The European Union CD 1999/83/EEC on well-established use

Size: px
Start display at page:

Download "The European Union CD 1999/83/EEC on well-established use"

Transcription

1 The European Union CD 1999/83/EEC on well-established use - application to herbal medicinal products - Dr. Konstantin Keller Chair of the Herbal Medicinal Products Working Group European Medicines Evaluation Agency, London European Council Directive 65/65 EEC of 26 January 1965 Article 4 No. 8 a) ii The applicant shall not be required to provide the results of... trials if he can demonstrate: (ii)... by detailed reference to published scientific literature... that the constituent or constituents of the proprietary medicinal product have a well established medicinal use, with recognised efficacy and an acceptable level of safety.

2 Herbal Medicinal Products in the EU COMMISSION DIRECTIVE 1999/83/EC of 8 September 1999 amending the Annex to Council Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of medicinal products Official Journal of the European Communities L 243/9 Herbal Medicinal Products in the EU COMMISSION DIRECTIVE 1999/83/EC of 8 September (6) Whereas it is in particular necessary to clarify that bibliographic reference to other sources of evidence (postmarketing studies, epidemiological studies, studies conducted with similar products, etc.) and not just tests and trials may serve as a valid proof of safety and efficacy of a product if an applicant explains and justifies the use of these sources of information satisfactorily...

3 Herbal Medicinal Products in the EU COMMISSION DIRECTIVE 1999/83/EC of 8 September 1999 New Section I in Part 3 and 4 of the Annex to Directive 75/318/EEC I. Well-established medicinal use For the purpose of demonstrating, pursuant to Article 4(8)(a)(ii) of Directive 65/65/EEC, that the constituent(s) of a medicinal product have a well established use, with an acceptable level of safety, the following specific rules shall apply:... Herbal Medicinal Products in the EU COMMISSION DIRECTIVE 1999/83/EC of 8 September 1999 (a) Factors which have to be taken into account the time over which a substance has been used quantitative aspects of the use of the substance the degree of scientific interest in the use of the substance (reflected in the published scientific literature) the coherence of scientific assessments different periods of time may be necessary for establishing well established use of different substances minimum of one decade from the first systematic and documented use of that substance as a medicinal product in the EU.

4 Herbal Medicinal Products in the EU Results COMMISSION DIRECTIVE 1999/83/EC (b) The documentation submitted should cover all aspects of the safety and efficacy assessment and must include or refer to a review of the relevant literature, taking into account pre-and postmarketing studies and published scientific literature concerning experience in the form of epidemiological studies and in particular of comparative epidemiological studies. All documentation, both favourable and unfavourable, should be communicated Herbal Medicinal Products in the EU COMMISSION DIRECTIVE 1999/83/EC (c) Particular attention must be paid to any missing information and justification must be given why demonstration of an acceptable level of safety/efficacy can be supported although some studies are lacking.

5 Interpretation of Art. 4(8)a ii of CD 65/65 EEC 49th Meeting of the Pharmaceutical Committee, March 2000 Bibliographic dossiers must always be full dossiers. Whenever information on specific points is missing, justification must be given why demonstration of an acceptable level of safety and efficacy can be supported although some studies are lacking. Well-established use always refers to the use of a specific substance for a specific therapeutic use. If well-known substances are used for entirely new therapeutic indications, it is not possible to refer to well-established use. Interpretation of Art. 4(8)a ii of CD 65/65 EEC 49th Meeting of the Pharmaceutical Committee, March 2000 Interpretative Guidance on the application of Directive 99/83 will be given both by the Commission (through the updated NTA) and the CPMP (through Guidance documents on the safety and efficacy of old substances)

6 Herbal Medicinal Products in the EU COMMISSION DIRECTIVE 1999/83/EC (d) The Expert report must explain the relevance of any data submitted which concern a product different from the product intended for marketing. A judgement must be made whether the product studied can be considered as similar to the product which will be granted a marketing authorisation in spite of the existing differences. Points to consider on the evidence of safety and efficacy required for well-established herbal medicinal products in bibliographic applications 3. Well-established use Can published literature on one herbal medicinal product be used in the assessment of another herbal medicinal product? Complex biological mixtures produced by different manufacturers are never identical. Sufficiently identical, if the specification is the same and no relevant differences in the manufacturing process exists. Particularly important in highly purified extracts or a new method of preparation of an extract

7 Points to consider on the evidence of safety and efficacy required for well-established herbal medicinal products in bibliographic applications 3. Well-established use In the case of classical herbal drug preparations such as tinctures and extracts described in pharmacopoeias and used for long time, a comprehensive specification will not be available from published literature in most cases. For these preparations the starting material and the extraction solvent must be identical. If there are reasons to expect a different pharmacological or toxicological profile, additional data and an update of the specification and/or appropriate data on bioavailability may be necessary. Herbal Medicinal Products in the EU COMMISSION DIRECTIVE 1999/83/EC (e) Post-marketing experience with other products containing the same constituents is of particular importance and applicants should put a special emphasis on this issue.

8 Herbal Medicinal Products in the EU COMMISSION DIRECTIVE 75/318/EEC Part 3: Toxicological and pharmacological Tests I. Introduction The toxicological and pharmacological tests must show: a) the potential toxicity... and any dangerous or undesirable toxic effects that may occur under the proposed conditions of use in human beings;... b) the pharmacological properties of the product, in both qualitative and quantitative relationship to the proposed use NON-CLINICAL TESTING OF HERBAL DRUG PREPARATIONS WITH LONG-TERM MARKETING EXPERIENCE Guidance to facilitate mutual recognition and use of bibliographic data September 1998 Effects that are difficult, even impossible to detect clinically - Toxicity to Reproduction - Genotoxicity - Carcinogenicity Expert-Report points out the necessity or not of new studies

9 NON-CLINICAL TESTING It is appropriate to assess genotoxicity initially in a bacterial reverse mutation test using a test battery of different bacterial strains and metabolic activation (s. CPMP/ICH and OECD Guidelines). This test has been shown to detect relevant genetic changes and the majority of genotoxic rodent carcinogens. If positive results can not be clearly attributed to specific constituents with a well-established safety-profile (e.g. Quercetin) additional in vitro and, if necessary, in vivo studies should be performed. A co-operative approach is encouraged to investigate herbal drug preparations with the same specification. NON-CLINICAL TESTING Tests not required, if sufficient experience in humans is available: single dose toxicity, repeated dose toxicity, immunotoxicity local tolerance testing pharmacological tests including safety pharmacology, pharmacokinetic studies. The expert report must address these aspects and give the grounds why the documented medical experience justifies a safe use of the herbal drug preparation.

