Explanation of the Continued Validity of Section 12(1) of the Medicines Act of 1968
When we dispense medicines on an individual basis from our own premises, we do so using “start up materials” such as tinctures and dried herbs which are not considered “finished products” and thus do not need marketing authorisation as they are herbal ingredients we use to make up individualised prescriptions. What we give our patients is an individualised prescription, which is not placed “on the market” and thus does not require a marketing authorisation (medicines licence). In summary, individualised medicine, prepared in accordance with Section 12 (1) of the Medicines Act of 1968 is not subject to European Union (EU) Directive 2001/83/EC (the main European medicines legislation).
This clarification in no small part originated from the Governments response to the 1994 campaign, when for a time, it seemed that we were in danger of losing our right to access our medicines.
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