The QRD has its’ pro’s and con’s.
We all agree that the QRD helps a great deal in structuring the information which provided to the patient. However, it is not always easy for respondents in a readability testing situation to understand the standard (QRD) texts in relation to the text provided next to the unique text of that specific product. We’ve seen leaflets which for example provide information concerning pregnancy and breast-feeding where the product is uniquely intended for children. In such a case, the following recommendation by the Committee for Mutual Recognition and Decentralised Procedures – Human is helpful: “Headings and standard statements given in the template must be used whenever they are applicable. If the applicant needs to deviate from these headings/statements to accommodate medicine-specific requirements (e.g. for medicines administered by healthcare professionals, “take”/”use” could be replaced by “are given” or “are administered”), alternative or additional headings/statements will be considered on a case-by-case basis. When requested, applicants should justify the use of alternative headings (e.g. by reference to user testing results). For certain medicines not all items may be relevant, in this case the corresponding heading should not be included.”
We make sure that the definite text contains the QRD texts required without interrupting the understanding of the vital information.