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Legal Status Switch

Switching from ‘Prescription Only’ to OTC (Over the Counter) 

One of the key milestones in the life-cycle of a medicine is potentially the change in restriction on availability of the product to the patient.  This can be achieved by changing the product’s legal classification from ‘Prescription Only’ to OTC allowing consumers to purchase the medicine themselves. 

Patients are becoming much better informed on healthcare issues and are demanding wider healthcare access.  This coupled with rising healthcare costs, means that most Member States and EU regulators tend to encourage ‘switching’ the legal classification of those medicines which have excellent safety records and are currently being prescribed by GPs to treat non-serious conditions. 

CambReg has plenty of experience in this area and can guide you on how best to capitalise on this current trend, allowing you to effectively breathe new life into your products. 

We can:

  • Identify suitable ‘switch’ products from your portfolio
  • Identify suitable ‘switch’ markets
  • Scope the project (timelines etc)
  • Provide strategic advice on the optimum procedure
  • Liaise with Health Authorities, professional and / or consumer bodies on your behalf
  • Prepare and submit the necessary documentation