Scribd Logo
Upload

Welcome to Scribd!

  • 43 views

    ADS 312 Additional Help Document: GH/OHA/SCMS "Restricted Commodity" Approval of Pharmaceuticals

    Uploaded by

    BrunoRibeiro
    This document provides guidance on the restricted commodity approval process for pharmaceuticals procured by USAID. It outlines that while source-origin waivers are no longer required for pharmaceuticals, restricted commodity approval under ADS 312 is still needed. It describes the approval process and categories of pharmaceuticals, including those that already have approval and those that require additional quality information to be submitted. The goal of the process is to ensure sufficient information is available on the quality of pharmaceuticals from specific manufacturers.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    ADS 312 Additional Help Document: GH/OHA/SCMS "Restricted Commodity" Approval of Pharmaceuticals

    Uploaded by

    BrunoRibeiro
    43 views7 pages
    This document provides guidance on the restricted commodity approval process for pharmaceuticals procured by USAID. It outlines that while source-origin waivers are no longer required for pharmaceuticals, restricted commodity approval under ADS 312 is still needed. It describes the approval process and categories of pharmaceuticals, including those that already have approval and those that require additional quality information to be submitted. The goal of the process is to ensure sufficient information is available on the quality of pharmaceuticals from specific manufacturers.

    Original Description:

    ffycvhtgf

    Original Title

    vghcfgctyf

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    This document provides guidance on the restricted commodity approval process for pharmaceuticals procured by USAID. It outlines that while source-origin waivers are no longer required for pharmaceuticals, restricted commodity approval under ADS 312 is still needed. It describes the approval process and categories of pharmaceuticals, including those that already have approval and those that require additional quality information to be submitted. The goal of the process is to ensure sufficient information is available on the quality of pharmaceuticals from specific manufacturers.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    43 views7 pages

    ADS 312 Additional Help Document: GH/OHA/SCMS "Restricted Commodity" Approval of Pharmaceuticals

    Uploaded by

    BrunoRibeiro
    This document provides guidance on the restricted commodity approval process for pharmaceuticals procured by USAID. It outlines that while source-origin waivers are no longer required for pharmaceuticals, restricted commodity approval under ADS 312 is still needed. It describes the approval process and categories of pharmaceuticals, including those that already have approval and those that require additional quality information to be submitted. The goal of the process is to ensure sufficient information is available on the quality of pharmaceuticals from specific manufacturers.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 7

    ADS

    312 Additional Help Document



    GH/OHA/SCMS Restricted Commodity Approval
    of Pharmaceuticals

    We have written this in an attempt to help USAID partners and USAID technical and
    procurement offices understand the restricted commodity approval process for
    pharmaceuticals. We hope that you find it helpful and welcome your feedback.

    We encourage you to contact us as you begin to consider procuring pharmaceuticals.

    I. Background
    On February 22, 2011, the Administrator approved:

    1. A sourceorigin waiver for all USAIDfinanced pharmaceuticals purchased
    through December 31, 2016.

    2. Changes to ADS 312.5.3c which, among other things, removed the requirements
    that nonU.S. pharmaceuticals may only be purchased if the pharmaceutical is either (i) not
    available from the US or (ii) the delivered price from the United States would be at least 50
    percent more expensive and for justifying why the pharmaceuticals are essential for the
    activity.

    Therefore, while you no longer need a sourceorigin waiver for pharmaceuticals you still
    need a restricted commodity approval under ADS 312.5.3c. This help document explains in
    greater detail the restricted commodity approval process for pharmaceuticals.

    II. Scope and Applicability


    1. Under ADS 312.5.3c ,Pharmaceuticals, noncontraceptive pharmaceuticals are a
    restricted commodity and require prior approval from OHA/SCMS. This restricted
    commodity approval does not apply to contraceptive pharmaceuticals which are approved
    under ADS 312.5.3d. This restricted commodity approval is different from the source
    origin requirements in ADS 310.

