10 December 2012: HMA concerns regarding the adoption of the new Falsified Medicines Directive

The implementation of the Directive 2011/62/EU as regards the prevention of entry into the legal supply chain on falsified medicines is to strengthen existing quality control and health protection measures for medicines and to introduce new measures aimed at preventing falsified medicines and their components from entering the legal supply chain in the European Union. It should be noted that the Falsified Medicines Directive was not transferred into Directive 2001/82 for veterinary medicinal products.

The main goal of the Directive is to strengthen the safety and continuity of the pharmaceutical chain within and outside Europe which is fully supported by the HMA. However the new good manufacturing practices GMP requirements for the import into the EU of active pharmaceutical ingredients (APIs) will have to be met and the HMA should encourage all parties involved to avoid potential shortages of medicines in the EU.

According to the Directive all imported active substances must be manufactured in compliance with the standards of GMP or at least an acceptable standard equivalent to the GMP of the EU.

The provisions of the Falsified Medicines Directive will apply from 2 January 2013, however regarding the import of APIs and excipients from third countries the provisions will apply from 2 July 2013 if the following conditions are fulfilled:

The active substances have been manufactured in accordance with the standards of good manufacturing practice or those equivalent to those laid down by the EU (third countries can apply for a list of equivalent countries regarding GMP rules that will be evaluated by the European Commission after an assessment of the country's API regulation, GMP inspections etc.) or

The exported API is accompanied by a written confirmation from competent authorities of the exporting third country verifying for each API produced at each particular manufacturing plant that the standards of GMP are applicable or

The requirements can be waived by an EU Member State if the manufacturing plant concerned has recently and successfully been inspected by an EU competent authority and is GMP compliant.

An overview of the API manufacturers carried out by the National Competent Authorities makes it clear that most of them are sourced outside the EU and EFTA (e.g Chinese, Indian, American and Japanese). The aforementioned countries are extremely important for import of API into the EU, however they do not subscribe to the "white list" (the "white list" of countries will be published in the Official Journal).

This means in practice that the national manufacturers of APIs located in countries which are not on the "white list" will need to have a 'written confirmation' of compliance with the EU standards of GMP as of 2 July 2013.

The HMA is deeply concerned that the main API producing countries exporting to the EU will not be on the "white list" neither will national manufacturers of APIs have a 'written confirmation'. This situation might endanger public health within the EU due to possible shortages of medicinal products for the European market and consequently become a serious public health risk. The HMA is considering at present all the possibilities to avoid such a threat to public health security.

To discuss possible solutions the HMA created the Taskforce on Falsified Medicines chaired by AEMPS (Spain) in which most National Competent Authorities do participate. The aim of the Taskforce is to make sure that the related delegated implementing acts should perform the follow up coordination and provide support for an harmonised approach for the members of the HMA when the new rules will come into force. The focus of the Taskforce will be on the new regulatory frame and several aspects such as the requirements for the distribution of medicinal products, including increased controls for active substances, and provisions to allow the identification of individual medicinal products with safety features and the rules of the legal sale at a distance of medicinal products.

The HMA Management Group has sent an email to the European Commission to express their concerns and to initiate a dialogue with the Commission to explore possible solutions.