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This form is designed to request advice from the Veterinary Medicines Directorate (VMD) regarding unauthorized products. It is necessary to provide detailed information about the product and its ingredients
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How to fill out borderline product advice form
How to fill out BORDERLINE PRODUCT ADVICE FORM
01
Begin by downloading the BORDERLINE PRODUCT ADVICE FORM from the relevant regulatory website.
02
Fill in the product details, including the name, description, and intended use.
03
Provide information about the manufacturer or distributor of the product.
04
Describe any existing regulations that the product may fall under.
05
Indicate any claims made about the product and the evidence supporting those claims.
06
Attach any supporting documentation, such as product samples or previous communications.
07
Review the form for completeness and accuracy.
08
Submit the completed form to the appropriate regulatory authority.
Who needs BORDERLINE PRODUCT ADVICE FORM?
01
Manufacturers or distributors of products that may fall into a gray area between regulatory categories.
02
Companies seeking clarification on how their product is classified.
03
Businesses needing advice on compliance with existing regulations for borderline products.
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People Also Ask about
What is the definition of borderline substance?
What is a borderline substance? A healthcare product which does not distinctly fall into a particular area is referred to as a 'borderline product'. This term is used when a product is not clearly identifiable as a medicine and maybe, for example, a cosmetic or food supplement.
What is the borderline cosmetic guidance?
The Borderline Manual is a guidance document created by the EC Working Group on cosmetic products. It aims to help companies determine whether their products fall within the scope of the EU Cosmetics Regulation. Nevertheless, it is essential to highlight that each product must be classified on a case-by-case basis.
What are examples of borderline products?
Types of borderline products medicines. herbal medicinal products. cosmetics. biocides. personal protective equipment. machinery or laboratory equipment. food supplements.
What is an example of a medicinal product?
Examples of medicinal product groups are: analgesics. anticoagulants. .
What is the EU cosmetic borderline?
The Borderline Manual is a guidance document created by the EC Working Group on cosmetic products. It aims to help companies determine whether their products fall within the scope of the EU Cosmetics Regulation. Nevertheless, it is essential to highlight that each product must be classified on a case-by-case basis.
What are the borderline products?
Overview. Some products are hard to distinguish from a medical device, for example products that might be medicines, cosmetics, food supplements, biocidal products or personal protective equipment. These products are called borderline products until their status has been decided.
What are borderline items?
Definition. “Borderline products” are products having combined characteristics of medicines along with foods, medical devices or cosmetics.
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What is BORDERLINE PRODUCT ADVICE FORM?
The Borderline Product Advice Form is a document used by manufacturers and importers to seek guidance from regulatory authorities regarding whether a product falls under specific regulatory definitions or requirements.
Who is required to file BORDERLINE PRODUCT ADVICE FORM?
Manufacturers, importers, or distributors of products that may fall into unclear regulatory categories are required to file the Borderline Product Advice Form to obtain clarification.
How to fill out BORDERLINE PRODUCT ADVICE FORM?
To fill out the form, provide detailed information about the product, including its intended use, ingredients, and any applicable labeling. Follow the instructions on the form carefully and submit it to the appropriate regulatory authority.
What is the purpose of BORDERLINE PRODUCT ADVICE FORM?
The purpose of the form is to assist stakeholders in determining the regulatory status of a product, ensuring compliance with safety and health regulations, and preventing misclassification.
What information must be reported on BORDERLINE PRODUCT ADVICE FORM?
The form must report information such as the product name, description, intended use, ingredients, and any claims associated with the product, along with relevant documentation to support the inquiry.
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