The dossier shall contain the information and documents referred to in Articles 8, 10, 10a, 10b, 10c and 11.

The dossier and the information from the review were also submitted to the Scientific Committee for Plants.

The dossier and the information from the review were also submitted to the Scientific Panel on Plant Health, Plant Protection Products and their Residues.

The personal register file (R) must contain a record for every person currently living in the household or temporarily absent.

The personal data file (P) must contain a record for every eligible person (RB245 = 1, 2 or 3) for whom the information could be completed from interview and/or registers (RB250 = 11, 12 or 13).

The household register file (D) must contain every household (selected + substituted + split off (longitudinal only)), also those where the address could not be contacted or which could not be interviewed.

The dossier shall contain the information and documents referred to in Articles 8, 10, 10a, 10b, 10c and 11.

The dossier and the information from the review were also submitted to the Scientific Committee for Plants (SCP).

The dossier and the information from the review were also submitted to the Scientific Panel on Plant Health, Plant Protection Products and their Residues.

dossier describing how the homeopathic stock or stocks is/are obtained and controlled, and justifying its/their homeopathic nature, on the basis of an adequate bibliography,

(1) Neither the International Bureau nor the International Preliminary Examining Authority shall, unless requested or authorized by the applicant, allow access within the meaning, and with the proviso, of Article 30(4) to the file of the international preliminary examination by any person or authority at any time, except by the elected Offices once the international preliminary examination report has been established.

The applicant shall send the complete dossier to the Member States and to the Commission.

where applicable, make available to the Authority the dossier provided for in Article 7(1) of Directive 82/471/EEC.

On receipt of the file relating to the request for approval or re-approval of a farm in a non-approved zone, the Commission shall have a month within which to examine that file.

the complete technical file supplying the information required under Annexes III and IV to Directive 2001/18/EC;

the complete technical dossier supplying the information required by Annexes III and IV to Directive 2001/18/EC;

"- dossier describing how the homeopathic stock or stocks is/are obtained and controlled, and justifying its/their homeopathic use, on the basis of an adequate bibliography,";

The investment firm shall establish a record that includes the document or documents agreed between the firm and the client that set out the rights and obligations of the parties, and the other terms on which the firm will provide services to the client.

make the summary of the dossier referred to in Article 5(3)(l) of Regulation (EC) No 1829/2003 available to the public.

make the summary of the dossier referred to in Article 17(3)(l) of Regulation (EC) No 1829/2003 available to the public.

the summary of the dossier referred to in Article 17(3)(l) of Regulation (EC) No 1829/2003 available to the public.

Where a request submitted under Article 7 of Council Directive 82/471/EEC(8), concerning products produced from GMOs, is transformed into an application under Regulation (EC) No 1829/2003, in accordance with Article 46(4) of that Regulation, the Commission shall ask the applicant without delay to submit a complete dossier in accordance with Article 17 of Regulation (EC) No 1829/2003.

The results of other tests and trials from the reference medicinal product's dossier shall not be provided.

Where a request submitted under Article 4 of Regulation (EC) No 258/97 of the European Parliament and of the Council(7) is transformed into an application under Regulation (EC) No 1829/2003, in accordance with Article 46(1) of that Regulation, the national competent authority of the Member State in which the request was submitted shall, without delay, ask the applicant to submit a complete dossier in accordance with Article 5 of Regulation (EC) No 1829/2003.

Where a notification concerning a product including its use as feed submitted under Article 13 of Directive 2001/18/EC is transformed into an application under Regulation (EC) No 1829/2003, in accordance with Article 46(3) of that Regulation, the national competent authority, within the meaning of Directive 2001/18/EC, of the Member State in which the notification was submitted shall ask without delay the notifier to submit a complete dossier in accordance with Article 17 of Regulation (EC) No 1829/2003.

With a view to the granting of a marketing authorisation for a medicinal product in more than one Member State, an applicant shall submit an application based on an identical dossier in these Member States.

Following the granting of a marketing authorisation, the authorisation holder may allow use to be made of the pharmaceutical, pre-clinical and clinical documentation contained in the file on the medicinal product, with a view to examining subsequent applications relating to other medicinal products possessing the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form.";

Should there exist major differences between the Commission's conclusions and the Member States' remarks, or should the Commission, after examining the file, consider that the approval or re-approval ought not be granted, the Commission shall have two months within which to refer the matter to the Standing Veterinary Committee and obtain its opinion.

REQUIREMENTS FOR THE COMPLETE DOSSIER AND THE SUMMARY DOSSIER

(a) the dossier complies with the requirements set out in Annex IV;

Where necessary, relevant product information (the quality dossier of an application/authorisation dossier) shall be provided in confidence to the inspectorate.

- in the case of a collective dossier, the name of all participants concerned and a person designated by them as being responsible for the collective dossier and the processing of the dossier in accordance with this Regulation;

(8) The dossier and the information from the review were also submitted to the Scientific Committee for Plants.

As in any scientific work, the dossier of residue tests shall include the following:

As in any scientific work, the dossier of safety tests shall include the following:

Preparation of the complete dossier

Where, in those circumstances, a collective dossier is not submitted, each individual dossier shall detail the efforts made to secure co-operation and the reasons for non-participation.

(8) The dossier and the information from the review were also submitted to the Scientific Committee for Plants (SCP).

(c) no other dossier concerns the same existing active substance/product type combination.

(b) no other dossier concerns the same existing active substance/product type combination.

Submission of the complete dossier

Completeness check of dossiers

- a check by the participant or, where appropriate, by the person designated as responsible for a collective dossier of the completeness of the dossier.

FILES TO TRANSMIT TO EUROSTAT

If the Rapporteur Member State considers that it has received sufficient evidence, it shall carry out its evaluation in accordance with Article 10 as if the dossier were complete.

A summary of the dossier must be entered in IUCLID.

These must be signed by the inspector and countersigned by the contractor or, as appropriate, the person in charge of the store, and must be included in the payment dossier.

(b) The summary dossier must include the following:

The official agency issuing certificates of unloading shall keep a register and files on all the certificates issued, in which it shall be recorded on the basis of which documentary evidence the certificates were delivered.

In the preparation of the complete dossier, all reasonable efforts shall be made, inter alia, to avoid duplication of testing on vertebrate animals and, where appropriate, to establish a collective complete dossier.