    2. The Director of GH/HIDN or designee(s) must provide concurrence on
    procurements of pharmaceuticals for the following programs: malaria, tuberculosis,
    neglected tropical diseases, emerging pandemic threats, and maternal and child health.
    Many of the pharmaceuticals, including diagnostic test kits that are required for these
    programs, have unique properties, require additional evidence on efficacy, and have

    specific quality requirements in addition to the standard pharmaceutical quality


    requirements. OHA/SCMS obtains GH/HIDN concurrence as part of the OHA/SCMS
    approval process.

    3. The Pharmaceutical Advisor in DCHA/OFDA approves OFDA pharmaceuticals
    under a delegation from OHA/SCMS.

    4. With the changes to ADS312, OHA/SCMS no longer processes pharmaceutical
    approvals under the Expedited Acquisition and Assistance Procedures for USAIDs
    Activities and Programs related to the Prevention, Care, and Treatment of HIV/AIDS.

    III. Purpose of OHA/SCMS Approval Process


    1. The purpose of the pharmaceutical approval process is to determine if there is
    sufficient information on file with USAID or available to USAID on the quality of a
    pharmaceutical from a specific manufacturer at a specific manufacturing site, or from a
    specific procurement agent or other source. A change in the manufacturer, manufacturing
    site [even from the same manufacturer], or procurement agent or other source requires a
    new approval.

    2. The focus of this process is on the quality of the drug at the point of manufacture,
    not on reviewing the means of transporting, storing, or distributing the pharmaceutical and
    the adequacy of distributors and other intermediaries in the supply chain. Shipment,
    storage and distribution through responsible distributors and other intermediaries can
    affect the quality of the pharmaceutical but these processes are part of the larger issues in
    supply chain management of any pharmaceutical procurement effort and are not part of
    the ADS 312 approval process.

    IV. Types of Pharmaceuticals


    There are different requirements for different categories of pharmaceuticals. Certain
    pharmaceuticals already have a restricted commodity approval and do not require any
    further OHA/SCMS approval. Others do not require additional information on the quality
    of the pharmaceutical for OHA/SCMS approval due to USAID experience and accessibility to
    other information already on file or available to OHA/SCMS.

    A. OHA/SCMS Approved Pharmaceuticals


    The following pharmaceuticals have ADS 312 approval and do not require further
    OHA/SCMS approval:

    1. Antiretrovirals (ARVs) on the PEPFAR and USAID Consolidated List of


    Approved ARVs. USAID policy is to limit procurement of ARVs for clinical use to
    those on the Consolidated List. Please refer to:
    http://www.usaid.gov/our_work/global_health/aids/TechAreas/treatment/scms.h
    tml.

    2. HIV/AIDS Rapid Test Kits on the USAID List of Approved HIV/AIDS Rapid
    Test Kits. USAID policy is to limit procurement of rapid test kits for clinical use to
    those on the USAID List. Please refer to:
    http://www.usaid.gov/our_work/global_health/aids/TechAreas/treatment/scms.h
    tml.

    B. OHA/SCMS Approved Sources


    OHA/SCMS approval is required for pharmaceuticals in the following three categories.
    However, because of USAID experience and other information already on file or available to
    USAID, as a general rule, you will not have to submit additional information on the quality
    of the pharmaceutical from these sources.

    1. Category 1: U.S. Food and Drug Administration (FDA) or a Stringent
    Regulatory Authority (SRA) Approved Manufacturers. OHA/SCMS recognizes as SRAs,
    national drug regulatory authorities of other countries that are comparable to the FDA in
    its standards and operations. For example, members or observers in the International
    Conference on Harmonization are considered SRAs. The current SRAs include:

    European Medicines Agency (EMEA);
    Health Canada (HCnda);
    Japanese Ministry of Health, Labor, and Welfare;
    Swiss Medic for the European Free Trade Area (EFTA); and
    European Union member states admitted prior to 1996.

    2. Category 2: UNICEF and World Health Organization (WHO) Approved
    Manufacturers. This category includes pharmaceuticals purchased from:

    UNICEF;
    A manufacturer inspected and approved by the WHO in compliance with
    Good Manufacturing Practices (GMP); and
    A pharmaceutical approved by the WHO Prequalification of Medicines
    Programme.

