PQTm acknowledges the advantages of carton-free supply of medicinal products that are presented in bottle packs and therefore support initiatives for carton free packaging being promoted by various stakeholders. Such presentations are acceptable to PQTm provided that the immediate container label (bottle label) contains all the product information that is required to be on the outer carton and immediate container labels.
In the interest of ensuring appropriate use and patient safety and since the state of scientific knowledge is evolving over time with new data becoming available, e.g. on new side effects and drug-drug interactions, it is regarded essential that every bottle dispensed to users/patients is accompanied by a patient information leaflet. Therefore, manufacturers, regulators and procurers are requested to ensure that every patient/user will have access to up-to-date product information when implementing the carton-free supply of products.
To this end, products that are not supplied with the required number of patient information leaflets shall not be regarded as prequalified, in principle.