REGULATION (EU) NO 11072009 (ARTICLE 33) DATE DDMMYYYY ACCORDING

 ARTICLE 32 PLANNING & DEVELOPMENT REGULATIONS 2001 TO
 CORRECTIONS REGULATIONS 1998 SR NO 521998 SCHEDULE 2
  SUBJECT REASONED OPINION (SUBSIDIARITY) ON THE REGULATION

2 FORM 12 CIVIL ENFORCEMENT REGULATION CLERK’S
5 DRAFT NEW UN REGULATION ON UNIFORM
COMPARATIVE STUDY OF LAWS AND REGULATIONS GOVERNING CHARITABLE

Completeness Check: Evaluation Form 3 -for use in checking that all test and study reports required in accordance with Annex IIA have been provided

REGULATION (EU) No 1107/2009 (Article 33) Date: DD/MM/YYYY

According to Article 33 of REGULATION (EC) No 1107/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC:


Application for:

Authorization of new PPP


Extension of uses (major uses)


Extension of uses (minor uses)


Amending conditions of authorization



Plant Protection Product:

Registration Holder:

Active substance/s:

ZRMS:

cMS:

Date of submission:


Point 3. The application shall be accompanied by the following:


Information

Information, summary or justification provided

  1. for the plant protection product concerned, a complete and a summary dossier for each point of the data requirements of the plant protection product;


  1. for each active substance, safener and synergist contained in the plant protection product, a complete and a summary dossier for each point of the data requirements of the active substance, safener and synergist;


  1. for each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplication of tests and studies on vertebrate animals;


  1. the reasons why the test and study reports submitted are necessary for first authorisation or for amendments to the conditions of the authorisation;


  1. where relevant a copy of the application for a maximum residue level as referred to in Article 7 of Regulation (EC) No 396/2005 or a justification for not supplying such information;


  1. where relevant for an amendment of an authorisation an assessment of all information submitted in accordance with point (h) of Article 8(1);


  1. a draft label.




The following information must be submitted:


Information

Y/N

Information, summary or justification provided


Declaration that the technical material uses in the formulation has been declared equivalent to the reference source. If not, provisions of Art. 38 are applicable




A statement confirming accessing to Annex II data




A dRR (Draft Registration Report) (Part A; B and C) of each section of the dossier following the new dRR format (2015)




Complete documentation (studies) – Doc K




Material Safety Data Sheets of the co-formulants and plant protection products



List of test and studies for which data protection is claimed




List of test and studies to be kept confidential (Art 63)





Conclusion of the ZRMS about the dossier submitted by the applicant:


Complete


Not Complete


Stop (Pending Art 38)




This report does not prevent the assessment entity from requesting additional information from the notifier during the evaluation process.


REGULATION (EU) No 1107/2009 (Article 33) Page 2 of 2


REFORM OF CONSUMER LAW DRAFT REGULATIONS PROFORMA FOR
REPORT OF A BREACH OF THE EXAMINATION REGULATIONS
RULE AND REGULATION 29 PERSONAL LINES PROPERTY AND


Tags: (article 33), 1107/2009 (article, ddmmyyyy, regulation, (article, according, 11072009