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Main Pharmaceutical Inspectorate: The Main Inspector statement related to impersonate Main Pharmaceutical Inspectorate employer.

26.10.2010
The Main Inspector statement related to impersonate Main Pharmaceutical Inspectorate employer. ...

EMA: Regulatory and procedural guideline: Implementation plan for the \'Note for guidance - EudraVigilance Human – Processing of safety messages and individual case safety reports (ICSRs) (EMEA/H/20665/04/Final Rev. 2)

26.10.2010
The scope of the revised note for guidance is to improve the quality and consistency of ICSRs reported electronically. This has been achieved by strengthening of the validation processes of ICH ...

EMA: Regulatory and procedural guideline: Guideline for the specifications of e-submissions of parallel distribution notification documents

26.10.2010
This Guidance is intended to assist Parallel Distributors with the submission of notifications or notifications of a change for parallel distribution in electronic format to the Agency. It is ...

EMA: Scientific guideline: Questions and answers on the guideline on the limits of genotoxic impurities

26.10.2010
The aim of this question-and-answer document is to provide clarification and harmonisation of the \'Guideline on the limits of genotoxic impurities\' (EMEA/CHMP/QWP/251344/2006), published in 2006. ...

FDA: Qualification Process for Drug Development Tools

26.10.2010
This guidance describes the qualification process for drug development tools (DDTs) intended for potential use, over time, in multiple drug development programs. DDTs include, but are not limited ...

Polish Ministry of Health: Project of the Act related to reimbrusment of medicinal products, Foods for particular nutritional uses and medical devices

19.10.2010
Project of the Act related to reimbrusment of medicinal products, Foods for particular nutritional uses and medical devices ...

EMA: Scientific guideline: ICH guideline E2F: Note for guidance on development safety update reports: Step 4

19.10.2010
The Development Safety Update Report (DSUR) proposed in this guideline is intended to be a common standard for periodic reporting on drugs under development (including marketed drugs that are ...

EMA: Scientific guideline: Reflection paper on the pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems (non-polymeric surfactants), draft: consultation open

19.10.2010
This paper describes a basic package of information which could be relevant to confirm the sound pharmaceutical development and full characterisation of products of this type. ...

EMA: Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures

19.10.2010
Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures, ec: Scientific advice, Extension of marketing authorisations, ...

EMA: Regulatory and procedural guideline: Post-authorisation procedural advice: Human medicinal products

19.10.2010
This guidance document addresses a number of questions which Marketing Authorisation Holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on ...

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