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EMEA: Concept Paper on the need for the development of a paediatric addendum to the CHMP guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension

16.02.2009
EMEA:
Concept Paper on the need for the development of a paediatric addendum to the CHMP guideline on the clinical investigations of medicinal products for the treatment of pulmonary ...

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 ...

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. ...

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 ...

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) ...

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) ...

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) ...

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 ...

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 ...

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 ...