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Drug Identification Number (DIN) Unlocked Inside Scoop

How to obtain your Drug Identification Number (DIN)

 

Many drug industries are working in every country. To sell any OTC drug in Canada is not possible without its legal authorization. A computer-generated eight-digit number is issued to every drug in Canada from Health Canada before it comes to market. This eight-digit number is known as Drug Identification Number (DIN).

Drug Identification Number (DIN)

A Drug Identification Number indicates the information about the drug and whether it meets all the Food and Drug Act criteria and its Regulation. It gives a favorable risk/benefit profile of drugs. DIN is on the label of prescription or over-the-counter drug products evaluated and authorized for sale in Canada.

DIN is a unique number for every drug according to its quality, safety, dosage, and effect. Manufacturers must meet these criteria; then, DIN is issued to the drug. Such measures provide surety about the medicines that have been assessed and are safe for use. It must appear like DIN: 123456, for example. Avoid purchasing and using products that lack a DIN. It is a property of Health Canada.

Aim of DIN

The primary purpose of DIN is to protect the health and safety of Canadians from taking unsafe and unauthorized drugs. And to provide them with reliable, timely, and 100% accurate information on the availability of drugs in Canada.

Objectives

A DIN identifies the following characteristics:

  • Manufacturer
  • Product Name
  • Active Ingredients
  • Strengths of active ingredients
  • Pharmaceutical form
  • Route of administration
  • Guidance document

Need help obtaining your (DIN) Drug Identification Number?

The Guidance Document

For all the drugs that have been issued a DIN number, there is a guidance document that is applied (i.e., human and veterinary drugs, biologics, disinfectants, and radiopharmaceuticals. The change in this document is limited if that affects the status of DIN.

This document covers by Health Canada to the manufacturer the following activities:

  • Issuance of a DIN
  • Issuance of revised Drug notification
  • Market notifications’ filing
  • 12 months of sale without notifications’ filing
  • Discontinuation of sale notifications’ filing

This document does not include management of drug submission, reporting adverse reactions, user and the right to sell drug fees, licensing, and annual drug notification processes.

Medical devices, veterinary health products, natural health products, experimental treatments for humans and animals, pest control products, and cannabis for medical purposes regulated under Part 14 of the Cannabis Regulations are also not included.

A DIN must be obtained by the Manufacturers of prescription and non-prescription drugs before they market their products in Canada. A Notice of Compliance (NOC) may also be required for the market authorization of a drug.

Issuance of DIN

Drug DIN is issued to the manufacturer; he acts as an agent on behalf of Health Canada. Because of this association, a person or any partner sells a drug using their name or trade name. After providing all the details and satisfying Health Canada, DIN is issued.

Cancellation of DIN

DIN can be canceled if the person fails to provide the required information for the safety and efficiency of the drug for its recommended use or on notice of noncompliance. Every year manufacturers must provide a signed copy of their Annual Drug Notification Form to Health Canada. Their DIN will be canceled if they fail to provide it before October 1st.

Drug Notification Form (DNF)

Every manufacturer must fill out this form before October 1st so that all information supplied before is correct about the drug. For more information on ADNF, consult the Guidance Document- Fees for the Rights to Sell Drugs. This form contains all the information about drugs and DIN that Health Canada has authorized.

According to the Food and Drug Regulations, the manufacturer, within the 30 days after the drug has been sold first, its date and sign the completed DNF. Please return it to Health Canada with a statement that all the information is correct and identifies the first sale date.

Product Name

The product name of a drug is named by the manufacturer so that they can sell and advertise it. If a manufacturer wants to sell his drug (already assigned DIN) under two or more product names, then he must file an application for this purpose- a separate DIN will be assigned for a separate product name. No other DIN is issued to the same product but to different retailers. This means manufacturers can sell drugs privately, but the DIN of the same product and manufacturer name will remain the same regardless of the retailer’s separate stores.

