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AGEPI and OSIM Continue Expertise Transfer: Mission Dedicated to Supplementary Protection Certificates

24.09.2026

An expertise transfer mission took place on September 22–23, 2026, in Chișinău as part of the cooperation between the State Agency on Intellectual Property (AGEPI) and the State Office for Inventions and Trademarks (OSIM) of Romania. The mission focused on the exchange of experience in the field of patents for invention, with an emphasis on examining supplementary protection certificate (SPC) applications for medicinal products and plant protection products.

This activity is part of the series of OSIM–AGEPI expertise transfer missions launched in September 2026 and is organized under the “Expertise Transfer in the Field of European Affairs” project, implemented by the Romanian Ministry of Foreign Affairs in cooperation with the Romanian Agency for International Development Cooperation (RoAid), and funded under the 2026 Annual Plan for International Development Cooperation and Humanitarian Assistance.

Supplementary protection certificates play a significant role in the pharmaceutical and agricultural sectors. They take effect after the expiration of the basic patent and partially compensate for the reduction in the effective protection period caused by the time required to obtain marketing authorization for the product.

This exchange of experience is particularly relevant in the context of the European integration path of the Republic of Moldova, a candidate state for European Union accession and, as of June 1, 2026, a party to the European Patent Convention. The experience gained by OSIM through the direct application of EU regulations provides AGEPI specialists with essential practical insights for aligning with European standards.

The agenda for the two-day working session included complex technical analyses focused on topics of interest formulated by AGEPI:

  • the examination procedure for SPC applications, from filing to certificate issuance;
  • verification of marketing authorizations, including the handling of cases where the indicated authorization is not the first one granted for the product in question;
  • extension of the certificate’s duration for medicinal products for which pediatric studies required by European legislation have been conducted;
  • specifics of the examination for plant protection products;
  • notification requirements and the applicable fee regime under Regulation (EU) 2019/933.

OSIM specialists presented the relevant SPC case law of the Court of Justice of the European Union (CJEU), as well as the status of the EU-level reform of the SPC system, including aspects concerning the future centralized procedure and unitary certificates.

OSIM was represented by Cătălina Mihăilescu, Head of the Chemistry-Pharmacy Substantive Examination Service, and Irina Babaligea, a specialist examiner within the same service of the Patents and Technological Information Directorate.

The mission contributes to strengthening AGEPI’s institutional capacity and aligning national practices with European Union standards and practices in the field of intellectual property.