Time to Simplify the Regulatory Framework for OTCs in Europe?

摘要

Over-the-counter medicinal products in the European Union are relatively harmless and this is exactly why they can be supplied without a prescription.OTC medicines are burdened, however, with regulatory requirements based on the risks posed by prescription-only medicines and they are trivialised by weak product claims.Under Directive 2001 / 83 /EC (as amended), companies applying for authorisation to market an OTC product must provide the same clinical data standards regarding efficacy for prescription-only substances, even though their products contain well-known substances that have longstanding tradition of use and low-risk profiles. They must also follow the same pharmacovigilance rules that govern prescription drugs.If OTC products are to continue to be marketed in the EU in a legally sound way with suitable OTC claims and on acceptable economic terms, there has to be a paradigm shift in medicinal product legislation.What we ask for are legally sound, long-term alternative regulations for OTC medicinal products. Marketing authorisation rules for OTC drugs should be differentiated from those for prescription medicines and should be less demanding.