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Application to withdraw a wholesale distribution authorisation

The withdrawal of a wholesale distribution authorisation may be initiated:

  • At the request of the authorisation holder.
  • If the HPRA's Compliance department receives information concerning other business-related situations which might necessitate the withdrawal of an authorisation. For example, information that a company is going into liquidation.
  • If the WDA holder has allowed their authorisation to expire, if an expiry date is set, as it is no longer applicable to their current operational activities. This situation may be noted by an inspector during inspection.

When can I apply to withdraw my Authorisation?

You can apply to withdraw an authorisation when the company has stopped trading under the General Conditions of the authorisation.

Reasons for withdrawal can be:

  • Commercial,
  • Quality, including GMP issues,
  • Safety issues,
  • Efficacy issues,
  • Other.

How do I apply to withdraw my Authorisation?

You must complete the Application to withdraw an authorisation licence approval or registration form. A copy of this form can be found below on this page.

You must make sure the application form is:

  • Completed in full.
  • Bears the signature of the applicant. Where the application is on behalf of a limited company, the declaration must be signed by a director or the secretary and, in the case of a partnership, by a partner.
  • Submitted to the return details provided on the form.
Application to withdraw an authorisation licence approval or registration DOCX : 111 KB | 28/01/2022