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

10.04.2009
Dossier requirements for (Co-) Rapporteur and CHMP members ...

EMEA: QRD Recommendations on the expression of strength in the name of centrally authorised human medicinal products

10.04.2009
Directive 2001/83/EC requires a medicinal product to be labelled as “(invented) name + strength + pharmaceutical form”. This is considered to be the full name of the product, therefore ...

EMEA: Guideline on Plasma-Derived Medicinal Products

10.04.2009
This guideline lays down the requirements for the collection of starting material, the manufacturing and the quality control of plasma-derived medicinal products. Specific attention will be given ...

EMEA: Community herbal monograph

10.04.2009
Draft documents for the community herbal monograph on Gentianae radix Gentiana lutea L., radix (gentian root) ...

EMEA: Guideline on Core SmPC for Human Fibrinogen Products - Overview of comments on above draft guideline

25.03.2009
EMEA:
Guideline on Core SmPC for Human Fibrinogen Products - Overview of comments on above draft guideline. This guideline describes the information to be included in the Summary of ...

EMEA: Adopted documents for Community Herbal Monograph on Boldi folium Peumus boldus Molina (Boldo leaf)

25.03.2009
EMEA:
Adopted documents for Community Herbal Monograph on Boldi folium Peumus boldus Molina (Boldo leaf) – Assessment report. ...

EMEA: Overview of comments received on draft guideline on Carcinogenicity Evaluation of Medicinal Products for the Treatment of HIV Infection

25.03.2009
EMEA:
Overview of comments received on draft guideline on Carcinogenicity Evaluation of Medicinal Products for the Treatment of HIV Infection. This overview contains the general comments ...

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 ...

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