1.An application for the approval of an active substance or for an amendment to the conditions of an approval shall be submitted by the producer of the active substance to a Member State, (the rapporteur Member State), together with a summary and a complete dossier as provided for in Article 8(1) and (2) or a scientifically reasoned justification for not providing certain parts of those dossiers, demonstrating that the active substance fulfils the approval criteria provided for in Article 4.
A joint application may be submitted by an association of producers designated by the producers for the purpose of compliance with this Regulation.
The application shall be examined by the Member State proposed by the applicant, unless another Member State agrees to examine it.
2.Assessment of an application may be performed by a number of Member States together under a co-rapporteur system.
3.When submitting the application, the applicant may pursuant to Article 63 request certain information, including certain parts of the dossier, to be kept confidential and shall physically separate that information.
Member States shall assess the confidentiality requests. Upon a request for access to information, the rapporteur Member State shall decide what information is to be kept confidential.
4.When submitting the application the applicant shall at the same time join a complete list of tests and studies submitted pursuant to Article 8(2) and a list of any claims for data protection pursuant to Article 59.
5.When assessing the application the rapporteur Member State may at any time consult the Authority.