Benefits & requirements of using a medical device MDEL Import Agent
Using a medical device import agent can offer several benefits, especially if you are navigating the complex process of importing medical devices into a new market or dealing with regulatory requirements that are unfamiliar to you. At the end of this blog, you’ll have a firm and developed idea of the regulatory requirements when
What You Need to Know About EFSA’s Novel Food Process
Introduction: The European Food Safety Authority (EFSA) provides regulatory guidance and oversees the approval process for novel foods in the European Union (EU). Novel foods are foods or ingredients not consumed significantly within the EU before May 15, 1997. If you are interested in submitting a novel food application to EFSA or seeking regulatory guidance, here
FDA Announces FSMA Food Traceability Proposed Rule
On Monday September 21st, the U.S. Food and Drug Administration (FDA) announced a proposed rule to establish additional traceability record keeping requirements for certain foods. Although existing FDA regulations already require that certain records are established and maintained, it only forms a baseline for traceability record keeping. These additional proposed requirements will not only allow
Protecting Canadians from Unsafe Drugs Act
The Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) introduces amendments to the Food and Drugs Act that will improve Health Canada’s ability to collect post-market safety information, and take appropriate action when a serious risk to health is identified. These amendments are designed to better protect a patient’s health and safety, and increase consumer confidence in therapeutic products
Reporting Adverse Reactions to Marketed Health Products
All marketed drugs and health products have benefits and risks. All health products are carefully evaluated before they are licensed in Canada. However, some adverse reactions or problems may become evident only after a product is in use by consumers. Reporting a suspected adverse reaction helps to identify potential safety issues and improve health product
Post-Drug Identification Number (DIN) Changes
All drugs subject to the Food and Drug Regulations are required to gain premarket authorization prior to issuance of a Drug Identification Number (DIN). After gaining authorization to market a drug, a sponsor may for various reasons wish to make changes to the drug or the information associated with the drug. For those drugs regulated
Regulatory requirements for Drug Identification Numbers (DIN Number Canada)
When Health Canada authorizes a drug to be marketed in Canada, a Drug Identification Number (DIN) is issued to the manufacturer and must be printed on the package labels. A DIN indicates that the evaluation of the drug determined that it met the relevant requirements of the Food and Drugs Act and its regulations, and
Plain Language Labelling Regulations
The label and package are the first points of interaction between a health product and a consumer. Prior to the implementation of the Plain Language Labelling (PLL) initiative, the general practice in Canada was to present key information within blocks of text on the product label. This sometimes made it difficult for the consumer to
Consumer Advertising of Health Products
In continuation to the last article on Canadian legislations and requirements regarding the marketing of drugs and medical devices, this article will discuss some of the specific requirements concerning the advertising of health products towards consumers. The overriding principle lies within the Canadian Food and Drugs Act, which prohibits health product advertising which is false,
Illegal Marketing of Drugs and Medical Devices in Canada
Health Canada is not only the national regulatory authority for issuing health product marketing authorizations, but it also oversees and enforces the regulatory requirements related to health product advertising. While smart marketing strategies are important for driving sales, it is also crucial to ensure those strategies comply with Canadian legislative and regulatory requirements. The
SFCR: What to expect when you’re inspected?
The Safe Food for Canadians Act (SFCA) and the Safe Food for Canadians Regulations (SFCR) are set to come into effect on January 15, 2019. The new regulations will require food businesses that import or prepare food for export/interprovincial shipping to have licences, as well as preventive controls that outline steps to address potential risks
Why EFSA’s Role as a Regulatory Authority is Important to Us
The European Food Safety Authority (EFSA) is a world renowned regulator which is known for its high scientific standards when it comes to food safety and claim substantiation. Formed in 2002 following several mishaps involving food safety, EFSA is responsible for the evaluation of scientific evidence and identification & communication of risks pertaining to safe
Food or NHP: Distinguishing Between a Natural Health Product and a Supplemented Food
Supplemented foods and natural health products (NHPs) can sometimes pose challenges when trying to determine the correct regulatory pathway to gain market access in Canada. Supplemented foods are broadly defined by Health Canada as pre-packaged products that are manufactured, sold or represented as foods, which contain added vitamins, minerals, amino acids, herbal or bioactive ingredients.
Sunscreen Regulatory Differences Between Canada and the United States
A sunscreen formulated for the Canadian market doesn’t automatically clear the U.S. market, and vice versa. Canada sorts sunscreens into two regulatory pathways based on their active ingredients, while the U.S. treats every sunscreen as a drug from the outset, regardless of its ingredients. The two systems ask different questions, require different data, and use
Safe Food for Canadians Regulations: How Does it Affect You?
The Safe Food for Canadians Act (SFCA) and the Safe Food for Canadians Regulations (SFCR) are set to come into effect on January 15, 2019. Under the new legislation and corresponding regulations, certain companies involved in the manufacturing, distribution, handling and sale of food will be required to implement regulatory changes to improve food safety
Plain Language Labelling for OTCs & NHPs
Health Canada implemented the Plain Language Labelling (PLL) initiative to help make the labels for non-prescription health products easier to read and understand for the consumer. These regulations are currently in effect for new non-prescription drug applications and the criteria outlined is recommended to be applied to Natural Health Products (NHPs) as well. What is
Imminent Changes to the Current Canada Natural Health Product (NPN) Licensing timelines
In October 2014, the Natural and Non-prescription Health Products released a policy to manage the overall application review process. It brought a streamlined and predictable timeline when NPNs would be issued (prior to this, there was a massive backlog of applications, NPNs sometimes took several years go be issued and many companies were selling natural