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

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

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

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

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

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

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

European Commision: Maximum Residue Limits - Key documents

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 ...

FDA: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document

This guidance is intended to clarify for industry where to include the integrated summary of effectiveness (ISE) and integrated summary of safety (ISS) when submitting applications in the common ...

EMEA: Application Procedures - Quality Review of Documents (QRD)

28.04.2009 ...

EMEA: Regulatory and Procedural Guidance - Article 58 Applications

Administrative information application form for a Scientific Opinion according to Article 58 of Regulation (EC) 726/2004 ...

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