10 Herbal Medicinal Products in the EU COMMISSION DIRECTIVE 75/318/EEC Part 4: Clinical Documentation Evaluation of the application for marketing authorisation shall be based on clinical trials including clinical pharmacological trials designed to determine the efficacy and safety of the product under normal conditions of use, having regard to the therapeutic indications for use in human beings. Therapeutic advantages must outweight potential risks. Herbal Medicinal Products in the EU COMMISSION DIRECTIVE 75/318/EEC Part 4: Clinical documentation A. General Requirements The clinical particulars to be provided pursuant to point 8 of Article 4(2) of Directive 65/65/EEC must enable a sufficiently well-founded and scientifically valid opinion to be formed as to whether the medicinal product satisfies the criteria governing the granting of a marketing authorisation.... an essential requirement is that the results of all clinical trials should be communicated, both favourable and unfavourable.

11 Herbal Medicinal Products in the EU COMMISSION DIRECTIVE 75/318/EEC Part 4: Clinical documentation F. Clinical Efficacy and Safety 1. In general, clinical trials shall be done as controlled clinical trials and if possible, randomised; any other design shall be justified.... As far as possible, and particularly in trials where the effect of the product cannot be objectively measured, steps shall be taken to avoid bias... Herbal Medicinal Products in the EU COMMISSION DIRECTIVE 75/318/EEC Part 4: Clinical documentation F. Clinical Efficacy and Safety 8. A critical assessment of relative safety, taking into account adverse reactions, shall be made in relation to: the disease to be treated, other therapeutic approaches, particular characteristics in sub-groups of patients, pre-clinical data on toxicology and pharmacology.

12 Points to consider on the evidence of safety and efficacy required for well-established herbal medicinal products in bibliographic applications 4. Recognised efficacy The requirements for... the documentation required to support the indicated claims should depend on the nature and the level of the indication(s). For treatment of minor disorders a lower level of evidence may be adequate, especially when the extent of long-term use, the experience with that particular herbal medicinal product and supportive pharmacological data are taken into account. The level of evidence and the grading of recommendations must correspond to the nature of the disease that is to be treated. The therapeutic alternatives available, the risks of a delayed or insufficient treatment and the risks of the herbal drug preparation have to be taken into account. Grading of Recommendations Grade A: Evidence Ia, Ib Requires at least one randomised controlled trial as part of the body of literature of overall good and consistency addressing the specific recommendation. Grade B: Evidence IIa, IIb, III Requires availability of well-conducted clinical studies but no randomised clinical trials on the topic of recommendation Grade C: Evidence IV Requires evidence from expert committee reports or opinions and/or clinical experience of respected authorities. Indicates absence of directly applicable studies of good quality

13 a lity o f I Truth Quality of Information Gossip Lies Grading of Recommendations A B C X expert committee reports opinions and/or clinical experience of respected authorities; minimum: documented long term use and supportive experimental data No or negative expert committee reports, no or negative opinions / clinical experience of respected authorities; documented or notdocumented long or short term use without supportive experimental data Truth Qu nformatio n Grading of Recommendations A B well-conducted clinical studies but no randomised clinical trials expert committee reports opinions and / or clinical C experience of respected authorities; documented long term use and supportive Gossip experimental data,... Lies X Stories and tales... Spectacular new uses Fraud solely based on experimental data,

14 Qual Truth ity of Information Gossip Lies Fraud Grading of Recommendations A B C X At least one well-conducted RCT well-conducted clinical studies but no randomised clinical trials expert committee reports opinions or clinical experience of respected authorities; documented long term use and supportive experimental data,... Stories and tales... Spectacular new uses solely based on experimental data core-spc for Isphagula Husk (January final draft march 2000) Submission to CPMP March THERAPEUTIC INDICATIONS Herbal medicinal product for a) the treatment of habitual constipation; conditions in which easy defecation with soft stools is desirable, e.g. in cases of painful defecation after rectal or anal surgery; (II-III) b) adjuvant symptomatic therapy in cases of diarrhoea from various causes; (III-IV, Decision by Majority) c) conditions which need an increased fibre intake, e.g. irritable bowel syndrome. (IIb-III; Decision by Majority)

15 Notice to Applicants Chapter I Marketing Authorisations, Section 4 Stand Alone Applications for a Marketing Authorisation... Scientific monographs... (e.g. those drafted by the European Scientific Co-operative on Phytotherapy (ESCOP) and the World Health Organisation (WHO) for herbal drugs) offer a valuable and updated overview on published scientific literature, which together may be used in support of the demonstration of the safety and efficacy of a medicinal product in a bibliographical application in... These monographs may help to avoid duplication of work and bring about gradual harmonisation in the evaluation of medicinal products, e.g. herbal medicinal products. Therefore the Commission and Member States recommend that both applicants and competent authorities should make use of these monographs... The Role of core-spcs 49th Meeting of the Pharmaceutical Committee, March 2000 The so-called core-spcs (e.g. those elaborated by the Herbal Working Group of the EMEA) are legally not binding. The value of these core-spcs is based on their persuasive power, underpinned by the fact that technical experts of all EU competent authorities have considered and agreed upon them.

16 The Role of core-spcs Joint Meeting of the Human and Veterinary Pharmaceutical Committees, November 2000 The intention to progressively harmonise generic medicinal products by agreeing upon core-spcs was in general supported by the Member States. Draft core-spc for Hop Strobile (draft march 2000) Submission to CPMP March THERAPEUTIC INDICATIONS None accepted on the basis of bibliographic data provided by the ESCOP monograph. (Decision by Majority)

17 Traditional Evidence X1 documented long term use without supportive experimental data / plausibility Quality of Information Fraud - Lies - Gossip X X2 negative expert committee reports, negative opinions / clinical experience of respected authorities; short term/new use; extrapolation of experimental data Perspectives Herbal medicinal Products are a reality in the European market Public Health concerns related to uncontrolled herbal medicinal products and starting material are a reality in the European market Lack of Interest in the Industry? Mutual recognition of herbal medicinal products not feasible?

