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EMEA: Corrected HMPC assessment reports\' on: Verbasci flos Verbascum sp., flos (mullein flower)

25.03.2009
EMEA:
Corrected HMPC assessment reports\' on: Verbasci flos Verbascum sp., flos (mullein flower). ...

EMEA: Dossier requirements in the centralised procedure

25.03.2009
EMEA:
Dossier requirements for Post-authorisation submissions in the centralised procedure. ...

EMEA: Concept Paper on the Implementation of ICH Q10

25.03.2009
EMEA:
Concept Paper on the Implementation of ICH Q10. This Concept Paper outlines a proposal to implement ICH Q10 (Pharmaceutical Quality System) in the EU (Step 5 of the ICH process). ...

EMEA: The e-submission roadmap of veterinary medicinal products documents

25.03.2009
EMEA:
The e-submission roadmap of veterinary medicinal products documents. The initiative to create a veterinary sub-group of the Telematics Implementation Group on electronic submission ...

EMEA: 2008 public status report on the implementation of the European Risk Management Strategy

25.03.2009
EMEA:
2008 public status report on the implementation of the European Risk Management Strategy. The European Risk Management Strategy (ERMS) is a joint EMEA – Heads of Medicines ...

EMEA: Draft guideline on the conduct of bioequivalence studies for veterinary medicinal products

25.03.2009
EMEA:
Draft guideline on the conduct of bioequivalence studies for veterinary medicinal products. The aim of this guideline is to provide guidance regarding study design, conduct and ...

EMEA: Draft guideline on data requirements for multi-strain dossiers for Inactivated vaccines against Avian Influenza (AI), Blue Tongue (BT) and Foot and Mouth Disease (FMD)

25.03.2009
EMEA:
Draft guideline on data requirements for multi-strain dossiers for Inactivated vaccines against Avian Influenza (AI), Blue Tongue (BT) and Foot and Mouth Disease (FMD). This ...

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

25.03.2009
EMEA:
Corrected Procedure for European Union guidelines and related documents within the pharmaceutical legislative framework. This paper describes and define the different guidelines that ...

EMEA: Corrected Procedure: 2nd step of the PMF certification procedure the centrally authorised medicinal products

25.03.2009
EMEA:
Corrected Procedure: 2nd step of the PMF certification procedure the centrally authorised medicinal products. The objective of this document is to give a practical guidance to the ...

EMEA: Corrected Procedure: 2nd step of the PMF certification procedure the centrally authorised medicinal products

25.03.2009
EMEA:
Corrected Procedure: 2nd step of the PMF certification procedure the centrally authorised medicinal products. The objective of this document is to give a practical guidance to the ...

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