[PPT] - Draft Administrative Order Revised Rules and Regulations Governing PowerPoint Presentation

SLIDE 1

Republic of the Philippines Department of Health Food and Drug Administration

Draft Administrative Order

Revised Rules and Regulations Governing the Generic Labelling Requirements of Pharmaceutical Products for Human Use

Food and Drug Administration

26 August 2014 AVR 3/f Annex Building, FDA

1

SLIDE 2

Discussion Flow

A. Background B. Draft Regulation C. Proposals D. Discussion

Center for Drug Regulation and Research 2

SLIDE 3

Regulation Outline

I. Rationale
II. Declaration of Policy

III.Objective IV.Scope

V. Definition of Terms

VI.General Requirements

Center for Drug Regulation and Research 3

SLIDE 4

Regulation Outline

VII. Specific Requirements

VIII.Special Labeling Instructions

IX. Exemptions

X. Sanctions

XI. Separability/Repealing Clause
XII. Transitory Provisions

XIII.Effectivity

Center for Drug Regulation and Research 4

SLIDE 5

Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 5

A. BACKGROUND

SLIDE 6

Full adoption of ACTD/ACTR

Center for Drug Regulation and Research 6

SLIDE 7

Center for Drug Regulation and Research 7

SLIDE 8

Other triggers

Gaps in the current regulations raised Harmonization of labeling requirements to some extent

Center for Drug Regulation and Research 8

SLIDE 9

Timelines

2006 – initial drafting by then PSD and PPAD May 2013 – endorsement to CDRR 22 May 2014 – focus group discussion (FGD) 28 July 2014 – posting for comments 25 August 2014

Center for Drug Regulation and Research 9

SLIDE 10

Comments and Suggestions

22 May – 28 Jul – 2 comments/position papers received 28 Jul – 25 Aug – 3 comments

Center for Drug Regulation and Research 10

SLIDE 11

Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 11

B. DRAFT

REGULATION

SLIDE 12

Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 12

I. RATIONALE

Revised Labeling Regulation

SLIDE 13

Rationale

Address the changes due to harmonization Address identified gaps in the regulation

Center for Drug Regulation and Research 13

SLIDE 14

Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 14

II. DECLARATION OF

POLICY

Revised Labeling Regulation

SLIDE 15

Declaration of Policy

Article II, Section 15 of 1987 Constitution Section 5(o) of RA 9711 RA 7394, RA 6675

Center for Drug Regulation and Research 15

SLIDE 16

Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 16

III. OBJECTIVE

Revised Labeling Regulation

SLIDE 17

Objective

rationalize the existing rules and regulations on generic labeling requirements of pharmaceutical products, consistent with the harmonized requirements of the ASEAN Member States; thus, providing a more updated and comprehensive guideline as a response to the needs of the pharmaceutical industry and the public

Center for Drug Regulation and Research 17

SLIDE 18

Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 18

IV. SCOPE

Revised Labeling Regulation

SLIDE 19

Scope

all manufacturers, traders and distributors (i.e. exporters, importers and wholesalers) of pharmaceutical products for human use, including herbal and traditional med

Center for Drug Regulation and Research 19

SLIDE 20

Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 20

V. DEFINITION OF

TERMS

Revised Labeling Regulation

SLIDE 21

(1) Active Moiety

The molecule, or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other non-covalent derivative (such as complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action

f the drug substance

Center for Drug Regulation and Research 21

SLIDE 22

(15) Generic Class Name

The identification of a pharmaceutical product containing those three or more APIs by its scientifically and internationally recognized name or by its

fficial generic name as determined by

FDA

Center for Drug Regulation and Research 22

SLIDE 23

(40) Small Containers

Are pharmaceutical packaging materials that hold less than or equal to 5 mL volume or 5 g weight, which include: a) Ampoules, vials, and nebules of small volume parenterals b) Packaging materials for ophthalmic, otic, and nasal liquid preparations c) Jars and tubes for semi-solid preparations; and d) Any other pacakging material of the same capacity

