Scientific Animal Protection
On 1 January 2013, the IMB became the competent authority responsible for the implementation of Directive 2010/63/EU on the protection of animals used for scientific purposes in accordance with the requirements of SI No 543 of 2012 . This authority was transferred from the Department of Health which regulated this area until 31 December 2012.
Notice regarding use of application forms and associated guidance documents relating to Directive 2010/63/EU – 17 January 2013 -Update
In order to assist applicants in their preparation for the new requirements for authorisation under the above Directive, the IMB has prepared draft establishment, project and individual application forms and related documents. These documents were prepared in advance of publication of the national legislation that transposes the Directive, therefore certain assumptions have been made regarding the content of the statutory instrument. The IMB is currently updating the forms and guidelines to be in line with the national legislation. This process is expected to take a number of weeks. The IMB remains committed to further enhancing the documents concerned based on stakeholder feedback and ongoing European developments.
From 1st January 2013 and until the finalised establishment, project and individual application forms and related documents are made available, the draft application forms currently available on the publications section of the IMB website (www.imb.ie) must be used to make an application for an establishment, project or individual authorisation. However, given the ongoing and planned changes to the documents on the website, applicants should ensure that they consult the website immediately prior to making any new application so that the most up-to-date forms and guidance notes available are used.
In order to make the applications forms as user-friendly as possible, the IMB is currently working on a smart electronic version of the draft application forms. The IMB aims to launch the smart application forms in March 2013 after an initial testing phase planned for February 2013. From the 1st of March 2013, the IMB expects to upload the finalised smart application forms for establishment, project and individual authorisations and related guidance notes. Once the final application forms have been made available the draft application forms will become invalid and should not be used. It is expected that even after the forms have been finalised and published, they may be subject to further revision during the course of 2013 based on experience in their use and feedback from applicants.
Applicants should therefore check the IMB website at the time of submission of any application for authorisation and ensure to use the most up-to-date forms available from the website. To assist users, the IMB recommends viewers to subscribe to alerts from the Veterinary Sciences Department on the IMB website, in order to receive notification on the availability of the finalised documents.
Preparations of a site master file for establishment authorisations – 17 January 2013
The IMB notes that establishments previously licensed by the Department of Health are regarded as authorised establishments under the new legislation for a two year period from the 1st of January 2013, providing there is no major change to the establishment during this time. Please note that any major changes in buildings, or the commissioning of new buildings or an establishment site, any change in the intended use of a building, or changes in the species approved for an establishment or in key personnel (i.e. those with specific responsibilities as outlined in Directive 2010/63/EU and SI No 543 of 2012) would require the submission of a new establishment authorisation application to the IMB.
From the 1st January 2015, the IMB notes that these existing establishment licences will expire and a new application for establishment authorisation will be required. An application for a new establishment authorisation should be submitted to the IMB at least six months in advance of the expiry of the existing licence i.e. by 30 June 2014, but can be made sooner upon request.
The IMB plans to begin inspections of all existing premises currently registered and licensed by the Department of Health during 2013. The submission of a new project application to the IMB from January 2013 may trigger a formal IMB inspection of the establishment concerned. Establishments licensed by the Department of Health prior to 1 January 2013 should ensure that they are ready for an IMB inspection and should update / prepare their Site Master File < http://www.imb.ie/EN/Publications/Publications/Establishment-authorisations-regulated-by-Directive-201063EU.aspx?page=1 > as soon as possible. The IMB requires that each establishment has an up-to-date Site Master File available in accordance with Regulation 36(2) of SI No. 543 of 2012. The availability of this information will assist the IMB in the planning of inspections (irrespective of whether an establishment requests an inspection or not). Further guidance on the content and construct of the site master file in available elsewhere on this site.
In order to assist establishments to understand the new requirements and to help familiarise those concerned with the new regulatory regime, the IMB is available to conduct a preliminary informal inspection of each currently authorised establishment at a mutually convenient time during 2013, provided that an appointment is made for the inspection before 28 February 2013 (the inspection does not have to take place before the end of February however) and that IMB resources allow. Such a preliminary inspection will not be regarded by the IMB as a formal inspection under Directive 2010/63/EU but will be still be conducted in a manner akin to a formal inspection. There will not be any charge for this inspection. No formal compliance notices or other regulatory sanctions will be issued following the preliminary inspection even though informal feedback on the outcome of the inspection will be provided to the establishment concerned. Where opportunities for improvement are observed they will be communicated to the establishment.
In parallel to the informal preliminary inspections being planned for 2013, the IMB also expects to conduct formal inspections of establishments and projects, as well as unannounced inspections. Such formal inspections will be undertaken whether or not a preliminary informal inspection has taken place at the establishment. Queries in relation to the conduct of inspections should be sent to scientificanimalprotection@imb.ie
About the Legislation
Directive 2010/63/EU was transposed into Irish law by the European Union (Protection of Animals Used for Scientific Purposes) Regulations 2012 [SI No. 543 of 2012]. The new legislation aims to improve the welfare of animals used for scientific purposes and to promote the principles of the Three Rs - Replacement, Reduction and Refinement:
• Replacement refers to the use of alternative methods which substitute the use of animals for scientific purposes. Where replacement is not possible, animal use must only be permitted where justified and where the expected benefits outweigh the potential adverse effects.
• Reduction measures must be applied so as to minimise the number of animals used in each research project.
• Refinement measures must also be applied to enable procedures to be carried out in the most humane manner possible and to minimise pain, suffering, distress and lasting harm.
IMB Authorisations
The IMB aims to achieve the objectives of the new legislation by regulating the use of animals for scientific purposes by means of authorisation at three levels:
1. Establishments: Breeders, suppliers and establishments where procedures are performed must be authorised and are subject to IMB inspections, including unannounced inspections.
2. Projects: Scientific procedures can only be performed on an animal following a detailed submission of the planned study and subsequent approval by the IMB.
3. Individuals: All individuals performing scientific procedures on animals in an authorised establishment must be adequately trained and hold an Individual authorisation.
The IMB’s role is that of regulatory authority acting within the confines of the legislation. The IMB is not a funding body and does not have responsibility for decisions already taken in respect of the national or EU legislation.
Communicating with Stakeholders
The IMB is currently seeking to indentify relevant parties who will be impacted by future IMB licensing activities as well as other stakeholders with an interest in the new legislation. We would appreciate if you could submit your contact details and confirm a relevant stakeholder category by completing and submitting < http://www.imb.ie/EN/Publications/Publications/Establishment-authorisations-regulated-by-Directive-201063EU.aspx?page=1 >
This information will be used solely for communication purposes relating to the changes outlined above and will be treated with the highest standards of security and confidentiality, strictly in accordance with the Data Protection Acts, 1988 & 2003. For more information please refer to our privacy statement.
Licences issued previously by the Department of Health
Queries relating to licences issued by the Department of Health prior to 1 January 2013 should be directed to the Department of Health.
Useful Links
For further relevant information please see the links below.
• Department of Health Website
• European Commission Website on Protection of Laboratory Animals
• Directive 2010/63/EU
• SI No. 543 of 2012
Contact the IMB
Please email scientificanimalprotection@imb.ie or telephone 01 676 4971