Supplementary Protection Certificate (SPC)

Upon accession of the Republic of Croatia to the European Union, as of 1 July 2013, the Office became the authority responsible for issuing a supplementary protection certificate by applying the provisions referred to in the Regulation (EC) No. 469/09 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products intended for humans or animals and the Regulation (EC) No. 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products.

The supplementary protection certificate is issued in the case when the basic patent is granted for a product that is an integral part of a medicinal product intended for humans or animals or a plant protection product, the placing on the market of which requires the prior approval of the competent state authority.

In the case of medicinal products and plant protection products, the use of a new product covered by a protected invention must be postponed until the marketing authorisation for that product has been issued by the competent health and agricultural authorities. For this reason, it is precisely for the period of time required for the issuance of the first such authorisation that their use is extended by issuing certificates of additional protection.

It should be noted that the certificate does not extend the duration of the entire patent, but only the protection derived from the basic patent for the active substance of the medicinal product or plant protection product.

To maintain the certificate, it is necessary to pay the prescribed costs.


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