QuestionsQuestions (DOH ADMINISTRATIVE ORDER NO. 2013-0027)
It adopts and implements the WHO Annex 5 Guide to Good Distribution Practices (GDP) for pharmaceutical products and the WHO Annex 9 Guide to Good Storage Practices (GSP) for pharmaceuticals in the Philippines.
The WHO Annex 5 GDP and Annex 9 GSP guides are adopted as standards to maintain pharmaceutical quality through proper control during distribution and storage activities.
It cites the 1987 Constitution (Sec. 12, Art. XIII) on an effective food and drug regulatory system, and RA 9711 (FDA Act of 2009), Sec. 3, on protecting and promoting the right to health and maintaining an effective health products regulatory system.
To officially adopt and implement the WHO Annex 5 GDP and WHO Annex 9 GSP guides, attached as Annex A and Annex B, respectively.
To use the WHO GDP and GSP guides as the standard in assessing compliance of drug establishments and retailers, and to have a coordinated transition from previous guidelines.
It applies to the FDA and to drug establishments and retailers.
GDP is that part of quality assurance ensuring pharmaceutical product quality is maintained through adequate control across the numerous activities during the distribution process.
GSP is that part of quality assurance ensuring pharmaceutical product quality is maintained through adequate control during storage.
Inspections shall use the WHO GDP and GSP guides as the standard for assessing Good Distribution and Good Storage Practices.
All supplements and revisions related to the WHO Annex 5 GDP and Annex 9 GSP are adopted automatically.
Establishments are given one year to comply with the WHO GDP and GSP guides, starting from the effectivity date of the Order.
Existing administrative and legal sanctions for violations of provisions of the Order or related regulations on licensing of drug establishments (including retail outlets) shall be imposed, and existing penalties for violations of Good Distribution and Storage Practice remain in full force unless later amended or superseded.
If any provision is declared void or unenforceable by a competent court, that provision is deemed deleted, but the rest remains effective.
All provisions of existing administrative orders, circulars, regulations, and other issuances inconsistent with the Order are repealed or amended accordingly.
After fifteen (15) days following its publication in a newspaper of national circulation and upon submission to the University of the Philippines Law Center.
The adopted guides shall be made accessible at the FDA website.
They shall provide trainings and workshops and may create technical working groups to ensure effective implementation of the WHO GDP and GSP guides.
It states that the WHO Annex 5 GDP and Annex 9 GSP serve as standards to supplement A.O. 56 s. 1989 and other related RA issuances.
A retailer is any establishment that sells or offers to sell any health product directly to the general public; this definition helps determine which outlets are covered by inspections and compliance standards.