Medicines which are not likely to present a danger either directly or indirectly if used without medical supervision, are not frequently used incorrectly, do not contain substances the activity and/or adverse reactions of which require further investigation, and can be suitably self-administered by patients, can be waived from being subject of medical prescription.
AccepTher assumes to act as a single contact point for its clients wishing to register their medicines for direct marketing to the patients.
Our experts experienced in OTC submissions and switches, do evaluate whether and how the non-prescription status can be obtained, prepare the supporting documentation. AccepTher also offers regulatory service for such submissions. Further, we support our clients to identify potential additional risks arising with the marketing without medical supervision, as well as preparation of the risk minimisation plan. The one-stop solution is completed with integration of services provided by our strategic partners evaluating the readability of the new labelling.