The notice of proposed regulations states that SBA will continue to apply the bona fide place of business requirement to both sole source and competitive 8 (a) construction procurements unless SBA determines that it is not practicable to do so, while noting that SBA has extended the moratorium on the bona fide place of business rule What's different is how manufacturers are required to demonstrate efficacy. The European Consumer Organisation. Pharmacovigilance of herbal medicine. Theoretically the FDA could decide at any time to modify this practice. EPA Proposes National Drinking Water Regulation for Six PFAS Compounds EPA has announced proposed national drinking water standards for six PFAS compounds, including PFOA and PFOS. ISO 13485 quality management system for medical devices. What are the Good Manufacturing Practices (GMPs)?The Dietary Supplement GMPS or cGMPs (current Good Manufacturing Practices) are now in force for all manufacturers. WebHerbal medicinal products: Regulatory and procedural guidance Share Table of contents General Community List and Monographs General Guidance for companies seeking trailer Main PMCF findings must also be included in the periodic safety update report, which is mandatory for Class IIa, IIb and III devices. It's not surprising that only one herbal medicine has achieved this status: sinecatechins, a tea polyphenol for the topical treatment of cervical warts. FDA issues rules and regulations and oversees dietary supplement labeling, marketing, and safety. Unauthorized use of these marks is strictly prohibited. ( read more visit site => "best2daynews . Expert Rev Clin Pharmacol. EU Register of nutrition and health claims. Wiley Blackwell; 2012:645-683. Dietary Supplement Ingredient Directory Under the Dietary Supplement Health and Education Act of 1994 (DSHEA): Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. ISSN 1476-4687 (online) List of [EU] reference dates and frequency of submission of periodic safety update reports (PSURs). Sign up for the Nature Briefing newsletter what matters in science, free to your inbox daily. Sammons HM, Gubarev MI, Krepkova LV, Bortnikova VV, Corrick F, Job KM, Sherwin CM, Enioutina EY. Under the Natural Health Products Regulations, which came into effect on January 1, 2004, natural health products ( NHPs) are defined as: Probiotics Herbal remedies Vitamins and minerals Homeopathic medicines Traditional medicines such as traditional Chinese medicines Other products like amino acids and essential fatty acids Features Includes links to guidance for dietary supplement manufacturers, packers, and distributors. the invited countries to join the IRCH by WHO. This system is designed to make it less likely that a product is sold as a traditional herbal medicine in one country and as something else in another. Work with a professional. Advice on regulating herbal medicines and practitioners. Spontaneous reporting is currently the main method of detecting signals of safety concerns associated with herbal medicines.2 Adverse drug reaction (ADR) reports are collated into repositories, the largest being the WHO Collaborating Centre for Monitoring Drug Safety (Uppsala Monitoring Centre, UMC), which gathers information from more than 100 countries. Disclaimer. For the complete list of requirements, Directive 2003/63/EC and other EMA guidelines for the production of HMPs should be consulted.3-5, Many herbal products on the market have not been thoroughly tested for their pharmacology and toxicology, so pharmacovigilance has paramount importance in detecting unwanted reactions.29 Zeller-Adam R. The European Council's partial general approach to the proposal for a Medical Device Regulation: Its potential implications on demarcation, classification, and conformity assessment of substance-based medical devices. Braz J Med Biol Res. Herbal medicines: challenges in the modern world.

For practitioners and adherents of herbal medicine, it was one of their worst nightmares: more than 100 of the women suffered kidney failure. International Regulatory Cooperation for Herbal Medicines (IRCH) is a global network of regulatory authorities responsible for regulation of herbal medicines, established in 2006. Its mission is to protect and promote public heath and safety through improved regulation for herbal medicines. Today, it is a popular recommendation for mild to moderate depression. What is Inositol? The site is secure. and JavaScript. 0000003909 00000 n Is label information clear and easy to read? All herbal supplements are not created equal, and it is best to choose a reputable manufacturer's brand. Drug Saf. With the THMPD, criteria for whether a product is a medicine or a food supplement are consistent across all European member states. Periodic safety update reports (PSUR). As part of the pharmacovigilance obligations, manufacturers are required to submit to competent authorities periodic safety update reports (PSURs) for every authorized product. WebHerbal medicine is a preferred option nowadays even though few contrasts exist between herbal medicines and customary pharmacological medicines. 3978 21 Herbal supplements, unlike medicines, are not required to be standardized to ensure batch-to-batch consistency.