Center for Drug Regulation and Research 23

SLIDE 24

Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 24

VI. GENERAL

REQUIREMENTS

Revised Labeling Regulation

SLIDE 25

Minimum Mandatory Information

1) Product Name 2) Dosage Form and Strength 3) Pharmacologic Category 4) Formulation/Composition 5) Indication(s) 6) Dosage and Mode of Administration

Center for Drug Regulation and Research 25

SLIDE 26

Minimum Mandatory Information

7) Contraindication(s), Precaution(s), Warning(s) (if applicable) 8) Interactions 9) Undesirable Effects 10)Overdose and Treatment 11)Storage Condition(s) 12)Net Content or Pack Size

Center for Drug Regulation and Research 26

SLIDE 27

Minimum Mandatory Information

13)Name and Address of MAH 14)Name and Address of Manufacturer 15)Rx Symbol and Caution Statement 16)ADR Reporting Statement 17)Registration Number 18)Batch Number and Lot Number (if any) 19)Expiration Date and Date of Manufacture

Center for Drug Regulation and Research 27

SLIDE 28

General Requirements

1) English and/or Filipino 2) Readable with normal vision without straining 3) Color contrast, position, and spacing must be considered

Center for Drug Regulation and Research 28

SLIDE 29

General Requirements

NCEs, biotech products, and Rx generic and herbal products –PI; NCEs and biotech – PI must be based from SPC HR, OTCs, Herbal non-Rx, TM – PIL

Center for Drug Regulation and Research 29

SLIDE 30

General Requirements

In lieu of PI or PIL - printed directly on the reverse side or inner panel of the

uter packaging material or inner

carton; provided, that the product is intended to be sold or dispensed together with such packaging material

r inner carton

Center for Drug Regulation and Research 30

SLIDE 31

Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 31

MANDATORY INFORMATION FOR LABELLING MATERIALS

Revised Labeling Regulation Annex A

SLIDE 32

Unit Carton

a) Product Name b) Dosage Form and Strength c) Pharmacologic Category d) Formulation/Composition e) Indication(s) f) Warning(s) (if applicable) g) Storage condition(s) h) Pack Size

Center for Drug Regulation and Research 32

SLIDE 33

Unit Carton

i) Name and Address of MAH j) Name and Address of Manufacturer k) Rx Symbol and Caution Statement l) ADR Reporting Statement m)Registration Number n) Batch Number and Lot Number (if any)

) Expiration Date and Date of Manufacture

Center for Drug Regulation and Research 33

SLIDE 34

Primary Label excluding blister pack, foil strip and small containers

a) Product Name b) Dosage Form and Strength c) Pharmacologic Category d) Formulation/Composition e) Indication(s) f) Warning(s) (if applicable) g) Storage condition(s) h) Net Content

Center for Drug Regulation and Research 34

SLIDE 35

Primary Label excluding blister pack, foil strip and small containers

i) Name and Address of MAH j) Name and Address of Manufacturer k) Rx Symbol and Caution Statement l) ADR Reporting Statement m)Registration Number n) Batch Number and Lot Number (if any)

) Expiration Date and Date of Manufacture

Center for Drug Regulation and Research 35

SLIDE 36

Blister Packs/Foil Strips

a) Product name on each unit or every two (2) units for multiple APIs; b) Dosage form and strength of API(s) on each unit or every (2) units for multiple APIs; provided, that if the pharmaceutical product is visible from its packaging, the dosage form may no longer be indicated; c) Name and/or logo of the MAH on each unit or every two (2) units for multiple APIs (for unbranded products only)

Center for Drug Regulation and Research 36

SLIDE 37

Blister Packs/Foil Strips

d) Rx symbol on each unit or every two (2) units for multiple APIs e) Batch number and expiration date on every standard blister pack/foil strip; provided when product is not restricted to be dispensed in quantities less than the standard blister pack or foil strip, the batch

r lot number and expiry date – each unit

Center for Drug Regulation and Research 37

SLIDE 38

a) Product name b) Dosage Form and Strength c) Warning(s) d) Net Content e) Name and/or Logo of MAH

Center for Drug Regulation and Research 38

Primary Label of Small Containers

SLIDE 39

Primary Label of Small Containers

f) Rx Symbol g) Registration Number h) Batch and/or Lot Number i) Expiration date and Date of Manufacture