Health Canada assigns only one DIN to the products with unfamiliar flavors, colors, and fragrances but has all other same characteristics as drug formulation, dosage, route, manufacturer, and product name.

Separate DINs will be issued to sugar and sugar-free drugs with the same manufacturer. Also, preservation and preservation-free formulations will be issued as separate DINs.

Expiry of Drug

The expiry date of the drug should be mentioned on the label. Drug expiry should contain its potency, purity, and physical characteristics. It should also mention when the medicine cannot be used. The expiry should be a minimum of a month or a year.

Label

A label can be any separate package inserted in the packaged drug or written on the container. Facts sheets, consumer/patient leaflets, product monograph, or any other material that contain information related to the drug. These labels may be included in the package or sent to the consumer at the time of sending.

New Drugs

The new drug that meets all the criteria Health Canada gives must have NOC and DIN for authorization of sale in Canada. Drugs before June 2018 were not given DIN, so they were offered to apply for DIN after June via the application. Manufacturers send a direct email of application (DNF) to Health Canada.

No new DINs are issued until the NOC is granted or other requirements are left. DIN is issued when the NOC is granted to the manufacturer. The original Din is given to the manufacturer if they mention any change in the process of the drug. Application for this purpose must be submitted as well. The DNF shows the market authorization, so no NOC is required.

The Bottom Line

No drug in Canada can be sold without issuing the Drug Identification Number (DIN). This is very important for the safety of every person in Canada. They take legal and authorized drugs that have benefits. Also, for the drugs that got DIN but are not sold by the manufacturer for 12 consecutive months (due to low market demand or any other reason), the manufacturer must write an application to Health Canada so that after proper roots, they consider the DIN of that drug dormant.

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How Quality Smart Solutions can help

Are you looking to have your drug product registered with Health Canada? Quality Smart Solutions has a team of experts who are skilled with DIN applications. If you need help with your Drug Establishment License (DEL) Registration we can help with that as well. Please contact us today or call us at 1-800-396-5144 to learn about how we can help you.

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FSVP Plan: What you should know about FSMA-FSVP Certification

FSMA-FSVP Certification and FSVP Plan

The FSVP Plan is a requirement for many companies to be FSMA compliant. It is the responsibility of the company to develop and maintain a plan that outlines how it will verify the safety of its food supply chain.

The FSVP-FSMA certification is required for all companies that want to export food products to other countries. It ensures that these companies are following the regulations set by the Food Safety Modernization Act, which was signed into law in 2011. The Foreign Supplier Verification Program (FSVP) provides this certification, which has been updated since its inception in 2012.

FSMA-FSVP Certification is a certification that is awarded to companies and organizations that have met the requirements of the FSVP Plan. The FSVP Plan was introduced by the Food Safety Modernization Act in 2011.

FSVP Program:

The FSVP Program is a voluntary program for food facilities to verify they are meeting FDA standards. This certification allows them to export their products with reduced inspections.

A company or organization can be awarded this certification if they follow the requirements of FSMP-FSMA and have successfully completed an FDA audit.

FSVP-FSMA – An Overview

FSVP stands for Food Safety Verification Program and FSMA stands for Food Safety Modernization Act. The FSVP Plan is a set of requirements to demonstrate that a company is compliant with the FSMA. A company can comply with the FSMA by either being certified or having an approved plan.

Need help with your FSVP Plan FSMA-FSVP Certification?

What is an FSVP Plan?

On May 30, 2017, the Foreign Supplier Verification Programs (FSVP) rule went into effect in the United States. The FDA Food Safety Modernization Act requires FSVP (FSMA). No matter where the food is produced, FSMA mandates that the same preventative food safety requirements apply to food eaten in the United States.

Importers are required by FSVP to confirm that the food they receive from overseas vendors meets all relevant FDA safety criteria. As your FSVP agent, Quality Smart Solutions is available. To find out more, call them right away.

FSVP Plans are required by the FDA for all food manufacturers. FSVP Plan ensures that you have a plan in place to prevent, detect, and respond to food safety hazards.

