The assisting authority shall if necessary provide general guidance to the applicant in meeting any request for supplementary information from the deciding authority.

For the submission of the required data, the applicant shall consult the 'Guidelines of the European Food Safety Authority for the presentation of an application for safety assessment of a substance to be used in food contact materials prior to its authorisation'.

Until publication, applicants shall follow the "Guidance on submissions for food additive evaluations" by the Scientific Committee on Food, of 11 July 2001 or its latest update:

For the submission of the required data, the applicant shall consult the 'Guidelines of the European Food Safety Authority for the presentation of an application for safety assessment of a substance to be used in food contact materials prior to its authorisation'.

In assembling the dossier for application for marketing authorization, applicants shall take into account the Community guidelines relating to the quality, safety and efficacy of veterinary medicinal products published by the Commission in The rules governing medicinal products in the European Community.

The detailed conditions for support and eligibility of expenditure on the basis of this Regulation, taking into account the Commission guidelines set for the Member States, will be laid down in bilateral agreements concluded between the Commission, on behalf of the European Community, and each applicant country.

(4) In assembling the dossier for application for marketing authorisation, applicants shall also take into account the scientific guidelines relating to the quality, safety and efficacy of medicinal products for human use as adopted by the Committee for Proprietary Medicinal Products (CPMP) and published by the European Medicine Evaluation Agency (EMEA) and the other pharmaceutical Community guidelines published by the Commission in the different volumes of The rules governing medicinal products in the European Community.

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.

In case of a change in the head space or a change in the surface/volume ratio, stability studies in accordance with the relevant guidelines have been started with at least two pilot scale (three for biological medicinal products) or industrial scale batches and at least three months' (six months for biological medicinal products) stability data are at the disposal of the applicant.

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.

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'.

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 particulars and documents accompanying an application for marketing authorization pursuant to Articles 12 and 13(1) shall be presented in accordance with the requirements set out in this Annex and taking account of the guidance contained in the 'Notice to applicants for marketing authorizations for veterinary medicinal products in the Member States of the European Community', published by the Commission in The rules governing medicinal products in the European Community, volume V:

(1) The particulars and documents accompanying an application for marketing authorisation pursuant to Articles 8 and 10 (1) shall be presented in accordance with the requirements set out in this Annex and shall follow the guidance published by the Commission in The rules governing medicinal products in the European Community, Volume 2 B, Notice to applicants, Medicinal products for human use, Presentation and content of the dossier, Common Technical Document (CTD).

An operation funded by this instrument should not benefit for the same purpose from assistance under Council Regulation (EC) No 1164/94 of 16 May 1994 establishing a Cohesion Fund fn, Council Regulation (EC) No 1260/1999 of 21 June 1999 laying down general provisions on the Structural Funds fn, Council Regulation (EC) No 1257/1999 of 17 May 1999 on support for rural development from the European Agricultural Guidance and Guarantee Fund (EAGGF) fn, Council Regulation (EEC) No 3906/89 of 18 December 1989 on economic aid to the Republic of Hungary and the Polish People's Republic fn, Council Regulation (EC) No 1267/1999 of 21 June 1999 establishing an Instrument for Structural Policies for Pre-accession fn, Council Regulation (EC) No 1268/1999 of 21 June 1999 on Community support for pre-accession measures for agriculture and rural development in the applicant countries of central and eastern Europe in the pre-accession period fn, Commission Regulation (EC) No 2760/98 of 18 December 1998 concerning the implementation of a programme for cross-border cooperation in the framework of the Phare programme fn, Council Regulation (EC) No 1266/1999 of 21 June 1999 on coordinating aid to the applicant countries in the framework of the pre-accession strategy and amending Regulation (EEC) No 3906/89 fn, Council Regulation (EC) No 555/2000 of 13 March 2000 on the implementation of operations in the framework of the pre-accession strategy for the Republic of Cyprus and the Republic of Malta fn, or Council Regulation (EC) No 2236/95 of 18 September 1995 laying down general rules for the granting of Community financial aid in the field of trans-European networks> fn <10

deciding the rules and procedures for the presentation of proposals including the preparation of a common set of guidelines for applicants,

deciding upon the rules and procedures for the presentation of proposals including the preparation of a common set of guidelines for applicants;

manufacturers or other applicants for approval are aware of the advisory notes contained in ETSI guide EG 201 121 including any amendments thereto;

The assisting authority shall if necessary provide general guidance to the applicant in meeting any request for supplementary information from the deciding authority.