Center for Drug Regulation and Research 39

SLIDE 40

Package Insert

a) Product Name b) Dosage Form and Strength c) Pharmacologic Category d) Product Description e) Formulation/Composition f) Pharmacodynamics/kinetics g) Indication(s)

Center for Drug Regulation and Research 40

SLIDE 41

Package Insert

h) Dosage and Mode/Route of Administration i) Contraindication(s), Precaution(s), Warning(s) (if applicable) j) Pregnancy and Lactation (if applicable) k) Interactions

Center for Drug Regulation and Research 41

SLIDE 42

Package Insert

l) Undesirable Effects m)Overdose and Treatment n) Storage Condition(s)

) Dosage Forms and Packaging Available

(pack size) p) Instructions and Special Precautions for Handling and Disposal (if applicable)

Center for Drug Regulation and Research 42

SLIDE 43

Package Insert

q) Name and Address of Marketing Authorization Holder r) Name and Address of Manufacturer s) Caution Statement t) ADR Reporting Statement u) Registration Number

Center for Drug Regulation and Research 43

SLIDE 44

Package Insert

v) Date of First Authorization/Renewal

f Authorization

w)Date of Revision of Package Insert

Center for Drug Regulation and Research 44

SLIDE 45

Patient Information Leaflet

a) Product Name b) Strength of the Medicine c) Description of the Product d) What is in the Medicine? e) What is this Medicine used for? f) How much and how often should you use this Medicine?

Center for Drug Regulation and Research 45

SLIDE 46

Patient Information Leaflet

g) When should you not take this Medicine? h) Care that should be taken when taking this Medicine? i) Undesirable Effects j) What other medicine or food should be avoided whilst taking this Medicine?

Center for Drug Regulation and Research 46

SLIDE 47

Patient Information Leaflet

k) What should you do if you miss a dose? l) Signs and Symptoms of Overdosage m)What to do when you have taken more than the recommended dosage? n) How should you keep this Medicine?

) When should you consult your doctor?

Center for Drug Regulation and Research 47

SLIDE 48

Patient Information Leaflet

p) Name and address of MAH q) Name and address of Manufacturer r) ADR Reporting Statement s) Registration Number t) Date of First Authorization/Renewal u) Date of Revision of PIL

Center for Drug Regulation and Research 48

SLIDE 49

Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 49

VII. SPECIFIC

REQUIREMENTS

Revised Labeling Regulation

SLIDE 50

Product Name

1) Generic and brand name (if any) 2) Generic name – as active moiety based in INN, consistent with the dosage strength; prodrugs – INN of prodrug 3) Generic name shall appear prominently, enclosed in an outline box; prominence

ver other information as determined by

common visual sense

Center for Drug Regulation and Research 50

SLIDE 51

Product Name

4) Herbal and TM: Botanical origin or as recognized by FDA 5) Generic name shall appear above brand name; for narrative texts, the brand name shall be preceded by the generic name and shall be enclosed in parenthesis or brackets

Center for Drug Regulation and Research 51

SLIDE 52

Product Name

6) Multiple APIs - all APIs shall be indicated, in order of decreasing pharmacological activity; of more or less similar activity, in decreasing potency; provided that if single approved name for FDC, single approved name shall be used;

Center for Drug Regulation and Research 52

SLIDE 53

Product Name

provided further if there is no single approved name but a generic class name exist, generic class name shall be used. The individual components shall be indicated under formulation

Center for Drug Regulation and Research 53

SLIDE 54

Product Name

6) Multiple APIs:

Center for Drug Regulation and Research 54

A B

SLIDE 55

Dosage Form and Strength

1) Label shall specify: a) Dosage form (tablet vs capsule) b) Special delivery system (sustained- release vs. extended-release) c) Specific mode of administration (vaginal

vs. rectal) if any and appropriate are

required d) No qualifier for tablets – oral, uncoated, IR tablet

Center for Drug Regulation and Research 55

SLIDE 56

Dosage Form and Strength

2) dosage strength - expressed in metric units reduced to lowest terms and in the number of the largest unit specified (e.g. 500mcg, not 0.5mg) 3) strength of certain dosage forms to be expressed as percentage

