These guidelines provide a rationale for recommendations of the Committee of Experts on the Classification of Medicines as Regards their Supply (CD-P-PH/PHO) on the classification of supply of active substances for human use.
They describe the assessment approach consisting of First level assessment, followed by Second level assessment if non-prescription status is considered.
First level assessment is based on evaluating the characteristics of the active substance(s), the pharmaceutical form and route of administration, and the therapeutic indication. Second level assessment includes evaluation of the use of the active substance for a given therapeutic indication in a non-prescription setting, assessment of the safety profile, the strength, posology and treatment duration, the needs of special populations, risk minimisation measures, available post-marketing data and the public health/socio-economic impact.
These guidelines provide examples illustrating different scenarios and may serve as guidance to marketing authorisation holders, national competent authorities or other interested parties in determining whether a medicinal product may be considered suitable for prescription or non-prescription status.