An OTC status, which allows the sale of the medicinal product without a prescription, can be applied for a medicinal product along with the marketing authorisation application. If the product already has a marketing authorisation, the OTC status cab be applied for by a national Type II variation application. The application must contain appropriate expert statements that justify why the preparation is efficient and safe as an OTC drug. The assessment makes use of a checklist that is based on an EU Commission guideline A Guideline on changing the classification for the supply of a medicinal product for human use (PDF).
For more information about the requirements and principles for approving a medicinal product as an OTC drug, see Fimea’s publication “Kansallinen itsehoitolääkeohjelma” (National OTC drug programme) (PDF, in Finnish). The requirements for an OTC drug are listed on pages 16–17. Pages 11–15 contain examples of medicines or groups of medicinal substances that have been grated or declined an OTC status in Finland. The national decision-making process is described on page 10.
If certain preconditions are met, an OTC status can be applied for via the centralised procedure (page 10 in the aforementioned document). In this case, the OTC status is granted simultaneously to all EU Member States and Iceland and Norway. Both the mutual recognition and decentralised procedure lead to a national marketing authorisation. In this case, the OTC status is decided nationally. If marketing authorisation is applied for a medicine intended as an OTC drug, the applicant should investigate in advance, how they can get the preparation directly approved as an OTC drug in all countries that participate in the application process. Otherwise, the medicine might become a prescription drug in some countries, with corresponding requirements for the SPC and package leaflet.
The simplest way to seek for an OTC status for a preparation is to first apply for a marketing authorisation as a prescription drug. After the marketing authorisations have been granted, submit a national Type II variation application in the countries that you think might approve it. Attach a suggested package leaflet for OTC packages to the application.
In Finland, a medicinal product can have package sizes that are authorised for marketing both as prescription and OTC products. In such a case, the prescription and OTC packages have different Vnr numbers. Moreover, the instructions require that packaging labels usually differ a little between the prescription and OTC package.