Question & AnswerQ&A (DOH ADMINISTRATIVE ORDER NO. 2013-0027)
The main purpose is the adoption and implementation of the World Health Organization Annex 5 Guide to Good Distribution Practices (GDP) for Pharmaceutical Products and Annex 9 Guide to Good Storage Practices (GSP) for Pharmaceuticals in the Philippines.
This Order applies to the Food and Drug Administration (FDA) and all drug establishments and retailers in the Philippines.
Authorization means permission granted by the FDA through a document such as a permit, license, certificate of registration, accreditation, compliance, or exemption to a natural or juridical person to manufacture, import, export, sell, distribute, transfer, test, promote, advertise, or sponsor health products.
A Distributor/Importer/Exporter imports or exports raw materials or finished products for its own use or wholesale distribution, and if selling to the general public, considered a retailer. A Distributor/Wholesaler procures raw materials or finished products locally for distribution on a wholesale basis only.
GDP is a part of quality assurance that ensures the quality of pharmaceutical products is maintained through adequate control during the entire distribution process.
Existing administrative and legal sanctions for violations of licensing of drug establishments, including retail outlets, and related regulations will be imposed. The existing penalties related to GDP and GSP violations remain in effect unless amended or superseded.
A one-year transition period from the effectivity date of the Order is given to establishments to comply with the WHO Annex 5 and Annex 9 guides.
GSP is the part of quality assurance that ensures the quality of pharmaceutical products is maintained through adequate control throughout storage.
Yes, all supplements and revisions related to these WHO guides shall be adopted automatically as stated in the Order.
The Order is supported by the 1987 Philippine Constitution, Article XIII Section 12, which mandates an effective food and drug regulatory system, and Republic Act No. 9711 (FDA Act of 2009), Section 3, which establishes the policy to maintain an effective health products regulatory system.