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Work Reviewer > Licensing and Registration Division > Flashcards

Licensing and Registration Division Flashcards

1
Q

Safety Data Sheet (SDS) Format

Information to be presented

an SDS is not a fixed length document.
The length shall commensurate with the hazard material and the information available

A
  • Identifications
  • Hazard Identifications
  • Composition/information on ingredients
  • First-aid measures
  • Accidental release measures
  • Handling and storage
  • Exposure controls/personal protection
  • Physical and chemical properties
  • Stability and reactivity
  • Ecological information
  • Disposal considerations
  • Regulatory information
  • Other information

an SDS is not a fixed length document.
The length shall commensurate with the hazard material and the information available

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2
Q

Where to secure QPIRA ID?

A

FDA Academy
Annex A of FMC 2015-010

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3
Q

Guidelines on Issuance of Center for Cosmetics Regulation and Research (CCRR) User Account to Access E-Portal

Guidelines on Issuances of CCHUHSRR User Account to Access E-portal

A

FDA Memorandum Circular 2015-010

Processing time must be 1 working day and 30 minutes

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4
Q

Guidelines for Electronic Notification of Cosmetic Products

A

FDA Memorandum Circular No. 2015-011

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5
Q

FDA Circular No. 2018-008

A

Ban of Chlorpyrifos and Dichlorvos for Use in HUP products and HUHS Products

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6
Q

FDA Circular No. 2018-007

A

Reiteration on the Classification of Cuticle Tints Containing Benzalkonium Chloride with Antiseptic, Antibacterial or Disinfectant Claim as Household Remedy

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7
Q

FDA Circular No. 2018-001

A

PRODUCT INFORMATION FILE (PIF)

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8
Q

FDA Circular No. 2015-002

A

Guidelines on the Electronic Notification of Toys and Childcare Articles ( TCCA)

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9
Q

FDA Circular No. 2016-009

A

Reiteration on the Classification of Diaper Rash Creams / Lotions/ Ointments /Powders and Other Products Containing Zinc Oxide

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10
Q

FDA Circular No. 2013-028

A

General Guidelines on the Promo Permit Applications and for Other Purposes

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11
Q

Requirements for CPN Application

Cosmetic Product

A

Eportal Account
Valid LTO
Substantiation (for further clarifications)
1. Artwork of the Product labeling
2. Instructions for use
3. Mechanism of action of the product
4. Certificate of Origin of the ingredient
5. Safety Data Sheet
6. Certificate of Analysis

must be accomplished within 17 working days and 1 hour

E V S (a i m c s c)

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12
Q

Requirements for CPN Application

Toys and Childcare Article

A
  • TCCA e-portal user account
  • Valid LTO
  • Laboratory Test Report
  • Labeling and Packaging including other informative materials

must be accomplished within 17 working days and 1 hour

Labels must be submitted within 30 days of CPN acknowledgement

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13
Q

Laboratory Test Report to be provided for Toys intended for children below 14 y/o

A
  • Parts 1 to 3 of the PNS/ISO 8124
  • Reports for phthalate testing if the toy product contains PVC
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14
Q

Laboratory Test Report to be provided for swings, slides and similar activity toys

A
  • Parts 1 to 4 of the PNS/ISO 8124
  • Reports for phthalate testing if the toy product contains PVC
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15
Q

Laboratory Test Report to be provided for Childcare Articles

A
  1. Phthalate testing
  2. Laboratory reports for migration of elements:
    * Antimony
    * Arsenic
    * Barium
    * Cadmium
    * Chromium
    * Lead
    * Mercury
    * Selenium
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16
Q

Requirements for CPR

Household Urban Pesticides (HUP)

A
  1. IAF
  2. Valid LTO
  3. Copy of Official Receipt
  4. AO 2019-0008 Annex A Requirements
  5. Proof of Manufacturer’s Compliance to Good Manufacturing Practices
  6. Submission of Actual Sample and Reference Standard
  7. Toxicity Data
  8. Human Exposure and Safety Data

must be accomplished withing 20 working days and 2 hours

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17
Q

AO 2019-0008 Annex A Requirements

A
  • Chemical Identity
  • Physical Properties of the Active Ingredient
  • Product Specifications
  • Certificate of Analysis
  • Safety Data Sheet
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18
Q

