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Regulatory Affairs and Pharmacovigilance

Medis Regulatory Affairs department has longstanding experience in registration and compiles, completes and submits dossiers for marketing authorisation.

We offer regulatory support with registration procedures and maintenance of approvals for medicinal products, food supplements, medical devices, food for special medical purposes, infant and follow-on formulas. We are centralized in Medis’ Headquarters in Slovenia and have local regulatory specialists in Austria, Bosnia and Herzegovina, Croatia, Hungary, Kosovo, Macedonia, Montenegro and Serbia.

Medis' Regulatory Affairs department works very closely with other departments in Medis, especially with Sales and Marketing team. This is crucial for optimal maintenance of the medicines through their life cycles and to ensure constant supply of the medicines to the market. We offer "all-in-one-service" for various types of products.

Medicinal products:

  • Regulatory consulting regarding local requirements and strategy advice with the support in our territory 
  • Preparation and maintenance of documentation according to local legislation for NP, MRP and DCP (registration, renewal, variations, notification, MAH transfer...), submission and follow up the status of procedures
  • Publishing of eCTD format or NeeS format
  • High quality translation activities of Patient Information
  • QRD formatting
  • Preparation/check of local labelling, foreign pack applications

Medical devices: 

  • Regulatory consulting regarding local requirements and strategy advice with the support in our territory
  • Preparation and maintenance of documentation according to local legislation (entry into local registers, renewal, variations, notification, MAH transfer...), submission and follow up the status of procedures
  • High quality translation activities of packaging material
  • Preparation/check of local labelling, foreign pack applications

Food supplements, food for special purposes:

  • Regulatory consulting regarding local requirements and strategy advice with the support in our territory (identifying the possibility of marketing a product in the dietary supplement category)
  • Preparing packaging labels in accordance with the legislation requirements 
  • Health claims review on promotional materials and labelling of food supplements
  • Notification of a dietary supplement

Outsource your regulatory projects to Medis Regulatory Affairs department and contact us directly:

E:   regulatory.affairs(at)medis.si 
T:   + 386 1 589 69 61
F:   + 386 1 561 21 08

Majority of Medis' regulatory specialists have been with the company for more than a decade. Vast experience and know-how enables us great insight into development of legislation and thus significantly fastens regulatory procedures.

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Pharmacovigilance

Medis' Drug Safety Office provides support in safety surveillance of your products and assures the safety of medicines to the patients. 

We provide efficient pharmacovigilance system for safety monitoring of medicinal products in the markets of Austria, Bosnia and Herzegovina, Croatia, Hungary, Kosovo, Macedonia, Montenegro, Serbia and Slovenia.

  • Monitoring safety of medicines in the market
  • Education of employees
  • Managing ADR procedures (initial, follow up)
  • Literature searches
  • Inserting text/updates to XEVMPD database
  • E2B reporting capabilities
  • PSUR, RMP and education material applications submissions
  • 24 hour availability
  • Communication with local authorities

 

 

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