Product Regulation

 

The regulatory solicitors at RT Coopers are experts in product regulatory law. 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.

 

We assist our clients in preparation of their dossiers to the MHRA and EMA for marketing authorisations for medicinal productsbiotechnology products and drugs. We also advise on borderline products such as cosmeticsfoods and food supplements.

 

We also advise and assist our clients in the preparation of their dossier and in obtaining authorisation and registration for their biocidal products under the Biocidal Regulation from the Health and Safety Executive (HSE). We advise clients 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 compliance in that country.

 

Our Services

 

Some examples of our expertise in product regulation include: 

 

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

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  Pesticides

 

 

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
  • Article: Are you ready for the Cosmetics Regulation 1223/2009? March 2013
  • See our dedicated Cosmetics Law 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 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
  • Article: Herbal Medicines: Traditional Herbal Registration, June 2013 
  • 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

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 


Related Services

 

 

Articles

 

Brochure


Licensing of Pharmaceutical Products
Pharmaceuticals

Seminars and Conferences
 

 

Testimonials
 

'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, Ice Healthcare Ltd

 

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