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5 reasons why Drug Identification Numbers are Important

Post author By Jessica Koves
Post date August 10, 2022
No Comments on 5 reasons why Drug Identification Numbers are Important

Overview

Manufacturers of prescription and non-prescription drugs are required to obtain a Drug Identification Number (DIN) before the drug product is marketed in Canada. A DIN is a unique, computer-generated, eight-digit number issued to the manufacturer and printed on the front of package labels. A DIN identifies the following product characteristics: manufacturer; product name; active ingredient(s); strength(s) of active ingredient(s); pharmaceutical form and route of administration.

A DIN indicates that the product has undergone an evaluation by Health Canada and has been determined to successfully meet relevant requirements of the Food and Drugs Act and its Regulations. A drug product sold in Canada without a DIN is not in compliance with Canadian law. While the authorization of a drug includes the issuance of a DIN to the manufacturer, the DIN is the property of Health Canada.

Why is a Drug Identification Number Important?

If a product has a DIN on the medication label, this indicates to consumers that Health Canada has approved the formulation, labeling, and instructions for use. Drug Identification Number’s are also important to the consumer for the following reasons:

Safety and Efficacy

Health Canada requires manufacturers to provide data ensuring product safety, effectiveness in satisfying label claims, potency, and purity. Once the manufacturer meets these criteria, Health Canada issues a registration number for the drug. These measures provide confidence that medicines have been adequately tested and are safe for the use intended when administered according to label directions.

Manufacturing Standards

Consumers can also be ensured that the DIN is manufactured at a site that has been authorized to conduct drug-related activities in compliance with Good Manufacturing Practices (GMP).
As part of Health Canada’s ongoing commitment to openness and transparency, the Department is publishing information regarding emerging issues identified via their drug inspection program. The information is posted in the form of a tracker and provides an insight into the potential health and safety issues Health Canada is tracking with companies that produce drugs for sale in Canada.

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3. Quality Monitoring

Continuous monitoring for adverse effects is required by DIN license holders while the product is on the market. Post-market monitoring is an important aspect that Health Canada has been increasingly focusing on over the last few years to improve health risks to the public. OTC Drugs

Verification for Consumers and Healthcare Professionals

Health Canada assigned DINs uniquely identifies each drug on the market in Canada, allowing both consumers and medical professionals the ability to verify drug products. Many products on the internet do not have DIN and consumers can be easily misled about the safety of the product. Drug Identification Numbers allow consumers to trust the product has been approved by Health Canada.
Additionally, DINs are used by drug insurance companies to identify whether or not a drug is covered.

Recall

If a DIN is recalled, the responsible party must complete a series of actions outlined by Health Canada. Health Canada’s recall procedure ensures that the responsible parties act in a timely and effective manner to mitigate potential risks to consumers.

How can DIN numbers help with product management?

DIN numbers can be a useful tool for product management, allowing manufacturers to track and classify their products more easily. A DIN number helps to identify a specific product and its various attributes, making it easier to locate the right product when needed. They also enable manufacturers to keep track of production batches and other information related to each product they make. This makes sharing Product Data Sheets (PDS) more efficient because manufacturers don’t have to manually sort through large amounts of data!

How do DIN numbers aid certification processes?

DIN numbers play an important role in product certification processes, as they allow manufacturers to register products and obtain the right certificates. For example, many electrical products have to be tested and certified according to specific regulations. To ensure that the necessary certificates are obtained quickly and accurately, manufacturers bundle different tests under the same DIN number. This way, all relevant tests related to a product can be carried out at the same time instead of separately.

What other applications do DIN numbers have?

While the primary use of DIN numbers is in product certification, they are also extremely useful as identifiers for individual components, parts and materials during internal product management processes. Using a unique ID number to mark every part simplifies product tracking and inventory oversight, and drastically streamlines sales orders. By doing so, businesses can quickly locate required components in their inventory and dispatch them on time.

Where can I find a list of all valid DINs?

