In our bulletin of June 2011, we looked at the framework of the Falsified Medicines Directive (the “Directive”) and its potential impact on the medicines supply chain and counterfeit medicines when it is implemented in January next year.
Below we consider recent developments including; the MHRA consultation on implementation in the UK, the European Commission’s guidelines on the import into the EU of active pharmaceutical ingredients ("APIs") and the European Commission’s concept paper on a common logo for online pharmacies and retailers.
Brokers - The Directive requires Member States to introduce regulatory controls over brokers operating in their territory including registered premises and addresses, a quality system, record keeping requirements and an inspection regime to be set up by the MHRA. In addition, brokers will only be allowed to deal in medicines that have a marketing authorisation, unless they are brokering medicines outside the EEA for direct export from the UK to a third country. Brokers will also need to verify that those they buy from and sell to hold appropriate licences and to report suspected counterfeit medicines to the MHRA and record batch numbers of medicines that they broker.
Wholesale dealers that engage in brokering activities will also be required to register such activity with the MHRA.
Wholesale Dealers - In addition to the current wholesale dealer regulatory regime, wholesale dealers will be required to:
Verify that wholesalers, manufacturers and importers of medicines with whom they deal hold appropriate licences and comply with Good Distribution or Good Manufacturing Practices (“GMP”);
Check the safety features on outer packaging to ensure that the medicines they receive are not falsified;
Record batch numbers of medicines they receive that are subject to the safety features; and
Maintain a quality system.
Details of wholesale distribution licence holders will be entered onto a public EU database by the MHRA and anyone importing medicine from outside the EEA for export to a third country must hold a Wholesale Dealer’s licence.
APIs - A new definition of API will be introduced i.e “Any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis.”
Manufacturers will be required to conduct audits to ensure compliance with GMP standards and all those involved in importing and distributing APIs must notify the national regulatory authority of their activities. The MHRA will have inspection powers in relation to manufacturers.
Excipients - Similarly an excipient is also redefined i.e. “Any constituent of a medicinal product other than the active substance and the packaging material”. The holder of a manufacturing authorisation must verify the authenticity of excipients used and undertake formal risk assessments to confirm their suitability.
Safety features for certain categories of medicines - The Commission will take into account the key risk factors when considering which medicines should be protected with safety features (which include a tamper seal on the outer packaging and a unique identifier) including price and volume, previous incidence of counterfeiting and product and disease characteristics.
Distanceselling - The Directive provides that distance sellers must register with a designated body in the Member State and the website must display the common EU logo (see below).
The consultation remains open until 19 November 2012.
New Rules on Importing APIs into the European Union
From 2 January 2013, all imported APIs must have been manufactured in accordance with GMP.
Common Logo for Online Pharmacies/Retailers
The legislation will introduce a “common logo” for the websites of online pharmacies which is both recognisable throughout the EU and identifies the Member State where the supplier is domiciled. The logo must be clearly shown on each page of the website.
A register of all legally-operating online suppliers within each Member State must be set up by Member State authorities. Every entry on the national list must include a hyperlink to the website of the particular online supplier and the common logo must have a reciprocal hyperlink to the entry of the online supplier on the national list.