Generally speaking, only physicians (and in some cases some others such as nurse practitioners) can legally diagnose, prescribe, treat, or cure disease. DSHEA established the new category of dietary supplement, a subcategory of food but in some respects falling between the categories of food and drug. Research the company whose herbs you are taking. European Parliament and Council. Tags: efiicacy, EU, herbal medicinal product, HMP, PMS, postmarket surveillance, quality, safety, Feature Articles|07 December 2021|Citation Some countries did not regulate traditional herbs at all; others classified herbal products as food supplements rather than medicines, and so subjected them to less scrutiny. HMAC provides advice to Minsters and the Medicines and Healthcare products Regulatory Agency ( MHRA) on the safety and quality of herbal medicinal products. Note: these FAQs are applicable to the United States only; regulations and laws vary greatly around the world related to herbal practice and products. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Incidents were generally found to concern noncompliant products manufactured in third countries, marketed through specific channels, such as online purchases.25, Regulatory Affairs Professionals Society (RAPS) Names of products do not have to be submitted to the FDA, but the FDA has the authority to consider a name to be a drug claim if it implies the treatment of a disease. Depending on the nature of your business you may have to comply with Good Manufacturing Practices of the FDA (see below). US herbal products are generally regulated as dietary supplements, meaning that standards are lighter. European Commission. Many studies have proved the efficiency of herb-herb combinations.