The FSVP Plan must include:

  • A written HACCP plan
  • A written preventive controls plan
  • An employee training program on the prevention of hazards and how to reduce or eliminate them

What Is FSVP certification?

FSVP certification is issued by the FDA for the “Food Safety and Veterinary Medicine” field. The FSVP Association is a non-profit organization that was founded in 2002. They offer this certification to food safety professionals and veterinarians who want to work in food safety.

This certification can be obtained by passing an exam and fulfilling a certain set of requirements. It is a voluntary program that helps to establish competency in food safety and veterinary medicine.

The FSMA-FSVP Certification program consists of three levels: Level 1 (basic), Level 2 (Enhanced), and Level 3 (Advanced). Companies can take advantage of the program based on their needs. For example, if a company just wants to register as an importer or as a foreign supplier, then they only need to complete Level 1 or Level 2. On the other hand, if they want to register as both an importer and a foreign supplier then they need to complete all 3 levels.

The FSVP Plan Certification is designed to help companies in the food industry comply with Food Safety Modernization Act (FSMA) rules, which are enforced by the FDA. The FSVP Plan Certification offers businesses a way to demonstrate their commitment to food safety, which may make them more attractive customers for other companies with similar interests.

Levels of FSVP Certification

The FSMA-FSVP Certification is a professional certification for food safety managers and supervisors. The FSVP stands for Food Safety and Quality Professionals. The FSMA-FSVP Certification is recognized as a valuable credential by employers and organizations that require food safety training.

The FSMA-FSVP Certification is recognized as a valuable credential by employers and organizations that require food safety training. There are three levels of certification: Basic, Enhanced, and Advanced.

Basic Certification

The basic certification is based on the FDA Guidance Document that was published on July 17, 2016. The Basic level of certification requires 30 hours of continuing education credits. It is designed to provide a general overview of the food safety and quality management system in the workplace with an emphasis on the fundamentals of the system.

Enhanced Certification

An enhanced certification includes additional requirements to demonstrate compliance with FSMA. The Enhanced level is more in-depth than the Basic Level. It includes an in-depth look at food safety regulations and practices, including HACCP principles, risk assessment, sanitation principles, personal hygiene practices, etc., as well as an understanding of how to apply these concepts to specific industries such as restaurants or grocery stores.

Advanced Certification

An advanced certification includes additional requirements to demonstrate compliance with the FDA Guidance Document and other guidelines such as HACCP and ISO 22000 standards. The advanced level requires 60 hours of continuing education credits. The FSMA-FSVP exam is a challenging test. The goal of the test is to evaluate your knowledge of food safety and quality assurance concepts, principles, regulations, and good practices. The advanced FSMA-FSVP certification also includes an evaluation of your ability to apply these concepts in the workplace.

This certification will provide you with the knowledge necessary to work as a food safety professional in the industry.

Want to know where to get FSMA-FSVP Certification? 

Quality Smart Solutions is a global consulting firm that provides strategic support for products, NHPs, pharmaceuticals, and medical devices. They are trusted by many clients in the industry to provide them with guidance on quality standards and regulations.

The FSMA-FSVP Certification training course will equip you with knowledge on the importance of food safety, how to be compliant with the regulations set by FSMA-FSVP and how to implement food safety best practices in your workplace. The certification process at Quality Smart Solutions is designed to help companies comply with the FDA’s Food Safety Modernization Act (FSMA) and the Foreign Supplier Verification Program (FSVP) requirements.

Get In Touch With Experts To Know Which Level Of Certification You Need!

How can Quality Smart Solutions serve you?

Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published. 

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). 

Help with facility registration, FSVP agent, and US Agent. 

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How Does FDA Classify Software As A Medical Device (SaMD)?

 

Nowadays almost all the facets of healthcare are well-equipped with the modern and latest technology tools, including software systems. The use of the software is fully incorporated into digital services for both medical and non-medical uses. One of three forms of software connected to medical devices is software that, on its own, qualifies as a medical device.

