Regulation Medicinal Products

Regulation (EU) 2019/933 of 20 May 2019 amending Regulation (EC) No 469/2009 on the supplementary certificate of protection for medicinal products (SPPF)

The Registrar of Patents in Cyprus has issued guidelines with respect to the amending Regulation (EC) No 469/2009 on the supplementary certificate of protection for medicinal products as follows.

The above Regulation concerns Certificates (SPPF) for which an application is registered earlier than July 1, 2019 and Certificates requested before July 1, 2019 and which will begin to produce results against or after that date. For applications registered before 1 July 2019, this Regulation will take effect from 2 July 2022.

The notification form, is registered with the Registrar of Patents by the Manufacturer not later than three months before the date of commencement of preparation in Cyprus or no later than 3 months before the first relevant act, preceding that preparation depending on which date is prior.

It is understood that such relevant acts could include: the possession, the supply, the offer to supply, importation, use or synthesis of an active ingredient for the purpose of manufacturing a medicinal product containing that product or temporary storage or advertising for the sole purpose of exporting to third country destinations.

"Manufacturer" means the legal entity established in the European Union on behalf of which the product or medicinal product contained in that product is made for the purpose of exporting to third countries or for the purpose of storage and is the holder of the Certificate.

The manufacturer shall also inform the beneficiary of the Certificate regarding the information referred to in the Notification Form, no later than 3 months prior to the date of commencement of the preparation in that Member State or no later than three months before the first relevant act preceding that preparation. The manufacturer shall also inform about any modifications to the information listed in the Notification Form, before the entry into force of these amendments.

The sole purpose of the above is the control by the beneficiary of compliance with the time limits set by this Regulation, for taking legal action.

The Registrar of Patents shall check whether the notification form that has been registered concerns Certificates for which an application is registered earlier than the 1st of July 2019 and Certificates requested before 1 July 2019 but which will begin to produce results against or after that date. For applications registered before 1 July 2019, this Regulation will take effect as of the 2nd of July 2022.

For any modifications to the information mentioned in the notification form, the manufacturer shall inform the Registrar of Patents before the entry into force of these amendments, re-registering the said form.