The GCC Guidance for Presenting the SPC, PIL and Labeling ...

IV. Summary of Product Characteristics (SPC)During the evaluation process, applicants may present SPCs for different strengths in onedocument, clearly indicating with grey-shaded titles the strength or presentation to whichalternative text elements refer. However, a separate SPC per strength and per pharmaceuticalform, containing all pack-sizes related to the strength and pharmaceutical form concerned willhave to be provided by the applicant.Bracketing convention:{text}: Information to be filled in.: Text to be selected or deleted as appropriate.1. Name of the medicinal productThe name should be followed by both the strength and the pharmaceutical form.{(Invented) name strength pharmaceutical form}2. Qualitative and quantitative composition− Full details of the qualitative and quantitative composition in terms of the activesubstance(s) and excipients.− A standard statement should be included at the end of the section, i.e. ‘For a full list ofexcipients, see section 6.1.3. Pharmaceutical form− Full description of the pharmaceutical form should be provided.− It is recommended that a visual description of the appearance of the product (color,markings, etc.) is given, including information on pH and osmolarity as required e.g.:‘Tablet White, circular flat bevelled-edge tablets marked ‘100’ on one side’.Page 19 of 52