Adopted on: 1 May 2017; effective date: 1 September 2017
The Guideline is issued with reference to and in compliance with the provision of Section 77, paragraph 1(f) of Act No 378/2007 Coll., on Pharmaceuticals, as amended at the time of effect of Guideline DIS-13, version 5.
The Guideline is legally binding.
Guideline DIS-13, version 5 supersedes Guideline DIS-13, version 4, effective as of 1 April 2011, including its Amendment effective as of 2 March 2016.
Changes to the previous version of the Guideline:
- In respect of medicinal products not authorised in the Czech Republic, deliveries thereof to another distributor and deliveries of medicinal products not authorised in the Czech Republic to foreign clients shall be newly also reported.
- In respect of non-regulated medicinal products (neither the maximum ex-factory price, nor the profit margin are subject to regulation – please refer to the Price Regulation of the Ministry of Health 1/2013/FAR of 7 December 2012, on the regulation of prices of medicinal products or foods for special medical purposes, as amended), the purchase price of the medicinal products ex. VAT shall be newly reported.
- Deliveries to marketing authorisation holders or sales representatives (promotion samples of medicinal products) shall be reported without producer price. In the communication interface, please enter “Price not specified”.
- Deliveries to blood centres, where blood derivatives are concerned, shall be reported.
- The subject of reporting has been extended by foods for special medical purposes.
- In respect of deliveries to other distributors, the producer price shall be newly reported for regulated medicinal products, and the purchase price ex. VAT for non-regulated medicinal products.