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.
eu/reg/2011/188
Key facts
Type
Regulation · Commission Regulation (EU) No 188/2011 · EEA relevant
6.By way of derogation from paragraph 5, for applications for which the draft assessment report had been submitted to the Commission and the Authority by 31 December 2009 at the latest, Articles 2 to 6 and the first subparagraph of Article 7(1) shall not apply. In such cases, the following procedure shall apply.By 18 April 2011, the rapporteur Member State shall request the applicant to inform that Member State and the Authority, within 1 month, in case the applicant considers that information that had not been submitted for the preparation of the draft assessment report and that might influence the outcome of the assessment, is available, specifying the nature of that information and its possible influence on the assessment.Within 2 months from receiving the reply of the applicant, the Authority shall decide whether that information might influence the outcome of the assessment. If so, the Authority shall, without undue delay, ask the rapporteur Member State to request the submission of that information by the applicant. The rapporteur Member State shall update the draft assessment report where appropriate in the light of that information.The Authority shall set a period of up to 6 months for the rapporteur Member State to prepare and submit to the Commission that updated draft assessment report, with a copy to the Authority. It shall at the same time inform the applicant that the draft assessment report has been submitted and request him to immediately forward to the Authority, the other Member States and the Commission the updated dossiers, where applicable. Article 6(2) to (5) shall apply mutatis mutandis, whereby the period referred to in the first subparagraph of Article 6(3) shall not exceed 3 months.