QuestionsQuestions (DOH ADMINISTRATIVE ORDER NO. 172, S. 2004)
It is issued pursuant to Sections 3(a) and (b) and 26(a) of R.A. 3720 (Food, Drug and Cosmetic Act), as amended by Sections 4 and 19 of E.O. 175.
The Department of Health through its Bureau of Food and Drugs (BFAD).
It applies to all herbal medicines except (1) items not within the Order’s definition of herbal medicines (then governed by general drug regulations), and (2) fresh plant material or herbal preparations that have undergone only essential drying, packaging, and storage with no further processing.
It refers to fresh or dried aerial or underground parts of plants (leaves, flowers, fruits, seeds, stems, wood, bark, roots, rhizomes, etc.), entire/fragmented/powdered, including juices, gums, fatty oils, essential oils, and other plant-derived substances to be used as-is or for further processing (e.g., for galenicals or dosage forms).
Herbal medicines are finished, labeled medicinal products containing plant parts/plant material as active ingredients (crude state or plant preparations), with therapeutic claims and intended use affecting diagnosis/alleviation/cure/treatment/promotion of health or modifying body structure/function in humans or animals. Drug preparations combining plant material with chemically defined therapeutically active substances (including isolated constituents used in conventional/western medicines) are not considered herbal medicines under the Order.
No person shall manufacture, import, export, distribute, sell, offer for sale, advertise, or transfer any herbal medicines that are not registered with BFAD.
Only establishments for herbal medicines with a valid license to operate may apply for registration; they may be manufacturer, trader, importer, or distributor.
It ensures proposed brand names do not resemble or conflict with previously registered BFAD brand names for other products (food, drugs/devices, cosmetics, household hazardous substances). It is required when applicable, and it precedes the filing of the registration application.
No. Imported herbal medicines will not be issued brand name clearance if the proposed brand name is identical or similar to any brand name registered with BFAD.
Examples include: (1) notarized letter of application and duly accomplished Form No. 8; (2) Certificate of Brand Name Clearance (when applicable); (3) notarized certificate of agreement among manufacturer/trader/importer/distributor; (4) list of all active plant materials and inactive ingredients with amounts per unit dose in metric system; (5) certification of authenticity of plant specimen from the Philippine National Museum or BFAD-recognized taxonomist (or consular-authenticated proof for imports); (6) physical description/tests/quality standards; (7) certificate of analysis of submitted samples; (8) full report on methods/facilities/quality control; (9) complete quality control procedures; (10) stability studies; (11) labeling requirements; and (12) sufficient samples for BFAD analysis.
Local: certification from the Philippine National Museum or a BFAD-recognized taxonomist. Imported: certification from the authorized government agency in the country of origin, authenticated by the Philippine Consulate.
Labels must meet format/language legibility rules and include mandatory information such as official name and brand name, dosage form and strength, therapeutic claim/pharmacologic category, manufacturer/trader/distributor/importer name and address, net content, Rx symbol if applicable, formulation, indications, contraindications/precautions/warnings where applicable, mode of administration/directions, batch/lot number, date of manufacture and expiry, BFAD registration number, storage conditions, and the formulation details (scientific name with common/local name and plant part(s), amounts in metric system, and alcohol content percentage if applicable).
Examples include LD50/no-adverse effect level and toxidrome; pharmacologic effects in animals (in vivo and in vitro); bioassay when applicable; non-mutagenicity (Ames and Micronucleus tests); and, depending on duration of use, sub-chronic (90 days) and chronic toxicity tests (rodents for specified durations). For galenicals, Phase I clinical trial; for pharmaceutical dosage forms, Phases I, II, and III clinical trials.
If there is a valid BFAD report of adverse drug reaction for the plant material; if there is a valid report of abuse or dependence potential; or if it contains chemically defined therapeutically active substances (including isolated plant constituents) used in conventional/western medicine.
A CPP issued by the competent health authority in the country of origin and authenticated by the Philippine Consulate is required. Also, no product may be registered unless it is freely sold in the country of origin; if not freely sold where manufactured, two CPPs are needed (one from the manufacturing country and one from a country where it is freely sold).
Initial (1 year): generic Php 2,000; branded Php 3,000. Renewal (5 years): generic Php 7,500; branded Php 10,000. (The Order also notes initial registration may be for 2–5 years with corresponding fees; renewal starts on the date of expiration of the CPR.)
BFAD’s Product Services Division evaluates documents. Quality conformance of samples with BFAD standards is verified by the Laboratory Services Division or any BFAD-accredited laboratory. BFAD then issues final approval or denial based on evaluation results.
It takes effect fifteen (15) days after publication in two newspapers of general circulation.