Legislative changes to Sativex™ mouth spray

The Home Office has confirmed that from 10th April 2013, Sativex™ (cannabinoid mouth spray) will become a Schedule 4 Part I drug and its continued availability for use in healthcare will be enabled under the 2001 Regulations.

Specific regulatory requirements coming into force on 10th April 2013 include the following:

 

• Any person authorised by, or under the 2001 Regulations, to possess or destroy Sativex™ is required to keep records of the amounts of Sativex® possessed or destroyed from 10th April 2013.
• Records must be kept for a minimum of two years.
• Patients, their representatives, and persons listed in Regulation 6(7) of the 2001 Regulations are specifically exempted from the requirement to keep records.