Directive 2011/62/EU The falsified medicinal products Directive – an assessment – Part 1 Norman C. Franklin Interactive Consulting Associates, Zug, Switzerland The increase in the number of falsified medicinal products in the European Union is of increasing concern to the regulating authorities and it is now apparent that the spread of the internet, the transfer of active substance manufacturer to Asia or the increase in the number of hands through which a medicinal product and their starting materials must pass before it reaches the patient has resulted not only in falsified medicinal products being purchased by patients on the Internet but even supplied unknowingly by the pharmacist on prescription.
Therefore, in order to reduce the number of falsified products on the European market, a new Directive, (2011/62/EU of 8 June 2011), listing revisions to the original pharmaceutical directive for human medicinal products (2001/83/EC), has been approved.
These revisions have been designed to strengthen the controls in the whole of the supply chain, from the manufacturer of the active substance – who must be physically audited by the medicinal products manufacturer or a third party – through the importers or distributors of such products to the manufacturers of medicinal products, so that these will be required to verify the authenticity and quality of the active substances and excipients that they use.
The controls are, however, extended to the distributors of medicinal products who must verify that each pack of medicinal product which is at risk of being falsified has the prescribed safety features.
The difficulty of controlling medicinal products supplied through the Internet has been recognised and this will now be regulated in this new Directive, so that the public can easily recognise those websites which are legally authorised to offer medicinal products for sale over the Internet.
The implementation of this Directive will require substantial adaptation of manufacturing processes and thus the necessary regulations will be introduced in two steps: the necessary Orders will need to be introduced by 2 January 2013 but there is a 3-year transition period for the introduction of the safety features once a decision has been made on the technical options for these features. |
