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.
- 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.
- 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.
- The exporting country is on the list of equivalent countries.
- 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.
- that the pack is authentic and identified
- that the outer packaging has not been tampered with
- Obligatory for Prescription only medicines (POM) unless specified on list
- Will not apply to non POM unless specified
- Registration of API manufacturers, importers and distributors
- Auditing of API manufacturers
- Excipient assessment of appropriate GMP
- 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
- GMP compliance of AS and
- Verification of the Active Substance supply chain traceability.
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.Understanding MDR: 8 Important Changes
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.Need A WDA? Read Our Step By Step Guide
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.How To Prepare For A Pharmacovigilance Inspection
A pharmacovigilance inspection can be a daunting prospect for many companies. Since 2002 we have worked with countless companies to guide them through their inspections. We look at the measures that your company can take to be prepared. Read the full article here.How To Complete A Type I Variation
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:- common deficiencies
- common validation issues
- 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