Day 3.MHRA Policy Collapses on Paragraph 14, pg 3. Thoughts Please

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westcoast2

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Apr 5, 2009
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Also posted at UK Vapers.

I posted this earlier on the thread it might be worth rereading --> http://www.mhra.gov.uk/home/groups/c.../con007544.pdf

This is the MHRA document on Borderline Medicinal Products.

Definition
17. Article 1 of Directive 2001/83/EC as amended defines a “medicinal product” as:
(a) “Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; [“the first limb”]
(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis” [“the second limb”]
For e-cig purposes (a) "the first limb" may not apply depending on claims possibly?.
(b) is where I believe the MHRA difinition comes from.

This is subject ot intepretation. The issue may revolve around the intepretation of 'with a view to'. Does this mean intention? What is the 'intention' associated with the e-cig? This is all very legal and for any non-legal person reading it, it is easily misinterpreted.

Medicinal products may well fall under both limbs of the definition but the European Court of Justice (“ECJ”) has confirmed that falling under either limb is sufficient to classify a product as a medicinal product. [Upjohn 1989 C-112/89]: “Directive 65/65 (now Directive 2001/83) provides two definitions of the term “medicinal product”: one relating to presentation, the other to function. A product is medicinal if it falls within either of those definitions.”
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