News

Last Updated: February 2012

This page is regularly updated with any interesting regulatory developments for foods making health claims.

Foods - Health claims

EU EC's Health and Consumer Health Directorate (DG Sanco), present European Parliament with health claims register that contains 222 approvals and about 2000 rejections Jan 2012 So far, 2,538 of 2,758 general function claims have not been successfully evaluated, amounting to a 92% rejection rate. Many of these evaluations were unsuccessful because insufficient data were provided, meaning that if companies are able to provide more of the right kind of data, further approvals will be issued. It is expected the EP will vote on the register within 90 days. If it passes, six months after that, the 2000 claim rejections will be banned across the EU.

EU EFSA open public consultation on a draft guidance on the scientific requirements for health claims related to physical performance Comment deadline March 2012. http://www.efsa.europa.eu/en/consultations/call/111219.htm

EU EFSA open public consultation on a draft guidance on the scientific requirements for health claims related to Comments required by 16 December 2011 This is followed up with a consultation to provide additional guidance to applicants on 2 December 2010 that will be webcast. http://www.efsa.europa.eu/en/consultationsclosed/call/111017.htm

EU EFSA issue guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health Dec 2011 Guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health http://www.efsa.europa.eu/en/efsajournal/doc/2474.pdf

UK Nutrition and health claims: Guidance to compliance with Regulation (EC) 1924/2006 on nutrition and health claims made on foods Nov2011 Updated guidance on how to achive compliane issued by DoH http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_130972

EU EU Food Information to Consumers Regulation Nov 2011 EU Food Information to Consumers Regulation was published as Regulation 1169/2011. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:304:0018:0063:EN:PDF

EU EC announce a delay in decision on the health claims for botanical substances September 2010 EC announced that claims for botanicals will follow "sometime after" the June 2011 deadline for all other substances.

EU Nutrition and Health Claims Regulation - EU register of published opinions health claims under Article 13, 13/5 and 14. Latest published opinions from EU Comission are available in the EU Register of nutrition and health claims made on food http://ec.europa.eu/food/food/labellingnutrition/claims/community_register/health_claims_en.htm

EU Nutrition and Health Claims Regulation - EFSA opinions health claims under Article 13, 13/5 and 14 All published opinions from EFSA are now available. http://www.efsa.europa.eu/en/topics/topic/article13.htm http://www.efsa.europa.eu/en/topics/topic/article13-5.htm http://www.efsa.europa.eu/en/topics/topic/article14.htm

EU European Commission announced change policy on health claims for botanicals September 2010 EC announced that claims for botanicals will follow "sometime after" the June 2011 for all other substances.

_______________________________________________________________________________________

This page is regularly updated with any interesting regulatory developments for Pharmaceuticals

Pharmaceuticals

EU New pharmacovigilance legislation adopted by the European Parliament Effective Jul 2012 New European Union (EU) pharmacovigilance legislation, Regulation (EU) No 1235/2010 and Directive 2010/84/EU was adopted by the European Parliament and Council of Ministers in December 2010. Many of the new provisions contained in the legislation must be implemented within 18 months (by July 2012). Check individual Agencies for local news and implementation plans.

EU New entries on to community list Feb 2012 Two new entries adopted vitis vinifera and thymus vitis http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:034:0005:0007:EN:PDF http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:034:0008:0011:EN:PDF

IE IE inveneted names guidance published Feb 2012 Guide for prescription and non-prescription medicinal products for human use, authorised by a national or mutual-recognition (MR) or decentralised procedure (DCP). http://www.imb.ie/EN/Publications/Medicines/Human-Medicines/Licensing/Guide-to-Invented-Names-of-Human-Medicines~.aspx?page=1&year=0&categoryid=&letter=&q= EU Article 30 harmonisation of SPC - latest information Jan 2012 http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Product_Information/Art30_Referrals/CMDh_140_2008_Rev20.xls

UK Review of unlicensed medicines supply by healthcare practitioners Jan 2012 The MHRA is currently reviewing the regulatory arrangements that exist in the UK which allow an authorised healthcare professional to commission an unlicensed medicinal product to meet the special needs of an individual patient http://www.mhra.gov.uk/Howweregulate/Medicines/Reviewofunlicensedmedicines/index.htm

UK Traditional Herbal Medicines Registration Scheme application numbers and latest news Dec 2011 The total number of applications received since the start of the THR scheme now stands at 236. 143 applications have so far been granted. This includes 14 transfers from product licence (PL) status to THR. The variety of herbal ingredients used continues to grow with 49 different herbs used in one or more applications granted to date. The total number of herbs in all applications stands at 97. http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedicinesregulation/RegisteredTraditionalHerbalMedicines/TraditionalHerbalMedicinesRegistrationSchemelatestnewsandapplicationnumbers/CON137799

UK Warning of the importance of using registered herbal medicines after discovering super-strength menopause remedy Dec 2011 The MHRA is urging consumers that natural does not always mean safe following a safety notice issued for FSC Black Cohosh http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON137768

EU Dec 2011 The EMEA have published an updated Inventory of herbal substances for assessment (EMEA/HMPC/494079/2007), and an updated list of the status of herbal monographs. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/12/WC500017723.pdf

EU Update on the use of eCTD in the MRP and DCP Nov 2011 The aim of this guidance is to encourage the submission of eCTD applications in the MRP and DCP and, therefore, to enable all parties to gain more experience. http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/eSubmissions/CMDh-084-2008-Rev3.2-Clean_2011_11.pdf

UK Nov 2011 MHRA introduces learning module for learning module aimed at pharmacovigilance in relation to clinial practice. http://www.mhra.gov.uk/ConferencesLearningCentre/LearningCentre/Medicineslearningmodules/pharmacovigilancelearningmodule/index.htm

UK UK legislation redrafted - consultation document Oct 2011 Formal consultation on the draft consolidated regulations and proposals for policy changes.requires repsonse by dealine of 17 January 2012. http://www.mhra.gov.uk/Howweregulate/Medicines/Overviewofmedicineslegislationandguidance/ProjecttoconsolidateandreviewUKmedicineslegislation/index.htm

EU Risk Management Plan and DPPS for MRp and DCP July 2011 CMDh Recommendation for Marketing Authorisation Holders on the Pharmacovigilance System and Risk Management Plan in the Mutual Recognition and Decentralised Procedures http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/01_General_Info/CMDh_067_2007_Rev1_Clean.pdf

SE Changes in procedure for requesting Sweden as RMS in DCP April 2011 New changes introduced in April 2011. http://www.lakemedelsverket.se/english/All-news/NYHETER-2011/Changes-in-procedure-for-requesting-Sweden-as-RMS-in-DCP/

EC Consultation on the conduct of clinical trials in children of herbal medicinal products Jan 2011 The EMA has launched a public consultation to initiate discussions on the conduct of clinical studies with herbal medicinal products in children. The call is open until 15 April 2011. No update from EMA yet. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/01/news_detail_001182.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1

© anngregulatory