EN PL

News

EMEA: Guideline on Clinical Investigation of Human Normal Immunoglobulin for Intravenous Administration (IVIg)

25.03.2009
EMEA:
Guideline on Clinical Investigation of Human Normal Immunoglobulin for Intravenous Administration (IVIg). This Guideline describes the information to be documented when an ...

EMEA: Guideline for Core SmSPC for Human Normal Immunoglobulin (IVIg) for Intravenous administration

25.03.2009
EMEA:
Guideline for Core SmSPC for Human Normal Immunoglobulin (IVIg) for Intravenous administration. This Guideline describes the information to be included in the Summary of Product ...

EMEA: Concept Paper on Revision of the EU Guideline on Good Distribution Practice (GDP)

25.03.2009
EMEA:
Concept Paper on Revision of the EU Guideline on Good Distribution Practice (GDP).
This concept paper addresses the need to update the Guideline on Good Distribution Practice ...

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 ...