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between receipt of application and assessment report
between receipt of application and assessment report
and communication of the summary of the notification ("SNIF") to the Commission and the CAs of the other member States
(Article 13(1), first paragraph)
and communication of the summary of the notification ("SNIF") to the Commission and the CAs of the other member States
(Article 13(1), first paragraph)
of whether the application contains all the information and data required by Article 13(2) (Article 13(1), second paragraph)
of whether the application contains all the information and data required by Article 13(2) (Article 13(1), second paragraph)
If yes:
If yes:
If no:
Request by lead CA to applicant for additional information
(Article 13(1), second paragraph)
If no:
Request by lead CA to applicant for additional information
(Article 13(1), second paragraph)
Requested data is provided by the applicant
Requested data is provided by the applicant
of compliance of application with the Directive and issuance of an assessment report (Article 14(1))
of compliance of application with the Directive and issuance of an assessment report (Article 14(1))
If positive, the lead CA forwards the assessment report to the Commission (Article 14(2), first paragraph)
If positive, the lead CA forwards the assessment report to the Commission (Article 14(2), first paragraph)
irculation of
irculation of
port to make
port to make
r reasoned
r reasoned
rticle 15(1))
rticle 15(1))
submitted to the competent authority ("CA") of the member State which is required to grant the written consent for the placing on the market of a GMO (so-called "lead CA") as or in a product to be used throughout the Community (Article 13(1), first paragraph)
submitted to the competent authority ("CA") of the member State which is required to grant the written consent for the placing on the market of a GMO (so-called "lead CA") as or in a product to be used throughout the Community (Article 13(1), first paragraph)
If negative, the lead CA informs the applicant and, after minimum 15 days, the Commission* (see endnote 1)
(Article 14(2), second paragraph)
If negative, the lead CA informs the applicant and, after minimum 15 days, the Commission* (see endnote 1)
(Article 14(2), second paragraph)
CONTINUE
CONTINUE
of the assessment report to the other member States within 30 days from receipt (Article 14(2), first paragraph)
of the assessment report to the other member States within 30 days from receipt (Article 14(2), first paragraph)
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Request for further information, comments or reasoned objections by the Commission or the member States
Request for further information, comments or reasoned objections by the Commission or the member States
Discussion between objecting CAs and the Commission to resolve outstanding issue
(Article 15(1))
for the placing on the market granted by the lead CA (Article 15(3) and 15(4))
Discussion between objecting CAs and the Commission to resolve outstanding issue
(Article 15(1))
for the placing on the market granted by the lead CA (Article 15(3) and 15(4))
Objections by the Commission or the member States resolved
Objections by the Commission or the member States resolved
Objections by the Commission or the member States maintained *
Commission presents a draft decision to the Regulatory Committee*
*before being issued, each Commission act has to be agreed among the services (Directorate Generals) concerned (so-called "inter-service consultations")
Commission presents a draft decision to the Regulatory Committee*
*before being issued, each Commission act has to be agreed among the services (Directorate Generals) concerned (so-called "inter-service consultations")
Regulatory Committee rejects, or does not decide on, Commission proposal
Regulatory Committee rejects, or does not decide on, Commission proposal
Regulatory Committee delivers a positive opinion on the Commission proposal
Regulatory Committee delivers a positive opinion on the Commission proposal
*(see endnote 1)
(Articles 18 and 30 and Article 5 Council Decision 1999/468/EC)
(Articles 18 and 30 and Article 5 Council Decision 1999/468/EC)
Commission presents the proposal to Council
Commission presents the proposal to Council
for the placing on the market granted by the lead CA (Article 18(2))
for the placing on the market granted by the lead CA (Article 18(2))
Council (a) rejects, or
(b) does not decide on, Commission proposal within 3 months
Council (a) rejects, or
(b) does not decide on, Commission proposal within 3 months
Commission has to (a) revise or
(b) adopt its proposal
Commission has to (a) revise or
(b) adopt its proposal
1 In these cases, the Commission has to consult its scientific committees, on its own initiative or at the request of a member State (Article 28(1)). The Commission may also consult the scientific committees on any matter arising under Directive 2001/18 (Article 28(2))