http://www.eipg.eu/ Latest information from the EIPG Website en communications@eipg.eu (Vice-President Communications) communications@eipg.eu (Vice-President Communications) Mon, 07 Jun 2010 22:17:59 +0200 http://www.eipg.eu/images/logaliten.jpg http://www.eipg.eu/ http://www.eipg.eu/indexposition papers.htm Comments from the European Industrial Pharmacists Group on the Commission’s Concept Paper on the Revision of Annex 16. Sun, 05 Feb 2012 16:04:15 +0100 ECC29A5A-2CE5-4D10-AA24-E8F3F22D9DAA http://www.eipg.eu/indexevents.htm To combat counterfeiting of medical products and related crime the Council of Europe has drawn up an international convention – the MEDICRIME Convention – a legally binding instrument criminalising all acts of counterfeiting of medical products. Sun, 05 Feb 2012 15:53:00 +0100 2A879185-F9E4-4A1F-80FB-CA445A42CE1E http://www.eipg.eu/indexguides.htm The European Industrial Pharmacists Group has updated its Guidelines on Good Distribution Practices of Medicinal Products to reflect changes in the WHO good distribution practices for pharmaceutical products. Wed, 25 Jan 2012 23:24:14 +0100 2365508F-E16B-4744-818A-244D79D4E071 http://www.eipg.eu/indexevents.htm Directive 2011/62/EU places an obligation on Member States to take appropriate measures to ensure that manufacturers of active substances on their territory comply with good manufacturing practice ('GMP') for active substances. It also places an obligation on the Commission to adopt, by means of delegated acts, the principles and guidelines of good manufacturing practice for active substances. This concept paper is being released for public consultation with a view to preparing the delegated act. Tue, 24 Jan 2012 21:33:02 +0100 C7B611D0-3A9B-42DF-84EC-3357D50EA065 http://www.eipg.eu/indexevents.htm The European Medicines Agency have published: Regulatory and procedural guideline: Qualification of novel methodologies for drug development: guidance to applicants. Tue, 24 Jan 2012 21:31:16 +0100 9999C2EF-3514-47BF-851A-AFF324A23E9D http://www.eipg.eu/indexevents.htm The European Medicines Agency have published: Scientific guideline: Draft guideline on active-substance-master-file procedure (revision 3), draft: consultation open. Tue, 24 Jan 2012 21:29:50 +0100 1F2A6FC5-607C-484F-9380-8A8B673CEBFF http://www.eipg.eu/indexposition papers.htm Comments from the European Industrial Pharmacists Group on the Commission’s Revised Guidelines on Good Distribution Practice of Medicinal Products for Human Use. Sat, 31 Dec 2011 12:57:09 +0100 834CAC5E-5B9F-4151-8F2B-9B1E5FAA9BEA http://www.eipg.eu/indexevents.htm The European Medicines Agency have published: Scientific guideline: Draft guideline on risk characterisation and assessment of Maximum Residue Limits (MRL) for biocides, draft: consultation open. Thu, 22 Dec 2011 12:52:44 +0100 3567335D-6BCE-40F0-8AF0-1D4F7C668FB3 http://www.eipg.eu/indexevents.htm The European Medicines Agency have published: Scientific guideline: Draft VICH GL51: Quality: statistical evaluation of stability data, draft: consultation open. Thu, 22 Dec 2011 12:52:18 +0100 59A656FA-36D7-46F4-9F9D-EE7CB4822623 http://www.eipg.eu/indexevents.htm The European Medicines Agency have published: Scientific guideline: Draft VICH GL50: Biologicals: testing harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use, draft: consultation open. Thu, 22 Dec 2011 12:51:43 +0100 880685CA-9F67-451B-BD33-6A2D291E3591 http://www.eipg.eu/indexevents.htm The European Medicines Agency have published: Scientific guideline: Draft VICH GL34: Biologicals: testing for the detection of mycoplasma contamination, draft: consultation open. Thu, 22 Dec 2011 12:50:53 +0100 A25C1101-C49D-4B6D-8902-C8BFC988F93A http://www.eipg.eu/indexevents.htm The European Medicines Agency have published: Scientific guideline: ICH guideline S2 (R1) - Genotoxicity testing and data interpretation for pharmaceuticals intended for human use, adopted. Mon, 19 Dec 2011 22:17:34 +0100 530ABB7F-392B-4343-AF3C-962A792D463E http://www.eipg.eu/indexevents.htm The European Medicines Agency have published: Scientific guideline: Guideline on the warning on transmissible agents in summary of product characteristics (SmPCs) and package leaflets for plasma-derived medicinal products, adopted. Mon, 19 Dec 2011 22:16:30 +0100 6743D36D-9150-463E-9457-62A2AD867B74 http://www.eipg.eu/indexevents.htm Directive 2011/62/EU introduces EU-wide rules for the importation of active substances. Article 111b(2) of Directive 2001/83/EC provides that the Commission adopts an implementing measure to apply these requirements. This concept paper is being rolled out for public consultation with a view to preparing this implementing act. Sun, 18 Dec 2011 20:59:52 +0100 E25B1DE0-9C20-413A-9421-F64B3C1FD696 http://www.industrialpharmacy.eipg.eu/indexissues.htm The 11th issue (December 2011) of the european Industrial Pharmacy journal has been published and is available from the journal's website. Sat, 10 Dec 2011 00:20:00 +0100 FED98015-6E2F-4FC4-ACB7-7FC6A6A84C3D