OTC medicinal products: development and licensing

Diapharm develops new OTC medicinal products for healthcare and pharmaceutical companies. We also broker existing marketing authorisations and licences.

OTC products like non-prescription medicines, self-care medical devices and food supplements make an important contribution to health and well-being of European citizens. People want to take responsibility for their own health, and this, combined with demographic changes and the increasing cost of professional healthcare, means that more must be done to develop and support-self-care.

We support our clients with portfolio advisory services and help them develop and fine-tune their portfolio strategy. Developing new products – on our own initiative as well as on behalf of our clients – and coordinating the development of medicinal products from start to finish is one of our strengths. Our development service goes beyond medical and regulatory duties to include complete project management. From formulation development and choosing the right contract manufacturer to the subsequent communication with the authorities and market entry, we stand by our clients’ side.

Developing new OTC medicines

We develop innovative medicinal products for pharmaceutical companies from the screening of appropriate active pharmaceutical ingredients (APIs) to marketing authorisations – Rx and especially OTC medinies. The result is new products and licensing options on an international scale to expand and strengthen product portfolios in a targeted manner, either on behalf of our clients or as in-house Diapharm developments. We also provide planning for pre-clinical tests of efficacy and safety, as well as support throughout clinical development and the marketing authorisation process.

Rx-OTC switch

Switching a medicinal product from prescription-only (Rx) to over-the-counter (OTC) can be a worthwhile option, both for patients and manufacturers. However, the challenges associated with such switches should not be taken lightly. This is because authorities are often sceptical when it comes to Rx-to-OTC switches, and because the classification of an API and/or product as prescription-only or over-the-counter in Europe is still a completely national matter. This makes it challenging for globally operating companies to switch a product to OTC status throughout Europe. But today there are also examples of centralised Rx-to-OTC switches, such as Orlistat, Pantoprazole and Esomeprazole. The advantages of a centralised switch from prescription-only status are interesting and highly enticing, since it gives pharmaceutical companies immediate access to the entire EU market. Still, it is important to carefully consider which path to take for an Rx-to-OTC switch, as a negative decision on a centralised OTC switch means resolving a legal dispute regarding the amount of national freedom that ultimately remains. We advise medicinal product manufacturers in strategic planning and implementation so that their Rx-to-OTC switches succeed with flying colours.

Marketing authorisation and licence brokerage

Purchasing existing OTC licences, approved OTC marketing authorisations / registrations or ready-to-submit OTC dossiers offers medicinal product manufacturers an opportunity to enter the market quickly. Once the decision has been made to focus on a certain indication or API, we research nationally or internationally on behalf of our clients to find out which marketing authorisations and products are in development or are immediately available on the market. We find product options while also supporting you in brokering your own marketing authorisations – for in-licensing, co-marketing or purchase.