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Ministry of Health: Regulation project concerning the changes in The Decree of Ministry of Health relating to the payment for Marketing Authorization of the medicinal products

22.05.2009
The regulation project introduce the updated basic amount (from 1126 PLN to 1276 PLN). The payment for MA of the medicinal products is established in relation to the basic amount. ...

EMEA: Guideline on Missing data in confirmatory clinical trials

19.05.2009
This guideline provides advice on how the presence of missing data in a confirmatory clinical trial should be addressed in a regulatory submission. ...

MHRA: Additional hypotensive effects following co-administration of non-selective alpha-blockers and phosphodiesterase-5-inhibitors: Guidance for marketing authorisation holders.

19.05.2009
Requirement for marketing authorisation holders to submit Type II variations by 15 June 2009 to update licences with additional guidance on hypotensive effects. During the discussion of this ...

MHRA: Guidance on signposting from patient information leaflets

19.05.2009
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

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 ...