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Commission Regulation (EU) No 188/2011Show full title
Commission Regulation (EU) No 188/2011 of 25 February 2011 laying down detailed rules for the implementation of Council Directive 91/414/EEC as regards the procedure for the assessment of active substances which were not on the market 2 years after the date of notification of that Directive (Text with EEA relevance)
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Article 2U.K.Application
1.An applicant wishing to secure the inclusion in Annex I to Directive 91/414/EEC of an active substance covered by Article 1 shall submit an application for that active substance to a Member State, hereinafter referred to as ‘rapporteur Member State’, together with a summary dossier and a complete dossier, as provided for in Article 3, or a scientifically reasoned justification for not providing certain parts of those dossiers, demonstrating that the active substance fulfils the criteria provided for in Article 5 of that Directive.
For the purposes of this Regulation ‘applicant’ means the person who manufactures the active substance himself or who contracts out the manufacturing to another party or a person designated by the manufacturer as his sole representative for the purpose of compliance with this Regulation.
2.When submitting his application, the applicant may, pursuant to Article 14 of Directive 91/414/EEC, request certain parts of the dossiers referred to in paragraph 1 of this Article to be kept confidential. The applicant shall explain for each document or each part of a document why it is to be considered as confidential.
Member States shall assess the confidentiality requests. Upon a request for access to information, the rapporteur Member State shall decide what information is to be kept confidential.
The applicant shall submit separately the information to be kept confidential.
The applicant shall at the same time submit any claims for data protection pursuant to Article 13 of Directive 91/414/EEC.
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