Proof of Manufacturer’s Compliance to Good Manufacturing Practices

A
  • Certificate of Free Sale
  • Certificate of Good Manufacturing Practice (GMP) based on international manufactuirng standards
  • Manufacturing License
  • ISO Certificate related to manufacturing

must be duly auntheticated and notarized by the Philippine Embassy

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19
Q

Toxicity Data includes:

A
  1. Acute Toxicity
  2. Corrosion / Irritation
  3. Allergy / Sensitization
  4. Sub-chronic Toxicity
  5. Reproduction Effects
  6. Teratogenicity
  7. Neurotoxicity
  8. Mutagenicity
  9. Carcinogenicity and Chronic (Long Term) Toxicity Studies in Rats
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20
Q

Human Exposure and Safety includes:

A
  1. Medical Data
  2. Personal Protective Equipment
  3. Other Precautions
  4. Environmental Data
  5. Labeling / Packaging
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21
Q

Requirements for bio-efficacy study:
Insecticidal Net

accepted protocols of the FDA

A

WHO Guidelines for Laboratory and Field Testing of Long-Lasting Insecticidal Nets

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22
Q

Requirements for bio-efficacy study:
Human Mosquito Repellent

accepted protocols of the FDA

A

WHO Guidelines for Efficacy Testing of Mosquito Repellents for Human Skin

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23
Q

Requirements for Bio-efficacy study:
Mosquito Coils, Vaporizer Mats, Liquid Vaporizersm Ambient Emanators & Aerosols

accepted protocols of the FDA

A

WHO Guidelines for Efficacy Testing of Household Insecticide Products

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24
Q

Requirements for Bio-Efficacy:
Mosquito Larvicide

accepted protocols of the FDA

A

WHO Guidelines for Laboratory and Field Testing of Mosquito Larvicide

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25
Q

INITIAL Registration of Formulated Product

A
  1. IAF with Declaration
  2. Valid LTO
  3. Copy of Official Receipt
  4. Product Identity
  5. Quantitative and Qualitative Composition of Product
  6. Technical Specification of the Formulated Product
  7. Product Specification - Tolerance for the Active Ingredient/s
  8. Certificate of Analysis
  9. Test Procedures/Methods Conducted on the Formulated Product
  10. Safety Data Sheet of Formulated Product
  11. Proof of Manufacturer’s compliance to Good Manufacturing Practices (GMP)
  12. Substantiation to Support Special Product Claims
  13. Product Stewardship Program
  14. Submission of Actual Sample and Reference Standard
  15. Toxicity Data
  16. Bio-efficacy Data
  17. Human Exposure and Safety
  18. Environmental Data
  19. Labeling / Packaging

must be accomplished withing 20 working Days and 2 hours

26
Q

Renewal of Product Registration

A
  1. IAF with Declaration
  2. Post-Marketing Surveillance Monitoring Report
  3. Unattached Legible, Comprehensive and Indellibe Specimen of All Labeling Materials per Pack Size (Including Outer, Immediate, Package Inserts)

must be accomplished within 20 working days and 2 hours

27
Q

Major Variations in Product Registration (HUP)

A
  1. Change in Product Name (Brand / Variant Name)
  2. Change in Label Claim / Request for Additional Target Pests
  3. Change in GHS Category / Hazard Class
28
Q

Minor Variations in Product Registration (HUP)

A
  1. Change in Business Name of the Manufacturer or Distributor
  2. Change in Product Ownership
  3. Change of Address of the Distributor of the Product
  4. Addition or Deletion of Packaging of the Product
29
Q

Requirements for Major Variations in Product Registration (HUP)

Change in Product Name (Brand / Variant Name)

A
  1. Notarized Affidavit/Declaration of No Change in the Formulation
  2. Extension of Use or Claim and New Bio-efficacy Study
  3. Complete Labelling Requirements Reflecting the Change (Primary, Secondary and Inserts)
30
Q

Requirements for Major Variations in Product Registration (HUP)