Center for Drug Regulation and Research 56

SLIDE 57

Dosage Form and Strength

4) For multiple APIs: dosage strength of each API shall be stated in accordance with the arrangement of the APIs, separated by a slash sign (/); provided, that if a single approved INN

f the combination drug is used, the

dosage strength shall be indicated as the whole

Center for Drug Regulation and Research 57

SLIDE 58

Dosage Form and Strength

Center for Drug Regulation and Research 58

SLIDE 59

Pharmacologic Category

As determined by FDA

Center for Drug Regulation and Research 59

SLIDE 60

Formulation/Composition

1) Name and strength of all APIs present per unit dose of product in generic names, arranged in decreasing potency 2) Name of API shall be stated in full (including its salt or hydrate form, if any), and correlated with active moiety when applicable; shall be in accordance with INN

r FDA approved name; for herbal/TM – in

accordance with PP or FDA approved name

Center for Drug Regulation and Research 60

SLIDE 61

Formulation/Composition

3) reference monograph finished product shall be indicated, unless non-official; for multiple API, it shall be indicated after the first API

Center for Drug Regulation and Research 61

SLIDE 62

Formulation/Composition

Center for Drug Regulation and Research 62

SLIDE 63

Formulation/Composition

4) Alcohol must be expressed as percentage; alcohol without qualification - ethanol 5) Excipients that may cause hypersensitivity shall be indicated, and/or other adverse reactions shall also be indicated, with the amount expressed in the same manner as the API 6) Preservative/antimicrobial agents shall be indicated, with the amount expressed in the same manner as the API

Center for Drug Regulation and Research 63

SLIDE 64

Indication

Only FDA approved clinical use

Center for Drug Regulation and Research 64

SLIDE 65

Dosage and Mode of Administration

1) Recommended dosage, where applicable: a) Initial/loading dose b) Optimal use or usual dose c) Frequency interval d) Duration of treatment e) Dosage adjustment

Center for Drug Regulation and Research 65

SLIDE 66

Dosage and Mode of Administration

2) Dilution/reconstitution/preparation instructions in all labeling materials; description of the reconstituted preparation; description of reconstituted solution is also required 3) Dosage for special populations, adults and children; if not for children, “adult dose” or any statement to that effect

Center for Drug Regulation and Research 66

SLIDE 67

Contraindication(s), Precaution(s), Warning(s)

1) Full information on contraindication, as well as the precautions to be

bserved

2) Special warnings should be included as required and specified by FDA 3) For products are to be used on one

ccasion only, “single use only”, “single

dose”

Center for Drug Regulation and Research 67

SLIDE 68

Interactions

1) Drug-Drug 2) Drug-Food 3) Drug-Laboratory test 4) Other relevant

Center for Drug Regulation and Research 68

SLIDE 69

Undesirable Effects

Shall include known ADE/ADRs for the drug product

Center for Drug Regulation and Research 69

SLIDE 70

Overdose and Treatment

1) Signs and Symptoms of Overdose 2) Treatment for overdose

Center for Drug Regulation and Research 70

SLIDE 71

Storage Condition

1) Appropriate storage conditions and special instructions for handling (e.g. cold chain) 2) Special labelling instructions:

Center for Drug Regulation and Research 71

SLIDE 72

Net Content/Pack Size

1) Unit carton – pack size expressed in terms

f the number of units or the volume of

each unit; for reconstitution products, the reconstituted volume

Center for Drug Regulation and Research 72

10 Blister Packs x 10 Tablets 12 Sachets x 5g 60mL 12 vials x 5mL 100 Tablets

SLIDE 73

Net Content/Pack Size

2) Primary label (except blisters and foil strips) – net content stating the total amount/quantity of dosage form in a given container

Center for Drug Regulation and Research 73

100 Tablets 5g 60mL 5mL

SLIDE 74

MAH

Name and address of MAH

Center for Drug Regulation and Research 74

Market Authorization Holder: Pavenus Ltd Mother Ignacia cor. Sgt. Esguerra St., Diliman Quezon City

