Administrative-Order-No.-2016-0008

Active Moiety

The molecule or ion responsible for the physiological or pharmacological action of a drug substance, excluding appended portions of the molecule.

Active Pharmaceutical Ingredient (API)

A substance or compound intended to be used as a therapeutically active compound in the manufacture of a pharmaceutical product.

Adverse Drug Reaction (ADR)

A noxious and unintended response to a medicine that occurs at doses normally used in humans.

Batch

A defined quantity of starting material, packaging material, or product that is manufactured in a single or series of processes and is expected to be homogeneous.

Batch Number

A distinctive combination of numbers and/or letters that specifically identifies a batch on labels, batch records, and certificates of analysis.

Biological Product

Any product of biological origin, prepared with biological processes, derived from human blood and plasma, or manufactured by biotechnology. Examples include vaccines, blood products, and products of genetic engineering.

Brand Name

The proprietary name assigned to a product by the Marketing Authorization Holder.

Contraindication

A statement regarding the conditions in which the use of a drug product may cause harm to the patient.1. Date of Manufacture:The date (month and year) when the processing of the bulk product is completed.

Dosage

The quantity of medicine given per administration.

Dosage Form

The type of drug product (e.g. tablet, capsule, solution, cream) that contains a drug substance.

Dosage Strength

The concentration or potency of the active ingredient in a given formulation.

Drug Product or Drug

Any article recognized in official pharmacopoeias or intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals.

Excipient

An ingredient intentionally added to a drug substance that does not have pharmacological properties.

Expiration Date

The date placed on the label of a drug product indicating the time before which the product is expected to remain within approved shelf life specifications.1. Guarantee:A promise that the product will remain within approved specifications and is suitable for use.

Formulation

The name, strength, and reference monograph of all active pharmaceutical ingredients (APIs) and/or excipients present in the drug product.

Generic Class Name

The identification of a drug product containing three or more APIs by its scientifically and internationally recognized name or by its official generic name as determined by FDA.

Generic Name

The identification of a drug product by its scientifically and internationally recognized API or by its official generic name as determined by FDA.

Indication

The FDA-approved clinical use of a drug product based on substantial, scientifically supported evidence of its safety and efficacy in the given dosage form.

Investigational Product

A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.

Label

The written, printed, or graphic matter on any drug product, its immediate container, tag, literature, or other suitable material affixed thereto for the purpose of giving information as to the identity, components, ingredients, attributes, directions for use, specifications, and such other information as may be required by law or regulation.

Labeling Materials

The label on the immediate container and other printed materials that are made available with the drug product at the time of purchase or when the product is used, such as outer wrapper cartons and package inserts/leaflets, which provide accurate and necessary detailed information for the identification and proper use of the product.

Lot Number

Any distinctive combination of letters and/or numbers assigned to a particular lot, defined as a portion of a batch.

Manufacturer

An establishment engaged in all operations involved in the production of health products, including the final release of the finished product, with the intention of storage, sale, or distribution. Excludes compounding and filling of prescriptions in drugstores and hospital pharmacies.

Marketing Authorization (MA)

An official document issued by the competent drug regulatory authority (DRA) for the purpose of marketing or free distribution of a product after evaluation for safety, efficacy, and quality. Contains information such as the name of the product, pharmaceutical dosage form, quantitative formula, shelf-life and storage conditions, packaging characteristics, and approved product information for health professionals and the public.1. Marketing Authorization (MA):The official approval granted by the regulatory authority for a drug product to be marketed.

Certificate of Product Registration (CPR)

The specific form of Marketing Authorization in the Philippines.

Marketing Authorization Holder (MAH)

The company or entity responsible for all aspects of a drug product, including quality and compliance with the conditions of the MA.

Mode of Administration

The manner and site where the drug product is introduced into or applied on the body.

Net Content

The total amount or quantity of the drug product in a certain container, expressed in the metric system.

New Chemical Entity (NCE)

A new chemical or biological active pharmaceutical ingredient (API) that has not been previously authorized for marketing in the country.

Over-the-Counter (OTC) Drugs

Drug products that can be dispensed without a written order from a licensed physician or dentist.

Pack Size

The quantity of the drug product in the final packaging, excluding the shipping carton.

Package Insert (PI)

The document supplied with prescription drug products by the MAH, containing information for healthcare professionals.

Patient Information Leaflet (PIL)

The document supplied with non-prescription drug products by the MAH, containing information for patients in layman's language.

Pharmacologic Category

The classification of the drug product based on its therapeutic action.

Precautions

The special care and instructions required for the safe and effective use of the drug product.

Prescription Drug Products

Drug products that can only be dispensed with a written order or prescription from a licensed physician or dentist.

Primary Label

The label on the primary packaging material of a drug product.

Prodrug

A drug substance that is inactive in its intended pharmacological actions and needs to be converted into the active agent.

Product Name

The registered name of the drug product, including the generic name and brand name if applicable.

Product Description

The complete organoleptic description of the finished drug product.

Registration Number

The unique combination of letters and/or numbers assigned by the regulatory authority as proof of registration.

Small Containers

Drug packaging materials with a volume or weight of less than or equal to 5 mL or 5 g, including ampoules, vials, and tubes.