One of the best places to find a full list of valid DINs is on the German Institute for Standardization’s (DIN) website. There, you can browse through specific DIN categories and view appropriate individual DIN numbers. Alternatively, there are multiple independent websites that curate lists of valid DINs, thus making it easier for companies to quickly identify correct codes and proceed with product certification processes.

Further information

The Drug Product Database (DPD) contains product-specific information on drugs approved for use in Canada. The database is managed by Health Canada and includes human pharmaceutical and biological drugs, veterinary drugs, and, disinfectant products.

It contains approximately 23,000 products that companies have notified Health Canada as being marketed. The DPD, allows consumers to search for information on products that have a DIN.

Bibliography

Canada, H. (2022, January 14). Government of Canada. Canada.ca. Retrieved August 9, 2022, from https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fact-sheets/drug-identification-number.html

Din’s and NPN’s: What are they? Stafford Pharmacy. (n.d.). Retrieved August 9, 2022, from https://www.staffordpharmacy.com/pharmacy/rx-pad/rx-center/dins-and-npns-what-are-they/

Ministry of Agriculture, Food and Rural Affairs. The Need to Read – Drug Label Directions Enhance Health of Livestock and Bottom Line. (n.d.). Retrieved August 9, 2022, from http://omafra.gov.on.ca/english/livestock/dairy/facts/need.htm

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 numbers and DIN applications. Please contact us today or call us at 1-800-396-5144 to learn about how we can help you.

Tags Din, Drug Identification Number, Fda, Health Canada

Blog

Food Labelling: 5 Reasons Why Food Labels are Important

Post author By Jessica Koves
Post date June 7, 2022
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Ever wonder why Why Food Labels are Important? Food labels provide important information about the food we eat, such as ingredients, nutritional content, and allergen warnings. Becoming familiar with these facts can help you make informed decisions when it comes to nutrition and potentially dangerous ingredients.

Importance of Knowing What’s In Your Food:

Knowing exactly what is in your food is especially important if you have allergies, as some foods can be contaminated with things that are not immediately obvious. Additionally, it’s essential to pay close attention to nutrition labels if you have diabetes or other dietary restrictions and want to monitor calorie, carbohydrate and fat intake.

Reading food ingredients carefully can also help reduce the risk of illness from eating contaminated or poorly processed foods.

Why Food Labels are Important: The benefits of Understanding Food Additives and Ingredients:

Comprehending food additives and ingredients listed on packaging is beneficial for two reasons. Not only does it help you to better understand the nutritional value of what you are buying, but it can also aid in avoiding anything that may lead to an allergic reaction or other health concerns. While some things on labels are easy to identify, others like preservatives and colours may be harder to quickly identify which is why it’s essential to take the time to research any questionable ingredients.

Avoiding Contamination Through Proper Labelling Practices:

Proper labelling not only helps protect the consumer’s health but also ensures that we are informed of any hazards that may be presented by contaminated food products. This includes allergens, chemicals, and poisons that can lead to serious risks if consumed. As such, it’s important to check the product label before purchasing to make sure that it is safe for you and your family. Additionally, a reliable food label should include contact information in case there are questions or feedback regarding the product.

Making Better Nutrition Choices Through Labels:

Proper food labelling also helps individuals make more informed nutrition choices. The ingredients and nutritional panel located on the product packaging provide important information that can help us determine whether an item is healthy or not. Foods may be high in trans-fat, or saturated fat or contain unhealthy artificial substances that should be avoided. Labels also allow us to compare different brands of similar items so that we can select the most nutritionally sound alternative.

Labelling as a Tool for Consumer Protection and Food Safety Regulations:

Food labelling provides a tool for consumer protection by informing individuals about the health properties of the food product that they are consuming. It also ensures that food products are following food safety regulations, providing an additional layer of security and awareness to individuals. Regulations from government bodies such as Health Canada or the United States Department of Agriculture (USDA) set out detailed requirements for the accurate and complete labelling of all commercially available food items. This means that labels must include information about the ingredients and nutrition facts, as well as any potential allergens to ensure adequate consumer protection.