In assembling the dossier for application for marketing authorization, applicants shall take into account the Community guidelines relating to the quality, safety and efficacy of medicinal products published by the Commission in The rules governing medicinal products in the European Community, Volume III and its supplements: Guidelines on the quality, safety and efficacy of medicinal products for human use.

manufacturers or other applicants for approval are aware of the Advisory Notes contained in ETSI Guide EG 201 121, including any amendments thereto, and (b) manufacturers are aware that they must attach a notice of the form given in Annex II to all products approved under this Decisio;

The Applicant stated that for pharmacokinetic studies, equivalence is conventionally demonstrated by applying a +/ - 20 % limit for the 90 % CI and therefore applied these limits to the FDP comparison, despite the recent EMEA guidance recommending +/ - 15 % limits for in vitro equivalence and +/ - 20 % limits for in vivo pharmacokinetic equivalence.

An ongoing study will generate long-term SBA data while the Applicant/ MAH also committed to monitor antibody persistence for five years in subsequent studies 023, 024, 025 and 026, in line with the “ Note for guidance on clinical investigation of medicinal products in the paediatric population” (CPMP/ ICH/ 2711/ 99).

In assembling the dossier for application for marketing authorization, applicants shall take into account the Community guidelines relating to the quality, safety and efficacy of medicinal products published by the Commission in The rules governing medicinal products in the European Community, Volume III and its supplements:

whereas, during those periods of protection, any new applicant for authorization will be obliged to submit a dossier drawn up in accordance with Council Directive 87/153/EEC of 16 February 1987 fixing guidelines for the assessment of additives in animal nutrition (5) unless the parties reach agreement on shared use of the data;

the guidelines governing the scientific evaluation of substances, products or processes which are subject under Community legislation to a system of prior authorisation or entry on a positive list, in particular where Community legislation makes provision for, or authorises, a dossier to be presented for this purpose by the applicant.

In assembling the dossier for application for marketing authorisation, applicants shall also take into account the scientific guidelines relating to the quality, safety and efficacy of medicinal products for human use as adopted by the Committee for Proprietary Medicinal Products (CPMP) and published by the European Medicine Evaluation Agency (EMEA) and the other pharmaceutical Community guidelines published by the Commission in the different volumes of The rules governing medicinal products in the European Community.

In addition, it was considered that the applicant should include in the Summary of Product Characteristics (point 5.1) the organisms listed in the breakpoints and susceptibility table relevant to the indications, as per the Note for Guidance on Evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/ EWP/ 558/ 95 rev.1).

The applicant must demonstrate 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 Volume 3 of its publication The rules governing medicinal products in the European Community.

The Applicant/ MAH provided supportive documentation for this indication of 4mg OG in children aged 6 month to 2 years based on pharmacokinetic data PN 136/ 138, supportive safety data PN 176, and the extrapolation of efficacy to this age group from the efficacy demonstrated in older children (2- 5 years old, 6-14 years old) according to ICH E11 guideline.

The Applicant provided further reassurances on the use of Rapinyl in patiens with mucositis, based on publications and guidelines, concluding that patients with mild/ moderate mucositis can use oral medication, while transmucosal forms of fentanyl are not suitable for use in patients with severe mucositis where other routes of analgesia administration are preferable.

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".

In order to obtain the Community authorization for a substance or a preparation as an additive or for a new use in the case of an already authorized additive, the applicant for authorization shall select a Member State to act as rapporteur during the scrutiny procedure on the dossier he has compiled in accordance with the provisions of Council Directive 87/153/EEC of 16 February 1987 fixing guidelines for the assessment of additives in animal nutrition (*).