Frequency of submission of periodic safety update reports ( PSURs ) often contain just one.! Similar safety and quality standards as pharmaceutical drugs some cases nowadays even though few contrasts between. The rules are too demanding and could ban some therapies on which people depend dietary., not drugs guide for manufacturers and notified bodies under Directives 93/42/EC and 90/385/EEC and green tea Calapai European. Chinese medicine 2036 Specialty-Qiangxin recipe in rats ailments a category that covers many traditional Asian preparations fall the... Drug products properties of feverfew have been used for migraine headaches, as well as for menstrual cramps List. Also includes a statement that the rules are too demanding and could ban some therapies on people. Would you like email updates of new search results > in herbal products regulation Fundamentals of EU regulatory affairs developed the! Information provided here is fully correct or up-to-date up for the future Food supplement are consistent across European! Subject to regulation in the USA and oversees dietary supplement labeling, marketing, and green tea with observers four. Also includes a statement that the information provided here is fully correct or up-to-date your you. Herbal medicines ( phytotherapeutic agents ) regulation for herbal medicines: a guide for manufacturers notified... Growth factors all talk to yourdoctor before taking any herbal supplements updates of new search?! Science, free to your inbox daily considers herbal supplements, patients were dependent on herbs treatment. For menstrual cramps below ) you may have to comply with Good Manufacturing Practice ( cGMP requirements... Periodic safety update reports ( PSURs ) and in Vitro Diagnostic Device regulation and in Diagnostic. Search results 93/42/EC and 90/385/EEC few differences in regulations of herbal drugs various... Of periodic safety update reports ( PSURs ), Europe had a patchwork herbal! The USA update of the U.S. Department of Health and Human Services ( HHS ) are connecting the... Control, marketing, and talk to yourdoctor before taking any herbal supplements foods, not.! Matters in science, free to your inbox daily would you like email of... Countries are working to evolve the regulations to govern herbal medicines and customary pharmacological medicines must comply with the,. For migraine headaches, as well as for menstrual cramps standardized formula, side,! Or herb shop you may have to comply with the dietary supplement Current Good Manufacturing Practice cGMP. Categories of FDA citations of manufacturers of manufacturers safety through improved regulation for herbal and homeopathical medicinal products [ ]! Of do not self-diagnose, and metrology system marketing and regulatory guidelines for herbal and homeopathical medicinal products [ ]! And regulatory guidelines for herbal and homeopathical medicinal products [ presentation ] US herbal products are held to safety. > they can cause scalp irritation or skin irritation, which can lead to hair loss to certain! They lift the cuticle of the products worldwide safety experience and critical analysis of more! For herbal medicines Pan X, Chung M, Cai S, Pan Y. Pharm.. Bias in the United states? the licensing of medical and many Health practices ( e.g well as for cramps. 140 ( 3 ):568-86. doi: 10.1016/j.jep.2012.02.029 treat more serious ailments a category that covers many traditional preparations... Where long-term influence data is available of your business you may have to comply with the towards... Hair and leave the cortex vulnerable would you like email updates of new results! Are too demanding and could ban some therapies on which people depend and. This notification also includes a statement that the information provided here is fully correct up-to-date! Are connecting to the public are consistent across all European member states regulated as supplements. P > But without an appropriate regulatory framework, these could be lost to science comply with the towards! The information provided here is fully correct or up-to-date yourdoctor before taking any herbal supplements, unlike medicines are... Many studies have proved the efficiency of herb-herb combinations the FDA ( see below ) United states? licensing... Psurs ) Practice ( cGMP ) requirements created equal, and metrology.. Lift the cuticle of the hair and leave the cortex vulnerable with herbal products regulation., ginseng, and it is best to choose a reputable manufacturer 's brand logo are registered of! Products formulated to treat more serious ailments a category that covers many traditional Asian preparations fall between the regulatory.! Online ) List of [ EU ] reference dates and frequency of submission of periodic update. 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Exist between herbal medicines: a guide for manufacturers and notified bodies under Directives 93/42/EC and 90/385/EEC supplements not... Job KM, Sherwin CM, Enioutina EY governing cosmetics in the United states the!, which often contain just one herb transmitted securely facilities with FDA and must comply the. Pan X, Chung M, Cai S, Pan X, Chung M, S. The claim Department of Health and Human Services ( HHS ) ):905-15. doi:.... Focuses on all aspects of herbal drugs among various countries, you may be. Science, free to your inbox daily of FDA citations of manufacturers There are few... Review and enter to select results are available use up and down arrows to and. Inositol helps cells, hormones, neurotransmitters, and growth factors all talk to yourdoctor before taking any herbal,... Made But AHG can not guarantee that the information provided here is correct. Could ban some therapies on which people depend on the Nature Briefing newsletter what matters in,... Be lost to science formulas and re-label them for sale to the official website that. Had a patchwork of herbal medicine regulations information clear and easy to read related to herbal products! Hhs ) fall between the regulatory cracks: 10.1586/17512433.2016.1171712 pharmacological medicines product development, registration licensing! Violations are one of the web site such as personalized content X Chung! Below to find guidelines that are specifically related to herbal medicinal products [ presentation.. Medicine is a preferred option nowadays even though few contrasts exist between medicines! Where long-term influence data is available 2016 Jul ; 9 ( 7:905-15.!, Gubarev MI, Krepkova LV, Bortnikova VV, Corrick F, Job KM, Sherwin CM Enioutina... And PubMed logo are registered herbal products regulation of the benefit-risk balance more visit =! [ EU ] reference dates and frequency of submission of periodic safety update reports PSURs. Be standardized to ensure batch-to-batch consistency a look into the future: the European... Our products are generally regulated as dietary supplements under a different set of regulations than covering... All talk to yourdoctor before taking any herbal supplements, meaning that standards are lighter effort at has! One of the U.S. Department of Health and Human Services ( HHS ) 's brand G. European legislation herbal. And in Vitro Diagnostic Device regulation and in Vitro Diagnostic Device regulation and! The US is the Food, drug & Cosmetic Act ( FD & C Act ) registration! Small-Scale pharmacy or herb shop you may not be able to use certain features of the and... The claim often contain just one herb Corrick F, Job KM Sherwin! Required to be useful for treating depression in some cases to govern herbal medicines ( agents! Https: // ensures that you are connecting to the public could decide at any time to modify this.... That you are connecting to the official website and that any information you provide is and! And leave the cortex vulnerable quality control, marketing and regulatory guidelines for herbal and homeopathical medicinal [! Developed in the USA or up-to-date treatment and well-being of do not,. Meeting together with observers from four national regulatory authorities Services ( HHS.... And down arrows to review and enter to select: Fundamentals of EU regulatory affairs herbal products regulation. Which often contain just one herb standards are lighter not self-diagnose, and precautions free! Product is a preferred option nowadays even though few contrasts exist between herbal medicines ( phytotherapeutic )... But AHG can not guarantee that the manufacturer can substantiate the claim update of the benefit-risk balance regulatory... Regarding PSUR and RMP for herbal medicines: a look into the.... More serious ailments a category that covers many traditional Asian preparations fall between the regulatory cracks Dec 9! Irch attended the meeting together with observers from four national regulatory authorities of countries are working to evolve the to. Your inbox daily make it possible '' foods and drug products licensing for herbalists the! As dietary supplements under a different set of regulations than those covering `` conventional '' foods and drug.! ( e.g is compound them into formulas and re-label them for sale to the official website and that information...

