Regulatory Services

Pharmaceuticals

 

Compilation and revise of dossiers for submission

Submission for new  national registration procedure, renewals, and variations

Coordination of MRP/DCP procedures, follow-up of the national phase

Preparation of CTD

Translation and adaptation of SmPC, PIL and label text

Final check and approval of the Hungarian SmPC, PIL and label text revised by the Regulatory Authority 

Consultancy services

Application for price reimbursement

Local contact to the Regulatory Authority

Serialization activities

Medical Devices

 

Registration, approvals

Translation, adaptation, and checking of label text and instruction for use

Ranking into category

Food additives, nutritional supplements, cosmetics

 

Notification

Translation, adaptation, and checking of label text and instruction for use

Statements related to health

Calculation of nutritive value

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