SaMD Software as a Medical Device

Software that is a part of a medical device (software in a medical device) and software used in the creation or upkeep of a medical device are the other two categories of software connected to medical devices. Due to this reason, FDA classifies software as a medical device (SaMD).

Let’s know about software as a medical device (SaMD) and why FDA classifies software as a medical device.

What is Software as a medical device (SaMD)?

Software is recognized as a medical device when it aids the healthcare system in a way that positively impacts one or two sectors or parts of the healthcare system without the usage of any hardware medical tools. This method demonstrates the benefits of using cutting-edge technological instruments that work as a software and don’t require any kind of physical setup.

The term Software as a Medical Device is very well defined and explained by the International Medical Device Regulators Forum (IMDRF) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”

The use of software as a medical device is on the rise, and we can see and comprehend the advantages it offers, particularly in emergencies or when patients want quick assistance. It can be applied to a wide variety of online activities, including VLANs, medical device operating systems, and industrial “off-the-shelf” platforms, to name a few. Previously, such software was regarded as “single-player software,” “healthcare industry software,” and/or “health operating systems” by businesses, global authorities, and healthcare professionals.

Why has the FDA classified Software as a Medical Device (SaMD)?

It is no secret that many nations throughout the world are still unaware of the enormous and significant benefits linked to the use of software for healthcare systems. Because of this, there is a need to raise public knowledge of its significance, importance, and overall influence of it on the healthcare system. The benefits of this software need to be made clear to the general public because they go well beyond those of conventional medical equipment. Harmonizing medical device regulations will be made easier with an understanding of these facts. FDA has classified software as a medical device to observe even further benefits of it in the future. IMDRF develops internationally agreed-upon documents related to a wide variety of topics affecting medical devices. In 2013, IMDRF formed the Software as a Medical Device Working Group (WG) to develop guidance supporting innovation and timely access to safe and effective SaMD globally.

 

Seeking Medical Device 510K or Software as a Medical Device (SaMD) Registration & Licensing?

How to know if your product is a part of the FDA? 

The definitions of Software as a Medical Device (SaMD) provided by IMDRF, and the FDA are essentially the same. It is also another supporting information that the FDA is also a member of IMDRF so when your product is approved by FDA, your software product can achieve the status of SaMD.

Firstly, it is important to know the quality of your product and whether it has the potential to be regarded as a medical device. The quality and the ability of the intended product can easily be evaluated in the light of the definition by IMDRF which says, “intended for one or more medical purposes”. FDA cites the FD&C act’s section 181(h) definition of a device, which reads as follows:

An item that is a tool, machine, implement, implant, contraption, in vitro reagent, or another similar or related item, including a component or accessory.

It must be:

  • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

Note: The term “device” does not include software functions excluded according to section 520(o).

Here it is worth mentioning that the term “intended use” refers to the actual use for which that particular software is designed and which particular problem it will address as a medical device.

How does SaMD qualify for 510k Registration?

The FDA is the regulatory body that sets out the standards for medical device registration. It reviews and approves any new medical device before it can be sold in the United States. The FDA is responsible for ensuring that these devices are safe and effective, as well as meeting certain requirements set out by law. A 510(k) clearance refers to a notification of a substantially equivalent device to an already cleared device. This notification allows the company to market its product without additional testing, providing that they abide by certain conditions set out by the FDA.

Final Verdict

Regulations and guidelines for SaMD still contain some ambiguities that will need to be clarified in the upcoming years. Concerning issues like cybersecurity, there is still considerable work to be done. The learning curve for software professionals transitioning into the medical device industry is very significant.

But this area also offers tremendous possibilities and excitement. We want you to reduce the effort required to create reliable software for medical devices by acquiring licenses so that your business can thrive through compliance and risk mitigation.

