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    Regulations for packaging and leaflet content of traditional medicines

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    Last update dateSunday 03 January 2016

    Food and Drug Organization

    Division of Pharmaceutical and Narcotic Affairs

    Title: Regulation for packaging and leaflet content of traditional medicines

    Type:             ü   Finalized

                              Draft

    No.:

    Date of Issue:

    Document No. : NM-RU-57-01

    Name of Office:    Natural Medicines and supplements

    Islamic Republic of Iran

    Ministry of Health and Medical Education

    Deputy of Food and Drug

    Pharmaceutical and narcotic affairs division

    Document Number

    NM-RU-57-01

    Document Title

    Regulations for packaging and leaflet content of traditional medicines

     

    Covering Page

    Regulations of patient information leaflet content of Traditional Medicine Product

    1) The phrase “Iranian Traditional Medicine”

    2) Product’s name

    3) Packaging (number of units, weight or volume per package)

    4) Name of ingredients

    5) Indication

    6) Dose and mode of administration

    7) Contraindications, adverse reactions and cautions

    8) Storage condition

    9) Manufacturer’s name and address

    10) Related References of traditional medicine used for preparation of the brochure

    Regulations of package content of Traditional Medicine Product

    1) The phrase “Iranian Traditional Medicine”

    2) Product’s name

    3) Number of units, weight or volume per package

    4) Name of ingrediants

    5) Storage condition

    6) Manufacturer’s name and address

    7) Production and expiry dates

    8) License number of traditional medicine product

    9) Price

    Regulations of Label content of Traditional Medicine Product

    If the product  introduce without leaflet or package:

    It is necessary to mention all items of leaflet except number 10. In addition, price, production and expiry dates, and License number of traditional medicine product must be mentioned on the label or package.

    If the product has a leaflet:

    It is necessary to mention all the box content on the label.

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