18 Herbal medicinal products with successful MR TM Year RMS CS Mucivital flavoured 1996 DE AU; BE; GR; I; (Isphagula husk) PORT; UK Nozoil 1997 SE FI (Sesame oil nasal spray) Minolest 1997 DE AU; BE; LUX; SE (Isphagula husk, Guar gum) Valerian Caps UK AU; GR; I; PORT (Valerian root) Gammaderm 1999 UK DE; IR (Evening primrose oil cream) Capsicum Pain Plaster (Capsicum extract) 2000 DE AU; DK; F; FI; LUX; NOR; SE; UK Herbal medicinal products with successful MR 6 applications for Mutual Recognition replacing 31 national applications

19 Phase of consolidation Perspectives European legislation / Update of procedures improvement of the current MR procedure responsibilities of scientific bodies / centers of excellence Implementation of expertise Implementation of scientific standards Exchange of information and transparency of criteria Constant update of standards in the light of experiences gathered by competent authorities and applicants harmonization of the EU market by core-spcs

EMEA WORKING PARTY ON HERBAL MEDICINAL PRODUCTS

EMEA WORKING PARTY ON HERBAL MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use 25 October 1999 EMEA/HMPWP/23/99 EMEA WORKING PARTY ON HERBAL MEDICINAL PRODUCTS UPDATED DRAFT POINTS

More information

COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC)

COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) European Medicines Agency Post-authorisation Evaluation of Medicines for Human Use London, 7 September 2006 Doc. Ref. EMEA/HMPC/104613/2005 COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) GUIDELINE ON THE

More information

DIRECTIVE 2004/24/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL. of 31 March 2004

DIRECTIVE 2004/24/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL. of 31 March 2004 30.4.2004 Official Journal of the European Union L 136/85 DIRECTIVE 2004/24/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 amending, as regards traditional herbal medicinal products,

More information

C 178/2 Official Journal of the European Union

C 178/2 Official Journal of the European Union C 178/2 Official Journal of the European Union 29.7.2003 Communication from the Commission on Regulation (EC) No 141/2000 of the European Parliament and of the Council on orphan medicinal products (2003/C

More information

Official Journal of the European Union L 109/11

Official Journal of the European Union L 109/11 19.4.2008 Official Journal of the European Union L 109/11 COMMISSION REGULATION (EC) No 353/2008 of 18 April 2008 establishing implementing rules for applications for authorisation of health claims as

More information

COMMISSION REGULATION (EU)

COMMISSION REGULATION (EU) 11.3.2011 Official Journal of the European Union L 64/15 COMMISSION REGULATION (EU) No 234/2011 of 10 March 2011 implementing Regulation (EC) No 1331/2008 of the European Parliament and of the Council

More information

A GUIDELINE ON CHANGING THE CLASSIFICATION FOR THE SUPPLY OF A MEDICINAL PRODUCT FOR HUMAN USE

A GUIDELINE ON CHANGING THE CLASSIFICATION FOR THE SUPPLY OF A MEDICINAL PRODUCT FOR HUMAN USE EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Revision January 2006 A GUIDELINE ON CHANGING THE CLASSIFICATION FOR THE SUPPLY OF A MEDICINAL PRODUCT FOR

More information

REPORT FROM THE AD HOC WORKING GROUP ON HERBAL MEDICINAL PRODUCTS 1997/1998

REPORT FROM THE AD HOC WORKING GROUP ON HERBAL MEDICINAL PRODUCTS 1997/1998 The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use REPORT FROM THE AD HOC WORKING GROUP ON HERBAL MEDICINAL PRODUCTS 1997/1998 The views presented in this

More information

REGULATION concerning Marketing Authorisations for Natural Medicinal Products and Registration of Traditional Herbal Medicinal Products, No. 142/2011.

REGULATION concerning Marketing Authorisations for Natural Medicinal Products and Registration of Traditional Herbal Medicinal Products, No. 142/2011. REGULATION concerning Marketing Authorisations for Natural Medicinal Products and Registration of Traditional Herbal Medicinal Products, No. 142/2011. CHAPTER I Scope and definitions. Article 1 Scope.

More information

Fang-Chi Chang (M.D.,Ph.D.) Center for Drug Evaluation, Taiwan

Fang-Chi Chang (M.D.,Ph.D.) Center for Drug Evaluation, Taiwan Fang-Chi Chang (M.D.,Ph.D.) Center for Drug Evaluation, Taiwan Outline Herbal Medicines in the U.S. Herbal Medicines in EU Herbal Medicines in Australia Herbal Medicines in Asia & Taiwan Regulatory Strategy

More information

Guideline on influenza vaccines submission and procedural requirements

Guideline on influenza vaccines submission and procedural requirements 1 2 3 October 2014 EMA/56793/2014 Human Medicines Research and Development Support 4 5 6 Guideline on influenza vaccines submission and procedural requirements Regulatory and procedural requirements module

More information

CHAPTER 3. September 2007

CHAPTER 3. September 2007 EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, ENTR/F2/SM D(2007) Revision September 2007 NOTICE TO APPLICANTS VOLUME 2A Procedures for marketing

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) The European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use London, 15 December 2005 EMEA/357981/2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON PROCEDURES

More information

COUNCIL OF THE EUROPEAN UNION. Brussels, 7 September 2009 (OR. en) 11261/09 Interinstitutional File: 2008/0002 (COD) DENLEG 51 CODEC 893

COUNCIL OF THE EUROPEAN UNION. Brussels, 7 September 2009 (OR. en) 11261/09 Interinstitutional File: 2008/0002 (COD) DENLEG 51 CODEC 893 COUNCIL OF THE EUROPEAN UNION Brussels, 7 September 2009 (OR. en) 11261/09 Interinstitutional File: 2008/0002 (COD) DLEG 51 CODEC 893 LEGISLATIVE ACTS AND OTHER INSTRUMTS Subject: Common Position with

More information

VOLUME 6A Procedures for marketing authorisation

VOLUME 6A Procedures for marketing authorisation EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, 27.09.2007 ENTR/F2/KK D(2007) Revision September 2007 NOTICE TO APPLICANTS VETERINARY MEDICINAL

More information

Official Journal of the European Union. (Non-legislative acts) REGULATIONS

Official Journal of the European Union. (Non-legislative acts) REGULATIONS 21.2.2015 L 50/1 II (Non-legislative acts) REGULATIONS COMMISSION REGULATION (EU) 2015/282 of 20 February 2015 amending Annexes VIII, IX and X to Regulation (EC) No 1907/2006 of the European Parliament

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)

COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP) European Medicines Agency Veterinary Medicines and Inspections London, 16 February 2006 Doc. Ref.EMEA/CVMP/IWP/46853/2006 COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP) REFLECTION PAPER: MINIMUM

More information

Meeting report, September 2005

Meeting report, September 2005 European Medicines Agency Post-authorisation Evaluation of Medicines for Human Use London, 24 October 2005 Doc. Ref. EMEA//322553/2005 COMMITTEE ON HERBAL MEDICINAL PRODUCTS () Meeting report, 19-20 September

