Regulatory Law: Consumer Product Regulation

You will benefit from the remarkable

knowledge and experience of our

leading consumer product regulatory

lawyers and naturally you can expect

powerful results beyond your expectations

Biocides - Biosimilars - Chemicals - Confectionery Products - Cosmetics - Disinfectants - Drugs - Electronic Cigarettes - Electronic Products - Food - Foods for Special Medical Purposes - Food Supplements - Herbal Medicines - Infant Food Products - Insecticides - Medical Devices - Medical Foods - Medicinal Products - Nutraceuticals and Functional Foods - Pesticides - Preservatives - Textiles - Toys - Veterinary Hygiene Products - Veterinary Products

Our quality regulatory solicitors are experts in consumer product regulatory law from cosmetics, electronic cigarettes, food, herbal medicines to medical devices. We advise and assist International and UK clients to ensure our clients meet the appropriate standards of safety, quality, efficacy and risk management laid down by the Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA) and other regulatory bodies in respect of medical devices, medicinal products and herbal medicines.

Our elite regulatory lawyers are experts in advising on Foods for Special Medical Purposes (FSMPs), whether you are a manufacturer, distributor or importer of FSMPs or looking to acquire or sell a FSMPs company or the FSMP division of a global group of companies.

We will assist you in the preparation of your dossiers to the MHRA and EMA for marketing authorisations for medicinal products, biotechnology products and drugs. We also advise on borderline products such as cosmetics, foods, FSMPs, food supplements and medical foods.

We will also advise and assist you in the preparation of your dossiers and in obtaining authorisation and registration for their biocidal products under the Biocidal Regulation from the Health and Safety Executive (HSE). We will advise you in relation to REACH regarding the registration, evaluation, authorisation and restriction of chemicals they are importing, supplying and/or marketing.

With regards to achieving compliance in a specific country, we work with our associates that are situated globally, to ensure your products achieve compliance.

Our Services

Some examples of our leading expertise in product regulation include:

