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EMA: Guidance on centrally authorised products requiring a notification of a change for update of annexes

23.02.2012
On 23 July 2010 and after a consultation phase, the EMA communicated to all Parallel Distributors that it is not required to inform the EMA on changes to the labelling or leaflet related to any ...

EMA: Guidelines on good pharmacovigilance practices (GVP) Introductory cover note to the public consultation of the first seven modules

23.02.2012
New legislation for pharmacovigilance will apply in the European Union (EU) as of July 2012, and to support its implementation a new set of guidelines for the conduct of pharmacovigilance in the ...

Polish Ministry of Health: Regulation of Polish Minister of Health concerning duties of entrepreneurs having wholesale marketing authorization of category 1 precursor chemicals and the conditions that marketing holder must fulfil.

16.02.2012
Regulation of Polish Minister of Health concerning duties of entrepreneurs having wholesale marketing authorization of category 1 precursor chemicals and the conditions that marketing holder must ...

EMA: Concept paper on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products

16.02.2012
Currently, there is limited information on the utilisation of a genomic biomarker during follow up (post marketing) or on the effect of labelling with genomic information. Therefore, guidance is ...

EMA: Concept paper introducing a review and update of existing EU guidelines on residues studies to bring these into line with the VICH metabolism and residues guidelines GL46 to 49

16.02.2012
Residues studies should be performed both for the establishment of MRLs and for the determination of withdrawal periods (WPs), and a number of guidance documents relating to the need for, and ...

EMA: New Questions and Answers about the Centralised Procedure - EMA publishes an Updated Q&A Document

09.02.2012
The \"Questions & Answers\" part on the EMA website deals with special issues regarding the European marketing authorisation procedure. In irregular intervals, the EMA updates this collection of ...

FDA: FDA Regulation of PET Drug Products Questions and Answers

09.02.2012
This guidance is intended to help producers of positron emission tomography (PET) drugs meet the requirements for FDA’s drug approval process. This guidance provides questions and answers that ...

Polish Ministry of Health: Regulation of Polish Minister of Health concerning preparations containing narcotic drugs or psychotropic substances.

09.02.2012
Regulation of Polish Minister of Health concerning preparations containing narcotic drugs or psychotropic substances, that might be hold for medical reasons and applied in clinical trials, after ...

GMP: Extension of Directive 2003/94/EC to GMP for APIs - EC Commission publishes Concept Paper for Comment

02.02.2012
The EU Commission published a concept paper to extend Directive 2003/94/EC to GMP for APIs. This had already been announced in Directive 2011/62/EU on the prevention of the entry of falsified ...

GMP: Significant Administrative Changes in the New Revision of the Guideline on the ASMF Procedure

02.02.2012
The Guideline on Active Substance Master File Procedure is an important document within the framework of a marketing authorisation. The ASMF describes the quality characteristics of the ...

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