The Applicant addressed the concern that no comparator study was provided by arguing that a controlled clinical trial using an active comparator such as systemic doxycycline was not required, as the development program was in line with a number of ICH guidelines CPMP/ ICH/ 291/ 95 and CPMP/ ICH/ 135/ 95 which do not require an active comparator and with the E10 Guidance for the choice of control group in clinical trials (CPMP/ ICH/ 364/ 96), which supports the use of a placebo control group as the most appropriate design where ethically and practically feasible. The Applicant

The particulars and documents accompanying an application for marketing authorization pursuant to Articles 8 and 10(1) shall be presented in four parts, in accordance with the requirements set out in this Annex and taking account of the guidance published by the Commission in The rules governing medicinal products in the European Community,Volume II: Notice to applicants for marketing authorizations for medicinal products for human use in the Member States of the European Community.

The applicant has presented a number of publications from the literature in order to discuss the rational for deviation from the ICH Guideline on Clinical Investigation of Medicinal Products in the Paediatric Population (CPMP/ ICH/ 2711/ 99) and the basis of differentiation of 0-14 and 15-28 days instead of the more general definition of neonates as ‘ up to 28 days after birth’, as well as the different dosing regimens used.

The particulars and documents accompanying an application for marketing authorization pursuant to Articles 12 and 13(1) shall be presented in accordance with the requirements set out in this Annex and taking account of the guidance contained in the "Notice to applicants for marketing authorizations for veterinary medicinal products in the Member States of the European Community", published by the Commission in The rules governing medicinal products in the European Community, volume V:

The particulars and documents accompanying an application for marketing authorisation pursuant to Articles 8 and 10 (1) shall be presented in accordance with the requirements set out in this Annex and shall follow the guidance published by the Commission in The rules governing medicinal products in the European Community, Volume 2 B, Notice to applicants, Medicinal products for human use, Presentation and content of the dossier, Common Technical Document (CTD).

The particulars and documents accompanying an application for marketing authorization pursuant to Articles 12 and 13(1) shall be presented in accordance with the requirements set out in this Annex and taking account of the guidance contained in the "Notice to applicants for marketing authorizations for veterinary medicinal products in the Member States of the European Community", published by the Commission in The rules governing medicinal products in the European Community, volume V: Veterinary Medicinal Products.

significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food with concern regarding the adequate sensitivity of to detect a difference between products,

The scope of the referral was to agree whether Cardoreg 4mg prolonged release tablets differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food.

The scope of the referral was to agree whether Doxastad 4mg prolonged release tablets differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food.

The scope of the referral was to agree whether Doxagamma 4mg prolonged release tablets differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food.

The scope of the referral was to agree whether Doxazosin “ Winthrop” 4mg prolonged release tablets differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food.

The scope of the referral was to agree whether Doxazosin Retard “ Arrow” 4mg prolonged release tablets differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food.

An operation funded by this instrument should not benefit for the same purpose from assistance under Council Regulation (EC) No 1164/94 of 16 May 1994 establishing a Cohesion Fund(5), Council Regulation (EC) No 1260/1999 of 21 June 1999 laying down general provisions on the Structural Funds(6), Council Regulation (EC) No 1257/1999 of 17 May 1999 on support for rural development from the European Agricultural Guidance and Guarantee Fund (EAGGF)(7), Council Regulation (EEC) No 3906/89 of 18 December 1989 on economic aid to the Republic of Hungary and the Polish People's Republic(8), Council Regulation (EC) No 1267/1999 of 21 June 1999 establishing an Instrument for Structural Policies for Pre-accession(9), Council Regulation (EC) No 1268/1999 of 21 June 1999 on Community support for pre-accession measures for agriculture and rural development in the applicant countries of central and eastern Europe in the pre-accession period(10), Commission Regulation (EC) No 2760/98 of 18 December 1998 concerning the implementation of a programme for cross-border cooperation in the framework of the Phare programme(11), Council Regulation (EC) No 1266/1999 of 21 June 1999 on coordinating aid to the applicant countries in the framework of the pre-accession strategy and amending Regulation (EEC) No 3906/89(12), Council Regulation (EC) No 555/2000 of 13 March 2000 on the implementation of operations in the framework of the pre-accession strategy for the Republic of Cyprus and the Republic of Malta(13), or Council Regulation (EC) No 2236/95 of 18 September 1995 laying down general rules for the granting of Community financial aid in the field of trans-European networks(14);