Biosimilars	Advice on the legal issues surrounding the Development, Protection, Enforcement, Distribution and Sales of new Biological Medicinal Products that are Biosimilars Preparation of Dossiers and Applications for Marketing Authorisations before the EMA or MHRA for Similar Biological Reference Products
Chemicals, Biocides, Disinfectants, Insecticides and Pesticides	Advice in relation to REACH regarding the Registration, Evaluation, Authorisation and Restriction of Chemical Products being imported, supplied and/or marketed Article: Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Made Simple: Compliance of Chemical Substances, Mixtures or Articles under Reach, November 2013 See our dedicated Chemicals and Articles containing Chemicals page Advice on complying with the Biocidal Product Regulation and the requirements for obtaining Authorisation Preparation of Application for Approval and Authorisation under the Biocidal Product Regulation Article: New EU Biocidal Regulation: Treated Articles, August 2013 See our dedicated Biocidal Products and Treated Articles page
Confectionery Products	Advice relating to the Manufacture, Distribution, Sale, Marketing, Advertising and Promotion of Confectionery Products.
Cosmetics	Advice on Cosmetic Safety and Compliance Advice on meeting the requirements of the Cosmetic Products Regulation, EU Regulation1223/2009 Advising on Cosmetic Product Safety Reports and whether these comply with the requirements EU Labelling and Packaging Compliance EU Regulation of Cosmetics Article: Are you ready for the Cosmetics Regulation 1223/2009? March 2013 See our dedicated Cosmetics Law page
Dietary Foods for Special Medical Purposes (FSMPs)	Advising on composition of FSMPs, labelling requirements and nutritional health claims See our dedicated FSMP page
Electronic Cigarettes	Advice on how to comply with the Medicinal Products Directive (Directive 2001/83/EC) Advice on the requirements for obtaining Marketing Authorisation Preparation of Dossiers for Marketing Authorisations under the Medicinal Products Directive See our dedicated Electronic Cigarettes page
Electronic Products	Advising on UK and European Law Advising on regulation of Electrical Equipment (WEEE and RoHS) Advising on intellectual property rights, including Branding, Trade Marks, Designs
Food Law, Food Supplements, Infant Food Products	Advice on Borderline Food and Medicinal Products Advice on the Food Safety Regulations Advice on the legality of the Importation and supply of Nutritional Supplements into the UK EU Regulation of Food Evaluation of products to determine whether products should be classed as Medicinal Products or Food Supplements Food Health Claims - Regulation on Nutrition and Health Claims 1924/2006 Food Labelling Food Law Food Regulation Food Safety Regulation Food Standards Food Supplements Infant Food Products Product Recalls Regulatory Compliance Article: Food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control, April 2015 Food Labelling: Presentation and Advertising of Foodstuffs: Nutrition Labelling: Provision of Food Information to Consumers, October 2013 Food Supplements (vitamins and minerals): How to ensure your Food Supplements are Compliant under the Law, July 2013
Healthcare	Care Homes Complimentary Therapists Dentists Doctors Opticians Veterinarians
Herbal Medicines	Advice on the classification of Herbal Medicines Advice on Regulatory issues concerning Traditional Herbal Medicine Registration and Marketing Authorisations for Herbal Medicinal Products Advice on Traditional Herbal Medicine Registration Preparation of Application for Traditional Herbal Medicine Registration See our dedicated Herbal Medicine page
Medical Devices	Advice on Advanced Therapy Medicinal Products Advice on Clinical Investigations for Non-CE Marked Medical Devices Advice on EU Commission Regulation 207/2012 on Electronic Labelling of Medical Devices Advice on Medicinal Devices Quality and Regulatory Compliance
Medicinal Products, Drugs	Advice on Advanced Therapy Medicinal Products Centralised Procedures Decentralised Procedures Dossier Preparation Labelling and Packaging Marketing Authorisations Mutual Recognition Procedures Regulatory Data Protection Renewal and Variation of Marketing Authorisations Quality and Regulatory Compliance Wholesale Dealers
Medical Foods	Advising on composition of FSMPs, labelling requirements and nutritional health claims Advice on reimbursements for FSMPs See our dedicated Medical Food page
Nutraceuticals and Functional Foods	Advising on composition of Nutraceuticals and Functional Foods, labelling requirements and nutritional health claims Advice on reimbursements for FSMPs See our dedicated Nutraceuticals and Functional Foods page
Textiles	Advising on UK and European regulations Advice in relation to REACH Regulatory advice, including substances of very high concern (SVHC), Restricted Substances List (RSL)
Toys	Advice and assistance with the creation of a Technical File Advice in relation to CE Marking of Toys Advice in relation to Classification, Labelling and Packaging of Toys Advice in relation to Compliance with Safety Requirements Advice on Liability and Risk Assessment Advice on the Presentation and Advertising of Toys Declaration of Conformity Article: Toys: How to Manufacture, Design and Supply Toys Safely - Compliance and Enforcement of Labelling and Packaging of Toys under the Law, September 2013 See our dedicated Toys page
Veterinary Products	Advice and assistance with Wholesale Dealer’s Authorisations for Veterinary Medicines Advice and assistance on Appeals against Regulatory Decisions Advice and assistance with manufacture, authorisation, marketing, distribution and post-authorisation surveillance of veterinary medicines Compliance with UK and European veterinary regulations, including Directive 2001/82/EC and the Veterinary Medicines Regulations Marketing Authorisations for Veterinary Medicinal Products

Related Services

Articles

Brochure

Seminars and Conferences

London. KOL Liaison and Best Practice,SMi 4th Annual UK Conference, 28 - 29 September 2011, Copthorne Tara Hotel
London. Compliance in the New World, Internet Law and the Pharma Industry, conference details, 30 June 2011
LOndon. Compliance in the New World, Data Privacy and the Pharma Industry, 30 June 2011 (Dr Rosanna Cooper and Tariq Sayfoo, Speakers)
Berlin. Strategies in Pharma Outsourcing,25-26 May 2011
Brussels. 5th Annual Clinical Operations Summit, Brussels, 25-26 May 2011
London. Clinical Trials Congress - Pre-conference Symposium, Kensington Olympia, London - Informa Life Sciences,27th May 2008
Brussels. Managing Multi-Jurisdictional Legal and Regulatory Risks in Clinical Trials, C5's Clinical Trials, 15- 16 April 2008
Brussels. EMEA Investigational Medicinal Products- C5's Clinical Trials International Conference (Brussels) on Managing Multi-Jurisdictional Legal and Regulatory Risks in Clinical Trials, 15- 16 April 2008
London. Clinical Trial Performance Metrics Conference, Danubius Hotel, London –Informa Life Sciences, 20 – 21 February 2008
London. How To get Medicinal Products Through The Regulatory Process - Central Law Training, February 2006

Testimonials

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'RT Coopers Solicitors operate in the real world and deliver what they say they’ll deliver. A highly responsive, straight talking, client focused team who will pull out all the stops to deliver on-time results of the highest standard. Definitely a team you want along side you when the going gets tough. I think that says it all…' Janet Dean, Operations Director

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