Published aricles: 33
List of reimbursed medicinal products valid as of 1.3.2014
Whole Article Friday, 28. February 2014 | 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”).
Which data/documents have to be submitted together with notification of the study?
Whole Article Monday, 2. September 2013 | Author Lucie Šustková
The MOST SIGNIFICANT CHANGE: Notification of SÚKL before the start of the study!
Whole Article Monday, 2. September 2013 | Author Lucie Šustková
Reporting ADRs related to MP of biological origin
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
What should not be reported from the Patient Support Programme - PSP?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
Reporting from post-authorisation studies – which information compiled during these studies should be reported to the SUKL or to the EV database within the terms of pharmacovigilance?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
Should suspicions on drug abuse , misuse or medication error of MP or generally off-label use of MP be reported in the case that these do not lead to adverse effects?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
What are Czech requirements for reporting serious adverse reactions and non-serious adverse reactions to MP?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
Amendment to the Decree on Marketing Authorisation
Whole Article Monday, 2. September 2013 | Author Lucie Šustková
Where is it possible to find the PSUR guidelines subject to new legislation?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
What is the maximum period for submitting the PSUR after the DLP?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
Is it necessary to submit the PSUR, if the EURD list does not specify a fixed combination, but only individual substances?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
Is it necessary to submit the PSUR for medicinal products with marketing authorisation based on a combination of generic and hybrid applications (e.g. one strength has been authorised as generic, the other one as hybrid)?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
Is it necessary to submit the PSUR for hybrid medicinal products?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
Is it necessary to apply for the MA variation to discharge the obligation submitting of the PSUR for MPs authorised according to Section 27, Sub-sect. 1 or 7, homeopathics products or trad. herbal MP according to Sect. 30 of AoP?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
If a change in the PSUR submission frequency occurs subject to the EURD list, is it necessary to apply for the marketing authorisation variation?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
Is it obligatory to submit the PSUR for medicaments authorised according to Section 27, Sub-section 1 or 7, homeopathic products or traditional herbal medicinal products pursuant to Section 30 of Act No. 378/2007 Coll.?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
Shall PSURs be submitted, if the active substance is not included in the EURD list?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
The most frequent safety studies conducted in the Czech Republic: PASS initiated, managed or financed by the MAH voluntarily – summary of obligations:
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
What are the Member States´ requirements for submissions of study documentation?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
In what format shall the final study report be submitted (to PRAC and to SÚKL)?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
In what format shall the protocol be submitted (to PRAC and to SÚKL)?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
Where, when and how to register PASS? Which PASS are to be registered?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
Since when have the new rules for the Post Authorisation Safety Studies (PASS) been in force?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
When should I submit the updated RMP?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
In what format should the RMP be submitted?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
Should I attach the marketing authorisation application with the risk management plan (RMP, Section 1.8.2 in the registration dossier)?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
Should I introduce a risk management plan for my medicinal product?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
Appointment of the contact person for PV issues in the CZ who will be subordinated to the QPPV in accordance with Section 91a, Sub-section 3. Is the appointment of the contact person for PV issues required in the CZ?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
Requirement for a MAH to be obliged to immediately provide information about changes in the PSMF in accordance with Section 91, Sub-section 2, Letter b). Does this mean that each change in the PSMF must be reported to SÚKL?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
In which way and by what deadline is it possible to submit the pharmacovigilance system summary of a marketing authorisation holder?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková
Where can one find the guidelines for Good Pharmacovigilance Practices – GVP?
Whole Article Friday, 5. April 2013 | Author Veronika Petláková