How to apply for a DIN Number?

To apply for a DIN number, you must be an authorized manufacturer holding a Drug Establishment License (DEL). You or your delegated representative must submit a completed Drug Identification Number Application Form to Health Canada directly. After review and approval, Health Canada will assign a DIN-NNN-NNNN format, providing you with the authorization to manufacture and sell the drug.

What are the benefits of having a DIN Number?

Having a unique Drug Identification Number (DIN) assigned to your product allows it to be tracked and its safety monitored by Health Canada. With this unique number, you can register your product in the Canadian marketplace, which allows retailers to purchase it without any concern or question of authenticity or safety. In addition, having a DIN also helps protect your brand name since you will be the only manufacturer associated with the specific DIN number.

What documents are required for obtaining a DIN number?

When applying for a DIN number, you will need to provide several documents. These documents include a completed application form, the product labeling text, evidence of Good Manufacturing Practice (GMP) approval, product safety and efficacy data reports, proof of payment of fees, and any supporting documents requested by Health Canada. All documents must be complete and accurate for your application to be approved.

What processing time and fees are Involved in obtaining a DIN Number?

Processing time for a DIN number can vary depending on the complexity of your application. Generally speaking, it may take 4-6 weeks to receive a response from Health Canada. There are also fees associated with obtaining a DIN number, including an initial set-up fee and an annual renewal fee for manufacturers. It is important to research the fees involved before submitting your application as changes may occur over time.

How can DIN numbers help with product management?

DIN numbers can be incredibly useful for product management, as the codes can tell you a lot about the product and its certification status. With this information, companies can determine where and how their products are available for purchase, track changes or updates that have been made to the product over time, and ensure that safety standards are being met. By using DIN numbers, companies can ensure proper management of their products and help improve consumer confidence in their products.

How do DIN numbers aid certification processes?

DIN numbers are incredibly helpful for product certification processes. Companies can use the codes to quickly verify that their products meet certain safety standards, ensuring that their products are safe for use and legal in different markets around the world. Additionally, the codes can be used to help trace back any changes or updates that have been made over time, making it easy to ensure that all versions of a product meet the necessary certifications.

What other applications do DIN numbers have?

DIN numbers are incredibly versatile and are used in a number of different applications. They’re often used to perform quality checks on products, to help identify different parts of an assembly or to confirm specifications and design details. The codes can also be used during the product management process, to reduce the risk of counterfeits entering the market and to make sure that all updates and revisions adhere to safety standards.

Why are DINs Important for labelling pharmaceuticals?

DINs are a crucial piece of information for drug labels. Not only do they make it easier to identify medications and ensure their authenticity, but DINs also provide manufacturers with the data necessary to meet Canadian safety regulations. This ensures that medical professionals can quickly access vital information such as product ingredients, recommended dosage limits, and contraindications. Every pharmaceutical produced in Canada requires a unique DIN associated with its label in order to be legally compliant.

How to obtain a DIN from Health Canada?

In order to obtain a DIN for a pharmaceutical product, manufacturers must submit an application to Health Canada. This needs to include detailed information about the product, such as its name, ingredient list, dosage form, therapeutic class information, and strength. Once approved by Health Canada, the issuing authority typically receives a notice of issuance within two weeks and will then be able to begin using the assigned DIN on labeling.

How to register as an authorized drug manufacturer with Health Canada?

Manufacturers of pharmaceutical drugs must first be authorized by Health Canada to use DINs on drug labels. This requires the drug manufacturer to obtain a Drug Establishment License (DEL) issued by Health Canada. Once an organization is licensed, it must then meet specific guidelines for each type of drug it manufactures. These guidelines outline best practices in the manufacturing, testing, packaging, and labeling of the drug that must be implemented before the product can be sold in Canada.

How to use your DINs to foster Pharmaceutical Safety Compliance?

