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Supplementary protection certificates

The Industrial Property Office of the Slovak Republic grants supplementary protection certificates for medicinal products and plant protection products pursuant to Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products, as amended, and 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, as amended (nariadenia Európskeho parlamentu a Rady (ES) č. 469/2009 zo 6. mája 2009 o dodatkovom ochrannom osvedčení pre liečivá v platnom znení a nariadenia Európskeho parlamentu a Rady č. 1610/96 z 23. júla 1996 o vytvorení dodatkového ochranného osvedčenia na výrobky na ochranu rastlín v platnom znení).

The SPC protects medicinal products and plant protection products which may be placed on the market only on the basis of an authorisation issued by the competent authority. An SPC may be granted only to the holder of the basic patent or his successor in title. The maximum period of validity of the certificate shall be five years.

In the case of medicinal products for which studies have been carried out in accordance with a paediatric investigation plan approved by the European Medicines Agency, Európskou agentúrou pre lieky (EMA), this period may be extended for a further six months, subject to the prescribed conditions.

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