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MHRA to Classify Some GCPs as Medicines

Posted 06 September 2018 | By Zachary Brennan 

MHRA to Classify Some GCPs as Medicines

After reviewing the level at which glucosamine containing products (GCPs) have a pharmacological effect on the body and evaluating why people use GCPs, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) intends to regard GCPs, with a level of base glucosamine equal to or greater than 1178mg/day, as medicines.

The decision follows a Court of Appeal Judgment in 2016 which began the review of the classification of GCPs, which are widely available as supplements used for joint health.

“This is based both on the evidence of pharmacological effect and because it is clear, from our review, that most people use GCP for a medicinal purpose,” MHRA said. “It should be noted GCPs containing less than 1178 mg/day of glucosamine will continue to be widely available as food supplements. The public can expect to continue to be able to use these products.”

As far as the determination, MHRA said it was made by weighing up a number of evidenced-based factors in the light of the definition of a medicinal product contained in legislation and relevant European Court of Justice and domestic Court precedents.

MHRA said it is now working with individual companies, trade bodies and other stakeholders to make sure all are fully aware of the impact of this decision.

Categories: Regulatory News

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