Storage Conditions

The specified temperature range, humidity, and other environmental factors required for optimal stability of the drug product.

Summary of Product Characteristics (SPC)

The approved product information provided by the regulatory authority, serving as a source of information for healthcare professionals and consumers.

Warnings

Statements regarding potential hazards, undesirable effects, and limitations of use associated with the drug product.

Dosage Form and Strength

The specific form and concentration of the drug product.

Formulation/Composition

The ingredients and composition of the drug product.

Indication(s)

The approved uses or conditions for which the drug product is intended.1. Labeling requirements:The regulations and guidelines that must be followed when creating product labels.

PI

Package Insert - A document that provides important information about a drug or product, including dosage instructions, side effects, and contraindications.

NCEs

New Chemical Entities - Newly developed drugs that have not been previously approved by regulatory authorities.

SPC

Summary of Product Characteristics - A document that provides detailed information about a drug, including its composition, indications, dosage, and contraindications.

PIL

Patient Information Leaflet - A document that provides information to patients about a drug or product, including its uses, side effects, and precautions.

Over-the-counter drug

Medications that can be purchased without a prescription.

Herbal medicines

Medicines made from plants or plant extracts that are used for medicinal purposes.

Traditionally-used herbal products

Herbal products that have been used for medicinal purposes for a long time and have a history of traditional use.

MA

Marketing Authorization - The approval granted by regulatory authorities to market and sell a drug or product.

Generic name

The non-proprietary name of a drug or product, usually based on its active ingredient.

Brand name

The proprietary name or trademark under which a drug or product is marketed.

Active moiety

The active component of a drug that is responsible for its therapeutic effect.

INN

International Non-proprietary Name - The official generic name assigned to a drug by the World Health Organization.

Prodrug

A biologically inactive compound that is converted into an active drug in the body.

Metabolite

A substance produced during the metabolism of a drug or other compound in the body.

Botanical origin

The plant species from which a herbal medicine or product is derived.

APIs

Active Pharmaceutical Ingredients - The active components of a drug that produce its therapeutic effect.

Potency

The strength or effectiveness of a drug or product.

Dosage form

The physical form in which a drug or product is presented, such as tablet, capsule, or ointment.

Delivery system

The method or technology used to deliver a drug to the body, such as modified release.

Mode of administration

The route or method by which a drug is administered to the body, such as oral or vaginal.

Qualifier

Additional information or specification about a dosage form, such as coated or immediate release.

Dosage strength

The amount of active ingredient(s) present in a specific dosage form.

Metric units

Units of measurement based on the metric system, such as milligrams (mg) or micrograms (mcg).

Percentage

A measurement expressed as a proportion of 100, often used to indicate the concentration of a substance in a product.

Formulation

The specific combination and composition of ingredients in a drug or product.

Contraindications

Factors or conditions that make a particular treatment or medication unsafe or unsuitable for a patient.1. Piperacillin Tazobactam:A brand name for a combination antibiotic medication used for intravenous injection.

Pharmacologic Category

The category of a drug determined by the FDA based on therapeutic standards.

Formulation/Composition

The ingredients and strength of the active pharmaceutical ingredients (APIs) in a drug product.

Generic Name

The non-proprietary name of an API, stated in full and correlated to the active moiety.

Reference Monograph

The official pharmacopoeial monograph used for the analysis of a finished drug product.

Sodium Ascorbate

An API used in a tablet formulation, equivalent to Ascorbic Acid (Vitamin C).

Calcium Carbonate

An API used in a tablet formulation, providing elemental Calcium.

Amoxicillin

An API used in a capsule formulation, as Amoxicillin Trihydrate.

Omeprazole

An API used in a vial formulation, as Omeprazole Sodium.

Sulfamethoxazole

An API used in a tablet formulation.

Trimethoprim

An API used in a tablet formulation.

Alcohol

When present in a product, it should be indicated, expressed as a percentage (%).

Coloring, Antimicrobial, Antioxidant Agents, and Preservatives

Ingredients used in the manufacture of a product that may cause hypersensitivity or adverse drug reactions.

Indication(s)

The FDA-approved clinical use(s) of a drug product.

Dosage and Mode of Administration

Information on the recommended dosage, frequency, duration, and other aspects of drug therapy.

Dilution, Reconstitution, Preparation, and Administration

Instructions for diluting, reconstituting, preparing, and administering a drug product.

Special Populations

Separate directions for use by special populations, adults, and children.

Contraindication(s)

Information on the contraindications of a drug product.

Precaution(s)

Information on the precautions to be observed in the administration and use of a drug product.

Warning(s)

Required warning statements specified by the FDA.

Single Use Only

A statement indicating that the contents of a container are for one-time use only.

Interactions

Information on drug-drug, drug-food, and drug-laboratory testing interactions.1. Adverse Drug Reaction(s):Detailed information on the negative effects of a drug product, organized by system organ class.

Overdose and Treatment

Signs and symptoms of taking too much of a drug, as well as possible treatment.

Storage Condition(s)

Instructions for how to store and handle the drug product.

Pack Size or Net Content

The quantity or volume of the drug product in a given container.

Name and Address of Marketing Authorization Holder

The name and full address of the organization responsible for marketing the drug product.

Name and Address of Manufacturer

The name and full address of the specific manufacturing site of the drug product.