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EMEA: User guide on how to generate PDF versions of the Product Information

10.04.2009
Revised PDF user guide for companies describing how to correctly generate PDF versions of the Product Information ...

EMEA: Status of EMEA guidelines and European Pharmacopoeia monographs in the regulatory framework

10.04.2009
The present guideline clarifies the status of EMEA scientific guidelines and European Pharmacopoeia monographs and chapters in the context of the regulatory framework applicable ...

EMEA: Concept paper on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use

10.04.2009
Unwanted immunogenicity is a significant problem with therapeutic biologicals. The clinical problems associated with unwanted immunogenicity vary in nature and incidence. The importance of the ...

EMEA: Adopted guideline on similar biological medicinal products containing low-molecular-weight-heparins

10.04.2009
This guideline lays down the non-clinical and clinical requirements for low molecular weight heparins (LMWHs, low molecular mass heparins, LMMH) containing medicinal products claiming to be ...

EMEA: Community herbal monograph

10.04.2009
Community herbal monograph on Centaurii herba Centaurium erythraea Rafn., herba (centaury herb) ...

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 ...