ao 2016-008

Rationale (Legal Basis)

Article III, Section 7 of the 1987 Philippine Constitution recognizes the right of the people to information on matters of public concern, including health and health products.

Rationale (Primary Source)

Labels and labeling materials serve as the primary sources of information for consumers regarding the safe, effective use and quality of a drug.

Rationale (Regulatory Need)

The FDA identified gaps in regulations due to globalization and ASEAN harmonization, creating a need for transparent, clear regulatory guidelines.

Objective of A.O. 2016-0008

To rationalize existing rules on generic labeling requirements of drug products, making them consistent with the harmonized requirements of ASEAN Member States.

Scope of A.O. 2016-0008

Applies to all manufacturers and distributors (exporters, importers, wholesalers) of drug products for human use, including herbal medicines and traditionally-used herbal products.

Language Requirements

All mandatory labeling information must be written in English and/or Filipino.

Visual Readability Requirements

Text must be readable with normal vision without straining, factoring in compliant color contrast, position, and spacing of printed matter.

Package Insert (PI) Scope

Mandatory for New Chemical Entities (NCEs), biological products, and prescription generic or herbal medicines; intended for healthcare professionals.

Patient Information Leaflet (PIL) Scope

Mandatory for household remedies, over-the-counter (OTC) drugs, herbal medicines, and traditionally-used herbal products; written in layman's language.

Exemptions for PI or PIL

Information may be printed directly on the reverse side or inner panel of the outer carton if the product is sold/dispensed together with that carton.

Primary Label Requirement

For products sold without any product information sheet (PI/PIL) or unit carton, the minimum mandatory information must be reflected directly on the primary label.

Minimum Mandatory Info (Product & Clinical)

Product Name, Dosage Form & Strength, Pharmacologic Category, Formulation or Composition, Indication(s), Dosage and Mode of Administration.

Minimum Mandatory Info (Safety & Risks)

Contraindication(s), Precaution(s), Warning(s), Interactions, Adverse Drug Reaction(s), Overdose and Treatment.

Minimum Mandatory Info (Logistics & Supply)

Storage Condition(s), Net Content or Pack Size, Name/Address of MAH, Name/Address of Manufacturer, Registration Number.

Minimum Mandatory Info (Traceability & Expiry)

Batch Number, Lot Number, Expiration Date, and Date of Manufacture.

Minimum Mandatory Info (Prescription & Safety)

For prescription drugs: the Rx Symbol and Caution Statement, along with an ADR Reporting Statement.

Product Name Components

The product name must explicitly indicate both the generic name and the brand name (if any) of the drug product.

Generic Name Basis

Must be based on the active moiety according to the International Non-proprietary Name (INN) and be consistent with the indicated dosage strength.

Prodrug Generic Naming

The generic name must be the INN of the prodrug itself, not its active chemical metabolite form.

Generic Name Prominence

The generic name must appear prominently within an outline box, ensuring its prominence over other information is clearly readable by normal vision.