MFLRC - MF License & Regulatory Consultants

MFLRC

Articles

Licensing and regulatory updates from our consultants.

EU-GMP Annex 15 Revision: What the Move Toward December 2026 Means for API Manufacturers

June 29, 2026 · Pharmaceuticals

EU-GMP Annex 15 Revision: What the Move Toward December 2026 Means for API Manufacturers

The EU-GMP Annex 15 revision will make qualification and validation mandatory for chemical and biological active substance (API) manufacturers, not just finished-product sites. A joint EMA and PIC/S concept paper set the direction, consultation closed in April 2026, and the final text is targeted for publication by December 2026. Here is what the timeline means and how API sites should prepare.

#EU-GMP

By Mussarat Fatima

FDA's New Wave of Compounded GLP-1 Warning Letters (2026)

June 29, 2026 · Pharmaceuticals

FDA's New Wave of Compounded GLP-1 Warning Letters (2026)

The FDA issued 25 warning letters in June 2026 over false or misleading promotion of compounded GLP-1 products. Here is what telehealth, pharmaceutical, and natural health product companies must fix, in the United States and Canada, to stay compliant.

#GLP-1

By Mussarat Fatima

CFIA's 2026 Food Fraud Report: What 150,000 kg of Seized Food Means for Your Compliance Program

June 27, 2026 · Food and Beverages

CFIA's 2026 Food Fraud Report: What 150,000 kg of Seized Food Means for Your Compliance Program

On June 25, 2026, the CFIA released its Food Fraud Annual Report 2024 to 2025: 886 authenticity samples tested and more than 150,000 kg of misrepresented food kept off the market. Olive oil had the lowest authenticity compliance and imported honey drove most of the seized volume. Here is what the findings mean for food manufacturers, importers and co-packers, and how to build food fraud controls into your compliance program.

#Food Fraud

By Mussarat Fatima

Texas Cannabis Licence: How to Apply Under the Expanded TCUP

June 21, 2026 · Compliance

Texas Cannabis Licence: How to Apply Under the Expanded TCUP

Texas expanded its Compassionate Use Program in 2025 under HB 46, adding 12 new dispensing organization licences. Here is how the Texas cannabis licence works, who can apply, and what a competitive application requires.

#Cannabis

By Mussarat Fatima

NHP Compliance in Canada: Licensing, GMP and Labelling

June 20, 2026 · Compliance

NHP Compliance in Canada: Licensing, GMP and Labelling

A current guide to natural health product compliance in Canada, covering product and site licensing, GMP, Vanessa's Law enforcement, modernized labelling and cost recovery.

#Natural Health Products

By Mussarat Fatima

Cannabis IPM in Canada: A Compliant Pest Control Guide

June 20, 2026 · Cultivation

Cannabis IPM in Canada: A Compliant Pest Control Guide

Integrated Pest Management protects cannabis crops without putting your licence at risk. This 2026 guide covers action thresholds, monitoring, prevention and controls, plus the Health Canada pesticide rules and mandatory testing every licensed producer must meet.

#Cannabis

By Mussarat Fatima

Labelling Compliance in Canada: 10 Ways to Prevent Errors

June 20, 2026 · Compliance

Labelling Compliance in Canada: 10 Ways to Prevent Errors

A practical, up-to-date guide to labelling compliance in Canada across food, cannabis and natural health products, with 10 ways to prevent costly label errors and recalls.

#Food Labelling

By Mussarat Fatima

Why Sensory Evaluation Is Crucial for Cannabis Products

June 20, 2026 · Cultivation

Why Sensory Evaluation Is Crucial for Cannabis Products

Sensory evaluation is a frontline quality control tool for cannabis. Learn how appearance, aroma and texture checks support Health Canada compliance, how they differ from lab testing, and how to build a defensible program.

#Cannabis

By Mussarat Fatima

FDA QMSR and ISO 13485:2016: What Medical Device Makers Must Do Now

June 20, 2026 · Medical Device

FDA QMSR and ISO 13485:2016: What Medical Device Makers Must Do Now

The FDA's Quality Management System Regulation replaced the QSR on February 2, 2026 and built 21 CFR Part 820 on ISO 13485:2016. Here is what changed, what records FDA can now inspect, and the steps device makers should take to stay compliant.