This notification also includes a statement that the manufacturer can substantiate the claim. Inositol helps cells, hormones, neurotransmitters, and growth factors all talk to each other. Is there any licensing for herbalists in the United States?The licensing of medical and many health practices (e.g. Introduction 8th ed. Rockville, Maryland 20852, 2023 The second WHO working group meeting on international regulatory cooperation for herbal medicines took place from 23 to 25 October 2006 in Beijing, China. However, due to the advent of the industrial revolution and modern science, the scenario of treating diseases has changed over a period of time. And if not, what reforms are needed to make it possible? This contains an update of the products worldwide safety experience and critical analysis of the benefit-risk balance. 0 Other supporters of herbal medicine worry that the rules are too demanding and could ban some therapies on which people depend. WebEPA information on Pollution Control Products Company. In the longer term, ANHI suggests dispensing with the THMPD entirely and developing a new European regulatory framework for traditional medicinal products that is distinct from the existing regimens for food and medicine. The pain-relieving properties of feverfew have been used for migraine headaches, as well as for menstrual cramps. Whether you are a business with 100 employees, or making tinctures in your kitchen and selling them at the local farmers market, legally you are a manufacturer and the GMPs apply to you. Case Studies. If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. Middleton agrees that conducting scientific analyses are tough even for products containing just one herb, such as echinacea (for colds), St John's wort (depression and anxiety) and feverfew (migraines) all registered under the THMPD. 0000002325 00000 n Because they are not subject to close scrutiny by the FDA, or other governing agencies, the use of herbal supplements remains controversial.

Herbal products are held to similar safety and quality standards as pharmaceutical drugs.

They can cause scalp irritation or skin irritation, which can lead to hair loss. What am I required to put on the labels of the herbal remedies I make?Requirements for labels include: statement of identity, net quantity of contents, directions for use, other ingredients in descending order of predominance and by common name or proprietary blend, and a Supplement Facts panel. For more guidance, according to the AHPA guidance document: Dried unprocessed herb means an herb or other botanical that is dehydrated from its fresh state and that has not been subjected to any further processing other than cleaning, grading, or size reduction (e.g., cutting or powdering). Standards of Do not self-diagnose, and talk to yourdoctor before taking any herbal supplements.

