Administrative Order No.2014-0034 || 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

I.    RATIONALE

Section 15, Article II of the 1987 Constitution declares it a policy of the State to protect and promote the right to health of the people and instill health consciousness among them. Section 11 of Article XIII further mandates the State to adopt an integrated and comprehensive approach to health development which shall endeavour to make essential goods, health and other social services available to all the people at affordable cost.

In implementing the abovementioned Constitutional policy, Republic Act No. 3720 created then the Bureau of Food and Drugs (BFAD) which was mandated to insure safe, effective, and good quality of foods, drugs, devices, and cosmetics. FDA was mandated to regulate and subsequent issuance of appropriate authorizations to establishments engaged in the manufacture, distribution, importation, exportation, and retailing of drug products, including the conduct, supervision, monitoring and auditing of research studies on health and safety issues on these products. Administrative Order No. 56 s. 1989, “Revised Regulations for the Licensing of Drug Establishments and Outlets”, was issued as guideline for the issuance of License to Operate (LTO) for these establishments.

From the creation of BFAD, other regulations were issued to strengthen its regulatory capacity and functions, thereby ensuring access to affordable, safe, effective, and quality medicines: Republic Act No. 9711, otherwise known as the “Food and Drug Administration (FDA) Act of 2009 and its Implementing Rules and Regulation, Republic Act No. 7394, otherwise known as the “Consumer Act of the Philippines”, and Republic Act No. 9502, otherwise known as the “Universally Accessible Cheaper and Quality Medicines Act of 2008. In addition, Republic Act No. 8792, otherwise known as “Electronic Commerce Act of 2000” was issued to facilitate domestic and international dealings, transactions, arrangements, agreements, contracts and exchanges, and storage of information through the utilization of electronic, optical and similar medium, mode, instrumentality and technology to recognize the authenticity and reliability of electronic documents related to such activities and to promote the universal use of electronic transaction in the government and general public.

 

 

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