More information

Toxicological assessment of phytopharmaceutics

Toxicological assessment of phytopharmaceutics Toxicological assessment of phytopharmaceutics Olavi Pelkonen Department of Pharmacology and Toxicology University of Oulu, Finland Co-opted member of HMPC, EMEA olavi.pelkonen@oulu.fi Kolloquium Toxikologie,

More information

COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL

COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL European Medicines Agency Evaluation of Medicines for Human Use London, 11 January 2007 Ref: EMEA/HMPC/182352/2005 Rev. 2 COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL PROCEDURE FOR THE PREPARATION

More information

Laura Beatriz Herrero Montarelo, Maria Dolores Gómez Vázquez and Victorio José Teruel Muñoz

Laura Beatriz Herrero Montarelo, Maria Dolores Gómez Vázquez and Victorio José Teruel Muñoz Collaboration Laura Beatriz Herrero Montarelo, Maria Dolores Gómez Vázquez and Victorio José Teruel Muñoz Nutritional Risk Management Area of the Subdirectorate-General for Food Safety Promotion Spanish

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) European Medicines Agency London, 26 July 2006 Doc. Ref. EMEA/186279/2006 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON LEGAL STATUS FOR THE SUPPLY TO THE PATIENT OF CENTRALLY AUTHORISED

More information

COMMISSION REGULATION (EU) / of XXX

COMMISSION REGULATION (EU) / of XXX Ref. Ares(2016)5616438-28/09/2016 EUROPEAN COMMISSION Brussels, XXX [ ](2016) XXX draft COMMISSION REGULATION (EU) / of XXX amending Annex III to Directive 2008/98/EC of the European Parliament and of

More information

HERBAL MEDICINES: Product Licence To Traditional Herbal Registration in the UK. Presented by: Mariam Aslam

HERBAL MEDICINES: Product Licence To Traditional Herbal Registration in the UK. Presented by: Mariam Aslam HERBAL MEDICINES: Product Licence To Traditional Herbal Registration in the UK Presented by: Mariam Aslam ESCOP European Scientific Cooperative On Phytotheapy (ESCOP) Founded in June 1989 as an umbrella

More information

EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL. PHARMACEUTICAL COMMITTEE 21 October 2015

EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL. PHARMACEUTICAL COMMITTEE 21 October 2015 EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL Health systems and products Medicinal products authorisations, European Medicines Agency PHARM 689 PHARMACEUTICAL COMMITTEE 21 October 2015

More information

Scientific and Regulatory Basis for Development, Quality Assurance and Marketing Authorisation

Scientific and Regulatory Basis for Development, Quality Assurance and Marketing Authorisation Scientific and Regulatory Basis for Development, Quality Assurance and Marketing Authorisation Dr. Frauke Gaedcke, Waidesch Dr. Barbara Steinhoff, Konigswinter In collaboration with Dr. Helga Blasius,

More information

Other EU Activities Contributing to Harmonization of Labeling

Other EU Activities Contributing to Harmonization of Labeling Other EU Activities Contributing to Harmonization of Labeling Dr Laurent Brassart European Medicines Agency Medical Information Sector DIA Labeling Harmonisation 2011 Workshop October 13-14. 2011 Disclaimer

More information

Discussion by HMPC Drafting Group on Quality February Start of public consultation 27 June 2012

Discussion by HMPC Drafting Group on Quality February Start of public consultation 27 June 2012 1 2 3 22 May 2012 EMA/HMPC/312890/2012 Committee on Herbal Medicinal Products (HMPC) 4 5 6 7 8 Concept paper on non-pharmacopoeial reference standards for herbal substances, herbal preparations and herbal

More information

EUROPEAN COMMISSION SUMMARY REPORT OF THE STANDING COMMITTEE ON PLANTS, ANIMALS, FOOD AND FEED HELD IN BRUSSELS ON 09 JUNE 2015

EUROPEAN COMMISSION SUMMARY REPORT OF THE STANDING COMMITTEE ON PLANTS, ANIMALS, FOOD AND FEED HELD IN BRUSSELS ON 09 JUNE 2015 EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL sante.ddg2.g.dir(2015)2952292 SUMMARY REPORT OF THE STANDING COMMITTEE ON PLANTS, ANIMALS, FOOD AND FEED HELD IN BRUSSELS ON 09 JUNE 2015

More information

October 2003 Revision 1, February INTRODUCTION AND SCOPE

October 2003 Revision 1, February INTRODUCTION AND SCOPE BEST PRACTICE GUIDE FOR THE EXCHANGE OF REGULATORY AND ADMINISTRATIVE INFORMATION REGARDING ORPHAN MEDICINAL PRODUCTS BETWEEN THE EMEA AND THE NATIONAL COMPETENT AUTHORITIES October 2003 Revision 1, February

More information

Report from the CMD(h) meeting held on 17 th, 18 th and 19 th September 2007

Report from the CMD(h) meeting held on 17 th, 18 th and 19 th September 2007 Report from the CMD(h) meeting held on 17 th, 18 th and 19 th September 2007 CMD(h)/EMEA Sub-Group on Paediatric Regulation The CMD(h) and the EMEA have agreed on a procedural guidance to facilitate the

More information

College ter Beoordeling van Geneesmiddelen / Medicines Evaluation Board. Graadt van Roggenweg AH Utrecht The Netherlands

College ter Beoordeling van Geneesmiddelen / Medicines Evaluation Board. Graadt van Roggenweg AH Utrecht The Netherlands College ter Beoordeling van Geneesmiddelen / Medicines Evaluation Board Graadt van Roggenweg 500 3531 AH Utrecht The Netherlands MUTUAL RECOGNITION PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A

More information

COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) DRAFT COMMUNITY HERBAL MONOGRAPH ON VALERIANA OFFICINALIS L., RADIX AND HUMULUS LUPULUS L.

COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) DRAFT COMMUNITY HERBAL MONOGRAPH ON VALERIANA OFFICINALIS L., RADIX AND HUMULUS LUPULUS L. European Medicines Agency Evaluation of Medicines for Human Use London, 14 May 2009 Doc. Ref.: EMEA/HMPC/585558/2007 COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) DRAFT COMMUNITY HERBAL MONOGRAPH ON VALERIANA

More information

OVERVIEW OF COMMENTS RECEIVED ON COMMUNITY HERBAL MONOGRAPH ON PLANTAGO OVATA FORSSK., SEMEN (EMEA/HMPC/340861/2005)

OVERVIEW OF COMMENTS RECEIVED ON COMMUNITY HERBAL MONOGRAPH ON PLANTAGO OVATA FORSSK., SEMEN (EMEA/HMPC/340861/2005) European Medicines Agency Post-authorisation Evaluation of Medicines for Human Use This document was valid from July 2006 until May 2013. London, 28 February 2007 Doc. Ref. EMEA/HMPC/65636/2006 OVERVIEW

More information

Good Laboratory Practice. EU-Serbia screening meeting Brussels, 19 June 2014

Good Laboratory Practice. EU-Serbia screening meeting Brussels, 19 June 2014 Good Laboratory Practice EU-Serbia screening meeting Brussels, 19 June 2014 Table of contents 1. Background information on the principles of GLP 2. EU legal basis for GLP 3. Role of Member States 4. Role

More information

Federation of EU Specialty Food Ingredients Industries

Federation of EU Specialty Food Ingredients Industries Federation of EU Specialty Food Ingredients Industries Additives: - Discovering the new EU positive lists of food additives and preparing for EFSA s re-evaluation system - Getting ready for a changing

More information

Prof.Dr.Theodor Dingermann, Institut für Pharmazeutische Biologie, Goethe-Universität Frankfurt a.m.

Prof.Dr.Theodor Dingermann, Institut für Pharmazeutische Biologie, Goethe-Universität Frankfurt a.m. 19 September 2017 EMA/HMPC/183134/2017 Rev. 1 Committee on Herbal Medicinal Products (HMPC) Guideline on the assessment of clinical safety and efficacy in the preparation of European Union herbal monographs

More information

GLP in the European Union Ecolabel detergents, GLP and accreditation

GLP in the European Union Ecolabel detergents, GLP and accreditation GLP in the European Union Ecolabel detergents, GLP and accreditation Maik Schmahl Brussels, 25/03/2010 Chemicals Unit Outline What is GLP? How has it developed? The role of the Member States, the European

More information

REGULATION (EC) No.141/2000

REGULATION (EC) No.141/2000 REGULATION (EC) No.141/2000 Community legislation in force Document 300R0141 Directory chapters where this document can be found: [15.30 Health promotion] Regulation (EC) No.141/2000 of the European Parliament

More information

Practical guidance for applicants on the submission of applications on food additives, food enzymes and food flavourings

Practical guidance for applicants on the submission of applications on food additives, food enzymes and food flavourings Version 2 Updated on 29/11/2011 Practical guidance for applicants on the submission of applications on food additives, food enzymes and food flavourings Valid as of: 11 September 2011 Disclaimer: This

More information

DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT DERMIPRED/PREDNISOLONE CEVA 10 MG DATE : JULY 2016

DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT DERMIPRED/PREDNISOLONE CEVA 10 MG DATE : JULY 2016 FRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS AGENCE NATIONALE DU MEDICAMENT VETERINAIRE 8 rue Claude Bourgelat Parc d activités de la grande Marche Javené CS 70611 35306 FOUGERES DECENTRALISED PROCEDURE

More information

Official Journal of the European Union

Official Journal of the European Union 1.6.2016 L 144/27 COMMISSION REGULATION (EU) 2016/863 of 31 May 2016 amending Annexes VII and VIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation,

More information

DOSE SELECTION FOR CARCINOGENICITY STUDIES OF PHARMACEUTICALS *)

DOSE SELECTION FOR CARCINOGENICITY STUDIES OF PHARMACEUTICALS *) DOSE SELECTION FOR CARCINOGENICITY STUDIES OF PHARMACEUTICALS *) Guideline Title Dose Selection for Carcinogenicity Studies of Pharmaceuticals *) Legislative basis Directive 75/318/EEC as amended Date

More information

WORKING PARTY ON HERBAL MEDICINAL PRODUCTS FINAL PROPOSAL FOR A CORE DATA FOR ISPAGHULA HUSK

WORKING PARTY ON HERBAL MEDICINAL PRODUCTS FINAL PROPOSAL FOR A CORE DATA FOR ISPAGHULA HUSK The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use 27 March 2003 EMEA/HMPWP/15/00 WORKING PARTY ON HERBAL MEDICINAL PRODUCTS FINAL PROPOSAL FOR A CORE DATA

More information

European Medicines Agency COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL

European Medicines Agency COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL European Medicines Agency London, 12 November 2009 Doc. Ref. EMEA/HMPC/67644/2009 COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL GUIDELINE ON SELECTION OF TEST MATERIALS FOR GENOTOXICITY TESTING FOR

More information

Procedural advice on the submission of variations for annual update of human influenza inactivated vaccines applications in the centralised procedure

Procedural advice on the submission of variations for annual update of human influenza inactivated vaccines applications in the centralised procedure 1 2 3 4 5 6 7 8 9 14 April 2010 EMA/CHMP/BWP/99698/2007 Rev. 1 Committee for Medicinal Products for Human Use (CHMP) Procedural advice on the submission of variations for annual update of human influenza

More information

DRAFT COMMISSION DELEGATED REGULATION (EU) /... of XXX

DRAFT COMMISSION DELEGATED REGULATION (EU) /... of XXX EUROPEAN COMMISSION Brussels, XXX C(2016) 3752 projet DRAFT COMMISSION DELEGATED REGULATION (EU) /... of XXX setting out scientific criteria for the determination of endocrine-disrupting properties pursuant

More information

(Text with EEA relevance)

(Text with EEA relevance) L 204/36 EN COMMISSION IMPLEMENTING REGULATION (EU) 2018/1122 of 10 August 2018 authorising the placing on the market of pyrroloquinoline quinone disodium salt as a novel food under Regulation (EU) 2015/2283

More information

Public Assessment Report. Scientific discussion. Granon (Acetylcysteine) DK/H/2352/ /MR. Date:

Public Assessment Report. Scientific discussion. Granon (Acetylcysteine) DK/H/2352/ /MR. Date: Public Assessment Report Scientific discussion Granon (Acetylcysteine) DK/H/2352/001-002/MR Date: 25-06-2015 This module reflects the scientific discussion for the approval of Granon. The procedure was

More information

GUIDANCE ON SUBMISSIONS FOR SAFETY EVALUATION OF SOURCES OF NUTRIENTS OR OF OTHER INGREDIENTS PROPOSED FOR USE IN THE MANUFACTURE OF FOODS

GUIDANCE ON SUBMISSIONS FOR SAFETY EVALUATION OF SOURCES OF NUTRIENTS OR OF OTHER INGREDIENTS PROPOSED FOR USE IN THE MANUFACTURE OF FOODS EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate C - Scientific Opinions C2 - Management of scientific committee; scientific co-operation and networks Scientific Committee