There is no reason why your organization can’t produce high-quality SaMD that enhances the quality of life for millions of patients with the appropriate tools and the finest available expert advice. One helpful platform in this regard is Quality Smart Solutions.

The time has arrived for you to realize your goal of having your software authorized as a medical device.

Need more information or want to know the SaMD licensing procedure?

How Quality Smart Solutions can help

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels. 

Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information here: 

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FDA Facility Registration & Renewals (FDA Medical Device, Food & Drugs)

Quality Smart Solutions offers the best FDA Facility Renewal & Registration services in North America for Medical Devices, Food, and Drug FDA domestic and foreign facilities!  With the facility renewal period fast approaching we’re going to touch upon the FDA Facility Registration and Renewal process for domestic/foreign medical devices, food, and drug facilities.

Why is Food Facility Registration & Renewal Important?

Individuals such as owners, operators, or agents that oversee domestic or foreign facilities that manufacture, process, or package food for consumption in the United States are required to register their food facility with the FDA. This requirement along with the FDA being given advance notice on shipments of imported food (Prior Notice of Imported Foods) became effective by the Bioterrorism Act on December 12th, 2003, as a protective to protect the U.S. food supply.

FDA Facility Renewal and Registration

Can the FDA suspend my Food Facility?

The FDA Food Safety Modernization Act (FSMA) which was started on January 4th, 2011, amended section 415 of the FD&C Act. As a result, additional registration information may be required, and the FDA can suspend the registration of a food facility if:

  1. The FDA finds the food held at the facility has a reasonable probability of causing serious adverse health consequences or death.
  2. The facility created, caused, or was otherwise responsible for such a reasonable probability
  3. The facility was aware or had reason to know of such reasonable probability, yet still packed received, or held food ignoring the potential for risk

For help obtaining your FSVP certification and/or registering/renewing your FDA Food Facility contact Quality Smart Solutions for assistance. The biennial renewal period is every other year during the period beginning on October 1 and ending on December 31 of each even-numbered year.

What do I need to know about the FDA Food Facility Renewals & Registration process?

Registering a food facility with the FDA seems to be simple, but it can sometimes be a confusing and lengthy process. At Quality Smart Solutions, we are committed to offering a full range of FDA Food Facility Registration/Renewal consulting services to domestic and foreign establishments. Our US compliance experts will also guide you with regard to paperwork and qualifications to move you quickly and efficiently through the registration or renewal process.

  • DUNS Request
  • Filing Online Application 
  • US Agent Appointment Authorization
  • Submission of Application for FDA Registration
  • Obtaining a Food Facility Registration Number
  • Receipt of Registration Certificate from US Agent

DUNS Requirement for 2022 Food Facility Registrations:

In October 2020, the Food and Drug Administration (FDA) released the requirement for all food facility registrations to include a UFI (Unique Facility Identifier). Currently, FDA has only approved Data Universal Numbering Systems (DUNS) numbers for use as UFIs for food facility registration.  Between October 1 and December 31 of this year, all FDA-registered facilities, must renew their registrations.

In March of 2021, FDA extended the deadline for food facility DUNS compliance to December 31, 2022, but it’s unlikely that it’s extended any further. If you have not registered for DUNS numbers for your food facility yet, obtaining a DUNS number should be a priority ahead of this upcoming FDA food renewal season. Your FDA facility registration information must line up with the information associated with the DUNS number.

Why is FDA Drug Registration & Renewal Essential?

Any United States-operated or foreign company that manufactures, repackages, or re-labels drug products to be sold in the U.S. must register with the FDA. The Drug Registration and Listing System (DRLS or eDRLS) is used to list each drug manufactured at these facilities for commercial distribution. The updated drug listing information needs to be submitted to the FDA twice per year in June and December.

Information Required for Drug Facility Registration

The below information is required by the FDA to meet the Drug Facility Registration requirements.