    3. Category 3: Approved Procurement Agents. OHA/SCMS has determined that
    the following procurement agents have in place adequate prequalification, quality
    assurance, and quality control systems for ensuring the quality of the pharmaceuticals that
    they purchase from their prequalified manufacturers:

    Action Medeor http://gb.medeor.org/Home
    Amstelfarma http://www.amstelfarma.nl
    Imres http://www.imres.nl/web/show/home
    International Dispensary Association Foundation (IDA) http://www.ida.nl/
    Medical Export Group (MEG) http://www.meg.nl

    Missionpharma http://www.missionpharma.com/.

    C. Category 4 Other Pharmaceuticals



    1. Category 4 Other Pharmaceuticals are pharmaceuticals that do not qualify
    under any of the above categories and require additional information on quality before
    they can be approved.

    2. Extraordinary Need. In exceptional circumstances, such as a natural disaster or
    an act of terrorism, it may be necessary to obtain pharmaceuticals immediately from local
    vendors. Most of these needs will be met by the USAID Office of Foreign Disaster
    Assistance (OFDA). Occasionally, however, other USAID operating units may have a need
    to procure pharmaceuticals for extraordinary need. On these occasions, OHA/SCMS may
    provide approval on an exceptional casebycase basis. Approval will be based on a risk
    benefit judgment considering available quality information for the pharmaceuticals,
    source(s) of the pharmaceuticals, previous performance of the vendor(s), and conditions
    present on the ground.

    V. Submitting a Request
    1. Template. Please use the template GH/OHA/SCMS ADS 312 "Restricted
    Commodity" Approval for Pharmaceuticals and include the following information:

    (1) Generic name
    (2) Strength
    (3) Dosage form
    (4) Approved OHA/SCMS source (as applicable)
    (5) Specific manufacturer, and city and country of specific manufacturer (as
    applicable.) *

    *Note: This information is not required if purchasing from an approved procurement agent.

    You can find the template on the USAID public website at:
    http://www.usaid.gov/our_work/global_health/aids/TechAreas/treatment/scms.html.

    2. Additional Information on quality. For Category 4 Other Pharmaceuticals
    you will also need to submit information on the quality of the pharmaceutical. Please
    contact OHA/SCMS before you submit the information to discuss what you may need to
    provide. For example, OHA/SCMS may require quality testing by a recognized laboratory
    as part of the approval.


    3. Please email your template and any information on quality to Mike Hope
    ([email protected]), Christine Malati ([email protected]), or Jan Miller
    ([email protected]) with a carbon copy (cc) to Quinn Cikaitoga ([email protected]).
    You can also fax your request to 2022163037.

    VI. Additional Information


    1. Express Authorization by U.S. Patent Holder. Under Section 606(c) of the
    Foreign Assistance Act of 1961, as amended (FAA), 22 USC 2356(c), USAID may not finance
    a pharmaceutical that is manufactured outside the United States if the pharmaceutical is
    covered by a valid U.S. patent, unless the U.S. patent owner expressly authorizes the
    manufacture of the pharmaceutical. Without such an express authorization, the
    pharmaceutical must be purchased from the U.S. patent holder. OHA/SCMS is available to
    assist with section 606(c) issues.

    2. Communicating OHA/SCMS Approval to Partners. Under the sourceorigin
    and restricted commodity award provisions (AIDAR clause 752.22570, Source, Origin,
    and Nationality Requirements for contracts and the standard provision "USAID Eligibility
    Rules for Goods and Services for assistance agreements), the Contracting
    Officer/Agreement Officer (CO/AO) is authorized to communicate the OHA/SCMS
    restricted commodity approval to the partner. The CO or AO may delegate this authority to
    the COTR and AOTR in a COTR or AOTR delegation letter or the contract or agreement.

    A sample letter for advance approval of pharmaceuticals is attached.

    3. Marking. The marking provisions of ADS 320 do not apply to the packaging of
    pharmaceuticals. ADS 320 otherwise applies to programs and activities utilizing
    pharmaceuticals. Missions and operating units can provide for the marking of
    pharmaceuticals as part of the marking and branding strategies and plans in ADS 320.

