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EMA: Guideline on good pharmacovigilance practices (GVP): P I - Vaccines for prophylaxis against infectious diseases – Definitions for inclusion in GVP annex I - Draft

18.04.2013
This is a draft guideline on good pharmacovigilance practices concering definitions for vaccines for prophylaxis against infectious diseases. ...

EMA: Guideline on good pharmacovigilance practices: Module II – Pharmacovigilance system master file

18.04.2013
The pharmacovigilance system master file definition is provided in Article 1(28e) of Directive 2001/83/EC and the minimum requirements for its content and maintenance are set out in the Commission ...

EMA: Concept paper on the need for a reflection paper on quality aspects of medicines for older people

11.04.2013
Unlike the paediatric case (regulation (EC) No 1901/2006), there is no specific legal requirement for the development of medicines for geriatric use. Nevertheless, there is a need to ensure that ...

GMP: FDA publishes Draft on Medical Devices Recalls Guideline

11.04.2013
The FDA has published an independent industry guideline on product recalls, biological and medical devices (\"Product Recalls, Including Removals and Corrections\"). According to this guideline, ...

MHRA: Public consultation on Medical Devices (Amendment) Regulations 2013

11.04.2013
The MHRA is seeking views on its approach to implementing into UK law the Commission Regulations 722/2012 on animal tissues and Commission Regulation 207/2012 on e-labelling. ...

EMA: Checking process of mock-ups and specimens of outer / immediate labelling and package leaflets of human medicinal products in the centralised procedure

11.04.2013
The EMA has now reviewed the experience with the checking process and considers that further amendments/simplification can be introduced. This document presents the proposed revision of the ...

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

04.04.2013
This document contains revised implementing rules to the Fee Regulation as of 1 April 2013. ...

GMP: WHO\'s New Draft Guideline on Submission of Quality Data for Generic Medicinal Products

04.04.2013
The guideline provides concrete recommendation on how to submit information within the CTD structure. The document ends with an appendix about conducting and assessing comparative dissolution ...

EMA: Concept paper on the development of medicinal products for the treatment of autism spectrum disorder

04.04.2013
Autism spectrum disorders (ASDs) are a group of neurodevelopmental disabilities with symptoms typically presenting before the age of 3 years and persisting into adulthood. They are described as ...

GMP: Simplification of Application Submissions for Centrally Authorised Products

04.04.2013
The document contains important information about the delivery of applications to the competent authority in the case of new marketing authorisations, renewals, type II variations, and further ...

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