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Drug Distributor & Medical Devices Distributor Checklist (Philippines) Mobile App

The Drug Distributor and Medical Devices Distributor Requirements mobile app provides an electronic checklist of items required by those who distribute or manufacture controlled substances and medical devices. There are many different requirements that health care wholesale distributors and medical device manufacturers must follow in order to meet regulatory requirements for conducting clinical trials and distributing products. Using the easy to follow checklist helps ensure that companies have the right policies and procedures in place before they begin doing business.

Instead of using paper checklists to keep track of the important documents needed to meet regulatory requirements, medical device manufacturing companies, developers of medical disposables, prescription drug companies and others in the health care industry can maintain an electronic record of the requirements using any smartphone or tablet. The app covers general requirements, including the company's registration number, notarized financial statement and business name, along with other details regarding labeling requirements, building design, logistics provider contract agreements and other important policies and procedures details.

  • Lendlease
  • The Cooperative
  • PG&E
  • Red Bull
  • Mirvac

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Take a peek inside the Drug Distributor & Medical Devices Distributor Checklist (Philippines) Mobile App

Included Features

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Included Fields

Customize to add, remove, or edit any of the fields below.

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    Information as to activity of the establishment

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    Notarized Accomplished Petition Form / Joint Affidavit of Undertaking

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    Photocopy of Business Name Registration with DTI (if single proprietor); with SEC (if corporation...

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    ID Picture of the Owner / Gen.

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    Photocopy of Pharmacist’s Registration Board Certificate, PRC-ID, PTR and Certificate of Attendan...

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    Notarized valid Contract of Lease of the space/building occupied, if the applicant does not own it.

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    Location Plan / Site (size, location, immediate environment, type of building)

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    List of Products to be manufactured/distributed in Generic and Brand Names (therapeutic classific...

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    Number of personnel (technical and non-technical), the academic qualification and relevant experi...

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    Duties and responsibilities of the Pharmacist and other Technical Personnel

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    Notarized Financial Statement of Cosmetic and Medical Device Establishment

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    If importing raw materials and/or finished products add C 1 requirements

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    Distribution Record Book duly registered with BFAD

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    Reference Books:

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    1. USP/NF (latest edition)

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    R.

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    Remington’s Pharmaceutical Sciences(latested.

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    4. Goodman & Gilman Pharmaceutical Basis of Therapeutics

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    5. British Pharmacopoeia

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    6. PNDF

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    A.

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    Information Sheet

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    Floor Plan with complete dimensions and proper identification of areas with description

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    Organizational structure

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    List of Manufacturing / Quality Control equipment and facilities (per AO 56)

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    B.

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    Notarized valid Contract of Agreement with the manufacturer with stipulation that bothManufacture...

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    C.

  • ...and More!

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