The MHRA is currently running a consultation process that invites views on the implementation of Directive 2011/62/EU ("Falsified Medicines Directive") into UK law. The Falsified Medicines Directive substantially changes the European framework concerned with the supply of medicines. Some of the changes may capture business that have traditionally not been directly regulated and, as such, its implementation into UK law is likely to be of interest to all players in the pharmaceutical supply chain.
The Falsified Medicines Directive (amending Directive 2001/83/EC) introduces a number of measures designed to prevent the entry of falsified medicines into the legal supply chain, which the UK Government is required to implement into law by 2 January 2013. It is proposed that the changes be implemented by way of regulations amending the Human Medicines Regulations 2012. A few of the key changes are described below.
Brokers, whose activities are not currently subject to any regulatory or licensing requirements, will be required to register their activities with the MHRA. "brokers" are those operators who are involved in negotiating independently and on behalf of others the sale or purchase of medicines and who do not take title to or physically handle the pharmaceutical products. The registration requirements will commence on 2nd January 2013. Brokers who commenced these activities before 2nd January 2013 must notify their activities by 2 March 2013.
It is proposed that wholesaler dealers who engage in brokering activities will need to (separately) register their brokering activities with the MHRA and will be subject to the specific regulatory requirements with respect to their brokering activities.
Wholesaler dealers will be subject to additional obligations including requirements to:
- Verify that their suppliers hold appropriate licences and comply with Good Distribution/Good Manufacturing Practices;
- Verify that their brokers fulfil the necessary registration requirements;
- Maintain a quality system that sets out responsibilities, processes and risk management measures in relation to their activities;
- Verify that medicines that they receive that are subject to the new safety feature provisions (to be introduced through the legislation) are not falsified by checking the safety features on the outer packaging; and
- Report to the MHRA and the marketing authorisation holder if they suspect that the medicines they receive are falsified.
Further, under the new legislation anyone importing a medicine from outside the EEA for export to a third country must now hold a Wholesale Dealer’s licence.
Manufacturers of active substances in the EU, importers and distributors of active substances must, under the new legislation, notify the MHRA of their activities. Authorised manufacturers of medicines who also manufacture active substances and wholesale dealers who wish to distribute finished active substances will also be required to register their activities with the MHRA.
Sales at a Distance
New measures are to be introduced in relation to offering medicinal products for sale at a distance to the public, designed to combat the illegal sale of medicinal products via the Internet. Significantly, it introduces a requirement that retailers who sell medicinal products at a distance to the public report their activities to the MHRA and hold all the necessary licenses to sell medicinal products from a distance. A common logo for websites of legally operating online retailers is to be established and will need to be displayed by retailers on their websites. Each member state is obliged to set up a dedicated website providing (among other things) a list of all legally operating online retailers, using the details supplied by those pharmacies/retailers through the notification process, and hyperlink to the websites of the authorised online retailers. In parallel, the common logo appearing on the online retailer website will link to that online retailer's entry in the national list.
The new requirements will capture not only pharmacies that offer dispensing services and licensed medicines online but also retailers of non-prescription medicinal products that sell on-line, such as supermarket chains providing Internet shopping.
The new measures will no doubt be welcomed by the industry as part of their efforts combat the ever-increasing threat posed to the industry and to public health by the growing number of counterfeit products finding their way on to the UK market.
Because the new legislation has the potential to capture business and activities not traditionally subject to regulatory requirements, entities are encouraged to consider their activities in light of the changes and seek specific guidance as required.
The MHRA's consultation closes on 19 November 2012. The consultation documents and information on how to respond can be found on the MHRA website.
Separately, the Commission is consulting on the technical, electronic and cryptographic requirements for verification of the authenticity of the common logo and the design of the logo. The Commission's consultation closes on 17 January 2013. Further information can be found on the Commission's website.