Policies on Over the Counter Drugs

General criteria for classification:
1. Drug must be time-tested with thorough investigation and extensive clinical use.
2. Active ingredients have proven safety and efficacy with a wide margin of safety and high therapeutic index.
3. Drug must not fall under bioequivalence problems or be listed as prohibited/controlled by Dangerous Drugs Board or International Narcotics Control Board.
Documentation required from manufacturer/importer includes:
1. Proof of safety and effectiveness under recommended conditions.
2. Active ingredient concentrations must be clinically safe and not exceed maximum limits for symptom relief.
3. Low and clinically insignificant worldwide adverse drug reactions.
4. Product must have been marketed internationally for at least 20 years and in the Philippines for at least 10 years.
5. Imported products must be classified as OTC in country of origin and marketed in at least two specified countries (Canada, UK, USA, Japan, Australia, Sweden).

Application for OTC classification is filed with BFAD.
BFAD Director refers application to Technical Advisory Committee for evaluation and recommendation.
Upon approval, applicant must comply with current standards for OTC reclassification.
Certificate of Product Registration issued upon compliance with registration standards.
Pharmaceutically equivalent products classified similarly (OTC or prescription).

Secretary of Health, through BFAD Director, may recall or withdraw OTC classification.
Grounds include documented adverse reactions threatening public health or reclassification as internationally controlled drug by INCB.
Registered manufacturer, trader, or importer must be given due notice before revocation.

All prior orders, rules, regulations inconsistent with these provisions are repealed or modified accordingly.

The order takes effect 15 days after publication in two newspapers of general circulation.