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EMEA: Draft Guideline on clinical investigation of medicinal products in the treatment of epileptic disorders

16.02.2009
EMEA:
Draft Guideline on clinical investigation of medicinal products in the treatment of epileptic disorders. This guideline applies to treatment of seizures in epileptic disorder ...

EMEA: Draft Guideline on the development of medicinal products for the treatment of alcohol dependence

16.02.2009
EMEA:
Draft Guideline on the development of medicinal products for the treatment of alcohol dependence. The guideline applies to provide guidance in the definition of treatment goals, ...

EMEA: Updated Procedure for European Union guidelines and related documents within the pharmaceutical legislative framework

16.02.2009
EMEA:
Updated Procedure for European Union guidelines and related documents within the pharmaceutical legislative framework. The purpose of this paper is to describe and define the ...

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) ...

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