Food Labelling 101: Why Food Labels are Important:

Food labelling is an important aspect for consumers across the globe. Food labels are used as reliable sources of information to help consumers make knowledgeable decisions. Consumers need to understand how to properly read and interpret food and nutrition labels.

Food Labelling for Food Products Infographic

What is on a Food Label?

Food labels will contain the following core labelling requirements in Canada:

Ingredient List

The ingredient list must list all the ingredients in food by weight, i.e. starts with the ingredient that weighs the most and ends with the ingredient that weighs the least.

Nutrition or health claims

Nutrition claims are considered optional on food labelling and must follow specific rules set by Health Canada to ensure the claims are consistent and not misleading.

There are two types of claims:

Nutrient claims: describe how much of a particular nutrient is in a food, i.e. the high source of fibre
Health claims: describe the effect of food on health and must be based on scientific evidence, i.e. Vitamin A aids in the development and maintenance of night vision

Food allergen

Allergen information is mandatory to be included on food labels as part of the ingredient list or on a ‘Contains’ or ‘May Contain’ list.

Date labelling

Prepackaged products with a durable shelf life of 90 days or less are to be labelled with date markings and even storage instructions.

Nutrition facts table (please see figure 1 below for reference)

The Nutrition Facts Table will give you information on the following:

Serving size
Calories
Percent daily values
Information on 13 major nutrients; fat, fib
re, saturated and trans fats, protein, cholesterol, vitamin A, vitamin C, sodium, carbohydrates, calcium, sugars, and iron.

5 reasons why Food Labels are Important!

The biggest reason why food labels are Important is that they help the average consumer make the right purchasing decision: The information these food labels provide include:

Nutrition/Dietary Intake

Food labels can help you understand the composition of your food via the information provided on the Nutrition Facts Table. The Nutrition Facts Table allows the purchaser to understand the type of vitamins, minerals, facts, etc. that they will be consuming. By monitoring your intake of micronutrients and macronutrients, you will be able to eat a balanced diet for your body.

Looking for assistance with food label reviews?

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Allergens

Food allergies are considered a rising, global epidemic. The proper comprehension of food labelling with regard to allergens is critical to avoid serious consequences. In Canada, common allergens and gluten sources must always be clearly declared on food labels when present as ingredients or components of ingredients. They will appear in the ingredient list or in a “Contains” statement located immediately after the ingredient list.

Origin

Origin information on food labels can be very important to consumers. For example, some consumers choose to purchase products from only local producers due to political or environmental motivations. Also, consumers are increasingly linking quality to geographical origins and traditions.

Production

Many consumers are invested in how their food is prepared due to religious, ethical, and cultural reasons. Production details on food labelling may include information for the following types of products: Halal, Kosher, Organic and free-range.

Compare and contrast products

Information is power and by understanding how to read and analyze food labels, the consumer has the power to take control of their own health. Food labels may be easy to ignore, but by taking a few extra minutes at the grocery store, will allow you to become more conscious of the products you are eating and may alter your purchases moving forward.

Tags #foodlabellingcompliancecanada, #foodlabellingrequirementscanada, #foodproductlabelling

News

Health Canada’s Annual Adjustment of Fees for Drugs & Medical Devices

Post author By Jessica Koves
Post date March 11, 2022
No Comments on Health Canada’s Annual Adjustment of Fees for Drugs & Medical Devices

On December 11, 2021, Health Canada issued a notice regarding the annual adjustment of fees for drugs and medical devices in the Canada Gazette, Part I.

Each year Health Canada’s fees for drugs and medical devices are subject to an annual fee adjustment. The fee adjustment is a cost-recovery practice by the federal government. Cost recovery as defined by Health Canada is “fees charged to recoup a portion, or the entirety, of costs incurred to deliver regulatory programs and ensure businesses pay their fair share.”

