Republic of the Philippines

Department of Health
Food and Drug Administration

CDRR QPIRA TRAINING

Workshop on Labeling Requirements
Eliza G. Sison
FDRO III
Licensing and Registration Division

Presented by:
Richard Simon R. Binos
Pharmacist II
Product Research and Standards Development Division
1
 Republic of the Philippines
Department of Health
Food and Drug Administration

SCOPE
1. Labeling Requirements
2. Product Information
• Summary of Product
Characteristics
• Package Insert
• Patient Information Leaflet
4. Generic Labeling Exemption
5. Proposed Labeling Requirement
6. Common Deficiencies 2
 Republic of the Philippines
Department of Health
Food and Drug Administration

LABELING
REQUIREMENTS

3
 GUIDELINES
Administrative Order No. 55 s.
1988
• Requirements for Labeling Materials of
Pharmaceutical Products

4
 GUIDELINES
Administrative Order No. 85 s.
1990
• Requirements for Labeling Materials of
Certain Categories of Products
Containing Two or More Active
Components

5
 GUIDELINES
Administrative Order No. 99 s.
1990
• Requirements for Labeling Materials of
Categories of Pharmaceutical
Products Containing Four or More
Active Ingredients Outside the
Coverage of A.O. 85 s. 1990

6
 Republic of the Philippines
Department of Health
Food and Drug Administration

PRODUCT
INFORMATION

7
SUMMARY OF PRODUCT
CHARACTERISTICS
VS

PACKAGE INSERT
VS

PATIENT INFORMATION
LEAFLET 8
 PRODUCT INFORMATION
• Where Are These Required?

Type of Application SPC PI PIL

New Chemical Entity 
Biotechnology Product 
Generic * *
OTC, Household Remedy 

*Either SPC or package insert is acceptable

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 SUMMARY OF
PRODUCT
CHARACTERISTICS

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 SUMMARY OF PRODUCT
CHARACTERISTICS
- “SPC”
- Product information as approved by
the drug regulatory authority (DRA)

11
 SUMMARY OF PRODUCT
CHARACTERISTICS
1. Name of the Medicinal Product
- Product Name
- Generic name
- Brand name (if applicable)
- Dosage Strength and Form

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 SUMMARY OF PRODUCT
CHARACTERISTICS
2. Qualitative and Quantitative Composition
- Qualitative-declared by its
recommended INN, accompanied by its
salt or hydrate form (if relevant).
- Quantitative-quantity of API expressed
per dosage unit, per unit volume, or per
unit weight.
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 SUMMARY OF PRODUCT
CHARACTERISTICS
3. Pharmaceutical Form
- Visual description of the
appearance of the product
including color, shape, markings or
imprints, coating, etc.

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 SUMMARY OF PRODUCT
CHARACTERISTICS
4. Clinical Particulars
4.1 Therapeutic indications
- based on clinical data and with approval of
competent DRA
- based on recognized references
(e.g. British National Formulary; Martindale)

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 SUMMARY OF PRODUCT
CHARACTERISTICS
4.2 Posology and method of
administration
-dosage (amount), frequency, duration,
route, direction for administration and
reconstitution/dilution instructions

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 SUMMARY OF PRODUCT
CHARACTERISTICS
- drugs that should not be crushed or
chewed
- for patients with difficulty swallowing oral
solid dosage forms, the drug may be
dispersed in a glass of water or juice

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 SUMMARY
• Products OF
Containing PRODUCT
Sodium Metabisulfite
and Other Derivatives of this Sodium Salt
CHARACTERISTICS
• Habit Forming Products
• Antidepressant
4.3 Contraindications
Drugs
• Erythromycin Products to any of the
e.g. hypersensitivity
• Products
product’sContaining
components
Phenylpropanolamine
(PPA)
• Selective COX-II Inhibitors and Prescription
4.4 Special warnings and precautions for
Non-steroidal Anti-inflammatory Drugs
use
(NSAIDs)
ProductsProducts
• Azithromycin with special/black box
warning statements 18
 SUMMARY OF PRODUCT
CHARACTERISTICS
4.5 Interaction with other medicinal
products and other forms of interactions
Types
Addition: 1+1=2
Synergism: 1 + 1 = 3
Potentiation: 0 + 1 = 2
Antagonism: 1 + 1 = 0
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SUMMARY OF PRODUCT
CHARACTERISTICS
4.6 Pregnancy and lactation
- reproductive toxicity
- risk to the fetus
- excretion in human milk

