Administrative

Requirements
Module 2: Administrative Requirements
I. Application Form
II. Letter of Authorization
III. Certifications

PRESENTATION OUTLINE
Part I: Administrative Data and
Product Information 3
 Integrated Application Form

For contract manufacturing

For manufacturing “under-license”

For locally-manufactured

For imported products

Part I: Administrative Data and
Product Information 4
I. Application Form
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Integrated Application Form
• Annex I: Application Form
• Annex IV: Declaration Form for
Pharmaceutical Product Registration

I. Application Form
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• Correct name and address of applicant consistent with
LTO
• Correct name and address of manufacturer consistent
with LTO/CPP
• Correct generic name consistent with WHO INN
• Correct details of the product consistent with the
submitted sample(s)
• Correct name and address of drug substance(s)’
manufacturer(s)

I. Application Form: Pointers

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• Correct shelf-life and storage condition consistent with
stability study results
• Suggested Retail Price (SRP) for all pack size/
presentations
• Signed and notarized

I. Application Form: Pointers

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Declaration:
• Assume primary responsibility over the product
• Label of the product conform to the labeling
regulations
• Advertisement is not false, deceptive,
misleading, or contrary to public morals/policy

I. Application Form: Petition

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Declaration:
• all data and information submitted in connection
with this application, as well as future applications
are true, correct, and reflect the total information
available
• Applicants certify to have examined and attest to their
accuracy
Non-observance – ground for disapproval,
suspension, or cancellation

I. Application Form: Petition

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A letter from the manufacturer or product
owner authorizing the local applicant to
be the registration holder and to be
responsible for all matters pertaining to the
registration of the product.

II. Letter of Authorization

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 Letterhead of manufacturer/product
owner
 Heading “ Letter of Authorization”
 Product owner’s name and
 Applicant’s name and address
 Product details:
 Product Name
 Dosage Form and Strength

II. Letter of Authorization

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 Company’s Letterhead
LETTER OF AUTHORIZATION
We, ______________________________________________________________
Product Owner’s Name and Address

Hereby appoint
__________________________________________________________
Applicant’s Name and Address

To apply for registration of our pharmaceutical product

Product Name ____________________
Dosage Form and Strength ____________________

With the Drug Regulatory Authority in (state country) on our behalf . They will be
the marketing authorization holder of the registration certificate and be responsible
for all matters pertaining to the regulation of this product.

Signature : __________________
Date : 13
1. For contract manufacturing
2. For manufacturing “under-license”
3. For locally manufactured products (excluding
the above)
4. For imported products

III. Certifications
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a. License of pharmaceutical industries and
contract manufacturer
b. Contract manufacturing agreement
c. GMP certificate of contract manufacturer

III. Certifications: For contract manufacturing

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a. License of pharmaceutical industries
b. GMP certificate of the manufacturer
c. Copy of “under-license’’ agreement

III. Certifications: For manufacturing “under-license”

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a. License of pharmaceutical industries
b. GMP certificate

III. Certifications: For locally manufactured

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a. License of pharmaceutical
industries/importer/wholesaler
b. Certificate of Pharmaceutical Product issued by the
competent authority in the country of origin
according to the current WHO format
c. Foreign GMP Clearance

III. Certifications: For imported products

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“License to Operate”
 Valid or with proof of renewal
 LTO should state the capability to produce
the specific product line/class and dosage
form (for manufacturers)

III. Certifications: License of pharmaceutical industries

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• Contract agreement (e.g.
manufacturing/distributorship)
• A written, dated, and signed agreement
between two or more involved parties that
sets out any arrangement on delegation
and distribution of tasks and obligations,
and if appropriate, on financial matters.

III. Certifications: Contract agreement

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May be between:
 a local manufacturer and a trader
 a local manufacturer and local distributor
 a foreign manufacturer and importer
 a foreign product license holder and
importer
 an importer and wholesaler

III. Certifications: Contract agreement

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Pointers:
 valid
 Duly signed by the responsible person(s) of the
parties involved
 Includes the list of products (product name,
dosage strength and form) covered in the
agreement
 Declares the specific activities that each party shall
undertake

III. Certifications: Contract agreement

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• A certificate of pharmaceutical product of the
type defined in the WHO Certification Scheme
on the Quality of Pharmaceutical Products
Moving in International Commerce
• For imported products
• Establishes:
 Registration status
 Marketing status
 GMP compliance

III. Certifications: CoPP

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Pointers:
 Conforms to the WHO requirement
 In original copy and written/translated in English
 Valid/Have not expired
 An open-ended certificate is deemed
expired one year after its issuance
 The Philippines as the importing/requesting
country

III. Certifications: CoPP

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Pointers:
 Complete quantitative composition of the
product, consistent with P1 and P3.1
 Statement that the product is both registered and
freely sold in the country of origin
 Statement that the production facilities conform
to Good Manufacturing Practice (GMP)]
 http://www.who.int/medicines/areas/quality_safet
y/regulation_legislation/certification/en/

III. Certifications: CoPP

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• For countries not issuing CPP:
Current Good Manufacturing Practice
(cGMP) Certificate
Issued by the DRA of the product’s country of
origin
Certificate of Free Sale (CFS)

III. Certifications: CoPP

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III. Certifications: Foreign GMP
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III. Certifications: Foreign GMP
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For applications for initial and renewal
registration of imported products received
beginning 28 September 2014
 Foreign GMP Clearance issued by FDA (or
proof of application for renewal)

III. Certifications: Foreign GMP

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III. Certifications: Foreign GMP
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