O z n á m e n i e č. 3
opening the administrative procedure
(categorisation of medicinal products with expected effect on 1.10.2011)
Ministry of Health of the Slovak Republic (hereinafter referred to as "the Ministry') pursuant to § 18 of Act No 71/1967 Coll. on Administrative Procedure (administrative order), as amended
o z n a m u j e,
that the following administrative procedures are initiated on its own initiative with regard to the amendment of the inclusion of a medicinal product in the list of medicinal products and medicinal products fully or partially reimbursed on the basis of public health insurance pursuant to § 39 (2) of Act No. 577/2004 Coll. on the scope of health care paid on the basis of public health insurance and reimbursements for services related to the provision of healthcare as amended (hereinafter referred to as "the Act'):
Č. | Subject /ATC- name of the active substance | Amendment | Reason for action |
1. | L03AB10 Peginterferon alfa-2b parent. PEN L03AB11 Peginterferon alfa-2a parent. sol.inj. | Add the list of hepatological and gastroenterological sites listed in the indicative restriction to the following areas: Hepatic ambulance, Hospital Poprad a.s., Poprad Psychological clinic, 5th internal clinic, University Hospital Bratislava, Bratislava - Ružinov | Expert guidance of the Ministry of Health of the Slovak Republic No. Z30848-2011 - OCS supplementing the Expert guidance of the Ministry of Health of the Slovak Republic on the standardisation of laboratory diagnostics of viral hepatitis (VH) A, B, C, D and E (A E) and on standardization of diagnosis, treatment procedures and dispensation of patients in chronic hepatitis B; and C of 4.12.2007 No 04533 |
According to § 33 of the Administrative Order, the Ministry calls on you to comment on the grounds of the decision within 3 days of receipt of the notification, or to propose evidence which, in your view, is important for the decision of the administrative body under Paragraph 39 (2) of the Act.
You can send your evidence and suggestions electronically to your email address medicines@health.gov.sk. Enter the text in the subject under the heading "Recast of the active substance'.
Mgr. Michaela Gajdoš, MPH
Director General of Pharmacy and Drug Policy Section
This notice of initiation is served by a public order and will be posted for 15 days on the official board of the Ministry and published on the website www.health.gov.sk.