Using Drug Identification Numbers (DINs) on pharmaceutical labels helps promote safety and traceability throughout your production process. It allows you to easily identify a product during the manufacturing process while also helping to avoid counterfeit medications and prescription medication errors. Additionally, it simplifies the recall process in the event of faulty or unsafe products being produced. By properly applying DINs, organizations can ensure their products are compliant with safety regulations and reduce the likelihood of recalls.

How are DINs assigned in Canada?

DINs are assigned by Health Canada after a thorough review of the drug's safety, efficacy, and quality. The drug manufacturer must submit a New Drug Submission (NDS) or Supplemental New Drug Submission (SNDS) to Health Canada, which includes all relevant information about the drug. Health Canada then evaluates the submission and assigns a DIN if the drug meets all necessary requirements. The DIN is a unique eight-digit number that is printed on the drug label and packaging.

What information is included in a DIN?

A Drug Identification Number (DIN) in Canada is a unique eight-digit number that is assigned to a drug after it has been approved by Health Canada. The DIN includes important information about the drug, such as its name, strength, dosage form, and manufacturer. This information is printed on the drug label and packaging, and is used by healthcare professionals and patients to identify and track the medication. It is important to note that a DIN does not indicate that a drug is safe or effective, but rather that it has been approved for sale in Canada after meeting Health Canada's rigorous standards for safety, efficacy, and quality.

How do DINs ensure the safety and efficacy of medications?

DINs are a crucial part of the Canadian drug approval process and play a significant role in ensuring the safety and efficacy of medications. Before a drug can be assigned a DIN, it must undergo a rigorous review process by Health Canada to ensure that it meets the highest standards for safety, efficacy, and quality. This includes testing the drug in clinical trials to determine its safety and effectiveness, as well as evaluating its manufacturing process to ensure that it meets strict quality control standards. Once a drug has been approved and assigned a DIN, it is closely monitored by Health Canada to ensure that it continues to meet these standards. This helps to ensure that Canadians have access to safe and effective medications that can improve their health and quality of life.

How can consumers use DINs to make informed decisions about their medications?

Consumers can use DINs to make informed decisions about their medications by checking the DIN on the label of their medication and comparing it to the DIN listed on Health Canada’s Drug Product Database. This database provides information on all drugs that have been approved for sale in Canada, including their DIN, brand name, active ingredients, and indications for use. By checking the DIN, consumers can ensure that they are taking the correct medication and that it has been approved by Health Canada. They can also use the database to learn more about their medication, including its side effects, interactions with other drugs, and any warnings or precautions that they should be aware of. This can help consumers to make informed decisions about their health and ensure that they are taking their medications safely and effectively.

What is a DIN and why is it important?

A DIN, or Drug Identification Number, is a unique identifier assigned to every drug product approved for sale in Canada. It is a way for Health Canada to track and monitor the safety and efficacy of health products in Canada. The DIN provides important information about the drug, including its active ingredients, strength, and manufacturer. It is important for consumers to look for the DIN on the label of any health product they purchase, as it ensures that the product has been approved by Health Canada and is safe for use.

How to apply for a DIN?

To apply for a DIN, you must submit an application to Health Canada that includes detailed information about the drug product, including its active ingredients, dosage form, strength, and intended use. The application must also include data from clinical trials and other studies that demonstrate the safety and efficacy of the drug. Once the application is submitted, Health Canada will review the information and make a decision about whether to approve the drug and assign a DIN. The process can take several months or even years, depending on the complexity of the drug and the amount of data that needs to be reviewed.

What is the difference between a DIN and a NPN?

While a DIN is used to identify drugs that have been approved for sale in Canada, a Natural Product Number (NPN) is used to identify natural health products that have been authorized for sale. Natural health products include vitamins, minerals, herbal remedies, and other supplements. Like DINs, NPNs are assigned by Health Canada after a thorough review of the product's safety and efficacy. However, the application process for NPNs is generally less rigorous than for DINs, as natural health products are considered to be lower risk than pharmaceutical drugs.

How to check if a product has a valid DIN?

