The Committee shall keep any such guidance under review and take into account any changes to the supplementary supervision carried out by such competent authorities.

The Committee may give general guidance as to whether the supplementary supervision arrangements of competent authorities in third countries are likely to achieve the objectives of the supplementary supervision as defined in this Directive, in relation to the regulated entities in a financial conglomerate, the head of which has its head office outside the Community.

the amendments to Annexes 1, 2, 3, 5, 7, 10, 12 and 15 to the Common Consular Instructions and the corresponding Annexes 5, 5A, 14B, 10, 6B, 6C and 14A to the Common Manual.

The Sirene Manual is a set of instructions to operators in the Sirene offices of each of the Member States which describes in detail the rules and procedures governing the bilateral or multilateral exchange of such supplementary information.

Article 1 The Sirene Manual shall constitute a set of instructions to operators in the Sirene offices of each Member State which establishes the rules and procedures governing the bilateral or multilateral exchange of supplementary information which is required in order to implement correctly certain provisions of the Schengen Convention, as integrated into the framework of the European Union.

B. The instructions in Titles I and II also apply to the continuation forms.

The guidance notes set out in the Annex to this Decision shall be used as a supplement to Annex VII of Directive 2001/18/EC.

(c) the equipment necessary to carry out the additional and special measures as indicated in the written instructions referred to in 5.4.3.

(c) the equipment needed to permit the carrying-out of the supplementary and special measures as indicated in the written instructions referred to in point 5.4.3. 8.3.6:

Each candidate shall be issued a form, in addition to the instructions just described, so as to make the test and the collection of the replies easier.

the amendments to Annexes 1, 2, 3, 5, 7, 10, 12 and 15 to the Common Consular Instructions and the corresponding Annexes 5, 5A, 14B, 10, 6B, 6C and 14A to the Common Manual.

It might be necessary to complement this framework with more specific, supplementary guidance on monitoring plans or checklists with regard to particular traits, crops or groups of GMOs.

(3) The Sirene Manual is a set of instructions to operators in the Sirene offices of each of the Member States which describes in detail the rules and procedures governing the bilateral or multilateral exchange of such supplementary information.

The supervisor shall have authority to issue to the contractor administrative orders incorporating such supplementary documents and instructions as shall be necessary for the proper and adequate execution of the works and the remedying of any defects therein.

The supervisor shall have authority to issue to the supplier, administrative orders incorporating such supplementary drawings and instructions as shall be necessary for the proper and adequate execution of the contract and the remedying of any defects therein.

The Sirene Manual shall constitute a set of instructions to operators in the Sirene offices of each Member State which establishes the rules and procedures governing the bilateral or multilateral exchange of supplementary information which is required in order to implement correctly certain provisions of the Schengen Convention, as integrated into the framework of the European Union.

at each step of the manufacturing process, the applicant must demonstrate the compliance of the materials used with the Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products and its updates, published by the Commission in the Official Journal of the European Union.

Regarding the specific measures for the prevention of the Transmission of animal Spongiform Encephalopathies, the applicant must demonstrate that the active substance complies with the Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products and its updates, published by the Commission in the Official Journal of the European Union.

Regarding the specific measures for the prevention of the Transmission of animal Spongiform Encephalopathies, the applicant must demonstrate also for excipients that the medicinal product is manufactured in accordance with the Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products and its updates, published by the Commission in the Official Journal of the European Union.

The applicant must demonstrate that the veterinary medical product is manufactured in accordance with the Note for Guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via veterinary medicinal products and its updates, published by the European Commission in Volume 7 of its publication 'The rules governing medicinal products in the European Community'.

The instructions in Titles I and II also apply to the continuation forms.

AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET

GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET

6 GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET

7 GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET

AMENDMENTS TO SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET AND LABELLING

10 GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET

GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET

Grounds for amendments of the Summaries of Products Characteristics, labelling and Package leaflet

8 GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET

14 GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET

THE SCIENTIFIC CONCLUSIONS AND THE GROUNDS FOR AMENDMENTS OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET

the equipment necessary to carry out the additional and special measures as indicated in the written instructions referred to in 5.4.3.

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET

the equipment needed to permit the carrying-out of the supplementary and special measures as indicated in the written instructions referred to in point 5.4.3.

Information, instructions and training Workers must be given the necessary information, instructions, training and retraining to ensure their health and safety.

14 The valid package leaflet is the final version achieved during the Coordination group procedure with the following amendments:

The harmonised phrases in Annex IV and Annex V provide the basis for complementary and specific instructions for use according to Article 16(1)(k), (l), (m) and (n).

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET PRESENTED BY THE EMEA

The harmonised phrases provide the basis for complementary and specific instructions for use and are, therefore, without prejudice to other elements of Article 16, in particular Article 16(1)(k) to (n) and 16(4).

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLETS PRESENTED BY THE EMEA

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA SCIENTIFIC CONCLUSIONS

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY(IES) OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLETS PRESENTED BY THE EMEA

In the case of complementary feedingstuffs intended for particular nutritional purposes guidance on the balance of the daily ration must be provided in the instructions for use contained on the label.

The CHMP has therefore recommended the granting of the Marketing Authorisation(s) and the amendment of the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State.

the CHMP has recommended the granting of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Oracea.