SLIDE 75

Manufacturer

Name and specific manufacturing site address of manufacturer below the MAH

Center for Drug Regulation and Research 75

Market Authorization Holder: Pavenus Ltd Mother Ignacia cor. Sgt. Esguerra St., Diliman Quezon City Manufacturer: Will Del Una Intl

Rm. 128, 1st Flr Main Building, Alabang, Muntinlupa

SLIDE 76

Rx Symbol and Caution Statement

1) Required for prescription products; allowed to be over-printed or superimposed 2) Caution Statement – unit carton, primary label except blister pack, foil strip, and small containers, and package insert:

Center for Drug Regulation and Research 76

SLIDE 77

Rx Symbol and Caution Statement

Foods, Drugs, Devices, and Cosmetics Act prohibits dispensing without prescription. For Dangerous drugs, additional caution statement as specified by PDEA

Center for Drug Regulation and Research 77

SLIDE 78

ADR Reporting Statement

1) For the unit carton and primary label (except blister pack, foil strip, and small containers) For suspected adverse drug reaction, report to the FDA: www.fda.gov.ph”

Center for Drug Regulation and Research 78

SLIDE 79

ADR Reporting Statement

2) For product information sheet, statement instructing the patient to seek medical attention immediately MAH may also include reporting statement for their own PV system

Center for Drug Regulation and Research 79

SLIDE 80

Registration Number

Registration number assigned by FDA

Center for Drug Regulation and Research 80

SLIDE 81

Batch and Lot Number

1) Batch number if marketed by one drug establishment 2) If divided into lots marketed by different establishments, lot and batch number

Center for Drug Regulation and Research 81

SLIDE 82

Expiration/Manufacturing Date

1) Month and year is required; if stated in numbers alone, year is stated completely; if day is specified, month is spelled out a) June 2007 b) 07/2007 c) 03 June 2007 or 03 Jun 2007

Center for Drug Regulation and Research 82

SLIDE 83

Expiration/Manufacturing Date

2) understood to be the last day of the month if no day specified 3) For reconstituted products or can be administered multiple times, the label shall include the period of guaranteed safety and efficacy after first opening at a given storage condition

Center for Drug Regulation and Research 83

SLIDE 84

Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 84

VIII. SPECIAL LABELLING

INSTRUCTIONS

Revised Labeling Regulation

SLIDE 85

Parenterals

1) All labeling materials: excipients and amounts - formulation 2) “intravenous”, “intramuscular” or “subcutaneous” 3) For concentrated solution – direction not to administer the solution undiluted and direction to dilute w/ specified diluent

Center for Drug Regulation and Research 85

SLIDE 86

Fluid Replacement and Dialysis Solution Products

1) follow standard formulations contained in official compendium, the nomenclature used in the official compendium shall be adopted as the generic class name; 2) Non-official solutions – FDA shall determine generic class name

Center for Drug Regulation and Research 86

SLIDE 87

Fluid Replacement and Dialysis Solution Products

3) directly below the generic class name but still inside the generic outline box – individual components w/ corresponding mEq/L or mmol/L enumerated in the

rder of decreasing pharmacologic

activity 4) amino acids and/or proteins - total amount

f nitrogen

5) Nominal osmolality and nominal pH range

Center for Drug Regulation and Research 87

SLIDE 88

For External Use

Rendered in all capital letters and red background or red font Ex.

Center for Drug Regulation and Research 88

SLIDE 89

Multivitamin/Mineral/Herbal Products with Standard Formulations and Non- vitamin/mineral/herbal Components

1) Generic class name - Multivitamins and Minerals for multi-vitamin and multi-mineral containing products 2) For multi-vitamin/mineral containing products with additional herbal ingredients (at least 3) – generic class name shall be herbs

Center for Drug Regulation and Research 89

SLIDE 90

Multivitamin/Mineral/Herbal Products with Standard Formulations and Non- vitamin/mineral/herbal Components

3) For multi-vitamin products with individual non-vitamin components (i.e. mineral or herbal ingredient), or multi-mineral products with individual non-mineral components (vitamin or herbal ingredient), the term “Multivitamins” or “Minerals” shall first be stated, followed by additional individual components