To check if a product has a valid DIN, you can search Health Canada's Drug Product Database. This database contains information on all drugs that have been approved for sale in Canada, including their DINs. You can search by product name, active ingredient, or DIN. It's important to note that not all health products require a DIN, so if you're looking for information on a natural health product, you'll need to search for its NPN instead.

What are some common misconceptions about DINs and Health Canada regulations?

One common misconception about DINs is that they guarantee the safety and effectiveness of a health product. While Health Canada does require products to have a DIN before they can be sold in Canada, this does not mean that the product has been extensively tested or proven to be safe and effective. Another misconception is that all health products require a DIN. In reality, only certain types of products, such as prescription drugs and some medical devices, require a DIN. It's important to do your own research and consult with a healthcare professional before using any health product.

How are DINs assigned?

DINs are assigned by Health Canada, the federal department responsible for regulating drugs and medical devices in Canada. Before a drug can be approved for sale in Canada, it must undergo a rigorous review process to ensure its safety, efficacy, and quality. Once a drug has been approved, Health Canada assigns it a unique DIN, which is printed on the drug's label and packaging. This number allows healthcare professionals and consumers to easily identify and track the drug product.

What information is included in a DIN?

A Drug Identification Number (DIN) is a unique eight-digit number assigned to each drug product approved for sale in Canada. The first four digits of the DIN represent the manufacturer or sponsor of the drug, while the last four digits represent the specific product. The DIN also includes information about the drug's formulation, strength, and route of administration. This information is important for healthcare professionals and consumers to ensure they are using the correct drug product for their needs.

How can you find a drug's DIN?

You can find a drug's DIN on the product label, packaging, or in the drug information provided by your healthcare provider or pharmacist. You can also search for a drug's DIN on Health Canada's Drug Product Database, which provides information on all drugs approved for sale in Canada. It's important to always check the DIN before using a drug product to ensure you are using the correct medication.

Why are DINs important?

DINs are important for several reasons. First, they ensure that all drugs sold in Canada have been approved by Health Canada and meet safety and efficacy standards. This helps to protect the health and safety of Canadians. Second, DINs allow for easy identification and tracking of drugs, which is important for drug safety monitoring and recall purposes. Finally, DINs are used for reimbursement purposes by public and private drug plans, so they are important for ensuring that patients have access to the medications they need.

How are DINs assigned to drugs in Canada?

In Canada, DINs are assigned by the Therapeutic Products Directorate (TPD), which is part of Health Canada. Before a drug can be authorized for sale in Canada, it must undergo a rigorous review process by the TPD to ensure that it is safe, effective, and of high quality. Once a drug has been approved, the TPD assigns it a unique DIN, which is printed on the drug's label and packaging. This number allows healthcare professionals and patients to easily identify and track the medication, helping to ensure that it is used safely and appropriately.

What information is included in a DIN?

A Drug Identification Number (DIN) is a unique eight-digit number assigned to each drug product approved for sale in Canada. The DIN includes information such as the manufacturer's name, the drug's brand name, the strength of the medication, and the dosage form. This information is important for healthcare professionals and patients to ensure that they are using the correct medication and dosage. Additionally, the DIN allows for easy tracking of the medication, which is crucial for drug safety and monitoring any potential adverse effects.

How do DINs help ensure drug safety?

DINs play a crucial role in ensuring drug safety in Canada. By providing a unique identifier for each drug product, healthcare professionals and patients can easily verify that they are using the correct medication and dosage. Additionally, the DIN allows for easy tracking of the medication, which is crucial for monitoring any potential adverse effects. This information is also important for regulatory bodies to ensure that drugs are being used safely and effectively. Overall, DINs are an important tool in promoting drug safety and ensuring that patients receive the best possible care.

What are the consequences of using drugs without a DIN?

Using drugs without a DIN can have serious consequences for patients. Without a unique identifier, it can be difficult to verify the authenticity and safety of the medication. Patients may unknowingly take counterfeit or expired drugs, which can lead to adverse effects or even death. Additionally, without a DIN, it can be difficult to track the medication and monitor any potential adverse effects. This can make it harder for healthcare professionals to provide the best possible care for their patients. Overall, using drugs without a DIN is a serious risk to patient safety and should be avoided.

