[Self-medication: Is regulation needed...from whom?].
The participants attending the 1999 French Clinical Pharmacological meeting in Giens eventually reached a consensus about the necessity to set up a clear policy regarding self-medication products in France. Despite a wish by French people to take more responsibility for their own health care, self-medication products' use and development in France have been held back for many years for the reasons reported below. However, self-medication could be developed while respecting or even improving public health care by applying the following key principles: (1) the acknowledgement of a consensual definition. 'A self-medication drug is a drug (the guarantees for which are provided by marketing authorization approval and dispensation and advice of a pharmacist) specifically suitable for use without any physician's prescription'; (2) the advertising of self-medication products to the general public is authorized; (3) the safe use of self-medication products is linked to the selected indications and the relevance of the information provided to the general public; (4) the self-medication drug approval procedure could be simplified, managed by a specific AFSSAPS unit; (5) the role of the pharmacist involved, as well as suitable pharmacovigilance, is mentioned; (6) more than 1000 previously marketed drugs without any clear status, the so called 'grey zone drugs', should be taken into consideration. According to the participants at the meeting, it is possible to set up a new clear and dynamic policy for self-medication products in France in conformity with EU requirements.
Caulin
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Service de Médecine Interne A, Hôpital Lariboisière, Paris, France.
Cranz
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D005602:France; D007880:Legislation, Drug / Q000639:trends; D011057:Politics; D012651:Self Medication / Q000639:trends*