Ann Godsell Regulatory 



Regulatory Affairs Consultancy

Regulatory Affairs Consultancy can support the development of a medicinal product throughout its lifestyle.
The development of a medicine is a costly process that can take a considerable time between concept, pharmaceutical and clinical development and the final step of obtaining a marketing authorisation from the necessary Health Authorities. Even after the first marketing authorisation is granted there are likely to be changes planned or required as the product lifecycle extends. Variations may be required as indications may be added, manufacturing sites or processes may change or the marketing authorisation holder may alter.  

We also offer a comprehensive Pharmacovigilance service to underpin all regulatory activities.

Regulatory Affairs Consultancy can support the development of food supplements, or other borderline medicinal products throughout i its lifestyle.
Medicines legislation has been long established. More recently European legislation has been introduced to harmonise requirements for the regulation of food supplements, and the nutrition and health claims that will be permitted for foods. There is now a transition period regarding the introduction of this new legislation.  We are gaining in experience in this aspect of Regulatory Affairs by working closely with those affected by this new legislation.

Why use regulatory consultancy?
There is a maze of regulations and guidelines to work through for any type of products including conventional medicines, traditional herbal medicinal products, generic medicines, homeopathic medicines or food supplements. It is often difficult to interpret what the particular requirements are for your project and we aim to cut out any uncertainties for you using our experience and knowledge to provide you with guidance and support. We can work for a client on a variety of projects of various scales to fit in with their own requirements. Our aim is to let you achieve your aims and deliver for you a successful conclusion for your project.

Consultancy specialising in offering regulatory affairs advice 
to pharmaceutical and healthcare industries

approvals in a timely and cost-effective manner

traditional herbal medicine registration, Directive 2004/24/EC, medicinal products, medicinal product, Directive 2001/83/EC, quality, safety, efficacy, efficacy, Marketing Authorisation, traditional herbal, medicine, traditional herbal medicinal product, 2004/24/EC, Traditional use evidence, Traditional use, Labelling, Patient Information Leaflet, based upon long standing use, common technical document, CTD, Medicine[Godsell, Ann] s  Act, Section 12, THMRS, Product Registration, European positive list, Registration scheme, Community herbal monograph, Herbal monograph, Traditional herbal medicinal substance, Qualified person, Voluntary pre-notification, Application for registration, the Committee on Herbal Medicinal Products, HMPC, European Directive, ESCOP, Auyverdic medicines, Food supplement, Food supplements, Good agricultural[Godsell, Ann] , THR, BHMA, community list, community monograph  Good agricultural and sourcing practices, GA[Godsell, Ann] C P, [Godsell, Ann] ESCOP, homeopathic, borderline product,
[Godsell, Ann]   , Licensed, Herbal legislation, Herbal pharmacopoeia, Herbal products">
[Godsell, Ann] PSUR, Periodic safety updates, MHRA, IMB, irish medicines board, medicines and healthcare regulatory agency,  maintenance, variation, renewal, Type I, Type II, Type IA ,Type IB, BROMI, MRP, DCP, readability, user testing, packaging components, due diligence, POM to P switch, P to GSL switch, legal category switch, manufacturing authorisation

traditional herbal medicine registration, training, seminar, medical writing, regulatory affairs consultancy, regulatory affairs

 

EUROPEAN HERBAL & TRADITIONAL MEDICINE PRACTITIONERS ASSOCIATION http://www.ehpa.eu/medicines_legislation/index.html

