance with the Medicines Regulations of Drug Control Department- Ministry of Health -UAE, I hereby apply for consent to distribute in UAE the product described above. I certify that the information supplied is complete and correct to the best of my knowledge and that no relevant information has been omitted
Email Address: Name of Applicant Signature Stamp Of the MAH Date:

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