#FDA

By Mussarat Fatima

How Cannabis Licensing Consultants Streamline Compliance

June 19, 2026 · Compliance

How Cannabis Licensing Consultants Streamline Compliance

How experienced cannabis licensing consultants help Canadian licence holders streamline Health Canada compliance, from licensing and SOPs to audits, CTLS reporting and QAP support.

#Cannabis

By Mussarat Fatima

How to Pass a Health Canada Cannabis Inspection: 6 Practical Steps

June 19, 2026 · Compliance

How to Pass a Health Canada Cannabis Inspection: 6 Practical Steps

A practical, up to date guide to passing a Health Canada cannabis inspection, built around the latest 2025 to 2026 inspection data, the March 2025 rule changes, Good Production Practices, recordkeeping and the right way to handle CAPA.

#Cannabis

By Mussarat Fatima

How to Write SOPs That Pass a Health Canada Inspection

June 18, 2026 · Quality Assurance

How to Write SOPs That Pass a Health Canada Inspection

A practical, cross-sector guide to writing Health Canada SOPs for cannabis, drugs, NHPs, medical devices and food, with the ALCOA+ standard, common findings and an inspection-ready checklist.

#Health Canada

By Mussarat Fatima

Cannabis Edibles vs Extracts: Classification Under the Cannabis Act

June 16, 2026 · Good Production Practices

Cannabis Edibles vs Extracts: Classification Under the Cannabis Act

Edible cannabis and cannabis extracts look similar but face very different rules. Learn how Health Canada classifies ingestible cannabis products, the 10 mg and 1,000 mg THC limits, the food-format test, and how to stay compliant.

#Cannabis

By Mussarat Fatima

Top 5 Cannabis Compliance Mistakes (and How to Avoid Them)

June 16, 2026 · Compliance

Top 5 Cannabis Compliance Mistakes (and How to Avoid Them)

Health Canada conducted 889 cannabis inspections in 2024-2025, and the same compliance gaps keep showing up. Learn the top five mistakes licensed producers make, what current inspection data reveals, and the practical fixes that keep you inspection-ready.

#Cannabis

By Mussarat Fatima

EU GMP Annex 22, Annex 11 and Chapter 4: AI Rules for 2026

June 16, 2026 · Regulatory Affairs

EU GMP Annex 22, Annex 11 and Chapter 4: AI Rules for 2026

The European Commission, EMA and PIC/S published draft revisions of Annex 11 and Chapter 4 and a brand new Annex 22 on artificial intelligence on 7 July 2025. Finals are expected mid-2026. Here is what changes and how to get ready.

#Compliance

By Mussarat Fatima

Cannabis Business Plan in Canada: A 2026 Founder's Guide

June 15, 2026 · License

Cannabis Business Plan in Canada: A 2026 Founder's Guide

A cannabis business plan in Canada is not just an investor document. It is the blueprint that proves to Health Canada you can operate safely and legally. This 2026 guide covers licence classes, the CTLS, market data, the quality and compliance backbone, financials and the mistakes that sink applications.

#Cannabis

By Mussarat Fatima

Psychedelic-Assisted Therapy in Canada: The 2025 Rules Explained

June 8, 2026 · Regulatory Affairs

Psychedelic-Assisted Therapy in Canada: The 2025 Rules Explained

How psychedelic-assisted therapy is regulated in Canada in 2025: the three legal pathways (clinical trials, the Special Access Program, and Section 56 exemptions), the controlled-substance rules for psilocybin and MDMA, and what the Toth v. Canada Federal Court ruling means for practitioner training.

#Health Canada

By Mussarat Fatima

EU GMP Annex 1 Contamination Control Strategy: The 2026 Exporter’s Guide

June 3, 2026 · Regulatory Affairs

EU GMP Annex 1 Contamination Control Strategy: The 2026 Exporter’s Guide

By 2026, EU GMP Annex 1 is fully in force and firmly enforced. Any Canadian pharmaceutical manufacturer or cannabis Licensed Producer exporting sterile or EU-GMP product to the EU or UK must have a documented, living Contamination Control Strategy (CCS) ready for inspection—or risk critical findings and loss of market access.

