Adoption of WHO GDP and GSP Guides

General Objective: Official adoption and implementation of WHO Annex 5 (GDP) and Annex 9 (GSP) guides.
Specific Objectives:
- Use WHO guides as assessment standards for drug establishments and retailers.
- Ensure coordinated transition from previous guidelines to WHO standards.

Applies to the Food and Drug Administration (FDA), drug establishments, and retailers involved in pharmaceutical distribution and storage.

Authorization: FDA permission via permit, license, certificate, or similar documents for health product-related activities.
Distributor/Importer/Exporter: Establishments handling import/export of raw materials or finished products, selling to the public categorizes as retailer.
Distributor/Wholesaler: Local procurement and wholesale distribution establishments.
Drug: Articles recognized by official pharmacopoeias intended for diagnosis, treatment, prevention, or affecting bodily structure/function excluding devices.
Drug Establishment: Entities engaged in manufacture, importation, distribution, sale, or other health product activities per RA 9711.
Establishment: Any sole proprietorship, partnership, corporation, or similar entities involved in health product activities including facilities.
Good Distribution Practices (GDP): Quality assurance ensuring pharmaceutical product quality through controlled distribution.
Good Manufacturing Practice (GMP): Quality assurance ensuring consistent production and control of medicines as per standards.
Good Storage Practices (GSP): Quality assurance ensuring pharmaceutical quality through proper storage controls.
Retailer: Establishments selling health products directly to the general public.

Official adoption of WHO Annex 5 (GDP) and Annex 9 (GSP) guides to supplement existing laws such as A.O. 56 s. 1989.

Automatic adoption of future supplements and revisions to WHO GDP and GSP guides.
Accessibility: Guides will be published on the FDA website.
Inspection: Drug establishments and retailers will be inspected based on WHO GDP and GSP standards.
Revision of FDA forms/templates to align with WHO guides.
Capacity building: FDA and industry shall conduct training, workshops, and may form technical working groups for implementation.

One-year transition period from effectivity date for establishments to comply with the WHO GDP and GSP guides.

Existing administrative and legal sanctions apply to violations of this Order or related regulations.
Until amended, penalties for Good Distribution and Storage Practice violations remain applicable.

Any void or unenforceable provision by court decision will be deleted without affecting the remaining provisions.

Existing inconsistent administrative orders, circulars, and regulations are repealed or amended accordingly.

The order takes effect fifteen days after publication in a newspaper of national circulation and upon submission to the University of the Philippines Law Center.