A.O. No. 2014-0034 Flashcards
Rules and Regulations on the Licensing of Establishments
Engaged in the Manufacture, Conduct of Clinical Trial,
Distribution, Importation, Exportation, and Retailing of
Drug Products, and Issuance of Other Related
Authorizations
ADMINISTRATIVE ORDER
No. 2014 - 0031
Aproved date of ADMINISTRATIVE ORDER No. 2014 - 0031
Oct. 13, 2014
Objectives of A.O. No. 2014 - 0031
A. To establish rules and regulations in the licensing of drug establishments
B. To ensure compliance of establishments to FDA and international regulatory standards and requirements of the following: GMP, GDP, GSP, GCP
C. To prescribe the use and implementation of innovations, electronic data messages, electronic submission of documents and electronic signatures in the FDA
Scope of of A.O. No. 2014 - 0031
Establishments including LGU, government owned and controlled corporations, NGO, other government offices and instrumentalities engaged in the manufacture, distribution, importation, exportation, sale, offer for sale and transfer of drug product and Contract Research Organizations (CROs) and/or Sponsors
General Guidelines of A.O. No. 2014 - 0031
A. No drug establishment shall operate without an LTO
B. No CRO and/or Sponsor shall be involved in the conduct of clinical trial without a license from FDA.
C. Ensuring the safety, efficacy, quality and/or purity of drug product sold in its original packaging of which the seal has not been broken or tampered
D. Risk management plan
E. All drug distributors shall not sell directly to the general public, unless they have an L TO as a drugstore.
F. All licensed establishments must continuously comply with the existing requirements, regulations and standards.
G. Violations will result in the suspension, revocation or cancellation of
the LTO
H. Banned or withdrawn for health and safety reasons shall be refused admission.
I. All licensed establishments shall immediately recall, withdraw, seize, or ban from public sale or distribution or donation any drug product that is
declared to be imminently injurious, unsafe or dangerous
J. All entities, whether government or non-government, that regularly
procure drugs on wholesale basis from appropriate FDA duly licensed drug establishment for distribution to their constituents must be licensed as drug distributor.
K. All institutional pharmacies procuring drugs to be dispensed whether at a
cost or as part of employee’s benefits and/or its dependents must secure a
LTO.
L. All establishments engaged in retail, whether privately owned or
government-owned, shall be under the supervision of a registered
pharmacist when operating or open for business, except otherwise allowed
by other pertinent laws.
M. All licensed establishments engaged in the manufacture, distribution,
exportation, importation, selling, transportation/shipment of vaccines,
biologics and other temperature-sensitive drug products are hereby
directed to comply with the cold chain management requirements.
N. All infonnation, education and communication campaign material
promoting the safe and rational use of drugs shall be displayed in a
conspicuous area of the drugstore.
0. The FDA shajl have the authority to enter any establishment for (1)
inspection of compliance and/or (2) verification of submitted documents in
relation to any application for issuance of appropriate authorization.
P. All establishments shall abide with the guidelines of the FDA on electronic
submissions and processes of L TO applications into electronic format
pursuant to Republic Act No. 8792 or the “Electronic Commerce Act of
2000”
Q. All CROs, sponsors and other concerned entities shall adhere to existing
standards of safety, efficacy and ethical practice in the conduct of clinical
trials.
R. For hospital pharmacies, Administrative Order No. 2012-0012 or Rules
and Regulations Governing the New Classification of Hospitals and Other
Health Facilities in the Philippines shall apply until modified or repealed.
Page 5 of 13
S. All CROs and/or Sponsors shall be given ninety (90) days and for
government-owned offices a one (1) year transition period to comply from
the date of effectivity of this Administrative Order.
Involved in all operations in the production of drug products
Manufacturer
Repacks a finished drug product into smaller quantities in aseparate container and/or into secondary package
Drug Manufacturer-Repacker
Packages a bulk drug product into its immediate container
Drug Manufacturer-Packer
Registered owner of a drug product and the formulation and procures the raw materials and packing components
Drug Manufacturer-Trader
Drug Manufacturer, Drug Manufacturer-Packer, Drug Manufacturer-Repacker may respectively engage in subcontracting activity which is referred to as
contract manufacturing, contract packing and
contract repacking.
Exports raw materials, active ingredients and finished products for distribution to other drug establishments outside the country.
Drug Distributor-Exporter
Imports raw materials, active ingredients and/or finished
products for wholesale distribution to other local FDA-licensed drug establishment.
Drug Distributor-Importer
Procures raw materials, active ingredients and/or finished
products from a local FDA-licensed drug establishment for
local distribution on wholesale basis.
Drug Distributor-Wholesaler
Dispensed directly to the general public on a retail basis.
Drugstore/Pharmacy/Botica, hospital pharmacy and institutional pharmacy
Does botika ng Barangay and Institutional Pharmacies required to secura an LTO before operating?
Yes