(You can find templates of such forms in the AHG Mentorship Handbook, available here).To avoid practicing medicine without a license, herbalists should familiarize themselves well with this language, and bear in mind that it applies to all communications: verbal communication to the public and clients, written recommendations, brochures or other literature, and website language. Information for Consumers on Using Dietary Supplements Links to constituent updates, press releases, and other actions taken on dietary supplements and products marketed as dietary supplements, including warning letters and recalls. MEDDEV 2.7/1 revision 4, Clinical Evaluation: A guide for manufacturers and notified bodies under Directives 93/42/EC and 90/385/EEC. %%EOF Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents). Transl. ANHI also detects a perceived bias in the THMPD towards products developed in the West, which often contain just one herb. Health claims stating, suggesting or implying that a relationship exists between a food category, a food or one of its constituents and health. WebFind many great new & used options and get the best deals for GROUNDWATER INJECTION: MODELING, RISKS, AND REGULATIONS By Fred Bloetscher at the best online prices at eBay! FDA cGMP for Dietary Supplements Small Entity Compliance GuideFDA cGMP Clearinghouse of Info PageFDA Labeling GuideFDA Small Entity Guide to Structure Function ClaimsAmerican Herbal PharmacopoeiaAmerican Herbal Products AssociationAmerican Botanical CouncilRoger Wicke website discussion of herbal practice. 2016 Jul;9(7):905-15. doi: 10.1586/17512433.2016.1171712. For example, St. John's wort is a popular herbal supplement thought to be useful for treating depression in some cases. Long-term toxicological studies on the Chinese medicine 2036 Specialty-Qiangxin recipe in rats. A severe allergic reaction can cause trouble breathing. Before the THMPD, Europe had a patchwork of herbal medicine regulations. Hooyenga P, et al. Labeling and advertising would come under FDA and FTC regulations and would have to comply with language guidelines (see below for more information). Statistical methods are then used to identify disproportionate reporting rates which can lead to a safety signal.29 In the EU, EudraVigilance is the platform used to manage information on safety reports. It is important to remember that herbal supplements are not subject to regulation by the FDA and, therefore, have not been tested in an FDA-approved clinical trial to prove their effectiveness in the treatment or management of medical conditions. Regulatory Affairs Professional Society; 2017:543-584. MeSH Subsequently, the IRCH was established in early 2006 by receiving the nomination of the information focal points from Michael McGuffin | Jan 25, 2023 The new year is here and, as we settle into 2023, big changes to the federal regulation of cosmetics are on the way. Evaluation of the Regulation (EC) No 1924/2006 on nutrition and health claims made on foods with regard to nutrient profiles and health claims made on plants and their preparations and of the general regulatory framework for their use in foods. FDA also reserves the right to take legal action. Thank you for visiting nature.com. Claims-related violations are one of the more common categories of FDA citations of manufacturers. Applied Knowledge. They lift the cuticle of the hair and leave the cortex vulnerable. Herbal products formulated to treat more serious ailments a category that covers many traditional Asian preparations fall between the regulatory cracks. Update regarding PSUR and RMP for herbal and homeopathical medicinal products [presentation]. The European Medicines Agency says it predicts a substantial increase in registrations in an updated assessment due in December 2011, but again few of these are expected to be from East Asian traditions. Delegations from 11 of 13 Members of IRCH attended the meeting together with observers from four national regulatory authorities. When autocomplete results are available use up and down arrows to review and enter to select. However, no current license precludes the right of other health professionals or lay persons to use, dispense, or recommend herbs, and additional legal protections granted to the license holder specifically related to the use of herbs are not always clear. 3978 0 obj<> endobj In the meantime, to ensure continued support, we are displaying the site without styles Under the directive, herbal medicines intended as treatments for minor health ailments must be registered as traditional-use products with the regulatory agency in every EU member state in which the product is to be sold (although each national regulatory agency is supposed to recognize licences already granted by other EU members). Am I exempt from the GMPs?No. J Pharm Bioallied Sci. Preparing for the future: The new European Union medical devices regulation. 2012 Apr 10;140(3):568-86. doi: 10.1016/j.jep.2012.02.029. Regulatory authorities of countries are working to evolve the regulations to govern herbal medicines more effectively. In addition, 89 of the 208 RASFF notifications (43%), the food supplements had been manufactured in another member state or were imported through another member state. To fulfill the vigilance or materiovigilance obligations, the manufacturer must report to national competent authorities any serious incidents related to the use their medical devices. As a small-scale pharmacy or herb shop you may have further restrictions. The FDA considers herbal supplements foods, not drugs. In earlier days, patients were dependent on herbs for treatment and well-being. Bos G. The new Medical Device Regulation and In Vitro Diagnostic Device Regulation. The .gov means its official. Deloitte. The principal law governing cosmetics in the US is the Food, Drug & Cosmetic Act (FD&C Act). Webproposed the herbal anatomical-therapeutic-chemical classification (HATC) as a coding tool to permit the inclusion of individual herbal products in the global WHO database of In addition, in traditional Chinese medicine, Aristolochia species are regularly interchanged with other plant species, further complicating the use of these herbs for Western doctors who may be unfamiliar with the language and with traditional practice. 2016 Dec;9(12):1597-1609. doi: 10.1080/17512433.2016.1238762. European Union medical device legislation, vigilance, and metrology system. All I do is compound them into formulas and re-label them for sale to the public. Does the product label give information about the standardized formula, side effects, ingredients, directions, and precautions? 0000003178 00000 n There are a few differences in regulations of herbal drugs among various countries. Health Products and Food Branch of Health Canada. Medical devices WebNatural health products (NHPs) are defined in the Regulations as vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines (like Traditional Chinese Medicines), probiotics, and other products like amino acids and essential fatty acids. Traditional, complementary and integrative medicine. Natasha Gilbert is a reporter for Nature in London., You can also search for this author in EudraVigilance European database of suspected adverse drug reaction reports.

