[11] Guidance on social responsability.

[11] "Guidance and social responsibility"

Guidance notes on import tolerances - Documento 7169/VI/99 rev. 1.

Guidance notes on import tolerances - Document 7169/VI/99 rev. 1.

Título EMEA guidance for companies requesting protocol assistance regarding scientific issues

68 EMEA Annual Report 2002Document title EMEA guidance for companies requesting protocol assistance regarding scientific issues

Título Revision of Note for guidance on carcinogenic potential (3BS7a, Volume 3B, 1998, p.

Work progamme for 2002 CPMP Safety Working Party Document title Revision of Note for guidance on carcinogenic potential (3BS7a, Volume 3B, 1998, p.

SETAC - guidance document on testing procedures for pesticides in freshwater mesocosms / Seminário de Hunting 3-4 de Julho de 1991.

Setac - Guidance document on testing procedures for pesticides in freshwater mesocosms/Workshop Huntingdon, 3 and 4 July 1991.

SETAC - Guidance document on testing procedures for pesticides in freshwater mesocosms / /Seminário de Huntingdon 3-4 de Julho de 1991 ou

Setac - Guidance document on testing procedures for pesticides in freshwater mesocosms/Workshop Huntingdon, 3 and 4 July 1991

Comments and proposals for revision Proposals for revision of Note for Guidance " Quality of Herbal Remedies " Proposal for new guidance:

Comments and proposals for revision Proposals for revision of Note for guidance 'Quality of herbal remedies'Proposal for new guidance:

This is an annex to the Note for guidance on gene therapy product quality aspects in the production of vectors and genetically modified somatic cells.

This is an annex to the Note for guidance on gene therapy product quality aspects in the production of vectors and genetically modif ied somatic cells

Documento conceptual Immunotoxicity and the need to update the notes for guidance on repeat dose toxicity and on non -clinical local tolerance testing of medicinal products

Concept paper Immunotoxicity and the need to update the notes for guidance on repeat dose toxicity and on non-clinical local tolerance testing of medicinal products

Título Note for Guidance on Criteria for Recall and Repackaging Following Urgent Safety Restriction and Variation Procedures CPMP Points-to-Consider Document on Xenogeneic Cell Therapy (CPMP/1199/02) ICH-V1:

Document titleNote for Guidance on Criteria for Recall and Repackaging Following Urgent Safety Restriction and Variation Procedures

Grupo de Trabalho " Eficácia " do CVMPTítulo Antimicrobials for veterinary use Summary of product characteristics for antimicrobial products Ectoparasiticide guidance for sheep, cattle and goats Fluid therapy

Page 46/62Points to consider on the assessment of the potential for QT interval prolongation by non-cardiovascular medicinal products Note for guidance on risk assessment of medicinal products on human reproductive and development toxicities: from data to labellingCVMP Efficacy Working PartyDocument title Antimicrobials for veterinary use Summary of product characteristics for antimicrobial products Ectoparasiticide guidance for sheep, cattle and goats Fluid therapy

Título Note for guidance on Cell Culture Inactivated Influenza Vaccines Annex to NfG on Harmonisation of requirements for Influenza Vaccines (CPMP/BWP/214/96) Public Statement on Lactose prepared using Calf Rennet:

Note for guidance on Cell Culture Inactivated Influenza Vaccines Annex to NfG on Harmonisation of requirements for Influenza Vaccines (CPMP/BWP/214/96) Public Statement on Lactose prepared using Calf Rennet:

Base jurídica: Approved programme under Title II, Chapter I, of Council Regulation (EC) No 1257/1999 on support for rural development from the European Guidance and Guarantee Fund (EAGGF)

Legal basis: Approved programme under Title II, Chapter I, of Council Regulation (EC) No 1257/1999 on support for rural development from the European Guidance and Guarantee Fund (EAGGF)

Appendix to the Note for Guidance on the Clinical investigation of medicinal products in the treatment of schizophrenia (CPMP/EWP/559/95) ­ methodology of clinical trials concerning the development of depot preparations of approved medicinal products in schizophrenia.

Appendix to the Note for Guidance on the Clinical investigationof medicinal products in the treatment of schizophrenia (CPMP/EWP/559/95) ­ methodology of clinical trials concerning the development of depot preparations of approved medicinal products in schizophrenia

Safety and Supply of Plasma -derived Medicinal Products Note for Guidance on Pharmaceutical Aspects of the Product Literature for Human Vaccines Position Paper on Re-establishment of Working Seeds and Working Cell Banks using TSE compliant materials

Safety and Supply of Plasma-derived Medicinal Products Position Paper on Re-establishment of Working Seeds and Working Cell Banks using TSE compliant materials Note for Guidance on the Use of Bovine Serum in the manufacture of Human Biological Medicinal Products Points to Consider on Quality Aspects of Medicinal Products containing Active Substances Produced by Stable Transgene Experession in Higher Plants Note for Guidance on Pharmaceutical Aspects of the Product Literature for Human Vaccines

Quando relevante, os ensaios devem ser realizados em conformidade com as orientações adequadas que satisfaçam pelo menos as exigências de ensaio incluídas em SETAC - Guidance document on regularity testing procedures for pesticides with non-target arthropods.

Where relevant testing should be done according to appropriate guidelines which satisfy as least the requirements for testing as included in Setac - Guidance document on regulatory testing procedures for pesticides with non-target arthropods.

Quando relevante, os ensaios devem ser realizados em conformidade com as orientações adequadas que satisfaçam pelo menos as exigências de ensaio incluídas em SETAC - Guidance document on regularity testing procedures for pesticides with non-target arthropods.

Where relevant testing should be done according to appropriate guidelines which satisfy at least the requirements for testing as included in Setac - Guidance document on regulatory testing procedures for pesticides with non-target arthropods.

Título Points to consider on the clinical development of fibrinolytic medicinal products in the treatment of patients with ST segment elevation acute myocardial infarction (STEMI) Note for Guidance on the clinical development of medicinal products for the treatment of HIV infection.

Note for Guidance on the clinical development of medicinal products for the treatment of HIV infection

é possível definir um intervalo de segurança tanto para os bovinos, como para os suínos utilizando a “ abordagem alternativa ”, conforme referido na linha directriz do CVMP “ Note for guidance on the approach towards harmonisation of withdrawal periods ” (EMEA/ CVMP/ 036/ 95);
http://www.emea.europa.eu/

A meat withdrawal period can be set in both cattle and pigs using the ‘ Alternative approach’ as stated in the CVMP Note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/ CVMP/ 036/ 95);
http://www.emea.europa.eu/

Título Note for Guidance on the Clinical Investigation of Plasma derived Antithrombin Products Core SPC for Human Plasma derived Antithrombin Note for Guidance on the Clinical Investigation of Human Normal Immunoglobulin for Subcutaneous and Intramuscular use Core SPC for Human Normal Immunoglobulin for Subcutaneous and Intramuscular use

Document title Note for Guidance on the Clinical Investigation of Plasma derived Antithrombin Products Core SPC for Human Plasma derived Antithrombin Note for Guidance on the Clinical Investigation of Human Normal Immunoglobulin for Subcutaneous and Intramuscular use Core SPC for Human Normal Immunoglobulin for Subcutaneous and Intramuscular use