Regulatory & Compliance

/Regulatory & Compliance
Regulatory & Compliance 2018-01-05T00:25:00+00:00

Regulatory Compliance &
Applications Assistance

Natural Health Products (NHPs)

A vital step in R&D for your product is ensuring there will be no hurdles in compliancy. Our NuYuga team can assist in the following:

  • Market authorization for NHPs, foods and cosmetics
  • A-Z steps in licensing your product
  • Guidance for import and distribution of products and Site Licence Application (SLA)
  • Report Preparation (QAP) and Standard Operating Procedures (SOPs)
  • Regulatory correspondence on your behalf
  • Compliance with FDA regulations
  • U.S. regulatory support
  • Analysis of marketing material for regulatory compliance (brochures, website, marketing materials) & avoidance of misleading advertising statements
  • Translators for bilingual regulations
  • Package & label compliance
  • Commercial labs for testing and analysis

If you have a Natural Health Product concept, prototype, or retail product – whatever stage you are at in the development process – compliancy with the NHPD (Natural Health Product Directorate) regulations are required by Health Canada, and NuYuga can safely navigate you through this complex regulatory maze.

Product Licences are required for all Natural Health Products sold in Canada. In the Product Licence Applications (PLAs), you must prove that the remedy is safe and efficacious and that it meets all Quality Standards. You will also need a site licence and a Good Manufacturing Practice (GMP) Program.

NuYuga handles the entire regulatory process behind the licensing of your private label products as well as any of your regulatory concerns. Our advisory team handles site licence applications, product licence applications and safety and efficacy research.

Health Canada has been vigilant in enforcing NHP (Natural Health Product) regulations and as a result, imports of NHPs and foods without the proper compliance have been refused entry into Canada.

Since the introduction of the NHP Regulations in Canada in 2004, NuYuga has successfully assessed products for compliancy, safety, efficacy and marketability on behalf of clients in Canada, US and internationally. This includes all natural health products (NHP’s) and food products.

We also specialize in Natural Health Product GMPs (NHP GMPs) – a  system of processes, procedures and documentation to set the appropriate standards and practices for manufacturing, packaging, labelling, importing and storage activities.

The licensing requirements of the Natural Health Products Regulations apply to any person or company that manufactures, packages, labels and/or imports NHPs for commercial sale in Canada. Also, Pharmacists will not sell any health products without a Natural Product Number (NPN) or Drug Identification Number for Homeopathic Medicine (DIN-HM). The requirements do not apply to health care practitioners who compound products on an individual basis for their patients, or to retailers of NHPs.

The type of activities our researchers provide in your application process include items such as:

  • Compiling detailed information about the product
  • Documenting medicinal ingredients, source, dose, potency, non-medicinal ingredients and recommended use(s).
  • Summary of the safety and efficacy of NHPs and their health claims.
  • Summary of the proper evidence so that consumers and Health Canada know the products are indeed safe and effective.
  • Compiling evidence such as clinical trial data or references to published studies, journals, pharmacopoeias and traditional resources. The type and amount of supporting evidence compiled by the researcher will depend on the proposed health claim of the product and its overall risks.
  • Completion of all paperwork from A-Z, submission of documents to the NHPD as well as handling any questions that may arise after submission.

Once Health Canada has assessed a product and decided it is safe, effective and of high quality, it issues a product licence along with an eight-digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM), which must appear on the label. This number lets you know that the product has been reviewed and approved by Health Canada.

Natural Health Product (NHP)

An NHP is a substance or a combination of substances described in Schedule 1 of the Natural Health Products Regulations (NHPR), a homeopathic medicine, or a traditional medicine, that is intended to provide a pharmacological activity or other direct effect in:

  • diagnosing, treating, mitigating, or preventing a disease, disorder, or abnormal physiological state or its symptoms in humans;
  • restoring or correcting organic functions in humans; or
  • modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.

Schedule 2 of the NHPR sets out substances which do not fall within the meaning of an NHP.

Medicinal Ingredient

A medicinal ingredient is a substance which is set out in Schedule 1 of the NHPR, is biologically active and is included in an NHP for the one of the purposes bulleted above. A medicinal ingredient is characterized by its physical form, its chemical attributes, its source, its preparation, as well as its dose and pharmacological action.

