Are You Ready for the Falsified Medicines Directive?

The Falsified Medicines Directive (FMD) was published in 2011 with the aim of preventing falsified medicines from entering the pharmaceutical supply chain in the European Economic Area. Conformity with the FMD will be required from February 9th, 2019 next.

The falsification of medicines has long been a problem.  In recent years the issue has escalated despite the best efforts of agencies such as Medi-Fake.  As such, there has been a need to introduce a stronger legislative framework to combat the growth of the problem.  The Falsified Medicines Directive (FMD) has been in place since 2013 and companies have been required to implement aspects of the directive since then.  Complete conformity with the Falsified Medicines Directive will be required from February 9th 2019.

Falsified Medicines Directive

In June 2011 the EU Council formally adopted the ‘Falsified Medicines’ Directive. This new Directive includes major changes in the provisions with respect to GMP/GDP for APIs and Excipients and will have broad consequences for the industry dealing with these materials.

The new falsified medicines directive amends directive 2001/83/EC to safeguard public health by introducing new legislation that protects the pharmaceutical supply chain from intrusion by counterfeit medicines. The Directive applies since January 2013.

What is a Falsified Medicine?

Falsified medicines:

  • are a major threat to public health and safety. Each year the risk of falsified medicines reaching the patient in the EU increases.
  • represent a serious threat to global health and call for a comprehensive strategy both at European and international level.
  • are fake medicines that pass themselves off as real, authorised medicines. Falsified medicines might contain ingredients, including active ingredients, which are of bad quality or in the incorrect dose. As they have not been properly evaluated to check their quality, safety and efficacy this could be detrimental to public health.

Directive 2001/83/EC defines a falsified medicinal product as any medicinal product with a false representation of:

  • Its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients;
  • Its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or its history, including the records and documents relating to the distribution channels used.

The main provisions of the Directive are:

  • An obligatory authenticity feature (Safety feature) which must appear on the outer packaging of the medicines.
  • A common, EU-wide logo to identify legal online pharmacies to allow the public to distinguish between legal and illegal online pharmacies throughout the European Union;
  • Tougher rules on the controls and inspections of producers of active pharmaceutical ingredients.
  • Strengthened requirements for wholesale distributors of medicines.
  • Written confirmation of compliance with EU-GMP for imported APIs from non-EU origin will be mandatory. Confirmation has to be provided by the competent authority of the API exporting country.

There are 2 waivers for the written confirmation requirement:

  1. The exporting country is on the list of equivalent countries.
  2. Under exceptional circumstances where a medicine’s availability is an issue in the EU. In this case the waiver will only be granted if an EU GMP certificate not older than 3 years exists and the European Commission is informed.

What are the Safety Feature Requirements?

The feature that will be used to verify authenticity is referred to, within the FMD, as a “safety feature”.  These safety features must be introduced by February 2019.

A safety feature is essentially a barcode that shall be printed on or attached to every single pack of medicines subject to prescription and other medicines at risk of being falsified. The barcodes shall be checked into a database by the manufacturer and checked out when dispensed by a pharmacy.

The purpose of the safety feature is to verify

  1. that the pack is authentic and identified
  2. that the outer packaging has not been tampered with

What it applies to:

  • Obligatory for Prescription only medicines (POM) unless specified on list
  • Will not apply to non POM unless specified

In Summary:

The key provisions of the directive are:

  • Registration of API manufacturers, importers and distributors
  • Auditing of API manufacturers
  • Excipient assessment of appropriate GMP

At a minimum, the finished product MA holder must show that

  • Good history of quality of AS
  • Based on comprehensive testing
  • Knowledge of GMP compliance of AS manufacturer, preferably by audit
  • GMP compliance information from questionnaire at least

The 2 key responsibilities of Finished Product manufacturers are:

  1. GMP compliance of AS and
  2. Verification of the Active Substance supply chain traceability.

If you would like to have a conversation with us regarding the falsified medicines directive and what we can do to help your company, then talk to us today. Complete the form below and we will get back to you straight away.

Further Reading from Acorn Regulatory

What Are Post-Marketing Surveillance Studies?

Post-marketing surveillance studies are defined in  Article 1(15) of Directive 2001/83/EC as studies carried out after a medicine has been authorised to obtain further information on a medicine’s safety or to measure the effectiveness of risk-management measures.  In this article, our Medical Manager, Dr. Danica Cvetkovic, looks at post-marketing surveillance studies and the link with Risk Minimisation Plans (RMP’s)

Read the article here.

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The advent of the new Medical Devices Regulation (MDR 2017/745) is a cause of much concern for manufacturers and others in the devices sector.  The new regulations will bring about many changes compared to the current regulatory framework.  We look at the basics of the new MDR and the changes that will impact the device sector from May 26th, 2020. Read the full article here.

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There has been significant growth in the number of companies seeking a Wholesale Distribution Authorisation (WDA) in recent years.  We have assisted many companies with every step of the process. Here, we outline a step by step guide for obtaining a WDA.  Read the full article here.

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Type I Variations to a Marketing Authorisation are surprisingly difficult.  The procedure that many people perceive to be a simple process can prove to be otherwise.  This article looks at how to complete a type 1 variation and we will consider:

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  • the challenges posed by the eAF
  • what to do when documentation is missing
  • how to handle GMP variations
  • what happens when a CEP is presented for an active substance instead of a GMP certificate

After reading this article you will be better placed to complete a Type I Variation to a Marketing Authorisation while avoiding the common pitfalls outlined below.  Read the full article here.

What Are The Initial Steps in Applying for a Marketing Authorisation?

We consistently receive questions regarding the steps required when applying for a marketing authorisation (MA).  In this article, we aim to provide a guide to assist companies applying for an MA

We have also provided a number of links throughout the article to relevant articles, authorities, organisations, and pieces of legislation to assist you.  Read the full article here.

KASA – What You Need To Know About Knowledge-Aided Assessment and Structured Application

What is KASA and how will it impact on getting a drug assessed by the US FDA?  We look at its ‘3 pillars’ and what it aims to be.  Importantly, we look at how the FDA believes it will change how drugs are assessed in the United States of America.

Read more about KASA here.