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.Within 12 months from the date of publication of the completeness decision, the rapporteur Member State shall prepare and submit to the Commission, with a copy to the Authority, a report assessing whether the active substance can be expected to fulfil the conditions provided for in Article 5 of Directive 91/414/EEC, hereinafter referred to as ‘draft assessment report’. 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.