From Department of Enterprise, Trade and Employment
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The Department of Enterprise, Trade and Employment is seeking views from stakeholders and interested parties on the proposed regulations to put in place a unitary supplementary protection certificate (SPC) and/or a single (‘unified’) procedure for granting national SPCs.
The current mechanism for applying for an SPC is decentralised, and national SPCs must be applied for in each EU member state.
The views of stakeholders and interested parties are a vital source of information and opinions, helping inform the development of a national position. Views from stakeholders and interested parties are requested no later than close of business on 22 September 2023.
Submissions should be marked ‘Proposals on SPC Regulation’ and be emailed to ipu@enterprise.gov.ie
The European Commission’s proposals, impact analysis, studies and public consultations are available here: Proposals for regulations on supplementary protection certificates (europa.eu)
The European Commission has proposed establishing a centralised procedure for the grant of national SPCs, in a recast of the current SPC regulations on medicinal products (Regulation (EC) 469/2009) and plant protection products (Regulation (EC) 1610/96). It also suggests amending Regulation (EC) 1901/2006 to enable the application for SPC paediatric extensions through the centralised procedure (for national and unitary SPCs).
In line with its IP Action Plan, the European Commission expects the implementation of the proposals will reduce fragmentation across the EU IP system and will improve transparency and legal certainty. The Proposals are also expected to involve cost reductions for SPC applicants.
Your attention is drawn to the fact that information provided to the department may be disclosed in response to a request under the Freedom of Information Act 2014. Therefore, should you consider that any information you provide is commercially sensitive, please identify same, and specify the reason for its sensitivity. The department will consult with you regarding information identified by you as sensitive before making a decision on any Freedom of Information request. Any personal information, which you volunteer to this department, will be treated with the highest standards of security and confidentiality, strictly in accordance with the Data Protection Acts 1988-2018.
The department may also decide to place any submissions received by it on the department’s website. A decision on any such placement may occur without prior consultation with respondents to this process. Thus, it is in the interests of respondents to highlight, in their submissions, any commercially sensitive or confidential information at the time of submission.