The annual fee adjustment is viewed as a common practice amongst international regulators of health products and Health Canada aims to provide license holders with sufficient notice, to allow companies to plan accordingly.

Starting April 1, 2022, Health Canada will be adjusting its human and veterinary drugs and medical devices fees for the fiscal year of 2022–2023 by the Consumer Price Index (CPI), 3.4%. Most of the CPI-adjusted fees are currently being phased in over 4 to 7 years and will therefore be different than those stipulated in the fees order.

Veterinary Drug Dealer’s Licence fees will also be adjusted by the Consumer Price Index. Fees for other regulatory and non-regulatory activities and services, including but not limited to Human Drug Dealer’s Licences, Certificate of Supplementary Protection and Drug Master File, will be subject to the established annual fee for drugs and medical devices increase of 2%.

The associated fee web pages and application forms will be updated to reflect the adjusted fees on the Health Canada website by April 1, 2022.

Furthermore, Health Canada made a prior commitment to engage with stakeholders annually to discuss key elements of cost recovery including performance, costs and program efficiencies. Originally, the Annual Cost Recovery Stakeholder meeting was scheduled to take place in spring 2020.

Looking to obtain a Medical Device Establishment Licence?

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However, due to the COVID-19 pandemic, the meeting was postponed. The meeting will now take place in February and will consist of four virtual sessions, articulated around specific health products and services. The sessions will take place over Zoom with simultaneous translations available.

Resources:

Government of Canada, P. W. and G. S. C. (2021, December 10). Government of Canada. Canada Gazette, Part 1, Volume 155, Number 50: Index. Retrieved February 11, 2022, from https://canadagazette.gc.ca/rp-pr/p1/2021/2021-12-11/html/index-eng.html

Tags Drugs, medical devices

Blog

What You Need to Know – Software as a Medical Device (SaMD)

Post author By Jessica Koves
Post date October 28, 2021
No Comments on What You Need to Know – Software as a Medical Device (SaMD)

The advancement of technology is rapidly progressing, and the evolution can be observed all around us. As cutting-edge technology becomes more available, there appears to be a shift with regard to how work is carried out across several industries. Within the last decade, the healthcare field has seen an increased amount of software being utilized in medical devices. Software has become an important aspect of medical devices and is proving to benefit both patient and provider.

What is Software as a Medical Device (SaMD)

There are various types of medical device software, but an emerging software of interest is known as ‘Software as a Medical Device’ or SaMD. As defined by several regulatory bodies, SaMD “is software intended to be used for one or more medical purposes and it performs these purposes without being part of a hardware medical device.” In other words, SaMD is a type of software that works independently from another device.

For example, a mobile application that takes input from a blood glucose meter to provide insulin dosage recommendations for diabetes is considered SaMD. But the software used to take the blood glucose meter reading is not considered SaMD, as this is software that supports the medical device and therefore can not function without it. Other examples include software that analyzes physiological signals that are collected from sleeping, software that uses digital mammograms to calculate breast density percentages and even software that permits smartphones to view images captured from a computerized tomography (CT) scan.

Advantages of Using (SaMD) in Healthcare

SaMD offers numerous opportunities and has the potential to refine integral systems in a healthcare setting. This is due to the possibility of automating certain aspects that can lead to better treatment for patients. SaMD’s main advantages include improving healthcare outcomes and faster response times.

There are several intended uses for SaMD that can benefit both the patient and the provider,

Treat or diagnose– information provided by SaMD can be used to accurately detect a disease or condition and help reduce the time from diagnosis to treatment.
Drive clinical/patient management– SaMD can help better identify early warning signs and provide real time recommendations. Also, can aid clinicians with making a definitive diagnosis, by analyzing relevant information.
Inform clinical/patient management- SaMD allows clinicians to better advise their patients regarding options for personalised treatment plans.