Non-medicinal Ingredient

A non-medicinal ingredient is defined as any substance that is added to a product to confer suitable consistency or form to the medicinal ingredients (suitable as per dosage form and route of administration). Non-medicinal ingredients are those deemed to:

  • not exhibit pharmacological effects;
  • not have any effect contradictory to the product’s recommended purpose;
  • not exceed the minimum concentration required for the formulation;
  • not adversely affect the bioavailability, pharmacological activity, or safety of the medicinal ingredients; and
  • be safe.

Recommended Conditions of Use

The recommended conditions of use are defined as:

  • recommended use or purpose;
  • dosage form;
  • recommended route of administration;
  • recommended dose (including sub-population, amount, dosage unit, frequency, and directions of use);
  • recommended duration of use, if any; and
  • risk information, including cautions, warnings, contraindications, or known adverse reactions associated with the use of the product or its medicinal ingredients.

Modern Health Claims

Our team can assist you in making claims based on evidence from a range of sources, including (but not limited to) clinical studies, animal and in vitro studies, pharmacopoeias, textbooks, peer-reviewed published articles, and regulatory authority reports. We also have a fruitful partnership with Wellpoint Health Services and can provide introduction to network with the industry’s premier occupational health teams. We also have an equally talented and diverse team representing holistic practitioners.

Traditional Health Claims

NuYuga is also proficient in putting forth Traditional claims based on the sum total of knowledge, skills, and practices based on theories, beliefs, and experiences indigenous to a specific culture, used in the maintenance of health, as well as prevention, diagnosis, improvement, or treatment of physical and mental illness. For a claim to be categorized as “traditional use,” it must be founded upon the theories, experiences and beliefs embodying the respective ancient practice of medicine. Our panel of holistic practitioners, including specialists in TCM and Ayurvedic practitioners, have a stellar track record of successful NPNs awarded based on Traditional health claims and can provide great benefit in this area.

Let our experts guide you.

In full, the regulatory cycle can be daunting: gone are the days of submission numbers and exemptions. As of 2013, products have been seized by Health Canada for a variety of reasons.  

Every product requires a lengthy paper application, an overseeing person with expertise available to respond to any questions given by the NHPD (often with a requirement to answer within 48 hours), and patience to follow the process to receive a response from the government…which has been known to span from weeks to more than a year.

If you are bringing products into Canada, there are additional importation requirements. Things like an importer of record, domestic site licence, annexation of foreign sites and other areas of expertise that require professional experience – these things must be put in place before any company outside of Canada can legally send any product in. Do not dismay – none of these challenges are insurmountable. The NuYuga team can assist or do it all for you, and we make every step of the process easy, informative and fun. 

Foods

Foods are handled differently than NHP’s; however, they still require compliance on a number of levels. We will review your product and determine what claims you can make, build your entire packaging from A-Z, ensure the Nutrition Facts Table is correct, labels are bilingual, compliant and so on. Some foods are also classified as ‘novel foods’ and they must follow an entirely different regulatory process. Also certain licenses must be in place for food production and a new law is projected to be in place this year (2014) which will require a site license for food products.

Most food inspections and seizures are initiated after others in the market with similar products report a violation they find, so it is important to have all aspects of your product compliant.

Horses, Dogs and Cats

Health Canada does accept applications for what is called a Notification Number (NN) for animal supplements for horses, cats and dogs. Although an NN is not an official authorization (such as a DIN), it is far less costly than a DIN, and the process is far easier. It does not completely remove the chance of investigation by the Inspectorate, but enforcement upon minor regulatory variances in new products with novel ingredients beyond their database at this stage is unlikely.

An NN is not for companies that want their health claims reviewed (although you are required to have done that research and provide it if asked), and as long as your ingredients are among the 1000+ medicinal ingredients that are pre-cleared, there are no dose limits or thresholds currently established.

We also have worked with the Low Risk Veterinary Health Products Interim Notification Program (LRVHP-List of Substances-Admissible Substance Application) and have filed on behalf of many companies.

The List of Substances (The List) includes substances that have been evaluated as admissible or non-admissible. Admissible substances are substances determined to represent a low risk when used appropriately and according to certain conditions such as route of administration, quantity or duration of use, and in doses at generally accepted safe and effective levels that are supported by available literature. Health Canada considers it unlikely that a product containing only admissible substances and that satisfies all other applicable requirements could present a significant risk to the health of humans or animals. 

For more information, please refer to:  NuYuga Animal Compliance