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Czech
and Slovak Republic
Regulatory and Pharmacovigilance Services
- Strategic Regulatory Consultations for the Czech Republic
- Submissions
and representation to SUKL
- National submissions
- RMS and CMS for DCP and MRP in the Czech Republic
- Pricing and reimbursement
- Maintenance of existing licenses
- Verification of acceptability of
regulatory documents for the national authorities before submission
and suggesting improvements
where deemed necessary;
- Providing advice and information to concerning
local regulations.
- Translation of regulatory documents (i.e.
summary of product characteristics, patient information leaflets,
labeling of packaging materials) into
the applicable national language.
- Proofreading
of printed packaging materials, which need to be or have been
translated into
the applicable
national
language
before submission.
- Suggestions for opportunities
to expedite the approval process of submitted regulatory
documents.
Pharmacovigilance Service for the Czech and Slovak Republic
- establish and maintenance of a pharmacovigilance system
- preparation
of a SOP for pharamcovigilance
- establish QPPV
- collect, process, classify and notify all suspected
adverse reactions
- report all suspicion of serious adverse reaction
to the State Authority (ICSR)
- to conduct continuous overall pharmacovigilance
evaluation during the post authorisation period
- to keep an overview
of the safety profiles and any emerging safety concerns to the
medical products for
which the MAH
holds authorisation
- to prepare and submit PSURs in
periodical interval (EU HBD)
- to follow up scientific literature
- to create and maintain a database
used for pharmacovigilance purposes (e.g.compilation of safety
reports, electronic reporting, sharing
and accessing global safety information)
- registration
with EUDRAVIGILANCE
- arranging for a MedDRA licence at MSSO
- electronic reporting of serious
adverse reaction (ICSRs)
Preferred Readability
Testing Providers for:
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Design: (c) 2008 