Tissue Establishment Authorisations

Applying for a new Tissue/Importing Tissue Establishment Authorisation

Any individual or site that carries out any prescribed activity is required to be authorised by the HPRA. To obtain authorisation, an application must be made to the HPRA for a tissue establishment or importing tissue establishment authorisation (TEA/ITEA).

'Prescribed activity' means any activity consisting of any aspect of -

1. The donation, procurement, testing, processing, preservation, storage or distribution of tissues or cells for human applications,
2. The donation, procurement, testing, processing, preservation, storage and distribution of tissues and cells for use in manufactured products, where these products are not covered by other Directives,
3. The donation, procurement and testing of tissues and cells for use in manufactured products, where those products are covered by other Directives.

To begin the process to obtain a TEA/ITEA, the applicant is required to complete an application for a new or importing tissue establishment authorisation. The application form should be submitted to the HPRA with the appropriate fee.

Applicants are strongly advised to contact the HPRA to discuss the application prior to submitting the form.

Variation to Tissue Establishment Authorisation

Regulation 6 (9) of S.I. 158 of 2006 states that 'A tissue establishment shall not make any substantial change in the prescribed activities which it undertakes without the prior written approval of the HPRA.'

If a tissue establishment needs to change any detail contained in their authorisation, they must submit an  application for a variation to a tissue or importing tissue establishment authorisation.

All applications must be submitted to the HPRA prior to the change being implemented by the authorisation holder, with the appropriate fee.

Variations to the tissue establishment authorisation are classified as either -

• administrative (fee code 330)- requiring a limited amount of assessment by an inspector, or 
• technical (fee code 331)- requiring significant assessment by an inspector with a possible site inspection required.

Applicants are welcome to contact the HPRA prior to applying to discuss the proposed changes further.

Applications to withdraw a Tissue Establishment Authorisation

The withdrawal of a Tissue 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 tissue 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.
• Submitted to the Licensing section of the HPRA as per the application form.