Foods For Special Medical Purposes

 

Our food lawyers have a phenomenal

grasp of the market pertaining to

Foods  For Special Medical Purposes

with remarkable legal expertise in this

area combinedwith professionalism and 

dedication to clients’ needs

 

Our leading team of food 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.

 

Our outstanding food solicitors fully appreciate the technical issues surrounding individuals that require FSMPs as they may have special nutritional requirements, may be unable to take, digest or absorb normal foods, they may have other metabolic disorders or conditions which the simple modification of their normal diets cannot address.

 

 

Our top food law solicitors will work closely with your company whether you are an existing manufacturer of FSMPs or looking to set up a food business to supply FSMPs and advise and assist you with the regulatory issues regarding the formulation, labelling, advertising, presentation and any nutritional and health claims of your FSMPs.

 

5 Stars Medis Health Ltd

 

We highly recommend their professional services to any company looking for a high standard legal

advice/solution with integrity and honesty.” David Raimundo, Director 


 

Our Services

 

Our food lawyers have the right level of expertise to advise and assist you if you are a business operator in the supply chain, supplying, manufacturing, importing or distributing FSMPs. You must ensure that you meet all regulatory and compliance requirements. When you instruct us, we will add value to your business as we know this industry and most importantly we are experts in the law on FSMPs.

 

Some of our legal services are as follows:
 

  • Dietary Foods for Special Medical Purposes
  • Composition of FSMPs
  • Advise and Assist with making Applications for Nutritional Products  to be considered for Approval by the Advisory Committee on Borderline Substances (ACBS):

 

Category 1

Non disease specific enteral tube feeds

Category 2

Non disease specific oral nutritional supplements

Category 3

Nutritional products for specific clinical conditions

Category 4

Nutritional products designed for the specific management of inherited metabolic disorders

Category 5

Staple food products designed to optimise nutritional status as part of the clinical    management of formally diagnosed chronic disease states

Category 6

Nutritional products designed to enhance the safety and / or acceptability of foods or feeds which are prescribable in any of the above categories

 

  • Borderline issues that may have to be referred to the ACBS
  • Evaluation of whether your Food Product is classed as a Medical Food and the Notifications that may be required
  • Labelling and Packaging of FSMPs
  • Nutrition and Health Claims on FSMPs
  • Reimbursements
  • Transactions for the Acquisition or Sale of FSMPs:
    • Advise and Assist with the Acquisition or Sale of the FSMPs
    • Advise on the impact of the Acquisition or Sale on the Reimbursement Status of the FSMPs
    • All Regulatory issues regarding the Acquisition or Sale of the FSMPs
    • Compliance issues
    • Due Diligence
    • Labelling
  • Transactions for the Acquisition or Sale of the Manufacturing Company for the FSMPs:
    • Advise and Assist with the Acquisition or Sale of the business/company
    • Advise and Assist with Regulatory issues for the Change of  Control if you are a Manufacturer or Importer of FSMPS
    • Advise on the impact of the Acquisition or Sale on the reimbursement status of the FSMPs
    • All Regulatory issues regarding the Acquisition or Sale of the business/company
    • Compliance issues
    • Due Diligence
    • Labelling

 

Related Services

 

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Testimonials

 

 5 Stars Private Cleint

 

'Working with the regulatory team at RT Coopers was a real pleasure. They took the time to understand our requirements and was patient with my many follow up questions. They provided excellent advice that we could rely on with confidence. A thoroughly professional firm of solicitors with great support staff. I would not hesitate in recommending the firm to anyone who needs solid legal advice. Thank you.” Prash Lagisetti

 

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