WHO Prequalification Team - Medicines (PQT/MED) has issued an updated version of its guidance on the recommended style to be used for visual description of oral dosage forms in WHOPARs. The guidance offers detailed advice on the description of the product to be used in WHOPAR Part 3 (Section 6) and WHOPAR Part 4 (Section 3), in order to ensure consistency and improve readability for the intended audiences.
Updated guidance on plain language descriptions of visual appearance for oral dosage forms in WHOPARs
This updated second version now also provides recommendations on how to describe multi-layer tablets and advice on describing the position of stamped or printed marks relative to a break line.
The guidance continues our ongoing commitment to ensure that all parts of the WHOPAR are as clearly written as possible, and to apply principles of readability shared with other stringent regulators. By updating it, PQT/MED aims to further support applicants for prequalification and improve transparency. We therefore welcome feedback on the document, which can be sent to Mr Wondiyfraw Worku (zelekew@who.int )