Payments for marketing authorisation variations

 

Amendment to the Reimbursement Decree effective as of 1 June 2019

On 1 June 2019, amendment to Decree No 427/2008 Coll., on determination of the amount of costs to be reimbursed for specialised tasks performed by the State Institute for Drug Control and the Institute for State Control of Veterinary Biologicals and Medicines, amending reimbursements of costs in the sphere of marketing authorisation of medicinal products, particularly for expert activities associated with applications for new marketing authorisations and type II variations to marketing authorisation, becomes effective.  

 

Amendment to the reimbursement decree – payments for marketing authorisation variations effective as of 15 October 2013

On 15 October 2013, the amendment to decree no. 427/2008 Coll., on determination of the amount of costs to be reimbursed for specialised tasks performed by the State Institute for Drug Control and the Institute for State Control of Veterinary Biologicals and Medicines (the “reimbursement decree”),  has come into effect.  

 

Payments for variations submitted before the effective date of the reimbursement decree (effective as of 15 October 2013)

The State Institute for Drug Control hereby informs of the rules of reimbursement of costs of marketing authorisation variations applied for before the effective date of the amended Decree No. 427/2008 Coll., on determination of the amount of costs to be reimbursed for specialised tasks performed by the State Institute for Drug Control and the Institute for State Control of Veterinary Biologicals and Medicines (the “reimbursement decree”), i.e. until 14 October 2013.