News
EMEA: Concept Paper on the need for the development of a paediatric addendum to the CHMP note for guidance on the clinical investigation of medicinal products in the treatment of lipid disorders
16.02.2009
EMEA:
Concept Paper on the need for the development of a paediatric addendum to the CHMP note for guidance on the clinical investigation of medicinal products in the treatment of lipid ...
Concept Paper on the need for the development of a paediatric addendum to the CHMP note for guidance on the clinical investigation of medicinal products in the treatment of lipid ...
EMEA: Overview of comments received on the draft revision of the guideline on the clinical development of medicinal products for the treatment of HIV infection
16.02.2009
EMEA:
Overview of comments received on the draft revision of the guideline on the clinical development of medicinal products for the treatment of HIV infection -EMEA/CPMP/EWP/633/02 Rev. ...
Overview of comments received on the draft revision of the guideline on the clinical development of medicinal products for the treatment of HIV infection -EMEA/CPMP/EWP/633/02 Rev. ...
EMEA: Draft Reflection paper on stability testing of herbal medicinal products and traditional herbal medicinal products
16.02.2009
EMEA:
Draft Reflection paper on stability testing of herbal medicinal products and traditional herbal medicinal products. This reflection paper is concerned with the specific requirements ...
Draft Reflection paper on stability testing of herbal medicinal products and traditional herbal medicinal products. This reflection paper is concerned with the specific requirements ...
EMEA: Centralised Procedures - recommended submission dates
16.02.2009
EMEA:
Centralised Procedures - recommended submission dates for: new applicants, anwers to the list of questions, type II variations and renewals. (January 2009) ...
Centralised Procedures - recommended submission dates for: new applicants, anwers to the list of questions, type II variations and renewals. (January 2009) ...
EMEA: Rapporteur’s Assessment Report for medicinal product for veterinary use – PSUR template
16.02.2009
EMEA:
Rapporteur’s Assessment Report for medicinal product for veterinary use – PSUR template (Word versions) ...
Rapporteur’s Assessment Report for medicinal product for veterinary use – PSUR template (Word versions) ...
EMEA: RMS/Member State Assessment Report for medicinal product for veterinary use – PSUR template
16.02.2009
EMEA:
RMS/Member State Assessment Report for medicinal product for veterinary use – PSUR template (Word versions) ...
RMS/Member State Assessment Report for medicinal product for veterinary use – PSUR template (Word versions) ...
EMEA: Public statement on fee reductions for designated orphan medicinal products
16.02.2009
EMEA:
Public statement on fee reductions for designated orphan medicinal products . This includes fees for pre-authorisation activities such as protocol assistance (scientific advice), and ...
Public statement on fee reductions for designated orphan medicinal products . This includes fees for pre-authorisation activities such as protocol assistance (scientific advice), and ...
EMEA: Draft Guideline on Declaration of Herbal Substances and Herbal Preparations in Herbal Medicinal Products/Traditional Herbal Medicinal Products in the SPC
16.02.2009
EMEA:
Draft Guideline on Declaration of Herbal Substances and Herbal Preparations in Herbal Medicinal Products/Traditional Herbal Medicinal Products in the SPC. This guideline addresses ...
Draft Guideline on Declaration of Herbal Substances and Herbal Preparations in Herbal Medicinal Products/Traditional Herbal Medicinal Products in the SPC. This guideline addresses ...
EMEA: Guideline on the Development of Medicinal Products for the Treatment of Post-Traumatic Stress Disorder (PTSD)
16.02.2009
EMEA:
Guideline on the Development of Medicinal Products for the Treatment of Post-Traumatic Stress Disorder (PTSD). This document provides guidance to Marketing Authorisation Applicants ...
Guideline on the Development of Medicinal Products for the Treatment of Post-Traumatic Stress Disorder (PTSD). This document provides guidance to Marketing Authorisation Applicants ...
EMEA: Concept paper on the need to update the current annex guideline on Cell culture inactivated influenza vaccines with respect to the Derivation of cell-isolated influenza vaccine viruses
16.02.2009
EMEA:
Concept paper on the need to update the current annex guideline on Cell culture inactivated influenza vaccines with respect to the Derivation of cell-isolated influenza vaccine ...
Concept paper on the need to update the current annex guideline on Cell culture inactivated influenza vaccines with respect to the Derivation of cell-isolated influenza vaccine ...