In response to growth in the increasingly sophisticated falsified human medicines market, in July 2011, the European Commission introduced the EU Falsified Medicines Directive, aimed at preventing their entry into the legal supply chain.
January 2 2013 marked the transposition of certain aspects of this new directive into the law of member states. In Ireland, the publication of transposing legislation is awaited. It is anticipated that draft legislation will be published for a short consultation period in the coming weeks. However, in the interim, the regulatory authority for medical products - the Irish Medicines Board - has issued guidance on the registration requirements for manufacturers, importers, distributors and brokers of active substances. This update examines the board's guidance and other upcoming developments.
Registration of manufacturers, importers and distributors of active substances
The Falsified Medicines Directive requires manufacturers, importers and distributors of active substances (ie, active ingredients of medicinal products) to register with the competent authority of the member state in which they are established. The board's Guide to Registration Requirements for Active Substance Manufacturers, Importers and Distributors addresses the administrative and technical aspects of the registration scheme in Ireland. The requirement to register applies to entities involved in both the total and partial manufacture of an active substance. Entities which have authorisations to manufacture, import or distribute finished medicinal products are not exempt from the new registration rules. Manufacturers, importers and distributors of active substances must register with the board.
Entities which carried out activities before January 2 2013 must register by March 2 2013. Others wishing to commence activities after January 2 2013 must register with the board before they can start. The board may inspect these businesses in order to ensure compliance with the relevant good practice standards. For example, under the Falsified Medicines Directive, manufacturers must comply with the principles of good manufacturing practices for medicinal products, and must use only active substances which have been manufactured in accordance with such practices. The European Commission will adopt a 'delegated act',(1) which will flesh out the principles and guidelines of good manufacturing practices for active substances. It is expected...