Aktualności
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 ...
EMEA: Questions/answers on Quality of IMPs - Inspections/QWP
16.02.2009
EMEA:
Questions/answers on Quality of IMPs - Inspections/QWP.
Reference to relevant paragraphs of the Guideline on the Requirements to the Chemical and Pharmaceutical Quality ...
Questions/answers on Quality of IMPs - Inspections/QWP.
Reference to relevant paragraphs of the Guideline on the Requirements to the Chemical and Pharmaceutical Quality ...
EMEA: Question/answer on Plastic Immediate Packaging Material - Inspections/QWP
16.02.2009
EMEA:
Question/answer on Plastic Immediate Packaging Material - Inspections/QWP
No specific requirements or recommendations are provided in the EU Guideline on plastic immediate ...
Question/answer on Plastic Immediate Packaging Material - Inspections/QWP
No specific requirements or recommendations are provided in the EU Guideline on plastic immediate ...
