ii. To support India s trade-related training institutions in strengthening their capacities.

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1 EU-India Capacity Building Initiative for Trade Development in India - CITD INSTITUTIONAL SUPPORT AND TRAINING REGARDING THE EU DIRECTIVE 2004/24/EC ON HERBAL MEDICINES 0. INTRODUCTION The Project (EU-India Capacity Building Initiative for Trade Development in India - CITD) Lot 1: Food Safety and SPS, Technical Regulations and Standardization, and Support to PCA/OSPCA in Customs) started on 13 May 2013 with the signature of the Contract, initiated its operations on 10 June 2013 and will end on 30 September The overall objective is to support India in strengthening its capacity to achieve economic growth and sustainable development, and ultimately poverty reduction, through further integration into the global trading system, by increasing the safety and quality of products, and by reducing costs and impediments to trade. The purpose is: i. To enhance capacity of India s trade-related regulatory institutions and enforcement systems in order to meet international standards and requirements and business needs. ii. To support India s trade-related training institutions in strengthening their capacities. 1. ABOUT THE PROGRAMMES As per 2004 Herbal Directive (2004/24/EC) only medicinal products which have been registered or authorised can remain on the EU market. The Herbal Directive introduces a simpler registration procedure than for other medicinal products, in respect of the long history of use of traditional herbal medicinal products. The Directive provides the necessary guarantees of their quality, safety and efficacy. Herbal Directive was adopted by the European Parliament and the European Council in It gave an exceptionally long transition period of 7 years for manufacturers to register their traditional herbal products already on the EU market when the Directive entered into force. Producers of traditional herbal medicines can apply for a registration through the simplified registration procedure. Under the Traditional Herbal Medicinal Products Directive, a company needs to demonstrate that the herbal medicine has been in use within the EU for at least 30 years or 15 years within the EU and 15 years outside the EU. There is concern that some herbal remedies of 30 years ago, which are no longer in widespread use, could still be sold but that valid new herbs which

2 cannot meet the 30 year rule may require to be withdrawn from sale. The rule could also mean that it may not be possible to license some traditional herbal medicines which were in common use more than 30 years ago, but have since fallen into disuse. India, with its biodiversity has a tremendous potential and advantage to increase export of herbal ingredients and products which use herbal ingredients, in particular herbal medicinal. In this regards, EU is the biggest herbal market. The forecast is that the global market for herbal products is expected to be $5 trillion by 2050 and in this regards India, has a great potential role to play. In order to promote the export of herbal ingredients, of herbal medicinal products and botanical food supplements from India to the EU, CITD project will organise a series of two days capacity building and technical trainings in Kolkata, Kochi, Mumbai and New Delhi covering all aspects which are governing the import of herbal medicines products and herbal medicinal ingredients to the EU. This will cover the EU Directive, 2004/24/EC, the EU Directive 2003/94/EC on relevant good manufacturing practices based on Directive 2003/94/EC and on elements of relevant clinical trials to enhance knowledge of relevant stakeholders on the requirements of EU Directive 2004/24/EC on herbal medicines explaining how are herbal medicines recipes considered traditional, what is considered as well established used herbal medicine, relevant requirements, including the appropriate relating documentation to be provided etc. Furthermore participants will be trained on the requirements of the EU Directive 2003/94/EC on good manufacturing process controlling standard manufacturing requirements for trading herbal medicines and herbal ingredients. Finally, relevant training will be provided regarding the requirements to be met by herbal medicine producers, herbal medicine ingredients providers and botanical food supplement producers as per relevant EU Directive.

