EMEA And Opportunities For Self-Medication

Although primarily and initially the new European Medicines Evaluation Agency drug approval system is intended for innovative prescription drugs and medicinal products, it can have relevance to the over-the-counter medicines sector, delegates at the recent European Proprietary Medicines Manufacturers' Association (AESGP) members' meeting in London were told.

EMEA director general Fernand Sauer explained the workings of the new system, as he did at two previous meetings (the inauguration of the agency at London's Canary Wharf and the subsequent EFPIA-Info meeting; Marketletter February 6), and he noted that the trend in OTC medicines seems to be convergence rather than harmonization. He also urged that the AESGP, which has always been active in responding to European Commission directives, should continue to be involved.

A point of particular interest to delegates was the legal status of medicines, ie Prescription or OTC, and switching, but Mr Sauer said that this would not be part of the agency's remit since legal status is not in the arbitration process for binding opinions. This point was reinforced by European Commission Member Marie Donnelly, who additionally pointed out that the system is intended to facilitate harmonization, not to impose it. She also stressed in a question session that since science has no national boundaries, using scientific criteria should mean that products are accepted on a scientific basis.