The registration of a drug is the basic requirement for its launch to the pharmaceutical market. To register a drug quickly and successfully, a thorough knowledge of the processes and required documentation is essential.
Registration
We provide professional consulting and services linked to the registration of a medicinal product:
- preparation of application and completion of documentation for submission
- administrative services, including preparation of e-forms (evar)
- representation before the national authority (State Institute for Drug Control , SIDC)
- professional translation of texts (SPC, PIL, packaging)
- checking package graphics (mock-ups)
- consulting on post-authorization obligations of the MA holder
- monitoring legislation and notification of changes thereof
Pharmacovigilance
We offer the service “Qualified person for pharmacovigilance in the Slovak Republic”, which involves:
- dealing with communication between local authority (State Institute for Drug Control, SIDC) and the Qualified person for pharmacovigilance (QPPV)
- co-operation with the MA holder and SIDC when reporting undesirable effects
- translation of DHPC and educational materials and co-operation in their approval
- pharmacovigilance training for employees
- monitoring legislation and notification of changes thereof
- monitoring local literature, compilation of reports and professional translations
Interested in our services?
We are happy to answer any questions you may have.
pharmin@pharmin.skWhere to find us
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