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

This document, when completed, will present a summary of the information entered under the corresponding points of the full dossier.

summary of the dossier, except for those parts for which the confidential character has been determined in accordance with Article 1(3);

Each Member State shall define the number of copies and the format of the summary and the complete dossiers to be submitted by the notifiers.

When a Member State has received the notification dossier or additional information referred to in Article 6 it shall forthwith send to the Commission a copy of the dossier or a summary thereof together with any relevant comments;

On receipt of the copy of the notification dossier, the summary thereof or the additional information sent by a Member State, the Commission shall forward:

make the summary of the dossier mentioned in paragraph 3(h) available to the public, subject to the confidentiality requirements laid down in Article 18(2).

The rapporteur Member State shall ensure that notifiers submit the updated summary dossiers to the Commission and the other Member States at the same time as the rapporteur's report of the evaluation of the updated dossiers is sent to the Commission.

and no other Member State, on the basis of the summary it receives, makes legitimate objection, in accordance with Article 18(2), to the completeness of the dossiers.

Furthermore, a short summary intended for publication, giving the basic information contained in dossiers, shall be forwarded in the English, French and German languages,

For the purposes of drawing up the summary of the dossier for submission to the competent national authority pursuant to Article 13(2)(h) of Directive 2001/18/EC, the notifier shall use the Summary Information Format set out in the Annex to this Decision.

Where a Member State receives a summary of the dossiers in accordance with Articles 11(1)(b) and 15(2) and has legitimate reason to believe the dossiers are incomplete, it shall immediately communicate its concerns to the competent authority responsible for the evaluation of the dossiers and shall without undue delay inform the Commission and other Member States of its concerns.

Furthermore, a short summary intended for publication, giving the basic information contained in dossiers and monographs, shall be forwarded in the English, French and German languages.

The MAHs are requested to provide from the dossier submitted for each country of the EEA where the products are authorised: a) the Part I Summary of the dossier including SPCs, expert reports and the full composition of the products; b) if applicable, Part IV of the application dossier; c) an Assessment of the Periodic Safety Update Reports (PSURs) in relation to target animal safety and possible lack of efficacy.

For the mutual recognition of authorisations, the application shall include a summary of the dossier as required in Article 8(2)(a) and Annex II B, Section X and a certified copy of the first authorisation granted.

the receiving competent authority has verified the dossiers and believes them to satisfy the requirements of Annex IVA and Annex IVB or the requirements of Annex IIA and Annex IIB and, where relevant, Annexes IIIA and IIIB, accepts them and agrees to the applicant forwarding a summary of the dossiers to the Commission and the other Member States.

The following format must be used for the summary of the dossier to accompany a notification, for submission to the competent national authority, concerning the placing on the market of a GMO or a combination of GMOs as or in products.

When a Member State has received the notification dossier referred to in Articles 7 (1) and 8 (1), or information on the supplementary testing carried out in accordance with Articles 7 (2) and 8 (3), or follow-up information submitted in conformity with Article 14, it shall as soon as possible send the Commission a copy of the dossier or of the further information or a summary thereof.

Each file shall contain at least a copy of the application, a record of the administrative decisions taken by the Member State concerning the application and concerning the dossiers submitted in accordance with paragraph 2, together with a summary of the latter.

Part I Summary of the dossier, including the Summary of Product Characteristics (SPC), the expert reports and the quantitative and qualitative composition of the product; b. If applicable, Part IV Efficacy information, including information on pharmacokinetics, pharmacodynamics and anti-microbial resistance data. Pivotal documents, including the SPC, should be presented in English. 2.

That notification comprises, inter alia, a summary of the relevant dossier, which the competent authority must send to the competent authorities of the other Member States and to the Commission, and which the Commission must immediately make available to the public.

The scope of the procedure were the necessary measures to achieve an harmonised Summary of Product Characteristics (SPC), and the harmonisation of module 3 of the dossier, for which the Marketing Authorisation Holder proposed to replace all existing formulas with a single formula in two strengths, and to optimize the manufacturing process for this formula.

The Marketing Authorisation Holders were requested in a list of questions to provide: • Justification of the recommended dose for each of the indications claimed in relation to efficacy and potential selection of antimicrobial resistant bacteria. o Part I Summary of the dossier, including the Summary of Product Characteristics, the expert reports and the quantitative and qualitative composition of the product; o If applicable, Part IV Efficacy information, including information on pharmacokinetics, pharmacodynamics and anti-microbial resistance data. o The Periodic Safety Update Reports for at least the last 3 years. • Justification of the withdrawal period, in case the recommended dose should increase.

Effects on other non-target organisms (flora and fauna) believed to be at risk Effects on biological methods for sewage treatment Summary and evaluation of points 7 and 8 Proposals including justification for the proposals for the classification and labelling of the active substance according to Council Directive 67/548/EEC - Hazard symbol(s) - Indications of danger - Risk phrases - Safety phrases A dossier as referred to in Annex III, part A, for a representative plant protection product

for each point of Annex III to Directive 91/414/EEC the summaries and results of studies and trials, the name of the person or institute that has carried out the trials, relevant to the assessment of the criteria referred to in Article 5 of Directive 91/414/EEC for one or more preparations which are representative for the uses referred to in subparagraph (b) taking into account that data gaps in the information of the Annex II dossier resulting from the proposed limited range of representative uses of the active substance may lead to restrictions in the inclusion into Annex I to Directive 91/414/EEC;