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
1.The Authority shall circulate the draft assessment report received from the rapporteur Member State to the applicant and the other Member States within 30 days from its receipt. Where within this 30-day period the Authority does not receive the dossier provided for in Article 6(1) it shall circulate that report as soon as it receives that dossier.The period for the submission of written comments to the Authority from Member States and the applicant shall be 2 months.