Published aricles: 16
List of reimbursed medicinal products valid as of 1.7.2018
Whole Article Friday, 29. June 2018 | Author PharmDr. Kamil Kalousek
Acting in compliance with Section 39n(1) of Act No. 48/1997 Coll., on Public Health Insurance, as amended (“Act”), the State Institute for Drug Control publishes the List of Prices and Reimbursements for Medicinal Products and Foods for Special Medicinal Purposes (“List”).
Notification of revocation of SÚKL guideline UST-32
Whole Article Friday, 8. June 2018 | Author Monika Knobová
As of 04 June 2018, SÚKL guideline UST-32 EAN Code Reporting and Registration is revoked. The obligation to mark all authorised medicinal products with the European Article Number (EAN) continues to be effective; SÚKL has terminated EAN code registration as of the guideline revocation date.
11. Will the statutory timeline of 180 days applicable to the placement of a product on the market in the presentation preceding a variation to marketing authorisation apply to the implementation of safety features?
Whole Article Tuesday, 29. May 2018 | Author Bc. Lucie Mrázková
10. Prior to 9 February 2019, is it possible to print the abbreviations PC and SN on the packaging of a medicinal product without printing the PC and SN details/2D code at the same time?
Whole Article Tuesday, 29. May 2018 | Author Bc. Lucie Mrázková
9. Will it be possible to show the EAN code on the packaging of a medicinal product after 9 February 2019?
Whole Article Friday, 29. December 2017 | Author Bc. Lucie Mrázková
8. Is it possible to grant an exemption from safety feature implementation for medicinal products which have not been placed on so called white list (i.e. Annex 1 to Delegated Acts)?
Whole Article Friday, 3. November 2017 | Author Lucie Klimentová Pospíšilová
7. Is it possible to implement the ATD for medicinal products dispensed without medical prescription which, at the same time, are not included on the list provided by Annex II to Commission delegated regulation (EU) 2016/161 (so called “black list”)?
Whole Article Friday, 3. November 2017 | Author Lucie Klimentová Pospíšilová
6. When, if an anti-tampering device (ATD) is implemented, is it necessary to submit a mock-up?
Whole Article Friday, 3. November 2017 | Author
5. When is it necessary to submit a mock-up in the implementation of a 2D code?
Whole Article Friday, 3. November 2017 | Author Lucie Klimentová Pospíšilová
3. Will it be mandatory to specify the SÚKL code as the national reimbursement number or another national number identifying the medicinal product? And is it necessary to incorporate the SÚKL code in the unique identifier (UI)?
Whole Article Friday, 3. November 2017 | Author Lucie Klimentová Pospíšilová
2. What are the requirements governing the serial number (SN)?
Whole Article Friday, 3. November 2017 | Author
1. What are the national requirements for product code (PC), how is it generated and what format should it assume?
Whole Article Friday, 3. November 2017 | Author
Questions and answers
Whole Article Friday, 3. November 2017 | Author Lucie Klimentová Pospíšilová
Questions and answers amending practical information on the implementation of safety features.
Correction of the List of reimbursed medicinal products valid as of 2.6.2018
Whole Article Monday, 4. June 2018 | Author PharmDr. Kamil Kalousek
Acting in compliance with Section 39n(1) of Act No. 48/1997 Coll., on Public Health Insurance, as amended (“Act”), the State Institute for Drug Control publishes the List of Prices and Reimbursements for Medicinal Products and Foods for Special Medicinal Purposes (“List”).