Diapharm advises and supports clients in planning, crafting a strategic approach and implementing Rx-to-OTC switches – whether for individual stages or throughout the entire process.
A switch from prescription to non-prescription status provides pharmaceutical manufacturers with the opportunity to market prescription-only medicinal products as OTC products, which no longer require a prescription. Strategically switching a product from Rx to OTC opens up new possibilities when it comes to market positioning.
The authorities are generally open to switch requests if it is possible to prove that the active pharmaceutical ingredients (API) meet the necessary requirements for medicinal product safety in the OTC segment.
Diapharm advises clients in the strategic planning of a switch, handles the project management and provides support in all stages of the application and implementation process.
Among other things, we evaluate suitable APIs, package sizes and the wording of indications, taking safety concerns into account. We review and assess existing documents with regard to the switch guideline’s requirements and in due consideration of the medical/clinical assessment and medicinal product safety.
Using this as a basis, we prepare the necessary arguments and documents to ensure a persuasive switch request – from the clinical/medical assessment, literature research and pharmacovigilance to compiling expert opinions and positions from key opinion leaders.
The comprehensive assistance we provide for switch projects also includes applying for and conducting a scientific advice meeting for the switch request – whether alone or accompanying our clients.
With the exception of the centralised procedure, switching medicinal products from prescription to non-prescription status is regulated at the national level. Currently, there is no harmonised set of rules for evaluating switches, which means that changing a product’s marketability must be applied for individually in each country.
However, pharmaceutical manufacturers have the possibility to apply for reclassification across all EU member states through a centralised procedure involving a single request submitted to the European Medicines Agency (EMA). A key condition is centralised authorisation or the resubmission of a centralised authorisation request, which provides immediate access to the entire EU market. However, only a few pharmaceutical manufacturers so far have chosen this route, as a negative decision in the centralised procedure can negatively impact the remaining options for achieving national switches.
Compared to countries where Rx-OTC switches in part are possible with a simple type II variation, Germany takes a more involved approach to switches. In Germany, the APIs must be removed from prescription-only use under Section 48 of the German Medicinal Products Act (Arzneimittelgesetz, AMG), in conjunction with the German Ordinance on the Prescription of Medicinal Products (Arzneimittelverschreibungsverordnung, AMVV). This can be tied to certain conditions regarding package size, indications, dosage, etc.
Once an Rx-to-OTC switch request has been submitted to the German Federal Institute for Drugs and Medical Devices (BfArM), the authorities then review it for completeness and prepare an opinion that is passed on to the Expert Advisory Committee for Prescription-Only Issues. The Expert Advisory Committee drafts a recommendation that is conveyed to the German Federal Ministry of Health. Then, as part of a multistage process in which the Bundesrat and the German Federal Ministry of Health must agree, lawmakers decide whether to issue an ordinance for amending the AMVV, with subsequent publication in the German Federal Law Gazette (Bundesgesetzblatt).