EN PL

News

European Commission: Notice to Applicants – Veterinary Medicinal Products - Volume 6C

21.09.2009
Electronic application form (XML file) for the renewal of a centrally marketing authorisation Electronic Application form (XML file) for the variation of a centrally marketing authorisation In ...

EMEA: Guideline on non-clicical and clinical development of Similar medicinal products containing recombinant Erythropoietins

21.09.2009
The non-clinical section addresses the pharmaco-toxicological assessment and the clinical section the requirements for pharmacokinetic, pharmacodynamic, efficacy and safety studies as well as the ...

EMEA: Revised Priority list for studies into off-patent paediatric medicinal products

21.09.2009
The aim of Regulation (EC) No1901/2006 of the European Parliament and the Council on Medicinal Products for Paediatric Use, as amended, is to increase availability of medicines authorised for ...

EMEA: Revised Qualification of novel methodologies for drug development: Guidance to applicants

21.09.2009
The qualification process addresses innovative drug development methods and tools. It will focus on the use of novel methodologies developed by consortia, networks, public/private partnerships, ...

MHRA: Draft guidance for comment on the UK\'s arrangements under the hospital exemption scheme for advanced therapy medicinal products.

11.09.2009
This draft guidance has been developed on the proposed UK exemption scheme for advanced therapy medicinal products (ATMPs) under Article 28 (2) of Regulation EC No 1394/2007 ...

European Commission: Requests for withdrawal of Community authorizations

09.09.2009
Holders of Community authorisations for the placing on the market of a medicinal product intending to request a withdrawal of their authorization with effect of the end of this year are asked to ...

European Commission: Substances considered as not falling within the scope of Council Regulation (EC) No. 470/2009 (Revision 16 – September 2009)

09.09.2009
The Committee for Veterinary Medicinal Products (CVMP) having reviewed all applications for the establishment of MRLs for \"old substances\" to be considered under Council Regulation (EC) ...

European Commission: Implementation of the Advanced Therapies Regulation

09.09.2009
Commission Regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of ...

Polish Office for Registration: The statement of the President of the Office for Registration relating to Braille

07.09.2009
The statement of the President refers to documents required to put the Braille on the packaging of the medicinal products. ...

EMEA: Mandate, objectives and rules of procedure of the Scientific Advice Working Party (SAWP)

07.09.2009
As a main objective, the Scientific Advice Working Party shall provide scientific advice for medicinal products for human use and protocol assistance for orphan medicinal products to facilitate ...