Company Information
Company Name:
Astellas Ireland Co. Ltd.
Address:
Damastown Road
Damastown Industrial Park
Mulhuddart
Dublin 15
Note:
In October 2008 the Morehampton Fertility Clinic was authorised under the European Communities (Quality and Safety of Human Tissues and Cells) Regulations 2006 (SI 158 of 2006) which gives effect to Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Following clarification by the European Commission in relation to the application of Directive 2004/23/EC, the IMB understands that the services offered by the Clinic, which were authorised, are outside the scope of SI 158 of 2006 and, therefore, the Clinic does not require authorisation by the IMB.
The Morehampton Fertility Clinic remains categorised as an Organisation Responsible for Human Application under the European Communities (Human Tissues and Cells Traceability Requirements, Notification of Serious Adverse Reactions and Events and Certain Technical Requirements) Regulations 2007 (SI 598 of 2007) and it may continue to offer the range of services which were specified under the authorisation, referred to above, that was previously held by the Clinic. If you have any queries in relation to this statement do not hesitate to contact the IMB.
Type:
Manufacturer
Site Status:
Authorisation & Site Details
| Site Name |
Status |
Address |
Scope |
Date |
| Astellas Ireland Co. Ltd. |
Authorised |
Killorglin, Ireland, Co. Kerry |
Human |
Current Date of Authorisation: 21/05/2013 |