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Ireland Reviewing Codeine's OTC Status

 
• By Tom Gallen

Ireland’s drug regulator HPRA has initiated a formal regulatory procedure to determine if OTC remains the appropriate classification for codeine-containing products. The agency says the move is in response to a growing understanding of the potential impacts of addiction to codeine at low doses.

hyotographics/Shutterstock.com
• Source: Shutterstock

Ireland’s Health Products Regulatory Authority is reviewing the OTC availability of codeine in response to concerns over addiction to the drug at low doses.

The agency has initiated a formal regulatory classification procedure under Article 74 of Directive 2001/83/EC, as amended, of all OTC products containing codeine. Article 74 states, “When new facts are...

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