More information

Herbal medicinal products an area of patient involvement? Steffen Bager, HMPC member

Herbal medicinal products an area of patient involvement? Steffen Bager, HMPC member Herbal medicinal products an area of patient involvement? Steffen Bager, HMPC member Herbal medicinal products in Europe Legislation: Procedures to market access: Classification: Borderline issues: Product

More information

Workshop for OIE national Focal Points for Veterinary Products November 2010, Johannesburg, South Africa. Presentation

Workshop for OIE national Focal Points for Veterinary Products November 2010, Johannesburg, South Africa. Presentation Dr. Anja Holm Chair of CVMP, EMA Danish Medicines Agency Copenhagen, DK - Denmark anh@dkma.dk Overview of existing structures relevant for Veterinary Products Regional Structures: Europe European Medicine

More information

(Text with EEA relevance)

(Text with EEA relevance) 13.8.2018 EN L 204/41 COMMISSION IMPLEMENTING REGULATION (EU) 2018/1123 of 10 August 2018 authorising the placing on the market of 1-methylnicotinamide chloride as a novel food under Regulation (EU) 2015/2283

More information

EUROPEAN COMMISSION SUMMARY REPORT OF THE STANDING COMMITTEE ON PLANTS, ANIMALS, FOOD AND FEED HELD IN BRUSSELS ON 10 FEBRUARY 2015

EUROPEAN COMMISSION SUMMARY REPORT OF THE STANDING COMMITTEE ON PLANTS, ANIMALS, FOOD AND FEED HELD IN BRUSSELS ON 10 FEBRUARY 2015 EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL Brussels sante.ddg2.g.dir(2015)934853 SUMMARY REPORT OF THE STANDING COMMITTEE ON PLANTS, ANIMALS, FOOD AND FEED HELD IN BRUSSELS ON 10 FEBRUARY

More information

Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products 1

Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products 1 5 April 2016 EMA/HMPC/71049/2007 Rev. 2 Committee on Herbal Medicinal Products (HMPC) Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal

More information

Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products 1

Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products 1 1 2 3 8 August 2012 EMA/HMPC/71049/2007 Rev. 1 Committee on Herbal Medicinal Products (HMPC) 4 5 6 7 Guideline on the use of the CTD format in the preparation of a registration application for traditional

More information

CHAPTER 3. Union Referral Procedures MAY 2014

CHAPTER 3. Union Referral Procedures MAY 2014 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products Brussels, Revision May 2014 NOTICE TO APPLICANTS VOLUME 2A Procedures for marketing authorisation

More information

Annex II. Scientific conclusions

Annex II. Scientific conclusions Annex II Scientific conclusions Scientific conclusions Between 29 September 2015 and 9 October 2015, the United States Food and Drug Administration (FDA) performed a Good Clinical Practice (GCP) inspection

More information

KEY DIFFERENCES BETWEEN THE NEW MEDICAL DEVICE AND THE OTC REGULATIONS IN EUROPE

KEY DIFFERENCES BETWEEN THE NEW MEDICAL DEVICE AND THE OTC REGULATIONS IN EUROPE RNI Conseil 2017 Tous droits réservés Toute reproduction interdite sans l'autorisation de l'auteur. KEY DIFFERENCES BETWEEN THE NEW MEDICAL DEVICE AND THE OTC REGULATIONS IN EUROPE Anne Laure TARDY, PhD

More information

COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL PROCEDURE FOR THE PREPARATION OF COMMUNITY MONOGRAPHS FOR TRADITIONAL HERBAL MEDICINAL PRODUCTS

COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL PROCEDURE FOR THE PREPARATION OF COMMUNITY MONOGRAPHS FOR TRADITIONAL HERBAL MEDICINAL PRODUCTS European Medicines Agency Evaluation of Medicines for Human Use London, 11 January 2007 Ref: EMEA/HMPC/182320/2005 Rev. 2 COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL PROCEDURE FOR THE PREPARATION

More information

Discussion by HMPC Drafting Group on Quality September Start of public consultation 15 February 2013

Discussion by HMPC Drafting Group on Quality September Start of public consultation 15 February 2013 1 2 3 15 January 2013 EMA/HMPC/13658/2013 Committee on Herbal Medicinal Products (HMPC) 4 5 6 7 Concept paper on use of recovered/recycled solvents in the manufacture of herbal preparations for use in

More information

IMPORTANT DISCLAIMER. Note

IMPORTANT DISCLAIMER. Note yn EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL June 2012 DRAFT GUIDANCE DOCUMENT FOR COMPETENT AUTHORITIES FOR THE CONTROL OF COMPLIANCE WITH EU LEGISLATION ON: Regulation (EU) No 1169/2011

More information

ehpm Discussion Paper on Botanical Health Claims

ehpm Discussion Paper on Botanical Health Claims ehpm Discussion Paper on Botanical Health Claims Jonathan Griffith (Chairperson Botanicals Working Group) ehpm July 2018 The Presenting Problem 1. Analysis of the EU Nutrition & Health Claim Register (

More information

Applicant (Invented) Name Strength Pharmaceutical Form. UMAN BIG 180 I.E./ml Injektionslösung. UMAN BIG 180 IU/ml Solution for injection

Applicant (Invented) Name Strength Pharmaceutical Form. UMAN BIG 180 I.E./ml Injektionslösung. UMAN BIG 180 IU/ml Solution for injection ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATE 1 Member State EU/EEA Marketing

More information

Regulation of FMD vaccines within the European Union

Regulation of FMD vaccines within the European Union Introduction Regulation of FMD vaccines within the European Union K De Clercq 1 and D K J Mackay 2 Appendix 36 The EUFMD European Pharmacopoeia Working Group made a proposal for revision of the FMD vaccine

More information

Secretary-General of the European Commission, signed by Mr Jordi AYET PUIGARNAU, Director

Secretary-General of the European Commission, signed by Mr Jordi AYET PUIGARNAU, Director COUNCIL OF THE EUROPEAN UNION Brussels, 13 February 2014 (OR. en) 6438/14 COVER NOTE From: date of receipt: 3 February 2014 To: No. Cion doc.: PHARM 14 SAN 72 MI 161 COMPET 107 DELACT 29 Secretary-General

More information

Adopted by CVMP 10 March Date for coming into effect 1 July Revised draft guideline agreed by Immunologicals Working Party 22 June 2017