traditional herbal medicine registration, Austria Bundesministerium für Geshundheit und Frauen www.bmgfj.gv.at Belgium Federal Public Service Health, Food Chain Safety and Environment www.afigp.fgov.be Bulgaria Bulgarian Drug Agency www.bda.bg Cyprus The Registrar Drugs Council Pharmaceutical Services www.moa.gov.cy Czech Republic State Institute for Drug Control www.sukl.cz/enindex.htm Denmark Danish Medicines Agency www.dkma.dk Estonia State Agency of Medicines www.ravimiamet.ee Finland National Agency for Medicines www.nam.fi/english/index.html France Agence Française de Sécurité Sanitaire des produits de Santé (AFSSAPS) www.agmed.sante.gouv.fr Germany Bundesinstitut für Arznemittel und Medizinprodukte (BfArM) http://www.bfarm.de/en/index.php Greece National Organisation for Medicines http://www.eof.gr/eof_en/enhome.html Hungary National Institute of Pharmacy www.ogyi.hu/ Iceland Icelandic Medicines Control Agency (ICMA) www.lyfjastofnun.is Ireland Irish Medicines Board (IMB) www.imb.ie/ Italy Italian Medicines Agency (AIFA) www.agenziafarmaco.it Latvia State Agency of Medicines www.vza.gov.lv/index.php?setlang=en&large= Liechtenstein www.llv.li/ Lithuania State Medicines Control Agency (SMCA) www.vvkt.lt/index.php?1950175871 Luxembourg Ministère de la Santé www.etat.lu/MS/ Malta Medicines Regulatory Unit www.sahha.mt Netherlands Medicines Evaluation Board (MEB) www.cbg-meb.nl/ Norway Norwegian Medicines Agency www.legemiddelverket.no/eng/default.htm Poland Office for Medicinal Products, Medical Devices and Biocides www.bip.urpl.gov.pl/ Portugal Instituto Nacional de Pharmacia e do Medicamento (INFARMED) www.infarmed.pt/en/index.html Romania National Medicines Agency www.anm.ro/en/home.html Slovak Republic State Institute for Drug Control www.sukl.sk/ Slovenia Ministrstvo za zdravje Republike Slovenije http://www.mju.gov.si Spain Agencia Española de Medicamentos y productos Sanitarios www.agemed.es/ Sweden Medicinal Products Agency (MPA) www.lakemedelsverket.se United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) www.mhra.gov.uk www.abpi.org.uk

http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/index.htm

www.topra.org

http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=95

http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=595 www.imb.ie/ http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=678 http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=677 http://www.atcm.co.uk/ www.traditionalmedicines.info www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=65 http://www.ehpa.eu/ http://www.apa.uk.com/ http://www.phytotherapists.org/ http://www.nimh.org.uk/ http://www.kam.se/ http://www.wmin.ac.uk/sih/page-878 http://www.wmin.ac.uk/sih/page-878 hcd2.bupa.co.uk/fact_sheets/html/herbal_medicine.html http://www.hfma.co.uk/ http://www.nutraingredients.com http://www.associationofmasterherbalists.co.uk/ http://www.imb.ie/images/uploaded/documents/2716588_Guide.pdf http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=686 http://www.fsai.ie

www.abhi.org.uk

www.farmavita.net

www.pharmafile.com

www.pharma-id.com

www.nutrition.org.uk NEW WORDS TO EMBED

Centre for Economic Botany, Royal Botanic Gardens, Kew, Richmond, Surrey, TW9 3AE UK. Tel: +44 (0)20 8332 5000 Fax: +44 (0)20 8332 5768 Telex: 296694 KEWGAR Email: ecbot@rbgkew.org.uk National Poisons Unit: United Kingdom National Poisons Information Service, Guy's Hospital Poisons Unit, Avonley Road, London SE14 SER Tel +44 (0) 171 955 5095, FAX +44 (0)20 7639 2101. The National Institute of Medical Herbalists, Elm House, 54 Mary Arches Street, Exeter, Devon EX4 3BA. Tel: + 44 (0)1392 426 022. Fax: + 44 (0)1392 498963. Email: nimh@ukexeter.freeserve.co.uk The College of Practitioners of Phytotherapy, Oak Glade, 9 Hythe Close, Polegate, East Sussex BN26 6LQ, United Kingdom. Tel: +44 (0)1323 484353. British Herbal Medicine Association (BHMA), attn. Mr. H.W. Mitchell, 1, Wickham Road, Bournemouth, Dorset BH7 6JX, United Kingdom, Tel: +44 (0)1202 433691, Fax: +44 (0)1202 417079. European Herbal Practitioners Association Veterinary Medicines Directorate (V.M.D.), Woodham Lane, New HAW, Addlestone, UK-KT15 3NB SURREY, UK.