How to find a drug's DIN?

You can find a drug's DIN on the drug label, packaging, or product monograph. The product monograph is a document that provides detailed information about the drug, including its uses, dosage, side effects, and precautions. It is available from the manufacturer or Health Canada's Drug Product Database. You can also ask your healthcare provider or pharmacist for the DIN of a specific drug product.

Why are DINs important?

DINs are vital because they provide a way to identify and track drug products in Canada. This helps ensure that drugs are safe and effective for Canadians to use. DINs are also used by healthcare professionals, pharmacists, and patients to identify specific drug products and ensure they use the correct medication. In addition, DINs are required for drug products to be eligible for reimbursement by public and private drug plans in Canada.

How to search for DINs?

If you need to search for a DIN, there are several resources available to you. The first place to look is Health Canada's Drug Product Database (DPD), which provides information on all drugs that have been approved for sale in Canada. To search for a DIN using the DPD, simply enter the name of the drug or the DIN into the search bar. The database will provide you with detailed information about the drug, including its DIN, dosage form, strength, and manufacturer. In addition to the DPD, there are several other resources available for searching for DINs. These include the Canadian Agency for Drugs and Technologies in Health (CADTH), the Canadian Pharmacists Association (CPhA), and the RxTx platform.

Why is DIN information important?

Accurate DIN information is crucial for healthcare professionals, regulatory agencies, and patients. Healthcare professionals use DINs to ensure that they are prescribing the correct medication and dosage for their patients. Regulatory agencies use DINs to track and monitor the safety and efficacy of pharmaceuticals. Patients use DINs to verify that they are taking the correct medication and that it has been approved for sale in Canada. If DIN information is inaccurate, it can lead to serious health consequences. For example, a patient may be prescribed the wrong medication or dosage, or a regulatory agency may not be able to track adverse drug reactions. To ensure that DIN information is accurate, it is important for manufacturers to submit complete and accurate data to Health Canada during the DIN application process. It is also important for healthcare professionals and patients to verify DIN information before prescribing or taking a medication.

How DINs are used in the pharmaceutical industry?

DINs are used in a variety of ways in the pharmaceutical industry. One of the most important uses of DINs is to track and monitor the safety and efficacy of pharmaceuticals. Regulatory agencies use DINs to track adverse drug reactions and to monitor the safety of drugs on the market. DINs are also used in drug pricing. The PMPRB uses DINs to track the prices of patented drugs and to ensure that Canadians have access to affordable medications. In addition to these uses, DINs are also used by healthcare professionals to ensure that they are prescribing the correct medication and dosage for their patients. Patients can also use DINs to verify that they are taking the correct medication and that it has been approved for sale in Canada.

What role do DINS play in drug safety?

DINs play a crucial role in ensuring the safety of pharmaceuticals. Health Canada uses DINs to track adverse drug reactions and to monitor the safety of drugs on the market. This helps ensure that drugs are safe and effective for their intended use. In addition to Health Canada, healthcare professionals also rely on DINs to ensure the safety of their patients. By verifying DIN information, healthcare professionals can ensure that they are prescribing the correct medication and dosage for their patients. Patients can also use DINs to ensure that they are taking the correct medication and that it has been approved for sale in Canada. This helps prevent medication errors and ensures that patients are receiving safe and effective treatments.

What role do DINS play in drug pricing?

DINs also play an important role in drug pricing. The PMPRB uses DINs to track the prices of patented drugs and to ensure that Canadians have access to affordable medications. The PMPRB sets price ceilings for patented drugs based on a comparison of the drug's price in Canada to its price in other countries. If the price of a drug in Canada exceeds the price ceiling, the manufacturer may be required to lower the price of the drug. By using DINs to track drug prices, the PMPRB helps ensure that Canadians have access to affordable medications. This helps reduce the financial burden of healthcare and ensures that patients can access the treatments they need.