Compliance Measures

The FDA and Health Canada have similar SaMD classification guidelines based on risk categorization. The class and/or category of SaMD is determined by the state of the healthcare situation and the significance of information provided by SaMD to make a healthcare decision. Other factors of consideration include the degree of invasiveness in the body, duration of contact and local versus systemic effects. Both regulatory bodies have stated that as the medical device software field evolves, policy reform will follow to prioritize patient safety and clinical effectiveness.

Aligned Interests

Are you a company operating in the medical device software space and need help navigating the complex classification system or want to enter the medical device software market? Our team of knowledgeable subject matter experts can provide the necessary regulatory support with respect to preparing and submitting SaMD applications. Contact us today or call us at 1-800-396-5144!

References

www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance-document.html

www.selecthub.com/medical-software/software-medical-device-samd/

www.torys.com/insights/publications/2018/11/software-as-medical-devices-and-digital-health-in-canada.

Tags medical devices

News

Important Notice Regarding the Transition of COVID-19 Site Licenses

Post author By Jessica Koves
Post date September 1, 2021
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In March 2020, Health Canada introduced interim measures to expedite the issuance of site licences for alcohol-based hand sanitizers, to address the shortage of these products due to the COVID-19 pandemic. Alcohol-based hand sanitizers are considered natural health products (NHP) and all Canadian companies engaged in manufacturing, packaging, labelling, or importing a natural health product for sale, require a natural health product site licence.

However, as the demand for alcohol-based hand sanitizers stabilizes, the interim order is approaching an end. The Natural and Non-Prescription Health Products Directorate (NNHPD) of Health Canada has set forth that temporary COVID-19 site licences (COVID-19 SL) for manufacturing, packaging, labelling and/or importing alcohol-based hand sanitizers will expire on September 30, 2021. Health Canada issued a bulletin to all temporary COVID-19 SL holders that gave a 60-day notice period in advance for the end of interim measures.

Therefore, COVID-19 SL holders are presented with two options prior to licence expiry:

Stop manufacturing, importing, packaging, labelling, or distributing alcohol-based hand sanitizers.
Apply for a valid SL to continue producing hand sanitizer until you receive a decision on your application.

If the SL holder would like to continue activities beyond September 30, 2021, then a complete site licence application (SLA) must be submitted, as per Section 28 of the NHPR, by September 30, 2021, at 11:59 pm PST. The applicant will be required to complete the web SLA form and must select the “COVID-19 SL Transition” option. The applicant will also be required to demonstrate compliance with the Good Manufacturing Practices (GMPs) (i.e. Quality Assurance Report (QAR), and applicable testing, release, and batch records).

Once the SLA form is completed and GMP evidence documents are collected, the applicant then must retrieve the ePost Connect conversation thread. If the applicant does not have a COVID Applications conversation, Health Canada has recommended to contact the following e-mail address: hc.nnhpd-dpsnso.sc@canada.ca with the subject line “COVID transition – No applications conversation”. It is worth noting that any applications submitted through other means will not be accepted.

If Health Canada deems that the application requires more information to be sent, then an Information Request Notice (IRN) may be sent. The IRN will state a timeline and define the additional information required. Failure to respond adequately or on time will result in an application refusal.

The service standards normally in place for new applications will not apply to COVID-19 SL transition applications. Therefore, temporary COVID-19 SL holders will be allowed to continue activities under the temporary licence, until a decision is issued. The NNHPD is striving to issue an acknowledgement within 30 days of receiving the application. Please be advised, if you receive a site licence, you will be required to renew it within one year.

Alternatively, if you wish to discontinue activities under the COVID-19 SL licence, Health Canada has requested that you send an email to the following e-mail address; hc.nnhpd-dpsnso.sc@canada.ca ahead of the September 30, 2021, end date. The email will need to include a cover letter, reference your COVID-19 SL number and the discontinuation date.

It is important to understand that if you choose to discontinue activities, you may liquidate the remaining stock that was imported or manufactured while the interim COVID-19 SL was valid. You will be asked to confirm that you have ceased licensable activities. Also, you must retain samples of your products and records to enable a recall should the need arise.

