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EMEA: Updated EMEA Post-Authorisation Procedural Advice Guidance

13.05.2009
Human Medicines: Updated EMEA Post-Authorisation Procedural Advice Guidance - Questions & Answers - Type I Variations, Type II Variations, Reneval, PSURs and others. ...

EMEA: Updated pre-submission procedural guidance, for users of the centralised procedure

13.05.2009
Human Medicines - EMEA Pre-Submission Procedural Advice - Questions & Answers ...

EMEA: Concept paper on the Development of a guideline on the use of Pharmacogenomics in the Pharmacokinetic Evaluation of medicinal products

13.05.2009
A Reflection paper on the use of pharmacogenetics in the pharmacokinetic evaluation of medicinal products (EMEA/128517/2006) was published by the EMEA in May 2007. Since the drafting of this ...

European Commision: Issues arising in the context of authorising non-prescription medicinal products through the centralised procedure

13.05.2009
The attached note summarizes and puts into context Community legislation and DG Enterprise and Industry\'s interpretation thereof with regard to a number of issues linked to prescription and ...

European Commision: Implementation of the new Regulation on maximum residue limits for pharmacologically active substances

13.05.2009
Public Consultation Paper on a Contribution for a future Commission regulation on the format and the content for applications and requests submitted for an opinion on a maximum residue limit for a ...

FDA: Labeling OTC Human Drug Products; Small Entity Compliance Guide

13.05.2009
In the Federal Register of March 17, 1999 (64 FR 13254), the FDA published a final regulation (§ 201.66) establishing standardized content and format for the labeling of OTC drug products (Drug ...

EMEA: Guideline on The replacement of rabbit pyrogen testing by an alternative test for plasma derived medicinal products

06.05.2009
This guideline lays down the requirements to be addressed in any justification for use of a test for bacterial endotoxins as an alternative to a test for pyrogens for plasma derived medicinal ...

EMEA: Updated inventory of herbal substances for assessment

06.05.2009
Updated inventory of herbal substances for assessment in Alphabetical order (New EU Legislation) ...

Polish Ministry of Health: Regulation project relating to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

28.04.2009
The regulation project introduce the new rights and obligations of the President of the Office for Registration. ...

European Commision: Maximum Residue Limits - Key documents

28.04.2009
Substances considered as not falling within the scope of Council Regulation (EEC) No 2377/90. Updated version (revision 14 April 2009) from the Committee for Veterinary Medicinal Products. The ...

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