What are the challenges and limitations of the DIN system

While DINs play an important role in ensuring the safety and effectiveness of pharmaceuticals, there are several challenges and limitations associated with the system. One of the main challenges is that DINs are not always assigned in a timely manner. The DIN application process can be complex and time-consuming, and delays in the approval process can lead to a shortage of medications. This can be particularly problematic for patients who rely on certain medications to manage chronic conditions. Another limitation of the DIN system is that it does not provide information on drug efficacy. While DINs are used to track the safety of drugs, they do not provide information on how effective a drug is at treating a particular condition. Finally, some critics argue that the DIN system does not go far enough in ensuring the safety and efficacy of pharmaceuticals. They argue that more rigorous testing and evaluation is needed to ensure that drugs are safe and effective for their intended use.

Drug Identification Number Registration (DIN Numbers)

You may wish to register your Drug Identification Number (DIN Number) to sell your product on the Canadian market as an NHP or if your product is considered a drug. A Drug Identification Number (DIN) is an eight-digit number assigned by Health Canada to show that it has been authorized for sale. Many organizations use DIN numbers to meet global standards for quality control, traceability, and safety. We can assist you with preparing and filing Drug Identification Number (DIN Number) applications and meeting the requirements set out by Health Canada. Learn more about how DIN Numbers aid prescription and patient safety and the DINs components, purpose and more. See our full list of DIN regulatory services.

Manufacturing of DIN Products

DIN products must be manufactured in a facility that follows good manufacturing practices (GMP)
If the facility is based in Canada, that business must obtain a drug establishment license
Foreign sites must also show evidence that they are following GMP through a Health Canada licensed importer
DIN products cannot be sold prior to license issuance
Licensing timelines vary and can be as fast as 45 days.
Health Canada’s fees for drug license application submissions are due initially upon submission of an application and annually after that.
The fee varies and increases annually based on the rate of inflation.

Monograph Categories for Over-the-Counter Drugs

There are many monograph categories for OTC Drugs in Canada. They are Labeling Standard, TPD Category IV, and Non-steroidal Anti-Inflammatory Drugs (i.e. NSAIDs).

Labelling Standards Non-prescription Monographs are:

Acetaminophen Labelling Standard	Acetylsalicylic Acid Labelling Standard	Anorectal Drug Products	Antacids	Anthelmintics	Antiflatulents
Antifungal (Naftifine & Imidazole)	Antifungals (topical)	Antitussive – Adult	Bismuth Subsalicylate	Cough and Cold	Paediatric Cough and Cold Products Attestation of Compliance
Cyproheptadine	Decongestant	Dimenhydrinate	Ethylene Oxide Gaseous Sterilants	Expectorant – Adult	Famotidine
Intravaginal (Miconazole & Clotrimazole)	Non-Classical Antihistamines	Poison Treatment	Sleep Aids	Topical Anaesthetic/Analgesic/Antipruritic	Topical Antibiotics

Category IV Monographs Include

Acne Therapy

Sunscreen Monographs

Medicated Skin Care Products

Diaper Rash Products

Anti-Dandruff Products

Antiseptic Skin Cleansers

Athlete’s Foot Treatments

Throat Lozenges

Note that these Category IV Monographs are also listed as NHP Monographs. Some of the ingredients in these monographs are classified as NHPs, while others are classified as drugs.

NSAIDS Monograph ingredients include:

Celecoxib
Diclofenac
Ibuprofen
Indomethacin
Meloxicam
Naproxen

What is a Drug Identification Number (DIN)?

A Drug Identification Number (DIN) is regulated by Health Canada, including OTC drugs (Over-the-Counter medicines sold directly to consumers without a prescription) to ensure they are safe to use. It is on the label of prescription and over-the-counter drug products evaluated and authorized for sale in Canada. It uniquely identifies all drug products sold in a dosage form in Canada. It is very important as this allows pharmacies to dispense the correct drug and helps ensure safe patient care. Here are 5 reasons why DINs are important.