Change in Label Claim / Request for Additional Target Pests

A
  • Extension of Use or Claim and New Bio-efficacy Study, If There Is Request To Include Additional Target Pests
  • Complete Labeling Requirements Reflecting the Change (Primary,Secondary and Inserts, If Any)
31
Q

Requirements for Major Variations in Product Registration (HUP)

Change in Rate, Timing /Frequency of Application/Method of Application

A
  • Extension of Use or Claim and New Bio-efficacy Study, If There Is Request To Include Additional Target Pests
  • Study or Studies That Shall Justify Request for Change in Rate, Timing or Frequency of Application or Method of Application
  • Complete Labeling Requirements Reflecting the Change (Primary,Secondary and Inserts, If Any)
32
Q

Requirements for Major Variation in Product Registration (HUP)

Change in GHS Category / Hazard Class

A
  • Copy of Safety Data Sheet
  • Copy of Complete Toxicity Studies, If Request is For Change in Hazard Class
  • Complete Labeling Requirements Reflecting the Change (Primary, Secondary and Inserts, If Any)
33
Q

Requirements for Minor Variation on Product Registration (HUP)

Change in Business Name of the Manufacturer or Distributor

A

Complete Labeling Requirements Reflecting the Change (Primary,Secondary and Inserts, If Any)

34
Q

Requirements for Minor Variation on Product Registration (HUP)

Change in Product Ownership

A
  • Copy of Termination Contract / Deed of Assignment
  • Copy of the Agreement of the New Market Authorization Holder and Manufacturer
  • Complete Labeling Requirements Reflecting the Change (Primary,Secondary and Inserts, If Any)
35
Q

Requirements for Minor Variation on Product Registration (HUP)

Change of Address of the Distributor of the Product

A
  • Any Valid Document/s Showing Proof of Transfer
  • Complete Labeling Requirements Reflecting the Change (Primary, Secondary and Inserts, If Any)
36
Q

Requirements for Minor Variation on Product Registration (HUP)

Addition or Deletion of Packaging of the Product

A
  • Notarized Affidavit/Declaration of No Change in the Formulation
  • Complete Labeling Requirements Reflecting the Change (Primary, Secondary and Inserts, If Any)
37
Q

Requirements for Off-Label Use / Public Health Emergency Use Exemption Permit for HUP

A
  1. Letter of Request
  2. Information Required for Public Health Exemption
  3. Description of the HUP Product
  4. Description of the Proposed Use
  5. Alternate Methods of Control
  6. Bio-Efficacy Study
  7. Toxicity Study
  8. Description of the Proposed Enforcement Program
  9. Copy of Official Receipt

to be accomplished within 20 working days and 2 hours

38
Q

Requirements for Certificate of Free Sale

CFS - issued to license establishments that will export their products to other countries for distribution

A
  1. Integrated Application Form
  2. Letter of Intent stating the country where the product will be exported
  3. Valid LTO with activity as exporter
  4. Copy of valid product registration/notification
  5. Copy of official receipt

to be accomplished within 7 working days and 3 hours

39
Q

Requirements for GMP Certificate

Issued to licensed cosmetic manufacturer that are at least one year operational.

A
  1. Letter of Intent
  2. Copy of Valid LTO as Cosmetic Manufacturer
  3. Copy of Official Receipt

to be accomplished within 7 working days and 3 hours

40
Q

Requirements for Sales and Promo Permit

issued to licensed establishments to have broad consumer participation which contains promises of gains which utilize mass media or other widespread means of information

A
  1. Integrated application form
  2. Information Sheet and Mechanics of the sales promotion
  3. Copy of Valid LTO
  4. Copy of valid product registration/notification
  5. Copy of lay-out of any promo materials
  6. Copy of official receipt

to be accomplished within 7 working days and 3 hours

41
Q

Fees to be Paid: CPR HUP

A
  • 2 year validity – Php 1,000 + 1% LRF
  • 3 year validity – Php 1,500 + 1% LRF
  • 4 year validity – Php 2,000 + 1% LRF
  • 5 year validity – Php 2,500 + 1% LRF
42
Q

Fees to be Paid: CPN TCCA

A

Php 100.00 + 1% LRF not less than Php 10.00 (maximum of five (5) SKUs)

