Information about waiver of reimbursement of costs for a micro, small or medium-sized enterprise

Pursuant to Section 112, paragraph 3 (b) of Act No 378/2007 Coll., on Pharmaceuticals, as amended, the Institute shall, upon request, waive the full amount of reimbursement of costs or part of it, where take-over of a marketing authorisation or acts conducted in public interest or those which may be of special relevance to a wider group of people, are concerned, and which involve, in particular, the following:

  • orphan human medicinal products;
  • medicinal products intended for use solely in persons under the age of 18 years;
  • acts conducted upon request of entities to which support referred to in a directly applicable Community regulation, e.g. Regulation no. 726/2004 (EC) of the European Parliament and of the Council, applies.

Pursuant to Section 3, letter b) Decree No 427/2008 Coll., on reimbursement of expert activities conducted by the State Institute for Drug Control and the Institute for the State Control of Veterinary Biologicals and Medicaments, the applicant shall reimburse as much as 50% of the amount of costs established by the Pricelist for the requested expert activity conducted on the basis of an application where the applicant meets the conditions for the classification as a micro, small or medium-sized enterprise referred to in Section 5, paragraph 2 and has not been contracted or otherwise engaged by any other entity which does not meet the criteria of a micro, small or medium company, to conduct an activity associated with the requested activity, hereto in compliance with a directly applicable regulation of the European Communities

Pursuant to Section 5, article 2. Decree No 427/2008 Coll., on reimbursement of expert activities conducted by the State Institute for Drug Control and the Institute for the State Control of Veterinary Biologicals and Medicaments, for the purposes of this decree, a micro, small and medium-sized enterprise shall mean an enterprise meeting the conditions stipulated by other legal regulations.

Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (Text with EEA relevance)

Commission recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (2003/361/EC)

European Commission - Enterprise and Industry - SME Definition