How are Drug Identification Numbers (DINs) assigned?

Health Canada assigns DINs, and the federal department responsible for regulating drugs and other health products in Canada assigns DINs. To obtain a DIN, a drug manufacturer must submit an application to Health Canada that includes detailed information about the drug product, including its composition, manufacturing process, and intended use. Health Canada reviews the application to ensure the drug meets all regulatory safety, efficacy, and quality requirements before assigning a DIN. It uniquely identifies all drug products sold in a dosage form in Canada. It is very important as this allows pharmacies to dispense the correct drug and helps ensure safe patient care.

What elements are on each Drug Identification Number DIN?

name of manufacturer (company name selling product and responsible for the product)
product brand name
active ingredient
strength of the active ingredient
form of product (such as pill, liquid, or capsule)
route of administration

What are some common misconceptions about Drug Identification Numbers (DINs)?

One common misconception about DINs is that they indicate the safety or effectiveness of a drug. However, DINs are unique identifiers assigned to a drug product approved for sale in Canada. Another misconception is that all drugs sold in Canada require a DIN. Some natural health products do not require a DIN but may have a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) instead.

Who needs to register their DIN Drug Identification Number?

A Drug Identification Number (DIN) is a unique identifier for health products and devices, including drugs, biologics, and medical devices. The DIN numbers are assigned by Health Canada after a review of the product’s chemistry, manufacturing methods, quality assurance systems, and packaging material. If you want to market your product in Canada as either an NHP or a drug, you will need one or both numbers. Anyone who wishes to sell their product as an NHP or as a drug in Canada must have their DIN registered with Health Canada.

What is the role of Drug Identification Numbers in drug recalls?

When a safety concern or quality issue is identified, regulatory authorities can use drug identification numbers to quickly and accurately identify the affected batches or lots of the drug. This enables them to notify healthcare professionals, pharmacies, and patients who may have received or dispensed the affected product, ensuring appropriate actions are taken to prevent harm.

Drug identification numbers also aid in tracking the progress of the recall, allowing regulatory authorities to monitor the effectiveness of the recall efforts and ensure that all affected products are removed from the market.

By utilizing drug identification numbers in the recall process, regulatory bodies can minimize the potential risks associated with unsafe or defective drugs, protecting the public from harm and upholding the highest standards of safety and regulation in the pharmaceutical industry.

How do we ensure the accuracy and reliability of Drug Identification Numbers?

Firstly, the assignment of drug identification numbers follows a standardized process that involves rigorous evaluation of the drug’s safety, efficacy, and quality. This ensures that only approved drugs receive a drug identification number, preventing misuse or misrepresentation of the identifiers.

Additionally, regulatory authorities implement quality control measures to verify the accuracy of the information submitted by pharmaceutical manufacturers during the application process. This includes conducting thorough inspections of manufacturing facilities, reviewing detailed documentation, and performing sample analysis to ensure that the information provided is consistent with the product.

Furthermore, regulatory bodies regularly update and maintain databases of drug identification numbers, ensuring that the information is current and accessible to healthcare professionals and patients. This allows for accurate and up-to-date tracking, monitoring, and control of pharmaceutical products, enhancing patient safety and regulatory compliance.

How do regulatory agencies use Drug Identification Numbers?

The Food and Drug Administration (FDA) assigns a unique drug identification number to every approved drug in the United States. This number is used by healthcare professionals, pharmacies, and patients to access accurate and up-to-date information about the medication. The FDA also utilizes drug identification numbers to track adverse events, conduct post-market surveillance, and enforce compliance with safety protocols.

Similarly, Health Canada assigns drug identification numbers to approved drugs in Canada. These numbers serve as a key reference for healthcare professionals, enabling them to access important information about drugs, including their indications, contraindications, and potential side effects. Health Canada also uses drug identification numbers to monitor the safety and quality of drugs in the Canadian market.

What are the challenges and limitations of Drug Identification Numbers?