  • Name of the company/facility/establishment
  • Address of manufacturing /Processing /Packaging /Testing Facility
  • DUNS number for the establishment
  • Telephone, email, and name of the contact person
  • US Agent information for foreign companies
  • Business operation information

Do you need FDA Facility Registration or Renewal help for your U.S/foreign site?

Remember that Drug Facility Registration and FDA approval are two different aspects.

  • Registration is a mandatory requirement for manufacturing, testing, process, and packing facilities
  • FDA approval is required before a drug is imported into the U.S

FDA Drug Registration and Data Collection:

The drug registration and data are submitted electronically (eDRLS) using structured product labeling (SPL) format. This ensures that the agency has a list of all the drug manufacturers producing drugs for sale in the U.S. and a current inventory of U.S. supply chain drugs. Portions of the data are published in the FDA National Drug Code Directory, FDA label repository, FDA drug establishment current registration site, and NIH’s DailyMed. Having the data accurate and up to date is essential for promoting patient safety and is relied upon for several key establishment registration and drug listing programs such as:

  • Drug establishment inspections
  • Post-market surveillance
  • Counterterrorism
  • Recalls
  • Drug quality reports
  • Adverse event reports
  • Monitoring of drug shortages and availability
  • Supply chain security
  • Drug import and export
  • Identification of products that are marketed without an approved application

Registration renewal occurs between October 1 and December 31 each year, while listing updates may occur at any time in the calendar year.

Why is FDA Medical Device Registration and Renewal Mandatory?

Anyone who owns an establishment or facility that produces and distributes medical devices in the U.S. must register (Establishment Registration) each year with the FDA. Most of these establishments are also required to list the devices made at the facility and activities performed with them. Depending on the type of activity that is being performed a registration fee may be applied to your facility registration.  Failure to do this results in delay or refusal of medical devices. Registering establishments or facilities with FDA is known as establishment registration.

Our team of experts can help with your FDA establishment registration for medical devices. The registration of a medical device establishment is a two-step process. First, you must pay the annual registration user fee. Once you have paid the fee, the registration process can be finalized.

Medical Devices that require a premarket submission:

If a premarket submission is required for the medical device before advertising it in the U.S then the owner should provide the FDA premarket submission number (510(k), De Novo, PMA, PDP, HDE) as part of the establishment registration. The registration and listing information needs to be submitted electronically. This information is essential to increasing the United States’ response and preparation for public health emergencies.

The FDA Establishment Registration renewal is due each year between October 1st and December 31st.

How Quality Smart Solutions can help

We can guide you through the entire FDA Facility Registration or FDA Facility Renewal process for domestic and foreign Food, Medical Devices, and Drug facilities

We’re here to serve your regulatory needs, so please reach out to us at info@qualitysmartsolutions.com with any regulatory questions.

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Health Canada’s Regulatory Enrollment Process (REP): Top 4 things to know

Industry people and experts considering working with a company not registered with Health Canada should be aware of the regulatory enrolment process. The REP is a regulatory enrollment process for medicinal products. It is an essential step in the pathway to market approval.

A drug company must apply to Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) for authorization of its product before it can be sold in Canada. The NNHPD reviews the application and, if it determines that the product meets safety, efficacy, and quality standards, will issue a Notice of Compliance (NOC) authorizing sale in Canada. This blog will outline the top things you need to know about Health Canada’s regulatory enrollment process.

regulatory enrolment process REP

What Does It Do?

First and foremost, we should know about Regulatory Enrolment Process. It is a set of web-based templates that are used to collect information from the industry related to:

  • The Company
  • Product and dossier
  • Regulatory Activities
  • Regulatory transactions

This program captures information in a structured form. REP templates have replaced the previous processes, which were processing Health Canada forms and Human drug submission application fee forms. This program utilizes extensible markup language (XML) format. Use of the REP has been made mandatory since October 1, 2020, by the Government of Canada.