20
 SUMMARY OF PRODUCT
CHARACTERISTICS
4.7 Effects on ability to drive and use
machines
- drowsiness; dizziness; blurred vision
4.8 Undesirable effects
- from the very common to the rare
4.9 Overdose
- including particulars on
management or treatment 21
 SUMMARY OF PRODUCT
CHARACTERISTICS
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
5.2 Pharmacokinetic Properties
- also known as the “ADME” Scheme
5.3 Preclinical Safety Data
- involves animal laboratory testing

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 SUMMARY OF PRODUCT
CHARACTERISTICS
6. Pharmaceutical Particulars
6.1 List of excipients
- ingredients added intentionally to the drug
substance, which should not have any
pharmacological properties in the quantity
used
- Complete

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 SUMMARY OF PRODUCT
CHARACTERISTICS
6.2 Incompatibilities
- physical, chemical or therapeutic
6.3 Shelf-life
- as (unopened) packages for sale
- after dilution or reconstitution
- after first opening the container
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 SUMMARY OF PRODUCT
CHARACTERISTICS
6.4 Special precautions for storage
6.5 Nature and contents of container
- “PVDC/alu blister – Packs containing 10,
50 and100 tablets (not all pack sizes
may be marketed)”

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 SUMMARY OF PRODUCT
CHARACTERISTICS
7. Marketing Authorization Holder
- Responsible for all aspects of the product,
including quality and compliance with the
conditions of marketing authorization

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 SUMMARY OF PRODUCT
CHARACTERISTICS
8. Marketing Authorization Number(s)
- Product license / registration
number(s)
9. Date of 1st Authorization / Renewal of
the Authorization
10. Date of the Revision of the Text

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PACKAGE INSERT

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 PACKAGE INSERT

- Also known as “PI”

- A document defining information that may
be supplied with a pharmaceutical
product by the marketing authorization
holder.

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 PACKAGE INSERT

1. Product Name
2. Name and Strength of the Active
Ingredient(s)
3. Product Description
4. Pharmacodynamics / Pharmacokinetics
5. Indication
6. Recommended Dose
7. Mode of Administration
8. Contraindications
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 PACKAGE INSERT
9. Warnings and Precautions
10. Interactions with Other Medicaments
11. Pregnancy and Lactation
12. Undesirable Effects
13. Overdose and Treatment
14. Storage Condition
15. Dosage Forms and Packaging Available
16. Name and Address of Manufacturer / Marketing
Authorization Holder
17. Date of Revision of Package Insert 31
 PATIENT
INFORMATION
LEAFLET

32
 PATIENT INFORMATION LEAFLET

- Also known as “PIL”

- A document defining information intended for
the patient that may be supplied with a
pharmaceutical product by the marketing
authorization holder
- Commonly appears in a Question and Answer
(Q&A) format

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PATIENT INFORMATION LEAFLET

1. Name of Product
2. Description of Product
3. What is in the medicine?
4. Strength of the medicine
5. What is the medicine used for?
6. How much and how often should
you use this medicine?
7. When you should not take the
medicine? 34
 PACKAGE INSERT
8. Undesirable Effects
9. What other medicine or food should be
avoided whilst taking this medicine?
10.What should you do if you miss a dose?
11.How should you keep this medicine?
12.Signs and symptoms of overdosage
13.What to do when you have taken more
than the recommended dosage
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 PACKAGE INSERT

14.Name (and logo) of manufacturer /

importer /Marketing Authorization
Holder
15.Care that should be taken when taking
this medicine
16.When should you consult your doctor?
17.Date of Revision of PIL

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 Republic of the Philippines
Department of Health
Food and Drug Administration

PROPOSED LABELING
REQUIREMENTS

37
 OBJECTIVE
The objective of this Administrative Order
is to rationalize the existing rules and
regulations on labeling requirements of
pharmaceutical products, consistent
with the harmonized requirements of the
ASEAN Member States

38
 OVERVIEW
Mandatory product information
requirements consistent with ASEAN
Requirements
• SPC submission
• PI submission
• PIL submission

