A new Legislative Decree no. 274, approved on 29 November 2007 and published in the Official Gazette on 14 February 2008 (the “Decree”), carries with it a raft of changes to the Italian Medicines Code (the “Code”), enacted in 2006 to implement the Medicines Directive in Italy.
The changes mandated by the new Decree also result from consultation within the industry after almost 18 months of the Code being applied and are aimed at simplifying and/or correcting some of its provisions.
Among the amendments which have been adopted by the Decree are the following which are particularly relevant to the licensing/transfer of marketing authorisations (“MA”):
- The Decree clarified that intermediate formulations, bulk medicinal products and semipackaged medicinal products are only subject to the provisions of Chapter IV of the Code relating to the manufacture of medicines;
- The Decree clarifies that the requirement of MAs for placing any medicinal products on the Italian market will gradually also be applied to medicinal gases as will be provided by a special Decree to be issued by the Ministry of Health on the basis of a bill proposal from the Italian Medicines Agency (AIFA);
- Type I variations will be possible through notification and consent by silence (i.e. failing any express denial by the AIFA within a certain period – 15 day from notification for IA variations, and 30 days from notification for IB variations). This means that, if following to the acquisition of a MA, type I variations are necessary, the timeline for those variations will be reduced significantly;
- Following type IA and IB variations authorised through the above mentioned procedure (i.e. notification and consent by silence), it will be possible to dispose of the stocks of product which has been subject to variation, unless the AIFA decides that the product is to be withdrawn from the market for public health or market transparency reasons;
- The AIFA, after consultation with industry associations, shall adopt and disclose the general criteria for the application of the provisions regarding the disposal of stocks of products which have undergone type I and type II variations. This means that the disposal of stock is i) automatically granted in case of authorised Type I variations and ii) may be granted by the AIFA upon request (and on the basis of the general criteria which will be set forth by the AIFA) in case of Type II variations;
- The provisions regarding the renewal of MAs have been amended to clarify that on the fifth anniversary renewal of a granted MA, if there is no express denial of renewal or request of modification by the AIFA, the MA is held as automatically renewed at its normal date of expiry;
- The GMP certification delivered by an EU regulatory authority with reference to starting materials which have been manufactured in non-EU manufacturing facilities shall be available as from 1 January 2009. This means that in case of the acquisition of an MA near to its expiry or pending its renewal, as well as where there have been variations to the manufacturing facilities, the certification will be requested by the AIFA.
- It has been clarified that, in addition to the particulars that must appear on the outer packaging or (if there is no outer packaging) on the immediate packaging of the product, information (after prior notification to the AIFA) concerning the company that actually carries out the marketing of the product in Italy must also be displayed on the outer packaging. This means that it will no longer be necessary to ask for authorisation of the AIFA to include in the labelling the name of the official distributor of the product, but it will suffice to make a prior notification to the Authority. As a consequence, it will be possible for companies acquiring an MA to market the product immediately, even during the acquisition phase (i.e. before the transfer of the MA is formally registered with the AIFA) by simply notifying their name as official distributors to the AIFA;
- By 7 July 2008, consignees, importers and re-packagers must also hold the relevant certifications/authorisations. Therefore, where an MA is acquired, it is advisable to ensure that all entities involved in the manufacturing or storage of the product have obtained the relevant authorisations.
The Decree will enter into force on 29 February 2008.