Question & AnswerQ&A (DOH ADMINISTRATIVE ORDER NO. 172, S. 2004)
The guidelines are based on Sections 3(a) and (b) and 26(a) of Republic Act No. 3720 (Food, Drug and Cosmetic Act), amended by Sections 4 and 19 of Executive Order No. 175.
The Department of Health through its Bureau of Food and Drugs (BFAD) is responsible for enforcing the registration of herbal medicines.
Herbal medicines are finished, labeled medicinal products containing active ingredients from plant materials, with specific therapeutic claims and intended for diagnosis, treatment, or health promotion in humans or animals. Products containing chemically defined therapeutically active substances from plants used in conventional medicine are not considered herbal medicines.
No, herbal preparations that are fresh plant materials which have undergone only drying, packaging, or storage are exempt from this regulation.
Only establishments with a valid license to operate, including manufacturers, traders, importers, or distributors, may apply for registration.
No, it is prohibited to manufacture, import, export, distribute, sell, offer for sale, advertise, or transfer any herbal medicines that are not registered with BFAD.
Required documents include a notarized letter of application with Form No. 8, certificate of brand name clearance, a notarized certificate of agreement among involved parties, list of active and inactive ingredients with quantities, certificate of authenticity of plant materials, product description and quality tests, certificate of analysis, manufacturing process details, quality control procedures, stability studies, labeling materials, samples for laboratory testing, and evidence of safety and efficacy.
Standards include identity verification through herbarium specimens, tests for extraneous matter, pharmacopoeial compliance or specific tests (e.g. organoleptic, ash content, heavy metals, microbial limits), identification tests like TLC profile, and bioassays, as detailed in Annex A.
Labels must have the official name and brand name, dosage form and strength, therapeutic claims, manufacturer or distributor details, net content, RX symbol for prescriptions, formulation, indications, contraindications, directions, batch/lot numbers, manufacturing and expiration dates, registration number, storage conditions, and legal dispensing notices among other specifics in both English or Filipino.
Manufacturing, importing, exporting, distributing, selling, or advertising unregistered herbal medicines are prohibited acts. Sanctions under Republic Act No. 3720 and Executive Order No. 175 apply.
Initial registration fees for one year: Php 2,000 for generic and Php 3,000 for branded. Renewal registration fees for five years: Php 7,500 for generic and Php 10,000 for branded products.
They must be freely sold in the country of origin, and submit a Certificate of Pharmaceutical Product authenticated by the Philippine Consulate. If not freely sold in the country of manufacture, additional CPP from a country where they are freely sold is required.
Evidence includes acute toxicity data (LD50), pharmacologic effects in animals, bioassays, mutagenicity testing, sub-chronic and chronic toxicity tests, and clinical trials (Phase I for galenicals, Phases I-III for pharmaceutical dosage forms).
The regulation takes effect fifteen (15) days after publication in two newspapers of general circulation.