WHO Drug Information 2021, vol. 35, 1 [‎‎‎‎‎‎‎‎full issue]‎

The declarations of the members to the Scheme were modified, they now need to declare their commitment of implementing the WHO guideline related to the Scheme, the WHO Model Certificate (WHO template), and to notify any change of the information submitted related to the certifying and/or requesting members (4.3). [...] The situation for using the CPP for a marketing Certificate of a authorization was modified including the information of the 10 pharmaceutical product marketing status of a product in the country of the certifying (CPP) authority (3.3 and 5.5). [...] A new point was inserted to fix the limits of the information within the scope of the Scheme to be provided by the 13 certifying authority: ¨Additional information is not within the scope of the Scheme. [...] A note was adjoined with As mentioned before, the Statement of Marketing the examples and Authorization Status was removed and is out of the scope of descriptions of the the Scheme. [...] Precision was included about the nature of the complaint and the origin of the defect: 7. Notifying and • the complaint is considered to be of a serious nature in investigating a quality 17 terms of risk by the latter authority; and defect • the defect, if it appeared after the delivery of the product into the importing country, is not attributable to local climatic or storage conditions (both 7.1