Medicine Licensing Application Form
Part 1 – Administrative data
Local agent full name and address
Contact Information
Name:
Tel:
Fax:
e-mail
Commercial Registration (CR) number of applicant
Address of storage premises
Business name to be shown in the license if different from the above
Marketing Authorization Holder’s(MAH) Name and address
Contact Information
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May 2014
V2.0
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Part 2 – Product Particulars
1.
Name of the product:
2.
Strength:
3.
Pharmaceutical form:
4.
Pack size:
5.
Product description
6.
Pharmacotherapuetic group & ATC code:
7.
Proposed shelf-life (in months)
8.
Active substance(s) - including relevant
quality standard i.e. Ph.Eur., USP etc.):
Unit*
Unit*
9.
Excipient(s) – including relevant quality
standard i.e. Ph.Eur., USP etc.):
Unit*
Unit*
*Quantity/dose unit or % quantity
10. Country of origin (Batch releaser Country)
11.
Name of the product in the country of origin
12.
Reference number of the marketing authorization for the product in the country of origin and the date of
authorization
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13.
State if the product is licensed by any of the following authorities with the grant date : SFDA, GCC-DR, US
FDA, HEALTH CANADA, TGA, SWISSMEDIC,MEDSAFE or EMA (EU).*
*Includes medicines licensed by the European Medicines Agency (EMA) under the Centralized Procedure
and medicines licensed by one of the following countries Denmark, France, Germany, Italy, Ireland,
Netherland, Portugal, Spain, Sweden, UK
14.
Name and address of the manufacturer(s) involved in all stages of manufacture and activities carried out by
each:
Manufacturer Name
Country
Manufacturer Address
API manufacturer name
Bulk Manufacturer
Primary Packaging
Secondary Packaging
Batch release of finished product
15.
16.
17.
Method of sale & supply
Package leaflet revision date and number
Invoicing &Shipping country must be declared
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PHARMACEUTICAL PRODUCT INFORMATION TEMPLATE
1. Name of the pharmaceutical product
2. Qualitative and quantitative composition
3. Pharmaceutical form
4. Clinical particulars
4.1. Indications
4.2. Posology and method of administration
4.3. Contraindications
4.4. Special warnings and precautions for use
4.5. Interaction with other medicinal products and other forms of interaction
4.6. Fertility, pregnancy and lactation
4.7. Effects on ability to drive and use machines
4.8. Undesirable effects
4.9. Overdose
5. Pharmacological properties
5.1. Pharmacodynamic properties
5.2. Pharmacokinetic properties
5.3. Preclinical safety data
6. Pharmaceutical particulars
6.1. List of excipients
6.2. Incompatibilities
6.3. Shelf life
6.4. Special precautions for storage
6.5. Nature and contents of container
6.6. Special precautions for disposal
7. Marketing authorisation holder
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8. Agent
9. Marketing authorisation number(s)
10. Date of first authorisation/ renewal of the authorisation
11. Date of revision of the text
I/we apply for a medicine license in respect of the product for which details are provided above.
It is hereby confirmed that all information relevant to the product have been supplied in the file as appropriate and
they are all correct (must be filled by the MAH).
Name of signatory
Signature
State capacity in which signed
Date
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May 2014
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