The American Herbalists Guild ,P.O. Box 746555, Arvada, CO 80006, Voice:(303) 423-8800, Fax: (770) 751-7472, email: ahg@earthlink.net American Botanical Council, attn. Mr. M. Blumenthal, Founder & Executive Director, American Botanical Council, P.O. Box 144345, Austin, Texas 78714-4345, USA, Tel: +1 512 926 4900, Fax: +1 512 926-2345; email: herbcowboy@aol.com; website www.herbalgram.org . Herb Research Foundation, 1007 Pearl Street, Suite 200, Boulder, Colorado, 80302, USA. Tel: +1 303 449 2265. The American Herbal Pharmacopoeia

Indian Society for Phytotherapy, attn. Dr. K. Parikh, c/o Zandu Phrmaceut. Works Ltd, P.O. Box 9144, Bombay 400 025, India, Tel: + 91 22 4307021, Fax: +91 22 4375491.

Irish Association on Phytotherapy,

Spots nutrition directive

Novel foods legislation

Food supplement directive

Regulation (EC) 258/97/EC

www.escop.com

herbcociety.org.uk bhta.org.uk phytox.

Bhma

British herbal medicine association

Health Claims - new EC regulation

New EU regulation on Nutrition and Health Claims (EC/1924/2006) The new regulation on nutrition and health claims was agreed in December 2006. It applies to all nutrition and health claims made in commercial communications, i.e. labelling, presentation or advertising of foods, and aims to provide a high level of consumer protection whilst allowing the EU market to function effectively. The regulation will apply from the 1st of July 2007. It describes how nutrition and health claims should be used, and the procedure to apply for the authorisation of a claim by the European Commission. The aim of this legislation is to put together a list of permitted nutrition and health claims that can be used by manufactures across the EU by January 2010. Ultimately, only health claims that are on this list will be permitted for use in the EU, although there are interim measures in place to give manufacturers time to adapt to the new rules. What is a nutrition claim? Nutrition claims are statements that suggest that a food has particular beneficial nutritional properties due to the nutrients it does or does not contain. Some examples of nutrition claims are 'low in fat', 'high in fibre' or 'no added sugar' What is a health claim? A health claim is any claim that states, suggests or implies that a relationship exists between a food category, a food, or one of its constituents and health. This could be a statement that a food can help a particular physiological function, such as calcium in dairy products maintaining bone health or dietary fibre aiding bowel function. Health claims may also be about the reduction of disease risk, such as "long chain omega 3 fatty acids may help reduce the risk of coronary heart disease". The new regulation on nutrition and health claims Overall any claim made should be truthful and not attempt to mislead consumers. Nor should it call into question the safety or nutritional content of other foods or the adequacy of a balanced diet. The claim itself must apply to the food as eaten, prepared according to the manufacturers instructions, and the effects described in the claim must be understandable to the average consumer. Claims that will not be permitted o Medicinal claims, about preventing, treating or curing a disease o Claims on alcoholic beverages (more than 1.2% alcohol) o Claims that suggest health could be affected by not consuming the food o Claims that make reference to the rate or amount of weight loss o Claims that make reference to recommendations of individual doctors and health professionals Nutrient profiling For a food to be able to carry a nutrition or health claim it must have a healthy nutrient profile overall. The nutrient profiling approach to be adopted has not yet been decided but is currently being considered by the European Food Safety Authority (EFSA) and will be published in 2009. Criteria are anticipated for various nutrients e.g. saturates and sodium, although the specifics have yet to be agreed. Nutrition claims will be allowed if the food exceeds a maximum of one of the criteria, but foods bearing health claims must meet all the criteria. Nutrition Claims

For a company to make a nutrition claim on its product, the specific claim must be listed in the annex of nutrition claims in the regulations Health Claims A list of permitted health claims will be available from January 2010. The way in which claims can get onto this list depends on the type of claim. Article 13 Claims These refer to o The role of a nutrient or other substance in growth development and the functions of the body o Behavioural or psychological functions o Slimming, weight control, an increased sensation of satiety or the reduction in available energy from the diet.

