Notification to persons liable for payment of annual fees in 2016

    |     Public announcement

In light of the payment of annual fees referred to in Article 94 of the Medicinal Products Act (Uradni list RS (Official Gazette of the Republic of Slovenia), Nos. 31/06 and 45/08 - ZZdr-1), Article 62 of the Medical Devices Act (Uradni list RS, No. 98/09 - ZMedPri), Article 4 of the Rules on fees in the area of medicines (Uradni list. RS, No. 65/11) and Article 4 of the Rules relating to fees in the field of medical devices (Uradni list RS, No. 37/10), 

we inform all persons liable for the payment of annual fees that payment notices for the payment of annual fees for 2015 must be received by no later than 28 February 2016.  A list of all the authorisations acquired up to 31 December 2015 shall form an integral part of the payment notice. The payment notice will be sent till 15 February 2016 and by which the persons liable for the payment of annual fees will be called upon will contain the amount and the method of payment of fees.

Payment notices will be received by:

·  the holders of the marketing authorisations for a medicinal product or the parallel import licence for a medicinal product;

·  the holders of the marketing authorisations for a homeopathic medicinal product;

·  the holders of medicinal product manufacturing authorisations;

·  the holders of wholesale distribution authorisations for medicinal products;

·  the holders of retail sale authorisations for medicinal products in specialised shops; and

·  notified bodies for the conformity assessment procedure.

Persons liable for payment shall send claims concerning payment notices to the following address: Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP), Sektor za finance in računovodstvo, Slovenčeva ulica 22, 1000 Ljubljana or by email to: fees@jazmp.si.