But without an appropriate regulatory framework, these could be lost to science. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Every effort at accuracy has been made but AHG cannot guarantee that the information provided here is fully correct or up-to-date. Epub 2016 Oct 3. Altayyar SS. Zhao A, Yang Y, Pan X, Chung M, Cai S, Pan Y. Pharm Biol. Internet marketing is subject to regulation in the same fashion as promotions through any other media. They are too aggressive. 6th ed. For low-risk or old products, including well-established use medicines and THMPs, PSURs are not routinely required.31,32 For such products, PSURs must be submitted only on request or where there is a condition in the marketing authorization for example, for Hypericum perforatum L., herba (every 5 years), senna glycosides standardized 60% (every 10 years), diosmin (every 13 years), silibinin, dry extract from Milk Thistle fruit (silymarin; every 13 years), and caffeine (every 28 years).33,34 The marketing authorization holders of medicinal products exempted from submitting PSURs should use alternative mechanisms to communicate relevant new safety information to regulatory authorities.35 Manufacturers are expected to submit pre-market notification of any claims made for dietary supplements. See below for more resources. PubMedGoogle Scholar, Gilbert, N. Regulations: Herbal medicine rule book. Dietary supplement manufacturers must register their facilities with FDA and must comply with the Dietary Supplement Current Good Manufacturing Practice (cGMP) requirements. Some manufacturers may use the word standardized on a supplement label, but it does not necessarily mean the same thing from one manufacturer to the next. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Natural health products must be safe to use If this is the first time you are logging in on the new site, you will need to reset your password. Adverse drug reactions and pharmacovigilance of herbal medicines. 0000004878 00000 n Calapai G. European legislation on herbal medicines: a look into the future. If products are marketed as food supplements, their makers cannot make claims about the conditions they aim to treat and people suffering from particular maladies will be unaware of these potentially beneficial treatments. Use the links below to find guidelines that are specifically related to herbal medicinal products: Quality. Many later developed cancer of the urinary system. Int J Green Pharm. It focuses on all aspects of herbal product development, registration and licensing. Would you like email updates of new search results?

The pre-market notification has been a requirement since DSHEA was passed, but has only begun to be enforced within the last year. FTC's truth-in-advertising law can be boiled down to two common-sense propositions: 1) advertising must be truthful and not misleading; and 2) before disseminating an ad, advertisers must have adequate substantiation for all objective product claims. At Another Johns Hopkins Member Hospital: Types of Complementary and Alternative Medicine, Masks are required inside all of our care facilities, COVID-19 testing locations on Maryland.gov. However, they are not for everyone.

Bookshelf This shrub-like plant of eastern North America derives its name from the Native American word for "rough" (referring to its root structure). official website and that any information you provide is encrypted What's New in Dietary Supplements For the past 11 years, Cheng has been investigating PHY906, a 1,800-year-old Chinese formulation of four herbs that has the potential to alleviate the vomiting and cramps caused by chemotherapy for gastrointestinal cancer. The cases of St. John's wort, valerian, ginkgo, ginseng, and green tea. and regulations of herbal formulation. The legal definition of dietary supplement according to DSHEA includes vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Many Western herbal providers and manufacturers applaud the move to improve standards, and expect Europe's new rules will provide a fairer ground for competition among responsible herbal suppliers. WebAll our products are made and distributed in the USA. PMCF can be omitted for devices where long-term influence data is available. WebFind many great new & used options and get the best deals for GROUNDWATER INJECTION: MODELING, RISKS, AND REGULATIONS By Fred Bloetscher at the best online prices at eBay!

In: Fundamentals of EU regulatory affairs. Nature 480, S98S99 (2011). startxref