EU Regulatory News Round Up: NSAIDs During Pregnancy, Estragole Excipients, ePIs
CMDh receives applications to change how NSAIDs are recommended for use during pregnancy; HMPC warns against use of estragole-containing excipients in herbals; EMA adopts new EU common standard for electronic product information on medicines marketed within the region.
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EU regulators have published the first electronic product information (ePI) documents under their pilot initiative to allow the transition to an electronic information system for medicines approved at both national and EU level.
The European Medicines Agency’s Committee on Herbal Medicinal Products (HMPC) says the EU herbal monograph for bitter fennel oil “cannot be supported anymore” because of new data on the genotoxicity and carcinogenicity of estragole.
Commitments to environmentally sustainable production processes and recyclable packaging for OTC products are increasingly important to UK consumers, according to a recent PAGB survey. Consumers would also like more information about how products should be recycled and are open to the idea of electronic product information.