Regulatory Law: Household & Consumer Products

 

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 

 

 

 

Agrochemicals - Antibacterial Wipes -  Antimicrobial Resistance - ,Antiviral Wipes - Beverages -  Biocides - Biosimilars - CBD: Cannabidiol Products  - Chemicals -  Confectionery Products  - Cosmetics - Disinfectants - Drugs - Electronic Cigarettes - Electronic Products - Food - Food Supplements - Herbal Medicines - Infant Food Products - Insecticides - Medical Devices - Medicinal Products - Nutraceuticals and Functional Foods  - Pesticides -  Plant Protection Prroducts - Preservatives - Textiles - Surgical Face Masks -  Toys -  Vaccines - Veterinary Hygiene Products - Veterinary Medicines

 

 

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:

 

Medicinal Products

CBD: Cannabidiol Products

  • Advice on Advanced Therapy Medicinal Products
  • Advice on Dossiers
  • Labelling and Packaging
  • Marketing Authorisations
  • Regulatory Data Protection
  • Regulatory Compliance 
  • Renewal and Variation of Marketing Authorisations
  • Legal and Regulatory Compliance
  • Wholesale Distribution Authorisations
  • Manufacturing Licences for Medicinal Products

 

Biocides: Antibacterial Wipes, Disinfectants, Antiviral Wipes, 
 Pesticides
  • 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
  • Product Evaluation
  • Labelling and Packaging
  • See our dedicated Biocidal Products and Treated Articles page

REACH Chemicals

 

  • Advice in relation to REACH regarding the Registration, Evaluation, Authorisation and Restriction of Products being imported, supplied and/or marketed
  • Authorisation and Registration
  • Classification of Products
  • Product Evaluation
  • Labelling and Packing
  • Regulatory Compliance
  • See our dedicated Chemicals and Articles containing Chemicals page

 

Cosmetics 

 

  • Advice on  Cosmetic Safety and Compliance
  • Advice on meeting the requirements of the Cosmetic Products Regulation, UK Cosmetic Regulation
  • Advising on Cosmetic Product Safety Reports and whether these comply with the requirements
  • Product Evaluation
  • Labelling and Packaging Compliance
  • See our dedicated Cosmetics Products page

Electronic Cigarettes

  • Advice on the requirements for obtaining Marketing Authorisations
  • Preparation of Dossiers for Marketing Authorisations 
  • See our dedicated Electronic Cigarettes page

Electronic Products

 

  • Advising on UK  Law
  • Advising on regulation of Electrical Equipment (WEEE and RoHS)
  • Advising on intellectual property rights

 

Food LawFood Supplements, Infant Food Products

 

 

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
  • Product Evaluation
  • See our dedicated Herbal Medicine page

Medical Devices

 

  • Advice on Advanced Therapy Medicinal Products
  • Advice on Clinical Investigations 
  • Advice on Labelling of Medical Devices
  • Advice on Medicinal Devices
  • Quality and Regulatory Compliance
  • Medical Devices Page
Surgical Face Masks and Surgical Gloves
  • Application for regulatory approval
  • Preparation of Application for Regulatory Approval
  • Classification of Products
  • Covid19 Exemption
  • Claims
  • Conformity
  • CE Marking
  • Requirements for Labelling and Packaging
  • Vigilance

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
  • REACH Chemicals
  • See our dedicated Toys page
Vaccines
  • Artificial Intelligence
  • Clinical Trials of Vaccines
  • Commercial Contracts & Corporate Finance
  • Preclinical and/or Clinical Development of Vaccines
  • R & D Agreements
  • Advice on the Preparation of Registration Dossier for Vaccines
  • Liaising with the MHRA for Approval of Vaccines
  • Approval of Vaccines from the MHRA
  • Evaluation of Clinical and Non clinical Data
  • Intellectual Property
  • Intellectual Property Protection in relation to the Patenting of Biosequences and Chemical Structures
  • Licensing
  • Manufacturing and Supply of Vaccines
  • Marketing Authorisations
  • Post Marketing Authorisation
  • Regulatory Approval
  • Preclinical Pharmacological and Toxicological Compliance
  • Safety Compliance

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 Veterinary Regulations including the Veterinary Medicines Regulations
  • Marketing Authorisations for Veterinary Medicinal Products 

 

Related Services

 

 

Articles

 

 

 

 

 

Testimonials
 

 

 Ice Healthcare Ltd 

 

 

'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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