Regulatory Affairs

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REGULATORY AFFAIRS

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

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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 Moja Farmacija in Macedonia and have local regulatory specialists in Bulgaria and Kosovo.

Moja Farmacija Regulatory Affairs department works very closely with other departments, 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 MOJA FARMACIJA Regulatory Affairs department and contact us directly:

E:   office(at)mojafarmacija.mk
T:   + 389 70 322 267

Moja Farmacija Info

Blvd. Jane Sandanski No.113B / 8
1000 Skopje, Macedonia (Google Map)

Phone. +389 78 244 045

Email address: office(at)mojafarmacija.mk

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