We manage the complete registration of various international companies’ medicinal products in Hungary. Based on the good connections with the Healthcare Authorities and the several decade long experience of our colleagues allow us a quick, routine work, where we keep the deadlines, and achieve an up-to-date monitoring within the European Union.
Preparation for application for Registration of Medicinal Products, forming process,- and requirement systems
- presentation of legislations, directives and guidelines regarding Application Request
- preliminary evaluation of chemical, pharmaceutical, preclinical and clinical documentation for submission
- defining the process for application for marketing authorization request
- preparation of Hungarian Summary of Product Characteristics, Patient Information Leaflet and draft Labeling
Request for Application for Marketing Authorization
- Filling in the Application Request Form
- Submission of Request for Application for Marketing Authorization
- Tracking the authority evaluation procedure and informing the client continuously
- In case of questions and missing documentation mediation between the authority and the client
- Checking the marketing authorization approval granted by the authority and making corrections if needed
- Submission of both modifications for marketing authorization approval and timely Renewals
We provide services for special product registration, for example in case of special nutritional product, baby milk, medical food and cosmetic products.
Go to Pharmacovigilance