In the event you have already stopped or never carried out activities under your interim COVID-19 site licence, you can notify the NNHPD that you wish to discontinue your license ahead of the September 30 deadline, following the same directions as above.

If you take no action, the activities listed on your interim COVID-19 SL will no longer be allowed after September 30, 2021.

Tags Covid-19, Nhp, NNHPD, Site License

News

Consultation Period Extension: Proposal to Improve Natural Health Product Labelling

Post author By Jessica Koves
Post date August 16, 2021
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On June 26, 2021, Health Canada launched a consultation on a proposal to improve natural health product labelling. Health Canada held extensive pre-consultation with a wide array of stakeholders in the development of the policy and prior to publication in Canada Gazette, Part I. The Canada Gazette, Part I consultation period process allows all stakeholders to review the proposed regulations and comment on the analysis of the potential positive and negative effects of a proposal on the health, safety, security, the social and economic well-being of Canadians, businesses and on the environment.

Recognizing that the timing of this consultation coincides with the summer holiday period and that there are a number of consultations underway at Health Canada, which may also be of interest to industry, the Canada Gazette, Part I public comment period is extended to 90 days and will now close on September 24, 2021. The details of how you can provide your feedback on the proposed amendments to the Natural Health Products Regulations can be accessed on Consulting with Canadians web page.

Tags Health Canada, Natural Health Products, NHPs, Npn

News

Proposal to Improve Natural Health Product Labelling

Post author By Jessica Koves
Post date August 13, 2021
No Comments on Proposal to Improve Natural Health Product Labelling

On June 25, 2021, Health Canada published a news release that announced proposed changes to the Natural Health Products Regulations. The proposed changes would directly affect natural health product (NHP) labelling requirements.

What are Natural Health Products?

As defined by Health Canada, natural health products are naturally occurring substances that are used to restore or maintain good health. They are often made from plants, but can also be made from animals, microorganisms, and marine sources.

A wide variety of NHP’s, such as vitamins, probiotics, and minerals, are used daily by many Canadians. The COVID-19 pandemic has increased the demand for these products, as consumers are becoming progressively self aware and are wanting to take more control of their own health.

Why Are Changes Being Proposed?

Health Canada is conscious of the growing usage of NHP’s among Canadians and is therefore trying to improve the understanding of NHP’s by proposing an amendment that will enhance plain language labelling. The goal of the amendment is to improve representation of key information on product labels to help consumers make more informed decisions.

The importance of labelling can be demonstrated by an online poll that was published by the Office of the Auditor General. The poll asked participants to rate different factors that influence the purchasing of NHP’s. The results of the poll identified that a product label was the second most important factor that influences consumer decisions, among other strong factors that were rated less significant, such as recommendations from family, and pricing.

What Are the Proposed Amendments?

The proposal by Health Canada includes four key elements that can be summarized below:

A Product Facts Table:Includes important product information, such as warnings and directions for use, that would be presented in a standardized table.
Clearly and prominently displayed label text:Rules would be introduced to improve NHP label legibility and readability (ie. minimum font size requirements).
Labelling of food allergens, gluten, and aspartame:Priority food allergens, gluten and aspartame would be identified in the warning section of the label.
Modernized contact information:A manufacturer may display either an e-mail address, telephone number or website instead of a postal address, as currently required.

If the proposal were to be registered as part of the Natural Health Products Regulations, there would be a transitional period of 3 years to allow NPN license holders to make the appropriate changes to product labels.

How to Participate in the Consultation

The public consultation for the proposal to improve natural health product labelling opened on June 26, 2021 and will close on September 4, 2021. Health Canada welcomes comments and feedback on the regulatory proposal from all interested parties.

Sources:

www.canada.ca, www.oag-bvg.gc.ca

Tags Health Canada, Natural Health Products, NHPs, Npn