Full Registration, Drug Facility Registration, Renewal, Variations and Drug Safety management. Food Supplements Registration.
On the territory of the Republic of Armenia is allowed to import, produce, store, distribute, sell and use only those medicinal products (originals/generics, biosimilars) and food supplements which have been preliminary approved and registered in The RA.
What we provide
- Consultation and support on preparation of all necessary documents for state registration, renewal, variations
- Submission of registration dossier ( paper, CTD), laboratory samples and standards to the MoH of RA
- Customs clearance service for lab samples and standards
- Necessary daily activities, correspondence with HA concerning registration, renewal, variation process
- PV activities, drug safety monitoring. CIOMS and PSUR submissions
- Partner reporting tool that provides everything you need to know about current registration, renewal and variation issues