Adopted by CVMP 10 March Date for coming into effect 1 July Revised draft guideline agreed by Immunologicals Working Party 22 June 2017 1 2 3 7 September 2017 EMA/CVMP/IWP/105506/2007-Rev.1 Committee for medicinal products for veterinary use (CVMP) 4 5 6 7 Guideline on data requirements for multi-strain dossiers for inactivated vaccines

More information

EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL VOLUME 2C. Guidelines. Medicinal products for human use

EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL VOLUME 2C. Guidelines. Medicinal products for human use EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL Brussels, Draft Revision 2 NOTICE TO APPLICANTS VOLUME 2C Guidelines Medicinal products for human use Safety, environment and information

More information

European Union legislation on Food additives, Food enzymes, Extractions solvents and Food flavourings

European Union legislation on Food additives, Food enzymes, Extractions solvents and Food flavourings European Union legislation on Food additives, Food enzymes, Extractions solvents and Food flavourings European Commission, DG, Unit E3 Chemicals, contaminants and pesticides Serbia-Screening meeting on

More information

BACKGROUND + GENERAL COMMENTS

BACKGROUND + GENERAL COMMENTS Response on behalf of Sobi (Swedish Orphan Biovitrum AB) to the European Commission s Public Consultation on a Commission Notice on the Application of Articles 3, 5 and 7 of Regulation (EC) No. 141/2000

More information

TECHNICAL REPORT OF EFSA. List of guidance, guidelines and working documents developed or in use by EFSA 1

TECHNICAL REPORT OF EFSA. List of guidance, guidelines and working documents developed or in use by EFSA 1 EFSA Technical Report (2009) 279, 1-13 TECHNICAL REPORT OF EFSA List of guidance, guidelines and working documents developed or in use by EFSA 1 Prepared by the Secretariat of the Scientific Committee

More information

Decentralised Procedure. Public Assessment Report. ALGOTRA 37.5 mg/325 mg überzogene Tabletten Tramadol/Paracetamol DE/H/3688/001/DC

Decentralised Procedure. Public Assessment Report. ALGOTRA 37.5 mg/325 mg überzogene Tabletten Tramadol/Paracetamol DE/H/3688/001/DC Decentralised Procedure Public Assessment Report ALGOTRA 37.5 mg/325 mg überzogene Tabletten Tramadol/Paracetamol DE/H/3688/001/DC Applicant: Laboratoires SMB S.A. Reference Member State DE TABLE OF CONTENTS

More information

EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL VOLUME 2C. Guidelines. Medicinal products for human use

EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL VOLUME 2C. Guidelines. Medicinal products for human use EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL Brussels, March 2018 SANTE-2017-11668 Revision 2 NOTICE TO APPLICANTS VOLUME 2C Guidelines Medicinal products for human use Safety, environment

More information

Draft Agreed by Immunologicals Working Party January Adoption by CVMP for release for consultation 12 March 2009

Draft Agreed by Immunologicals Working Party January Adoption by CVMP for release for consultation 12 March 2009 15 March 2010 EMA/CVMP/IWP/105506/2007 Committee for medicinal products for veterinary use (CVMP) Guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza

More information

The EU PIP - a step in Pediatric Drug Development. Thomas Severin Bonn,

The EU PIP - a step in Pediatric Drug Development. Thomas Severin Bonn, The EU PIP - a step in Pediatric Drug Development Thomas Severin Bonn, 13.01.2009 Agenda Implications for Industry Company Preparation Time of PIP Submission Content of the PIP The PIP Process and first

More information

Guidance for food business operators on the verification of the status of a new food under the new Novel Foods Regulation 2015/2283 (NFR)

Guidance for food business operators on the verification of the status of a new food under the new Novel Foods Regulation 2015/2283 (NFR) food supplements europe Novel Food Guidance for food business operators on the verification of the status of a new food under the new Novel Foods Regulation 2015/2283 (NFR) January 2018 TABLE OF CONTENTS

More information

Feed Additive Approval An Industry View. Dr Heidi Burrows Regulatory manager

Feed Additive Approval An Industry View. Dr Heidi Burrows Regulatory manager Feed Additive Approval An Industry View Dr Heidi Burrows Regulatory manager Classification of substances and products used in Animal Nutrition Processing Aid (EC No 1831/2003) Veterinary Substance / Products

More information

ICH Topic S1B Carcinogenicity: Testing for Carcinogenicity of Pharmaceuticals. Step 5

ICH Topic S1B Carcinogenicity: Testing for Carcinogenicity of Pharmaceuticals. Step 5 European Medicines Agency March 1998 CPMP/ICH/299/95 ICH Topic S1B Carcinogenicity: Testing for Carcinogenicity of Pharmaceuticals Step 5 NOTE FOR GUIDANCE ON CARCINOGENICITY: TESTING FOR CARCINOGENICITY

More information

NOTICE TO APPLICANTS

NOTICE TO APPLICANTS EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Food and feed safety, innovation Animal nutrition, veterinary medicines NOTICE TO APPLICANTS VETERINARY MEDICINAL PRODUCTS VOLUME 6A Procedures

More information

SCIENTIFIC DISCUSSION

SCIENTIFIC DISCUSSION SCIENTIFIC DISCUSSION 1 INTRODUCTION This application has been submitted to the EMEA for the CHMP to issue a scientific opinion in accordance with Article 58 of Regulation (EC) No 726/2004, in the context

More information

NOVEL FOODS REGULATION PROPOSAL

NOVEL FOODS REGULATION PROPOSAL NOVEL FOODS REGULATION PROPOSAL BEUC Position Contact: Ruth Veale food@beuc.eu Ref.: X/005/2010-29/01/10 Summary On 14 January 2008 the European Commission published a proposal 1 for a Regulation laying

More information

Delegations will find attached document D056135/03.

