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European Commission: Public consultation on revisions of GMP Annex 14 on \"Manufacture of medicinal products derived from human blood or plasma”

30.01.2009
European Commission:
Public consultation on revisions of GMP Annex 14 on \"Manufacture of medicinal products derived from human blood or plasma”. It applies to medicinal products ...

MHRA: Global shortage of acetonitrile: Advice to the pharmaceutical industry on changes requiring variation submissions to update Marketing Authorisations

30.01.2009
MHRA:
Global shortage of acetonitrile: Advice to the pharmaceutical industry on changes requiring variation submissions to update Marketing Authorisations. There is currently a global ...

EMEA: COMP Recommendation on elements required to support the medical plausibility and the assumption of significant benefit for an orphan designation

30.01.2009
EMEA:
Committee for Orhphan Medicinal Products Recommendation on elements required to support the medical plausibility and the assumption of significant benefit for an orphan designation ...

EMEA: List of questions & answers (Q&A) received during the HMPC assessors training on quality issues emerging for herbal medicinal products

30.01.2009
EMEA:
List of questions & answers (Q&A) received during the Committee on Herbal Medicinal products (HMPC) assessors training on quality issues emerging for herbal medicinal products (held ...

EMEA: Draft EudraVigilance access policy for medicines for Veterinary use

30.01.2009
EMEA:
Draft EudraVigilance access policy for medicines for Veterinary use. This document should serve as a starting point for the elaboration of EudraVigilance access policies and the ...

FDA: Guidance for Industry - Labeling OTC Human Drug Products – Questions and Answers

30.01.2009
FDA:
Guidance for industry - Labeling OTC Human Drug Products – Questions and Answers. This guidance is intended to assist manufacturers, packers, and distributors of over-the-counter ...

FDA: Comprehensive List of Guidance Documents

30.01.2009
FDA:
Center For Drug Evaluation and Research - Comprehensive List of Guidance Documents ...

FDA: Guidance for Industry - Annex 2 Test for Extractable Volume of Parenteral Preparations General Chapter

30.01.2009
FDA:
Guidance for Industry - Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions. Annex 2 Test for Extractable Volume of Parenteral Preparations General ...

FDA: Guidance for Industry - Annex 3 Test for Particulate Contamination: Subvisible Particles General Chapter

30.01.2009
FDA:
Guidance for Industry - Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions. Annex 3 Test for Particulate Contamination: Subvisible Particles General ...

FDA: Guidance for Industry - Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages (draft)

30.01.2009
FDA:
Guidance for Industry - Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages (draft). In this guidance, FDA is ...