    Date:July5,2011

    Attachment: Sample Letter to Contractors/Recipients for Approval of


    Pharmaceuticals


    [Contractor or Recipient name and address]

    Subject: Pharmaceuticals Source/Origin/Nationality Waiver and ADS 312
    Approval

    Reference: [Award number and title]

    Dear:

    The purpose of this letter is to provide USAID waiver approval of source, origin, and
    nationality requirements for the purchase of pharmaceuticals and ADS 312 approval of
    noncontraceptive pharmaceuticals.

    Use this paragraph for contracts only:
    Advance approval is given under the AIDAR provision 752.22570, Source, Origin, and
    Nationality Requirements for the purchase of pharmaceuticals as set out below.

    Use this paragraph for assistance awards only:
    Advance approval is given under the source/origin or restricted commodity provisions of
    the Mandatory Standard Provisions for U.S., Nongovernmental Recipients "USAID Eligibility
    Rules for Goods and Services", in your grant/cooperative agreement for the purchase of
    pharmaceuticals as set out below.

    1. Source/Origin/Nationality Waiver for Pharmaceuticals. On February 22, 2011, the
    Administrator approved a source/origin/nationality waiver for all USAIDfinanced
    pharmaceuticals purchased through December 31, 2016. Accordingly, Geographic Code
    935 is established as the authorized source, origin, and nationality code for
    pharmaceuticals purchased through December 31, 2016. Code 935 includes all countries,
    except certain foreign policy restricted countries see 22 CFR 228 for further details on
    geographic codes.

    2. Restricted Commodity Approval of Pharmaceuticals.

    (a) AntiRetrovirals (ARVs). Advance approval is given for ARVs on the "USAID
    Consolidated List of Approved ARVs", are approved. The list can be found at
    http://www.usaid.gov/our_work/global_health/aids/TechAreas/treatment/scms.html.
    Procurement of ARVs must comply with the procedures in the AAPD when purchasing
    ARVs.

    (b) HIV/AIDS Rapid Test Kits. Advance approval is given for the test kits listed in
    the "USAID List of Approved HIV/AIDS Test Kits which can be found at
    http://www.usaid.gov/our_work/global_health/aids/TechAreas/treatment/scms.html.
    The authority for this approval is the HIV/AIDS and Infectious Disease Initiatives: Source
    and Origin Waiver for HIV/AIDS Diagnostic Materials (testing kits), as set forth in AAPD 07
    05 USAID List of Approved HIV/AIDS Test Kits. Contractors/recipients must comply
    with the procedures in the AAPD when purchasing test kits.

    (3) Other Pharmaceuticals. For noncontraceptive pharmaceuticals other than
    ARVs and HIV/AIDS rapid test kits, advance approval is given provided they are approved
    by the Office of HIV/AIDS/Supply Chain Management System (GH/OHA/SCMS). Further
    information and the procedures for OHA/SCMS approval are at
    http://www.usaid.gov/our_work/global_health/aids/TechAreas/treatment/scms.htmll.

    Documentation: Prime Select one: [contractors] [recipients] and CTOs, as applicable, are
    responsible for providing to the Select one: [Contracting Officer] [Agreement Officer]
    copies of all GH/OHA/SCMS approvals for Other Pharmaceuticals for inclusion in the
    Award file.

    OPTIONAL: Add language on any additional approvals by, or coordination with,
    AOTR/COTR or other conditions.

    Use this paragraph for contracts only
    Advance consent Select one: [is given] [is still required] for subcontracts solely for
    Approved ARVs, test kits, and/or pharmaceuticals in amounts in excess of the simplified
    acquisition threshold, under FAR clause 52.2442, Subcontracts.

    All approvals herein are provided with the understanding that: 1) sufficient funding exists
    in the award to cover the approved expenditures; 2) the approval does not increase the
    total estimated amount of the award; and 3) additional funding will not be required. All
    other terms and conditions of the award remain unchanged.

    Please do not hesitate to contact me with any questions...

    Sincerely,

    ______________________________
    [NameandtitleofCO/AOor,ifauthorized,
    COTR/AOTR]

    You might also like