3 Page 1 Capacity Building Initiative for Trade Development in India (CITD) Herbal Products for the EU market - Traditional Herbal Products Directive & Good Manufacturing Practice Purpose of training Outline Summary Two-day training programme on the Traditional Herbal Medicinal Products Directive 2004/24/EC and Good Manufacturing Practice Directive In the EU there is extensive legislation to protect public health by ensuring the safety, efficacy and quality of medicinal products, including traditional herbal medicinal products. The main purpose of the training is to provide knowledge of the requirements to supply herbal starting materials and herbal medicines in compliance with all the relevant legislation. Benefit to participants Particularly this technical training programme will provide education to the delegates to enhance the capacity of Indian exporters to trade in herbal drug substances and herbal medicines. Key learning points: Education on the EU regulatory framework relevant to herbal products to provide an understanding of the options allowed for the legal supply of a herbal product in the EU. Education to provide an understanding of the key pharmaceutical legislation relevant to herbal medicinal products EU Directive 2004/24/EC, and EU Directive 2001/83/EC as amended. Education on the data required and the process to follow for submitting an application for registration of a traditional herbal medicinal product. Education to provide an understanding of the requirements for producers, traders and processors of medicinal plants/herbal substances to comply with good agricultural and collection practice (GACP) for herbal starting materials. Education to provide an understanding of the requirements for manufacturers of drug products to comply with good manufacturing practice (GMP) as required in EU Directive 2003/94/EC in order to ensure appropriate and consistent quality of herbal medicinal products. Content of training Each 2 day training course will take place in, Mumbai, Kochi, Kolkata and New Delhi, 28 Jun-12 Jul 2017 Delivery will by the nominated two experts, and include workshop sessions to allow delegates to apply their learning in case studies, and opportunities for Q and A sessions. Day 1: EU Regulatory Framework of Legislation GACP and GMP Requirements for Herbal Medicines Challenges Faced by Indian Manufacturers in the EU Introduction to EU Regulatory Framework for Herbal products Brief Overview of Permitted claims under Regulation 1924/2006 on nutrition and health claims on foods Good Agricultural and Collection Practice for herbs to be used in Medicines Introduction to EU Good Manufacturing Practice Directive 2003/94/EC for Medicines Differences in EU GMP and Indian GMP AYUSH Accreditation Programme in India Review of Common Areas of Non-compliance with EU GMP Day 2: Traditional Herbal Medicinal Products Traditional Herbal Medicinal Products Directive 2004/24/EC Feasibility to Register as either a Traditional Herbal Medicinal Products or as a Medicine Overview of the Common Technical Document Practical Examples of Products Quality Requirements - Herbal Substance Quality Requirements - Drug Product EU Competent Authorities and Assessment Process of an Application for a Medicine Brief listing of other EU Requirements for Medicines

4 Programme for Activity 214b on EU Herbal Medicine Directive and relating GMPs 28 June July 2017 Wednesday 28 June Briefing at QCI/NABCB, Consequent review of the presentations Venue: Hotel Marine Plaza Hall The Plaza, 29 Marine Drive Mumbai Thursday 29 June Flying to Mumbai, meeting relevant competent authorities Friday 30 June Provision of Training in Mumbai Saturday 1 st July Provision of training in Mumbai Venue: The Gateway Hotel, Hall Marina Marine Drive, Ernakulam, Cochin , Kerala Sunday 2 nd July Flying to Kochi Monday 3 rd July Provision of training to Kochi Tuesday 4 th July Provision of training to Kochi Venue : The Gateway Hotel, Hall Poolside, EM Bypass, 1930 Rajdanga Main Road, Kolkata Wednesday 5 th July Flying to Kolkata, meeting relevant local Authorities Thursday 6 th July Provision of training in Kolkata Friday 7 th July Provision of training in Kolkata Venue : Hotel The Royal Plaza, Hall Edward 19, Ashoka Road, New Delhi Saturday 8 th July Flying to Delhi, review of the presentations for Delhi meeting Sunday 9 th July Day off Monday 10th July Training in Delhi Tuesday 11 th July Training in Delhi Wednesday 12th July Debriefing in QCI/NABCB. Start drafting the summary report

5 Capacity Building Initiative for Trade Development in India (CITD) Herbal Products for the EU market - Traditional Herbal Products Directive & Good Manufacturing Practice Location & Venue: 30 June 01 July 2017 Mumbai (Hotel Marine Plaza, Hall The Plaza Marine Drive Mumbai ) 3-4 July 2017 Kochi (The Gateway Hotel, Hall Marina Marine Drive, Ernakulam, Cochin ) 6-7 July 2017 Kolkata The Gateway Hotel, Hall Poolside, EM Bypass, Main Road, Kolkata ) July 2017 Delhi (Hotel The Royal Plaza, Hall Edward 19, Ashoka Road, New Delhi ) Ms Sona Sharma QCI Secretariat * ayushmark@qcin.org, Tel: /57; Extn. 34 *Sending by is preferable. NOMINATION FORM Please tick Mumbai Kochi Kolkata Delhi A. PERSONAL PARITCULARS Title (please tick) Mr. Mrs. Ms. Dr. Name : Organization : Position / : Designation Organization : Address City State Fax Address Postal Code / Zip Telephone (O) Telephone (R) Mobile Note: The training registration is free of cost. Please note that seats are limited and will be registered on first come first basis.