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.
3.Where the rapporteur Member State needs additional information, it shall request it from the applicant setting a period of up to 6 months for it to be supplied. The rapporteur Member State shall inform the Commission and the Authority. In its assessment the rapporteur Member State shall only take into account information which was requested and submitted within the period granted.In cases where the rapporteur Member State requests additional information, the 12-month period provided for in paragraph 1 for the submission of the draft assessment report shall be extended by the period granted by the rapporteur Member State for the submission of the additional information. If the requested information is submitted to the rapporteur Member State before the end of the period granted the extension shall correspond to the part of that period actually used.