Essentials of European Medical Device Regulatory Affairs

ASA – Examples of cases taken

B continued, "FLEXISEQ is not a pharmaceutical FLEXISEQ is registered as a medical device. FLEXISEQ does not contain any pharmaceutically active ingredients and this means it doesn't contain any drugs that might interact with medication you may be taking for your pain or any other ailment."

The Organisationfor Professionals inRegulatory Affairs

Pro Bono Bio Complaint received by ASA

• The complainant, a GP who believed that if the product did relieve joint pain by absorption of 'Sequessome' vesicles through the skin into the joint then it must contain a drug, challenged whether the claims "Drug Free" in ad (a) and "doesn't contain any drugs" in ad (b) were misleading and could be substantiated

• What are your thoughts ?

https://www.asa.org.uk/rulings/pro-bono-bio-entrepreneur- ltd-a14-289922.html

The Organisationfor Professionals inRegulatory Affairs