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Blood Establishment Authorisations

Legally all blood establishments must:

  • Apply to the HPRA for a blood establishment authorisation
  • Undergo inspections by the HPRA to obtain an authorisation and regular inspections thereafter
  • Once authorised, notify the HPRA of any substantial changes it intends to make to its activities.
  • Submit an annual activity report to the HPRA by 1st March each year. More information on the blood establishment annual report can be found here.
  • Comply with all requirements laid down in all relevant legislation.

Who Needs a Blood Establishment Authorisation?

An authorisation is required for:

  1. The collection and testing of blood and blood components whatever their intended purpose, and
  2. The processing, storage and distribution of blood and blood components when they are in intended to be used for transfusion.

None of these activities can take place unless the blood establishment has been authorised for that activity by the HPRA.

How to Apply for a Blood Establishment Authorisation

Applicants must submit an Application for a blood establishment authorisation to the HPRA for review, along with the appropriate fee.

We recommend that applicants contact us prior to applying for an authorisation to discuss the application process. Please see the Contact Us page for details.

Application for a blood establishment authorisation DOCX : 68 KB | 29/06/2016

Variation to a Blood Establishment Authorisation

If an authorised blood establishment needs to change any detail contained in their authorisation, they must apply to vary the authorisation. An Application for variation to a blood establishment authorisation must be submitted, along with with the appropriate fee. The variation must be approved prior to the change being implemented.

Our Guide to applying for a variation to a blood establishment authorisation provides additional information.

Applicants are encouraged to contact us prior to applying to discuss the proposed changes. Please see the Contact Us page.

Application for variation to a blood establishment authorisation DOCX : 73 KB | 09/10/2023

Applications to withdraw a Blood Establishment Authorisation

The withdrawal of a Blood Establishment 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 a registration. For example, information that a company has decided to discontinue blood establishement activities.
  • If the authorisation 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.

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.
  • Returned to the contact details provided on the application form.
Application to withdraw an authorisation licence approval or registration DOCX : 111 KB | 28/01/2022