(2000; 31 pages)
4.4 Assessment of new strengths, formulations, doses, indications or combinations
Careful assessment is also necessary when it is proposed to make the medicinal product available without prescription in a new strength, in a new formulation, at a new dose, using a new route of administration, for a new age group or for a new indication, particularly if the indication has not previously been approved without a medical prescription. In addition to an assessment of the rationality of such a proposal, the safety and benefit/risk of a medicinal product in the new circumstances should be evaluated.
A medicinal product containing a new combination of two or more active substances, which are available in two separate products, neither of which is subject to a medical prescription, will not automatically be classified as a non-prescription product. The applicant needs to demonstrate that the combination offers an advantage over the separate active substances, and that the risk is acceptable.