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.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.