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 

 

 

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

ChemicalsBiocides, Disinfectants, Insecticides and  Pesticides

 

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 LawFood SupplementsInfant Food Products

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

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

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 

 

 
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