SPC Manufacturing Waiver Compromise Text Approved

21 February 2019

On 28 May 2018 the European Commission published a proposal for a change in the law which would permit third parties to manufacture a medicinal product protected by a Supplementary Protection Certificate (see discussion here and here).

Earlier this month we reported the Council’s position for negotiations with the European Parliament (see discussion here and here). The European Parliament published its own position and the negotiators have since met. The outcome was briefly reported in our news item here, including the agreement to Parliament’s amendment allowing for an extension of the waiver to stockpiling for day 1 release in the EU. The compromise text approved by the Permanent Representatives Committee on 20 February is available here.

The compromise broadly follows the Council’s proposals (see discussion here and here) modified to provide for the SPC manufacturing waiver to extend to manufacture within 6 months of SPC expiry for the purpose of stockpiling for release in the EU the day after SPC expiry.

Can We Help You?

keyboard_arrow_up