Romania Implements SPC Manufacturing Waiver

Oct 3 2022 - 15:03

On August 22, 2022, the Romanian Intellectual Property Office issued Order No. 84/2022 implementing the supplementary protection certificate (SPC) manufacturing waiver introduced by EU Regulation 2019/933.

The Order enables companies in Romania to produce a generic or biosimilar version of an SPC-protected medicine during the SPC term, for the purpose of:

  • Exporting to countries where SPC protection is not available or not enforceable; or
  • Stockpiling during the final six months of the SPC term in order to place the product on the EU market once the SPC expires.

According to EU Regulation 2019/933, before the medicine production begins, manufacturers must notify the SPC granting authority of the EU Member State in which the production is to take place. In this case, the Romanian IPO must be notified at least three months ahead of the production start date, or at least three months before the first related and necessary pre-production activity takes place.

The Order introduces a standard notification form – manufacturers or their legal representatives are required to submit a hard-copy of the completed form to the IPO, which then verifies the information and notifies the manufacturer regarding any deficiencies or regarding the publication date in the Official Bulletin. Notifying the IPO is free of charge.

Prepared by: Monica Viciu

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Source: Romanian Intellectual Property Office website

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