39
 OVERVIEW
Mandatory information for specific
labeling materials consistent with
ASEAN Requirements

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 OVERVIEW
The reference monograph used for the
analysis of the finished product shall
also be indicated in the formulation,
unless a non-official method is used
Each tablet contains:
Sulfamethoxazole, USP...................................800mg
Trimethoprim...........................................160mg

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 OVERVIEW
Special labeling instructions shall be
added for pharmaceutical products
with the following properties:
Properties Special labeling
instructions
Cannot tolerate “Do not refrigerate or
refrigeration freeze”
Cannot tolerate freezing “Do not freeze”
Light-sensitive “Protect from light”
Cannot tolerate excessive “Store and transport not
heat, e.g. suppositories above 30 °C”
Hygroscopic “Store in dry conditions” 42
 OVERVIEW
Inclusion of other mandatory
information:
• ADR Reporting Statement
• Overdose and Treatment
• Interactions

43
 OVERVIEW
Guidelines for Generic Labeling
Exemption

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 Republic of the Philippines
Department of Health
Food and Drug Administration

GENERIC LABELING
EXEMPTION

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 BASIS
1. Republic Act No. 3720
2. Administrative Order No. 55 s. 1988
3. Bureau Circular No. 05 s. 1997

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 GROUNDS
1. Primary pack is enclosed in
transparent covering and the
particulars are clearly visible
2. Compounded by a pharmacist
3. Investigational products
4. Donated products

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 GROUNDS
5. Available only on a limited basis upon
physician’s request
6. In containers that cannot be
made/packed locally
7. Low volume of importation (500
units/month or 6000 units/yr)
8. Drug product requires special
handling
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 FDA Circular No. 2013-012

Validity of Generic Labeling Exemption

(GLE) for Pharmaceutical Products

49
 GENERAL GUIDELINES

validity
1. For incoming registration, the
of the GLE shall be the same as the
validity of the Certificate of Product
Registration (CPR) except for
pharmaceutical products with low
volume of importation
50
 GENERAL GUIDELINES
2. Low volume of importation =
GLE annually
3. For pharmaceutical products already
registered, marketing authorization
apply for
holders are advised to
GLE with the same validity as the
unexpired term of the CPR 51
 GENERAL GUIDELINES
4. Payment:
• a fraction of a year shall be
counted as one year
5. All submitted requests prior
to the issuance of this Circular shall be
given one year validity
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 Republic of the Philippines
Department of Health
Food and Drug Administration

COMMON
DEFICIENCIES
PRACTICE SET

53
 NAME OF PRODUCT

generic box
outline color

Background
color

54
 NAME OF PRODUCT

Salt form

Font
Color

55
 NAME OF PRODUCT

Background
color Font
size

56
DOSAGE FORM AND STRENGTH

mg 300

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DOSAGE FORM AND STRENGTH

“Capsule should be swallowed whole

and not opened, chewed, or crushed.”

Special
delivery
system

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Rx SYMBOL and Caution Statement

Height

59
Rx SYMBOL and CAUTION
STATEMENT

Foods, Drugs, Devices, and

Cosmetics Act prohibits dispensing
without prescription.
Caution
Statement

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 NAME AND ADDRESS OF
NameMANUFACTURER/TRADER
and Address of Local
• Consistent with LTO
Name and Address of Source
• Consistent with cGMP
Complete Source/Manufacturer
• Manufactured by:
• Manufactured for:
• Imported and distributed by:
• Packed by: Complete
• Repacked by: address
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 Republic of the Philippines
Department of Health
Food and Drug Administration

COMMON
DEFICIENCIES
EVALUATION SET

62
Generic nameLABEL
font 1
color and generic Rx symbol
outline box color
Brand name
style, size

Dosage Strength

Caution statement
63
 LABEL 2

• Generic and Brand name

Brand
• Company name or logo
Name size
• Strength
• Mode of Administration
Net content
• Batch Number
• Expiry date

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 LABEL 3

Generic name
• Generic and Brand name
in box
• number
Batch Company name or logo
• Strength
• Expiry date

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 LABEL 4
Net volume
For use in the hospital or sickroom as a
rundown or for general massage
purposes. This compound made from
isopropyl alcoholFordoes not contain nor is
external
it offered as a substitute
use onlyfor ethyl or grain
alcohol
Flammable
Drug
registration
number 66
 LABEL 5
Rx symbol should
Generic box
be on PDP

MDRP
Manufacturer
name and
address 67
Thank you!

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