1. Purpose of REP

REP has been designed to modernize how regulatory information is shared with Health Canada. The primary purpose of using this program is to implement a common approach for all product lines, which includes the following:

  • To send all the regulatory transactions by using a single process. By using this process, the other ways like media (CDs, DVDs, etc.) got, and email transmission of submission to The Health Products and Food Branch (HPFB) gets eliminated. It expands the scope of the standard electronic submissions gateway (CESG) to allow regulatory transactions in The Electronic Common Technical Document (eCTD).
  • Since that REP files will be sent in the form of the XML format by the sponsors, it will ensure the information’s accuracy, consistency, and reliability. And data will be uploaded to the internal Health Canada System.
  • The web-based REP templates are designed to support more accessible and faster data entry for sponsors with the help of drop-down lists, predictive text, help text, etc.
  • HPFB will collect routing IDs using the REP template to secure two-way communication between Health Canada and sponsors. By this, sponsors send all regulatory transactions to Health Canada and receive correspondence from them using CESG.

2. Scope of Mandatory REP

Mandatory filing of regulatory transactions using REP will apply to pharmaceutical, biological, and radiopharmaceutical drugs for human use and disinfectants, which is being implemented from Oct 2020. It is voluntary for veterinary medications and has been implemented since October 1, 2022.

3. Acceptable and Unacceptable Regulatory Activities

The regulatory authority provides segregated lists of acceptable and unacceptable regulatory activities to assist medical device manufacturers in better comprehending the prospects of their application requests. Details of the Class wise type of applications/ amendments concerning said activities are highlighted in the ensuing paragraphs:

Want to learn more about the Regulatory Enrollment Process? We can help!

Scenarios wherein Regulatory Enrollment Process could be applied:

  • Class II, III, and IV license applications
  • Class II, III, and IV license amendments
  • Class II, III, IV minor change amendments
  • Class II, III, IV Private Label applications
  • Class II, III, IV Private Label amendments

Scenarios/ Applications wherein Regulatory Enrollment Process could not be applied:

4. Process for Participation in the Regulatory Enrollment Program

To begin participating in the Regulatory Enrollment Program, a comprehensive procedure has been laid out to provide requisite guidance for the manufacturers. Details of the said procedure are highlighted in the following points. Health Canada also encourages submitting the proper requests within a short period.

Submission of Application

To submit the appropriate request, the platform used shall be through email.

Additional Information

  • The name of the medical device which the manufacturer is applying for participation
  • Contact details
  • The number of existing dossiers and the ones the manufacturer intends to submit.

Dossier ID Process

The Dossier ID Request Form is the only method for requesting REP and eCTD dossiers from Health Canada. A maximum of eight weeks’ time cushion be considered before filing the regulatory transaction.

Fees

While it is essential to highlight that REP is imperative for Human Drugs and Disinfectants, it is optional (voluntary) for Drugs to be administered to animals (Veterinary Drugs). In either case, the fees are an essential consideration during the procedure for REP.

To ensure the human safety and wellbeing of the users/ patients (human and animals), Health Canada reviews the drug’s efficacy in the intended species to ensure its effectiveness before its use. Fees are further categorized into Fees for Human Drugs and Fees for Veterinary Drugs.

Fees for Human Drugs

In the case of Fees for Human Drugs, comprehensive guidelines are available on the official website, wherein all the essential information related to the regulatory activities concerning Human Drugs (including both pharmaceutical and biological drugs) are stated.

Fees for Veterinary Drugs

In the case of Fees for regulatory activities related to Veterinary Drugs, detailed guidelines are stated on the official website.

Miscellaneous Fees

To further strengthen the compliance and enforcement programs so that all manufacturers conform to the desired standards, additional fees will be charged, such as Fees for examination of an application for an establishment license, Fees for the right to sell drugs, and Master file fees. These fees are standard for both Drug Categories (Human Drugs and Veterinary Drugs)

The Bottom Line

The abovementioned procedures and guidelines are meant only to state a streamlined process for Canadian health regulatory enrollment for drugs as per the publicly available guidelines. However, these guidelines are subject to change per the country’s latest rules, regulations, and amendments (if any). All the latest policy changes or updates to existing laws, rules, and procedures in vogue are generally reflected on the official website of the Government of Canada (official weblink: Home – Canada.ca).

