The GCC Guidance for Presenting the SPC, PIL and Labeling ...
The GCC Guidance for Presenting the SPC, PIL and Labeling ...
The GCC Guidance for Presenting the SPC, PIL and Labeling ...
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II. <strong>Labeling</strong><strong>The</strong> data should be presented according to <strong>the</strong> template below, irrespectively of <strong>the</strong>ir sequenceon <strong>the</strong> actual labeling <strong>and</strong> <strong>the</strong>ir position <strong>and</strong> possible repetition on <strong>the</strong> individual sides/flaps of<strong>the</strong> packaging (e.g. top flap, front, back etc.).A separate text <strong>for</strong> outer <strong>and</strong> inner packaging labeling should be completed per strength <strong>and</strong> perpharmaceutical <strong>for</strong>m.Bracketing convention:{text}:In<strong>for</strong>mation to be filled in.:Text to be selected or deleted as appropriate.1. Particulars to appear on <strong>the</strong> a. Name of <strong>the</strong> medicinal product{(Invented) name strength pharmaceutical <strong>for</strong>m}{Active substance(s)}• Note: <strong>The</strong> invented (trade) name in Arabic language should be added.b. Statement of active substance(s)Expressed qualitatively <strong>and</strong> quantitatively per dosage unit or according to <strong>the</strong> <strong>for</strong>m ofadministration <strong>for</strong> a given volume or weight. Where <strong>the</strong> active substance is present asa salt, this should be clearly indicated.c. List of excipientsExpress qualitatively those excipients known to have a recognised action or effect.However, if <strong>the</strong> medicinal product is a parenteral, a topical or an eye preparation or ifused <strong>for</strong> inhalation, all excipients must be stated.Page 5 of 52
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