Pristojbine za določitev NKZ

Fees for establishing MRL

To je pristojbina za vlogo za prvo določitev NKZ za učinkovino.

This is the fee for an application for the first MRL to be established for a substance.

Določitev najvišjih količin zaostankov (NKZ) za veterinarska zdravila

Establishment of maximum residue limits (MRL) for veterinary medicinal products

Pristojbina za najvišjo količino zaostankov (NKZ): 40 000 ekujev

Maximum residue limits (MRL) fee: ECU 40 000

Pristojbine za NKZ

MRL fee

Pristojbina se odtegne od zneska polne pristojbine NKZ, določene v točki 1.

The fee shall be deducted from the amount of the full MRL fee laid down in point 1.

Za vlogo za prvo določitev NKZ za določeno učinkovino se zaračuna polna pristojbina za NKZ v višini 50000 ekujev.

A full MRL fee of ECU 50 000 shall be charged for an application to set an initial MRL for a given substance.

Za kakršno koli vlogo za določitev NKZ z namenom izvajanja kliničnih preskušanj se zaračuna pristojbina v višini 15000 ekujev.

A fee of ECU 15 000 shall be charged for any application to set an MRL with a view to clinical trials.

Za vsako vlogo za spremembo ali razširitev obstoječih NKZ ali pokrivanje novih vrst se plača dodatna pristojbina za NKZ v višini 15000 ekujev.

An additional MRL fee of ECU 15 000 shall be payable for each application to amend or extend an existing MRL, or to cover new species.

To je pristojbina za vlogo za prvo določitev NKZ za učinkovino. Pristojbina za vsako zahtevo za spremembo ali razširitev obstoječe NKZznaša 10 000 ekujev.

This is the fee for an application for the first MRL to be established for a substance. The fee for each request for modification or extension of an existing MRL shall be ECU 10 000.

ker je treba, če se vlagatelj namenoma odloči, da bo za določitev NKZ zaprosil ločeno, dodatno delo in stroške plačati z ločeno pristojbino za določitev NKZ;

whereas, however, if the applicant deliberately chooses to apply separately for the establishment of MRLs, the additional work and expenditure should be recouped by means of an isolated MRL fee;

Ta pristojbina se odtegne od pristojbine, ki se zaračuna za pridobitev dovoljenja za promet z zdravilom, ki vsebuje učinkovino, kadar za pridobitev takšnega dovoljenje zaprosi podjetje, ki je sprožilo določanje NKZ.

This fee shall be deducted from that charged for a marketing authorization for a medicinal product containing the substance where such authorization is applied for by the undertaking originating the establishment of the MRL.

Pristojbine NKZ se odtegnejo od pristojbine, ki se plača za vlogo za pridobitev dovoljenja za promet ali vlogo za razširitev dovoljenja za promet za zdravilo, ki vsebuje učinkovino, za katero je NKZ določena, če take vloge vloži isti vlagatelj.

MRL fees shall be deducted from the fee payable for an application for marketing authorisation or an application to extend a marketing authorisation for the medicinal product containing the substance for which an MRL has been set where such applications are submitted by the same applicant.

ker je v zvezi z vrednotenjem vlog za določitev najvišjih količin zaostankov (NKZ) odvisno od vlagatelja, ali bo za določitev NKZ zaprosil ločeno ali skupaj s svojo vlogo za pridobitev dovoljenja Skupnosti za promet, ko mora pristojbina za ovrednotenje vloge za odobritev vključevati pristojbino za določitev NKZ;

Whereas, as regards the evaluation of applications to establish maximum residue limits (MRLs), it is up to the applicant to decide whether to apply separately for the establishment of MRLs or to do so together with his application for a Community marketing authorization in which case the fee incurred for the evaluation of the application for authorization should cover the one for the establishment of MRLs;

Pristojbine NKZ se odtegnejo od pristojbine, ki se plača za vlogo za pridobitev dovoljenja za promet ali vlogo za razširitev dovoljenja za promet za zdravilo, ki vsebuje učinkovino, za katero je NKZ določena, če take vloge vloži isti vlagatelj. Znižanje pa ne sme biti višje od polovice pristojbine, na katero se nanaša.

MRL fees shall be deducted from the fee payable for an application for marketing authorisation or an application to extend a marketing authorisation for the medicinal product containing the substance for which an MRL has been set where such applications are submitted by the same applicant. However, this deduction may total no more than one half of the fee to which it applies.

ker je v zvezi z vrednotenjem vlog za določitev najvišjih količin zaostankov (NKZ) odvisno od vlagatelja, ali bo za določitev NKZ zaprosil ločeno ali skupaj s svojo vlogo za pridobitev dovoljenja Skupnosti za promet, ko mora pristojbina za ovrednotenje vloge za odobritev vključevati pristojbino za določitev NKZ; ker je treba, če se vlagatelj namenoma odloči, da bo za določitev NKZ zaprosil ločeno, dodatno delo in stroške plačati z ločeno pristojbino za določitev NKZ;

Whereas, as regards the evaluation of applications to establish maximum residue limits (MRLs), it is up to the applicant to decide whether to apply separately for the establishment of MRLs or to do so together with his application for a Community marketing authorization in which case the fee incurred for the evaluation of the application for authorization should cover the one for the establishment of MRLs; whereas, however, if the applicant deliberately chooses to apply separately for the establishment of MRLs, the additional work and expenditure should be recouped by means of an isolated MRL fee;