How Quality Smart Solutions can help

Quality Smart Solutions can help your business with compliance in the following categories; food labels, OTC Drugs, Cosmetics, Natural Health Products, Medical Devices, and much more. Our specialists are here to help!  

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What are (HACCP & PCP) Requirements for GFSI Certification?

HACCP, PCP, GMP, GFSI Certification

Since the publishing of the Safe Foods for Canadians Regulations in 2017, there is now a requirement for a Preventative Control Plan (PCP) for your food facility or food program. This blog aims to explain several different programs and certifications that a food facility may want to consider for your sites or products.

HACCP, PCP, or GFSI are GMP-related programs (Training) that can be used in your food processing or storage facility that will help to ensure high-quality and safe products are being made. Having programs like these in place can help protect your company from a food safety incident or issue.

Hazard Analysis Control Point (HACCP)

Hazard Analysis Critical Control Points (HACCP) is a program designed for the evaluation and oversight of biological, chemical, and physical hazards, throughout (from start to finish) the production and life cycle of your product. From the raw material to final human/consumer consumption. HACCP plans are tailored to the product and processes of the facility to ensure a high level of food safety for consumers. HACCP plans are broken into seven principles:

  1. Conduct a Hazard Analysis
  2. Identify Critical Control Points
  3. Establish Critical Limits
  4. Monitor Critical Control Points
  5. Establish Corrective Actions
  6. Establish Record Keeping Procedures
  7. Establish Verification Procedures

Auditing and review of the Food Safety Plan (HACCP) are keys to ensuring it is running properly and producing a safe and high-quality product. If your processes change, it will likely require a change to your HACCP plan as well.

Preventive Control Plan (PCP)

The Preventative Control Plan (PCP) is like a HACCP Program as mentioned above. But with a greater focus on documentation and traceability. This is aimed at controlling and addressing any risk to food and food animals. This would explain how hazards to your products are identified, prevented, and eliminated to a level deemed acceptable. The main principles of PCP are:

  1. Explain biological, chemical, and physical hazards associated with the product/food.
  2. Document how you will handle each hazard identified.
  3. Provide plan information for development.
  4. Show how the plan is used and implemented.

Need help with your HACCP, PCP, or GFSI GMP-Related Programs?

This type of plan is required within and to meet the Safe Foods for Canadians Regulations and is required to hold a Food Import license. Health Canada has published several helpful guidance documents and policies to help you determine if you need a PCP plan and how to start creating it.  

GFSI Certification

The Global Food Safety Initiative Certification (GFSI) is a trusted process for confirming high standards in food safety. The concept is aiming to allow a holder to access multiple markets with this approval. You are required to undergo an audit by a certifying company of your internal practices, policies, and facility to obtain this type of certification.

In summary, a HACCP program will usually incorporate all elements of the PCP program, and you would use this plan in daily activities. This plan would be reviewed when applying for any certifications such as GFSI. Please reach out to our team of specialists to discuss a Food Safety Program that may suit your products or facilities.

Working with regulatory consultants such as Quality Smart Solutions and Quality Import Solutions will help bring your products into Canada in a safe and compliant manner. We hold a Safe Foods for Canadians Import License (SFCR) which allows us to provide quality sites for our clients. Please reach out to our team of specialists for all your Food Regulatory needs!

References

  1. https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/hazard-analysis-critical-control-point-haccp
  2. https://inspection.canada.ca/preventive-controls/preventive-control-plans/eng/1512152894577/1512152952810
  3. https://mygfsi.com/how-to-implement/certification/?utm_source=website&utm_medium=homepage&utm_campaign=home-shortcut

How can Quality Smart Solutions serve you?

Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published. 

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). 

Help with facility registration, FSVP agent, and US Agent. 

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