Center for Drug Regulation and Research 90

SLIDE 91

Multivitamin/Mineral/Herbal Products with Standard Formulations and Non- vitamin/mineral/herbal Components

Center for Drug Regulation and Research 91

SLIDE 92

Multivitamin/Mineral/Herbal Products with Standard Formulations and Non- vitamin/mineral/herbal Components

content of each vitamin present shall no longer be required to be indicated in the generic box, but shall appear in the Formulation

Center for Drug Regulation and Research 92

SLIDE 93

MDRP

On the label of the minimum pack for drugs listed under Section 1 of E.O. No. 821:

Center for Drug Regulation and Research 93

SLIDE 94

Unique Global Product Identification Number

The existing rules and regulations for GTIN shall be followed

Center for Drug Regulation and Research 94

SLIDE 95

Reproductive Health Products

PIL as product information Shall be writeen in English and Filipino, and/or local dialect

Center for Drug Regulation and Research 95

SLIDE 96

Generic Drug Products with Proven Interchangeability

This product has the same therapeutic efficacy as any other generic product

f the same name

This product has the same therepaeutic efficacy as the innovaor product of the same generic name

Center for Drug Regulation and Research 96

SLIDE 97

Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 97

EXEMPTIONS

Revised Labeling Regulation

SLIDE 98

Exemptions

1) Drug products manufactured for export; 2) Veterinary drug products; 3) The container or primary pack containing the product is enclosed in a transparent covering and the particulars which are required to be set on the label on the container or primary pack are clearly visible through transparent covering, the transparent covering is exempted; 4) Products that are compounded by a pharmacist in accordance with the individual prescription of a medical practitioner or dentist for immediate use;

Center for Drug Regulation and Research 98

SLIDE 99

Exemptions

5) Investigational drugs, i.e. new chemical or structural modification of a tried and tested or established drug proposed to be used for a specific therapeutic indication(s); 6) Foreign donated pharmaceutical products; 7) Products that require special handling (pre-filled syringes, cold chain); and 8) Low volume of importation

Center for Drug Regulation and Research 99

SLIDE 100

Exemptions

1) GLE application – submitted with registration application 2) Approval – GLE Certificate w/ validity and number 3) Registration Number shall be reflected on the label

Center for Drug Regulation and Research 100

SLIDE 101

Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 101

X. SANCTIONS

Revised Labeling Regulation

SLIDE 102

Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 102

XI. REPEALING AND

SEPARABILITY CLAUSE

Revised Labeling Regulation

SLIDE 103

Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 103

XII. TRANSITORY

PROVISIONS

Revised Labeling Regulation

SLIDE 104

Transitory Provisions

All registered pharmaceutical product shall be required to submit the revised labeling materials compliant with this Administrative Order upon renewal of their MA Reasonable exhaustion shall be given for products subject to renewal within 1 yr of approval of this AO

Center for Drug Regulation and Research 104

SLIDE 105

Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 105

XIII. EFFECTIVITY

Revised Labeling Regulation

SLIDE 106

Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 106

C. PROPOSALS

SLIDE 107

Proposals

Product name – placed in the larger panel Requirements for blisters/foil – a) retain the current reqt of expiry on per standard blister/foil strip b) Varying depending on the justification c) If susceptible for tingi-tingi, the expiration, batch and lot shall be per minimum number of units ot be dispensed

Center for Drug Regulation and Research 107

SLIDE 108

Proposals

ADR Reporting Statement – mandatory reporting to MAH as well Prominence of generic name a) Retain the current requirement except same font type b) Use of illustrative provision

Center for Drug Regulation and Research 108

SLIDE 109

Proposals

Prominence of Rx symbol a) Retain the current requirement b) Use of illustrative provision Low volume of importation a) 10,000 SKUs b) Minimum ordering quantity w/ justification

Center for Drug Regulation and Research 109

SLIDE 110

Republic of the Philippines Department of Health Food and Drug Administration

Center for Drug Regulation and Research 110

D. DISCUSSION

SLIDE 111