Article 14 claims These refer to o Reduction of disease risk o Children's growth and development Authorisation Article 13 claims that are based on 'generally accepted scientific evidence' will be incorporated into a list by each Member State and submitted to the EC. These lists will be scrutinised by experts and provided these are accepted, they will be added to the list of permitted health claims in 2010. In the UK, the Food Standards Agency is responsible for collating the list. Manufacturers and retailers have until September 2007 to submit their additions to the UK list. Examples of health claims based on generally accepted scientific evidence from the UK list: 'Folate is necessary for the normal structure of the neural tube in developing embryos.' 'Calcium helps build strong bones and teeth.' 'Iron helps make red blood cells, which carry oxygen around the body.'

Proposers of article 13 claims based on emerging evidence and article 14 claims must submit a dossier to the competent authority in their country (the Food Standards Agency in the UK) who will send it to the EC for consideration. If the data supporting the claim has been produced by the company and is new, the data and the claim may be protected for 5 years after it has been accepted. Transitional Measures Although this Regulation on nutrition and health claims will apply from July 2007, it will obviously take some time for claims to be assessed and published. With this in mind, transitional measures have been adopted as part of the regulation to help manufacturers and retailers phase in changes to the packaging and advertising of their products. traditional herbal medicine registration

ABHI Association of British Healthcare Industries

ABPI Association of the British Pharmaceutical Industry

API Association of Pharmaceutical Importers

AXREM Association of X-ray Equipment Manufacturers

BGMA British Generic Manufacturers Association

BHMA British Herbal Medicines Association

BIR British Institute of Radiology

BMA British Medical Association

BPC British Pharmacopoeia Commission

BSI British Standards Institution CEN Comité Européen de Normalisation

CENELEC Comité Européen de Normalisation Electrotechnique CHAI Commission for Healthcare Audit and Inspection CHI Commission for Health Improvement

CHMP Committee on Human Medicinal Products

CIOMS Council for International Organisations of Medical Sciences

COMP Committee for Orphan Medicinal Products

CPMP Committee for Proprietary Medicinal Products

CPS Chemistry Pharmacy and Standards Subcommittee

CRM Committee on Review of Medicines

CSCI Commission of Social Care Inspection

CSD Committee on the Safety of Devices

CSM Committee on Safety of Medicines

CVMP Committee for Veterinary Medicinal Products

DG Directorate General (of the European Commission) DoH Department of Health ECPHIN European Community Pharmaceutical Information Network

EDQM European Department for Quality of Medicines

EFTA European Free Trade Association

EFPIA European Federation of Pharmaceutical Industries Associations

EFQM European Foundation for Quality Management

EGA European Generic Medicines Association

EMEA European Medicines Agency

EPHA European Public Health Alliance

ETSI European Telecommunications Standards Institute

FDA Food and Drug Administration

HFMA Health Food Manufacturers' Association

HMPC European Committee for Herbal Medicinal Products

HMSO Her Majesty's Stationery Office

HPA Health Protection Agency

HSE Health & Safety Executive ICH International Conference on Harmonisation

ICNIRP International Commission on Non-Ionizing Radiation Protection

IEC International Electrotechnical Commission

IIP Investors In People

IPEM Institute of Physics and Engineering in Medicine

IRG Independent Review Group

MAC Microbiology Advisory Committee

MagNET Magnetic Resonance National Evaluation Team

MC Medicines Commission

MHRA Medicines and Healthcare products Regulatory Agency

MRGFMutual Recognition Facilitation Group NAO National Audit Office

NBOG Notified Body Operations Group

NHS National Health Service

NIBSC National Institute for Biological Standards and Control

NICE National Institute for Clinical Excellence

NPSA National Patient Safety Agency

NRPB National Radiological Protection Board

OECD Organisation for European Co-operation and Development

PAGB Proprietary Association of Great Britain

PIC Pharmaceutical Inspection Convention

RCGP Royal College of General Practitioners

RCR Royal College of Radiologists

RPSGBRoyal Pharmaceutical Society of Great Britain

RSC Royal Society of Chemistry

RSM Royal Society of Medicine SCOP Sub-Committee on Pharmacovigilance

SEAC Spongiform Encephalopathy Advisory Committee

TAG Technical Advisory Group

TSO The Stationery Office

WHO World Health Organisation