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. Read more