MHRA: Guidance on signposting from patient information leaflets

This guidance has been developed by the MHRA with advice from the Commission on Human Medicines Expert Advisory Group on Patient Information and in consultation with industry representatives. It ...

EMEA: Updated EMEA Post-Authorisation Procedural Advice Guidance

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

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

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

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. ...

kapitał ludzki

fundusz społeczny

Narodowe Centrum Badań i Rozwoju

innowacyjna gospodarka

rozwój regionalny