43
Q

Fees to be Paid: CPN Cosmetics

A

Php 500.00 + 1% LRF not less than Php 10.00 for 1 year validity
Additional Php 100.00 per variant

44
Q

Fees to be paid: Off-Label Use / Public Health Emergency Exemption Permit (HUP)

A

Php 500.00 + 1% LRF not less than Php 10.00

45
Q

Requirements for Bureau of Custom Clearance

Issued to licensed establishments that will import products that are not yet notified but will be used for testing, research and development, clinical trial, exhibition and so forth

A
  1. Letter of intent stating the purpose of importation
  2. Airway Bill or Bill of Lading
  3. Packing List
  4. Proforma Invoice
    * For Exhibition (Notarized affidavit of undertaking, Product Information)
    * For clinical trial/research (Copy of protocol)
    * For Donation (Letter of endorsement from DOH-BIHC, Deed of donation)
  5. Copy of Valid LTO
  6. Copy of Official Receipt
46
Q

Fees to be paid: Sales and Promotion Permit

A
  1. Php 300,000 and below – Php 1,000
  2. Php 300,001 to Php 500,000 – Php 2,000
  3. Php 500,001 to Php 1 million – Php 3,000
  4. Above Php 1 million – Php 5,000

Amendment application
Php 300.00 + 1% LRF not less than Php 10.00

47
Q

Repacker is:

A

refers to any establishment that repacks a finished product into smaller quantities in a separate container and/or secondary packaging including but not limited to relabeling, stickering and bundling for promo packs.

48
Q

Risk Management Plan is:

A

refers to the document that contains on how to identify, characterize, prevent or minimise the risk relating to the products that the establishment is engaged in.

49
Q

Site Master File:

A

refers to the specific information about the quality assurance the production and/or quality control of manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings.

50
Q

Requirements for Initial LTO

A
  1. Accomplished e-Application Form with Declaration of Undertaking.
  2. Proof of Business Name Registration
  3. Proof of Income (Latest Audited Financial Statement w/ Balance Sheet)
  4. Payment of Fees
51
Q

Requirements for Renewal of LTO

A
  1. Accomplished e-Application Form with Declaration of Undertaking
  2. Payment of Fees
52
Q

Proof of Business Name Registration for Single Proprietorship

A

Certificate of Business Registration issued by Department of Trade and Industry (DTI)

53
Q

Proof of Business Name Registration for Corporation, Partnership and other Judicial Person

A

Certificate of Business Registration issued by the Securities and Exchange Commission (SEC) and Articles of Incorporation

54
Q

Proof of Business Name Registration for Cooperative

A

Certificate of Registration issued by the Cooperative Authority and Articles of Cooperation

55
Q

Proof of Business Name Registration for Government Owned or Controlled Corporation

A

Certificate of Registration issued by the Securities and Exchange Commission (SEC) and Articles of Incorporation

56
Q

Requirements for LTO Variation

A
  1. Accomplished e-Application with Declaration of Undertaking
  2. Documentary requirements depending on the variation or circumstances of the establishment or the product.
  3. Payment of Fees
57
Q

When the business or establishment address is different from the business name registration address

A

Submit a Copy of the Business Permit (e.g. Mayor’s Permit)

58
Q

Types of Major LTO Variation

A
  1. Transfer of Location of Manufacturing Plant
  2. Expansion of Manufacturer and/or Additional Product Line
  3. Change of Manufacturing Activity
59
Q

Types of Major LTO Variation

A
  1. Transfer of Location of Manufacturing Plant
  2. Expansion of Manufacturer and/or Additional Product Line
  3. Change of Manufacturing Activity
60
Q

Procedure of LTO Application

A
  1. Filing of Applications
  2. Payment of prescribed fees
  3. Evaluation of Application
  4. Inspection (Pre-LTO Inspection)
  5. Checking of Application status through the E-Portal
  6. Releasing of LTO
  7. Inspection (Post-Licensing Inspection for non-Manufacturers)
61
Q

An LTO may be cancelled through:

A
  1. Automatic cancellation if the MAH failed to renew after the 120 days
  2. Imposed by the FDA as a penalty
  3. Voluntary filing through a formal notification with the FDA

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