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Michael Faraday, in addition to his electromagnetic studies, played a part in devising zoetrope-like instruments that presented a series of still drawings to the eyes in rapid succession, demonstrating that at a critical rate these could be fused by the brain to create a sensation of motion. King said he had sent messages to his best friend telling him thatevil entities were planning to euthanize patients. This problem is exacerbated in the study of nutrition, obesity, and chronic disease because significant observations emerge from so many diverse disciplines. Indeed, the argument can be made that, to fully understand obesity alone, researchers should have a working familiarity with the literature in clinical treatment of obesity in humans, body-weight regulation in animals, mammalian reproduction, endocrinology, metabolism, anthropology, exercise physiology, and perhaps human psychology, not to mention having a critical understanding and familiarity with the nuances of clinical trials and observational epidemiology. Most researchers and clinicians barely have time to read the journals in their own subspecialty or sub-sub-specialty, let alone the dozens of significant journals that cover the other disciplines involved. This is a primary reason why the relevant science is plagued with misconceptions propagated about some of the most basic notions. Researchers will be suitably scientific and critical when addressing the limitations of their own experiments, and then will cite something as gospel because thats what they were taught in medical school, however many years earlier, or because they read it inThe New England Journal of Medicine. Speculations, assumptions, and erroneous interpretations of the evidence then become truth by virtue of constant repetition. It is my belief that whenall the evidence is taken into account, rather than just a prejudicial subset, the picture that emerges will be more revealing of the underlying reality. 137forensic all-stars: Wecht and Kaufmann,A Question of Murder, p. 286.

License to Operate

Pharmacy

For a company to be able to import, distribute, market, advertise or manufacture their products here in the Philippines, they must first secure a License to Operate (LTO) as Importer/Distributor/Wholesaler, for products imported from different countries, or as Manufacturer, for locally manufactured products. After obtaining an LTO companies may then proceed to apply for a Certificate of Product Registration (CPR), which states that the product has been evaluated and officially registered with the Philippine FDA.

Establishments under industries requiring a License to Operate as manufacturer, importer, distributor, wholesaler, or exporter:

• Food
• Drugs
• Cosmetics
• Household Hazards
• Veterinary Products
• Medical Devices (to be submitted to the Department Of Health – Center for Device, Regulation, Radiation Health and Research)

_

Requirements:

• Accomplished and duly notarized Petition Form and Joint Affidavit of Undertaking;
• List of products to be distributed, identified by generic names and brand names intended for use;
• Copies of Pharmacist Board Registration Certificate, PRC ID, valid PTR, ID picture, and Duties and Responsibilities;
• Certificate of Attendance of owner or pharmacist to an FDA seminar on Licensing of Drug Establishments;
• Certificate of Registration with SEC and Articles of Incorporation/Partnership (for corporations or partnerships);
• Certificate of Business Name Registration with DTI (for single proprietorships);
• Locational plan and floor plan (office and storage room) with dimensions; and
• Contract of lease for the space to be occupied.

If Importer

• Foreign Agency Agreement (FAA) from each supplier, duly authenticated by the Territorial Philippine Consulate
• Certificate of Registration of manufacturer and its conformity with the Good Manufacturing Practices From Health Authority authenticated by the Philippine Consulate

If Wholesaler

• Valid current contract with FDA licensed supplier/manufacturer
• Certificate of product registration from FDA
• Copy of LTO from supplier/manufacturer

If Exporter

• Valid current contract with FDA licensed supplier/manufacturer
• Certificate of product registration from FDA
• Copy of LTO from supplier/manufacturer

Requirements for verification during inspection:

• Reference materials:
– Philippine National Drug Formulary (latest edition)
– R.A. 3720: Foods, Drugs, Devices & Cosmetics Act
– R.A. 6675: Generics Act of 1988 and Relevant Implementing Rules and Regulations
– R.A. 5921: Pharmacy Law as amended and Relevant Implementing Rules and Regulations
– Latest edition of United State Pharmacopoeia/National Formulary (USP/NF), or Remington’s Pharmaceutical Sciences, or Goodman & Gilman’s The Pharmacological Basis of Therapeutics
• Batch Distribution Record Book

_

Procedure:

• Submit application requirements to FDA;
• Proceed with interview with the Food and Drug Registration Office (FDRO);
• Review of completion of requirements and application by the Licensing Department;
• Receive Order for Payment and complete application;
• Request for schedule of inspection;
• Physical inspection of office and facility by the FDRO;
• Approval of the LTO by the Director; and
• Release of documents to applicant.

Metro Manila Head Office

Address: 12F Sagittarius Building,
111, H.V. Dela Costa Street Salcedo Village, Makati City 1227
Tel: +63 (02) 5519012
+63 905 313 0064
Fax: +63 2 551 8052
Email: info@tripleiconsulting.com
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