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EMA: Guideline on the investigation of drug interactions

12.07.2012
The potential for pharmacokinetic interactions between new medicinal products and already marketed drugs should be evaluated. This applies to both effects of the medicinal product on other drugs ...

Polish Ministry of Health: Regulation of Polish Minister of Health on the Veterinary Good Clinical Practice

12.07.2012
This document concerns Veterinary Good Clinical Practice. ...

EMA: Concept paper on non-pharmacopoeial reference standards for herbal substances, herbal preparations and herbal medicinal products / traditional herbal medicinal products

05.07.2012
This concept paper applies to non-pharmacopoeial reference standards for herbal substances, herbal preparations and herbal medicinal products (HMPs) / traditional herbal medicinal products (THMPs). ...

EMA: Concept paper on extrapolation of efficacy and safety in medicine development

05.07.2012
This concept paper is intended to discuss the need and possibility to develop a framework for extrapolation approaches that are considered scientifically valid and reliable to support medicine ...

EMA: Guideline on requirements for the production and control of immunological veterinary medicinal products

05.07.2012
This document provides information on items to be considered for the production and control of all immunological veterinary medicinal products (IVMPs). ...

EMA: CHMP guideline on detection and management of duplicate individual cases and individual case safety reports (ICSRs)

05.07.2012
Duplicate cases can pose significant problems for analysing signals arising from pharmacovigilance databases, both artificially inflating and masking signals of disproportionate reporting. ...

EMA: Guideline on good pharmacovigilance practices (GVP) Module I – Pharmacovigilance systems and their quality systems

28.06.2012
This Module contains guidance for the establishment and maintenance of quality assured pharmacovigilance systems for marketing authorisation holders, competent authorities of Member States and the ...

EMA: Guideline on good pharmacovigilance practices (GVP) Module II – Pharmacovigilance system master file

28.06.2012
The pharmacovigilance system master file is a legal requirement in the EU. This guidance concerns the requirements for the pharmacovigilance system master file and is applicable for any medicinal ...

EMA: Guideline on good pharmacovigilance practices (GVP) Module V – Risk management systems

28.06.2012
The purpose of risk identification and characterisation is to allow for risk minimisation or mitigation wherever possible. ...

EMA: Guideline on good pharmacovigilance practices (GVP) Module VI – Management and reporting of adverse reactions to medicinal products

28.06.2012
This Module addresses the legal requirements detailed in Title IX of Directive 2001/83/EC [DIR] and Chapter 3 of Regulation (EC) No 726/2004 [REG], which are applicable to competent authorities in ...

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