Trac Services | Generic & Abridged Applications | TRAC Services
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Generic & Abridged Applications

The consultancy for global, pharmaceutical regulatory affairs

Generic medicinal products must meet the same levels of safety, quality and efficacy as the innovator product. They must also comply with good manufacturing processes and the monitoring of adverse effects after the drug has gone to market.

The TRAC team has extensive experience in carrying out abridged applications, focusing on:

  • identifying the most appropriate reference medicinal product
  • presenting bioequivalence data
  • employing PIL user tests and eCTD publishing
  • managing applications to multiple countries

Licences for generic medicinal products can be obtained once the innovator product’s patent has expired.

European marketing authorisations for generic medicines are obtained via the abridged application route.

A generic medicinal product is one that has:

  • the same qualitative and quantitative composition in active substances
  • the same pharmaceutical form as the reference medicinal product
  • bioequivalence with the reference medicinal product demonstrated through the appropriate bioavailability studies.

(Article 10(2)(b) of Directive 2001/83/EC)

The abridged application route can also be used for:

  • existing drugs with new forms, routes and indications (Article 10(3)
  • existing drugs in new combinations (Article 10b)
  • “well established” drugs and products (Article 10)
  • informed consent and change of ownership (Article 10c)

At TRAC, we’re also experts on all post marketing activities, including renewals and variations.

Our team has extensive experience in abridged applications