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Borderline and Classification Work Group – Introduction - TOPRA

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Currently under discussion<br />

• Nearing Completion?<br />

– Ear c<strong>and</strong>les<br />

– Eye drops<br />

– Glycerol / macrogol, polyethylene glycol containing products<br />

– Zinc oxide containing creams<br />

– Peritoneal dialysis solutions<br />

– Alcohol <strong>and</strong> alcohol free wipes<br />

– Agents for transport, nutrition <strong>and</strong> storage of organs intended for transplantation<br />

– Defibrillator electrodes<br />

• On Agenda<br />

– Bone anchored hearing aids<br />

– Ovules of lactobacillus<br />

– Simethicone<br />

• New to Agenda<br />

– Products containing triamcinolone acetonide <strong>and</strong> used in intravitreal injection for visualisation of ophthalmic<br />

tissues during a surgical procedure<br />

– Software<br />

– Haemostatic agents<br />

– Advanced Therapy Medicinal Products<br />

– Herbal products<br />

The Organisation for Professionals in Regulatory Affairs<br />

11

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