The Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No. 469/2009 concerning the supplementary protection certificate for medicinal products (SPC) came into effect on 1 July 2019 (published in the Official Journal of the European Union L 153 of 11 June 2019).
The relevant Regulation introduced an exception to the protection granted by the supplementary protection certificate for medicinal products in the Regulation (EC) No. 469/2009 (SPC waiver). This exception allows EU manufacturers of generics and/or biosimilars (G/Bs) to manufacture SPC-protected medicines for export to third-country markets outside the EU and for storage to allow entry into the EU market from the first day after the SPC expires. Production for export purposes is allowed during the entire duration of the SPC, while storage is allowed only during the last six months before the expiry of the SPC.
The SPC exemption applies to all SPCs for which an application for issuance was submitted on or after 1 July 2019; and from 2 July 2022, it will also apply to SPCs for which an application for issuance was submitted before 1 July 2019, but only to those that produce effects on or after that date. Thus, the exemption from SPCs does not apply to SPCs that started producing effects before 1 July 2019.
G/Bs producers wishing to benefit from an exception to the exclusive rights of SPC holders must fulfil certain requirements and, inter alia, have the obligation to notify in standardized form the SPC holder and the SPC issuing authority in EU Member States where production and/or related actions take place (in the Republic of Croatia, it is the State Intellectual Property Office) earlier than the following deadlines: no later than three months before the date of commencement of production or no later than three months before the commencement of the first related operation that would otherwise be prohibited on the basis of protection obtained by the SPC. In addition, the manufacturer must inform the holder of the SPC and the competent authority of any changes to this information before they take effect.
There is currently no fee for submitting this notice in the Republic of Croatia, and manufacturers need to submit to the SIPO a paper version of the form filled in. The text of the Regulation and the prescribed form in Croatian in HTML and PDF format are available at the following link.
SIPO will publish the submitted data as soon as possible as well as their changes together with the date of submission.