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Compliance as a Medicine

The alternative route to compliance with the TPD is to register your product as a medicine.

How easy is it to get a Marketing Authorisation (MA)?

There are many issues that need to be considered when making an application, but one important thing to note is that nicotine is the subject of a monograph of the European Pharmacopoeia. The application for an MA should therefore ensure that the quality of the active substance is controlled, by a drug substance specification, in line with the European monograph for nicotine and the general monograph on substances for pharmaceutical use.

The MHRA has advised that an abridged application submitted under Article 10 of Directive 2001/83/EC would be appropriate.

It is worth mentioning that although to take the medicines licensing route will be a more expensive one there are some distinct advantages:

  • Products licensed as Medicines in the UK, qualify for 5% rather than 20% sales tax
  • They will be able to be prescribed by health practitioners throughout the health service as well as on being on general sale
  • They can be advertised as cessation or harm reduction products