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Generics

A generic drug is a medicine which is produced and distributed without patent protection.  It is considered to be bioequivalent to the brand medicine with regards to its pharmacokinetic and pharmacodymanic properties.  Usually a generic product won't be available until after its patent protection has expired.  The time it takes for a generic to reach the market can vary.  Drug patents normally provide protection for twenty years, however, patents are applied for before clinical trials start and, therefore, the effective life of the patent can be anywhere from seven and twelve years.

Bringing a generic drug to market can be fraught with regulatory challenges and compliance issues.  Global Regulatory Services keeps up-to-date with all the latest regulatory changes to affect the generics industry and in particular generic drug submissions.  Our services include:

  • Compilation and submission of Marketing Authorisation Applications via the most appropriate regulatory submission pathway
  • Change of Ownership activities
  • Variations
  • Updating labelling and leaflets
  • Notarised documentation (if required)
  • Patient Information Leaflet (PIL) Readability Testing

Please contact us with your specific regulatory compliance requirements.