There are four ways in which a medicinal product can obtain marketing authorisation in the UK:

  • the centralised procedure;
  • the national procedure;
  • the mutual recognition procedure; and
  • the decentralised procedure.

The choice of which procedure to follow depends on the number of countries in which the medicine is going to be marketed and the type of medicine concerned.

This Guidance Note describes these procedures, the types of application that can be
made, the obligations arising and how a marketing authorisation may be revoked . . .

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