#Health Canada

By Mussarat Fatima

Are Exosome Skincare Products Cosmetics or Drugs in Canada? Health Canada's April 2026 Classification Notice, Decoded for Brands

May 24, 2026 · Regulatory Affairs

Are Exosome Skincare Products Cosmetics or Drugs in Canada? Health Canada's April 2026 Classification Notice, Decoded for Brands

Health Canada's April 2026 Final Notice (following its 14 August 2025 consultation Notice) clarifies how exosome, extracellular vesicle, and cell-conditioned media topical products are classified at the cosmetic-drug interface. Learn the three statutory considerations, MFLRC's six-trigger framework, the cosmetic/NHP/drug/biologic decision tree, and a reformulation checklist for skin-care, hair-care, and medi-aesthetic brands.

#Exosomes

By Mussarat Fatima

Front-of-Package Nutrition Labelling Is Now Mandatory in Canada: What Every Food and Beverage Business Must Do Next

May 21, 2026 · Food and Beverages

Front-of-Package Nutrition Labelling Is Now Mandatory in Canada: What Every Food and Beverage Business Must Do Next

As of January 1, 2026, Health Canada’s Front-of-Package (FOP) nutrition symbol is mandatory on prepackaged foods and beverages that are high in saturated fat, sugars, or sodium. Learn what the new rules require, who must comply, key exemptions, and how to complete a defensible FOP readiness assessment for your full SKU portfolio.

#FOP Nutrition Labelling

By Mussarat Fatima

Good Production Practices (GPP) for Cannabis in Canada

December 8, 2025 · Good Production Practices

Good Production Practices (GPP) for Cannabis in Canada

Good Production Practices (GPP) are the legal foundation of every federal cannabis licence in Canada. This guide explains the Part 5 requirements, the QAP role, GPP versus EU-GMP, and how to stay inspection-ready.

#Good Production Practices

By Mussarat Fatima

How to Pass a Cannabis Regulatory Audit: A Complete Guide

June 3, 2025 · Compliance

How to Pass a Cannabis Regulatory Audit: A Complete Guide

A Health Canada inspection rewards everyday discipline, not last-minute cramming. Here is what inspectors check, the findings that trip producers up, and how to stay audit-ready every day.

#Cannabis

By Mussarat Fatima

GMP Certification for Cannabis: A Complete Guide for Producers

September 25, 2024 · GMP

GMP Certification for Cannabis: A Complete Guide for Producers

In Canada, cannabis producers follow Good Production Practices, while EU-GMP certification unlocks export markets like Germany. Here is what GMP certification involves, what it costs, and how to prepare.

#Cannabis

By Mussarat Fatima

Cannabis Research Licence in Canada: A Step-by-Step Guide

December 19, 2023 · License

Cannabis Research Licence in Canada: A Step-by-Step Guide

A cannabis research licence is how universities, companies and clinicians legally study cannabis in Canada. This guide explains the licence types, the CTLS application process, NTRC and clinical-trial rules, and how to build an approvable file.

#Cannabis Research

By Mussarat Fatima

Cannabis Quality Assurance in Canada: The Risks of Ignoring QA

March 23, 2023 · Compliance

Cannabis Quality Assurance in Canada: The Risks of Ignoring QA

Quality assurance is not optional for Canadian cannabis licence holders. Here is what QA involves under current Health Canada rules, the real risks of cutting corners, and a practical compliance checklist.

#Cannabis

By Mussarat Fatima

Cannabis Product Recalls in Canada: 9 Ways to Avoid Them

September 9, 2022 · Good Production Practices

Cannabis Product Recalls in Canada: 9 Ways to Avoid Them

Cannabis recalls are preventable quality failures. Here are nine practical ways to avoid them, plus Health Canada recall types, timelines, and mock recall rules.

#Cannabis

By Mussarat Fatima

How to Open and Operate a Cannabis Retail Store or Farmgate in Ontario

September 9, 2022 · License

How to Open and Operate a Cannabis Retail Store or Farmgate in Ontario

A practical, up to date guide to opening and operating a cannabis retail store or farmgate in Ontario, covering AGCO licences, OCS wholesale, store rules, fees, staff training and the compliance habits that keep your authorization in good standing.

#Cannabis

By Mussarat Fatima

Cannabis Compliance in Canada: 10 Essentials to Succeed

September 8, 2022 · Compliance

Cannabis Compliance in Canada: 10 Essentials to Succeed

Ten practical essentials for cannabis compliance in Canada, from building a compliance team and internal audits to marketing rules, provincial age limits and recordkeeping.

#Cannabis

By Mussarat Fatima

Book a consultation