One challenge is the potential for counterfeit drugs to enter the market. Despite the stringent measures to prevent this, criminals may attempt to reproduce drug identification numbers or use phony numbers on counterfeit products. This poses a significant risk to patient safety and highlights the need for ongoing vigilance and enforcement by regulatory authorities.

Another limitation is the reliance on accurate and timely reporting of adverse events and other safety concerns associated with specific drug identification numbers. While regulatory bodies actively encourage healthcare professionals and patients to report such events, underreporting still needs to be improved. This can delay identifying and addressing safety concerns, potentially putting patients at risk.

Additionally, the global nature of the pharmaceutical industry presents challenges in harmonizing drug identification number systems across different countries.

Frequently Asked Questions - Drug Identification Numbers

Why is DIN registration important?

Obtaining a Drug Identification Number (DIN) is important because this number indicates the drug has met Health Canada’s requirements for safety, quality, and effectiveness.

What is the purpose of DIN?

A Drug Identification Number (DIN) is located on the label of prescription and OTC drugs and confirms that the product has been evaluated and authorized for sale in Canada.

How can I get a DIN number?

To obtain a DIN for your drug products, a DIN submission must be filed with Health Canada. Prior to issuing DINs, Health Canada’s Drugs Directorate requires the submission of sufficient data to evaluate the safety and efficacy of a drug for its intended use. A submission for a DIN should contain the following information for review:

a completed Drug Submission Application, including proposed Canadian labels and prescribing information or a package insert where applicable
a completed DIN Submission Certification or Category IV Drug Submission Certification as appropriate
specific product type information as requested by Health Canada

What is a DIN number?

A Drug Identification Number (DIN) is a computer-generated digit number, assigned to a drug product prior to being sold in Canada.

Who regulates over-the-counter drugs?

Health Canada regulates OTC (Over-the-counter medicines sold directly to consumers without a prescription) drugs to ensure they are safe to use and decrease the health risks for Canadians. In the USA, the FDA carries out a regulatory review of OTC drugs based on active pharmaceutical ingredients and labeling. More than 300,000 OTC drug products are available in the US market.

How are DIN products manufactured?

DIN products must be manufactured in a facility that follows good manufacturing practices (GMP)
If the facility is based in Canada, that business must obtain a drug establishment license
Foreign sites must also show evidence that they are following GMP through a Health Canada licensed importer
DIN products cannot be sold prior to license issuance
Licensing timelines vary as fast as 45 days
Health Canada’s fees for drug license application submissions are due initially and annually thereafter
The fee varies and increases annually based on the rate of inflation

What are Nonsteroidal Anti-inflammatory Drugs (NSAID) Monograph ingredients for OTC Drugs?

Celecoxib
Diclofenac
Ibuprofen
Indomethacin
Meloxicam
Naproxen

What are the monograph categories for OTC Drugs in Canada?

Labeling Standard
TPD Category IV
Non-steroidal Anti-Inflammatory Drugs (NSAIDS)

What do category IV monographs include?

Acne Therapy
Sunscreen Monographs
Medicated Skin Care Products
Diaper Rash Products
Anti-Dandruff Products
Antiseptic Skin Cleansers
Athlete’s Foot Treatments
Throat Lozenges

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Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.

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Drug Identification Number Registration (DIN Numbers)

Manufacturing of DIN Products

Monograph Categories for Over-the-Counter Drugs

Labelling Standards Non-prescription Monographs are:

Category IV Monographs Include

What is a Drug Identification Number (DIN)?

How are Drug Identification Numbers (DINs) assigned?

What elements are on each Drug Identification Number DIN?

What are some common misconceptions about Drug Identification Numbers (DINs)?

Who needs to register their DIN Drug Identification Number?

What is the role of Drug Identification Numbers in drug recalls?

How do we ensure the accuracy and reliability of Drug Identification Numbers?

How do regulatory agencies use Drug Identification Numbers?

What are the challenges and limitations of Drug Identification Numbers?

Frequently Asked Questions - Drug Identification Numbers

Need Support for Drug Identification Number (DIN) Registration?

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