Delegations will find attached document D056135/03. Council of the European Union Brussels, 1 June 2018 (OR. en) 9586/18 DLEG 46 SAN 175 AGRI 260 COVER NOTE From: European Commission date of receipt: 30 May 2018 To: No. Cion doc.: D056135/03 Subject: General

More information

EUROPEAN COMMISSION SUMMARY REPORT OF THE STANDING COMMITTEE ON THE FOOD CHAIN AND ANIMAL HEALTH HELD IN BRUSSELS ON 13 JUNE 2014

EUROPEAN COMMISSION SUMMARY REPORT OF THE STANDING COMMITTEE ON THE FOOD CHAIN AND ANIMAL HEALTH HELD IN BRUSSELS ON 13 JUNE 2014 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Brussels, SANCO G ARES(2014)2253750 SUMMARY REPORT OF THE STANDING COMMITTEE ON THE FOOD CHAIN AND ANIMAL HEALTH HELD IN BRUSSELS ON 13 JUNE

More information

Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)

Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 Consultation document Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs) Recommendations

More information

EUR-Lex L EN. Council Directive 93/74/EEC of 13 September 1993 on feedingstuffs intended for particular nutritional purposes

EUR-Lex L EN. Council Directive 93/74/EEC of 13 September 1993 on feedingstuffs intended for particular nutritional purposes Page 1 of 5 Avis juridique important 31993L0074 Council Directive 93/74/EEC of 13 September 1993 on feedingstuffs intended for particular nutritional purposes Official Journal L 237, 22/09/1993 P. 0023-0027

More information

Food additives. FAO guidelines on the structure and content of the document called "Chemical and Technical Assessment (CTA)" Rome, February 2003

Food additives. FAO guidelines on the structure and content of the document called Chemical and Technical Assessment (CTA) Rome, February 2003 FAO Joint Secretariat to JECFA Joint FAO/WHO Expert Committee on Food Additives Food additives FAO guidelines on the structure and content of the document called "Chemical and Technical Assessment (CTA)"

More information

EUROPEAN COMMISSION SUMMARY REPORT OF THE STANDING COMMITTEE ON THE FOOD CHAIN AND ANIMAL HEALTH HELD IN BRUSSELS ON 23 APRIL 2014

EUROPEAN COMMISSION SUMMARY REPORT OF THE STANDING COMMITTEE ON THE FOOD CHAIN AND ANIMAL HEALTH HELD IN BRUSSELS ON 23 APRIL 2014 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Brussels, SANCO G ARES(2014)1527282 SUMMARY REPORT OF THE STANDING COMMITTEE ON THE FOOD CHAIN AND ANIMAL HEALTH Chairmen : HELD IN BRUSSELS

More information

Report from the CMD(h) meeting held on 17 th and 18 th March 2008

Report from the CMD(h) meeting held on 17 th and 18 th March 2008 Report from the CMD(h) meeting held on 17 th and 18 th March 2008 CMD(h)/EMEA Sub-Group on Paediatric Regulation Further to the line listings received for authorised medicinal products (including purely

More information

Decentralised Procedure. Public Assessment Report. Lorazepam-neuraxpharm 1/ 2,5 mg Schmelztabletten. Lorazepam DE/H/4558/ /DC

Decentralised Procedure. Public Assessment Report. Lorazepam-neuraxpharm 1/ 2,5 mg Schmelztabletten. Lorazepam DE/H/4558/ /DC Decentralised Procedure Public Assessment Report Lorazepam-neuraxpharm 1/ 2,5 mg Schmelztabletten Lorazepam DE/H/4558/001-002/DC Applicant: neuraxpharm Arzneimittel GmbH, Germany Reference Member State

More information

European Medicines Agency Evaluation of Medicines for Human Use COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL

European Medicines Agency Evaluation of Medicines for Human Use COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL European Medicines Agency Evaluation of Medicines for Human Use London, 11 July 2008 Doc. Ref. EMEA/HMPC/513617/2006 COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL COMMUNITY HERBAL MONOGRAPH ON HUMULUS

More information

Paediatrics: Paediatric Investigation Plan National Agency Assessor s Point of View

Paediatrics: Paediatric Investigation Plan National Agency Assessor s Point of View Paediatrics: Paediatric Investigation Plan National Agency Assessor s Point of View Presented by: Dr Ljiljana Milosevic-Kapetanovic Afssaps, France EC Twinning Project 2006-2009 -Relation between ALIMS/MoH

More information

Agencia Española de Medicamentos y Productos Sanitarios C/Campezo 1, Edificio Madrid España (Reference Member State)

Agencia Española de Medicamentos y Productos Sanitarios C/Campezo 1, Edificio Madrid España (Reference Member State) DEPARTAMENTO DE MEDICAMENTOS VETERINARIOS Medicamentos y Productos C/Campezo 1, Edificio 8 28022 Madrid España (Reference Member State) MUTUAL RECOGNITION PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT

More information

(Legislative acts) REGULATIONS

(Legislative acts) REGULATIONS 31.12.2010 Official Journal of the European Union L 348/1 I (Legislative acts) REGULATIONS REGULATION (EU) No 1235/2010 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December 2010 amending, as regards

More information

European Medicines Agency decision

European Medicines Agency decision EMA/131632/2016 European Medicines Agency decision P/0082/2016 of 18 March 2016 on the agreement of a paediatric investigation plan and on the granting of a waiver for tetracaine (hydrochloride) / oxymetazoline

More information

European public MRL assessment report (EPMAR)

European public MRL assessment report (EPMAR) 10 February 2012 EMA/CVMP/504089/2010 Committee for Medicinal Products for Veterinary Use European public MRL assessment report (EPMAR) Lasalocid (bovine species) On 1 February 2012 the European Commission

More information

REASONED OPINION. European Food Safety Authority 2, 3. European Food Safety Authority (EFSA), Parma, Italy

REASONED OPINION. European Food Safety Authority 2, 3. European Food Safety Authority (EFSA), Parma, Italy EFSA Journal 2012;10(7):2841 REASONED OPINION Reasoned opinion on the review of the existing maximum residue levels (MRLs) for paraffin oil (CAS 64742-54-7) according to Article 12 of Regulation (EC) No

More information

(Text with EEA relevance)

(Text with EEA relevance) L 274/51 COMMISSION IMPLEMENTING REGULATION (EU) 2018/1647 of 31 October 2018 authorising the placing on the market of egg membrane hydrolysate as a novel food under Regulation (EU) 2015/2283 of the European

More information

STANDING COMMITTEE ON THE FOOD CHAIN AND ANIMAL HEALTH. Section on General Food Law. Summary Record of 6th meeting July 18th 2003

STANDING COMMITTEE ON THE FOOD CHAIN AND ANIMAL HEALTH. Section on General Food Law. Summary Record of 6th meeting July 18th 2003 STANDING COMMITTEE ON THE FOOD CHAIN AND ANIMAL HEALTH Section on General Food Law Summary Record of 6th meeting July 18th 2003 Chairman : Mr Patrick Deboyser Adoption of the Rules of procedure: 1. Opinion

More information

This Administrative regulation will come into force on 1 st August 2013 and will remain so until further notice.

This Administrative regulation will come into force on 1 st August 2013 and will remain so until further notice. Administrative regulation 01.08.2013 Dnro 4000/03.01.01/2012 2/2013 UNOFFICIAL TRANSLATION Finnish Medicines Agency Administrative Regulation APPLYING FOR AND MAINTAINING A MARKETING AUTHORI- SATION AND

More information