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Muenster, North Rhine-Westfalia, Germany, 2010/03/10 - Dr Annemarie Jasper from the pharmaceutical service provider Diapharm maintains that European lawmakers are not differentiating between Rx and OTC and called for a legislatory paradigm shift during the DIA AnnualEuro Meeting.
Due to the undifferentiated regulations in the European market for over-the-counter (OTC) medicinal products, a paradigm shift in the legislation is overdue. This point was emphasised by Dr Annemarie Jasper, manager of business development services for the pharmaceutical service provider Diapharm during the DIA 22nd Annual EuroMeeting in Monaco. At the largest European symposium for the pharmaceutical sector, which was attended by more than 3,000 experts from private companies, public authorities and universities, Jasper criticised the constant growth in legal regulations that are valid not only for medicinal products requiring prescriptions, but also for non-prescription OTC products.
National procedures have been preferred until now in the OTC market
The expert demanded a general easing of restrictions for the authorisation of OTCs and so-called ’well-known substances‘. In her lecture at the session entitled “New Chances for well-known substances: CP or MRP/DCP” (Session 0608), she suggested an expansion of the THMP-directive (2004/24/EC) into a TMPD. She also stressed the differences in the management of regulations by the different EU countries. Because of these differences, manufacturers of OTC medicinal products very often use national authorisation procedures. “We are demanding that our political leaders create adequate incentives so that international procedures such as MRP and DCP can become more applicable for the OTC industry.”
Lawmakers are not differentiating between Rx and OTC
As a whole, the regulatory requirements for OTCs are overextended: “As long as lawmakers fail to distinguish between OTC and Rx medicinal products, the relatively harmless OTCs that do not require prescriptions are being burdened with disproportionate requirements and are all too often trivialized with product claims that are far too weak”, Jasper said. As a first sign of this change in perspective, she pointed to the 2004/24/EU directive for traditional herbal medicinal products. This allows phyto-pharmaceuticals to be registered under certain circumstances by using a simplified procedure. She asked that this procedure be established not only for herbals, but for well-known OTC substances in general. “Working towards this goal should be an urgent task for the pharmaceutical industry in Europe,” explains Dr Annemarie Jasper.
Diapharm (diapharm.com), which has offices in Germany, Great Britain and Romania, was also present at the symposium in Monaco with its own booth (no. 181-182). Diapharm is a full-service provider for the healthcare industry. Founded in 1988, Diapharm supports pharmaceutical companies in all questions concerning regulatory affairs, medical & clinical development, quality and business development.