SUPPORTING REGULARITY AUTHORITIES
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Mimer Hellas is the manufacturing company of all the pharmaceutical applications of the National Organization for Medicines of Greece and the Pharmaceutical Services of Cyprus and is responsible for their maintenance, as well as for the support of users since 1987 and 2009, respectively.
Regulatory
Management of Marketing Authorizations/Notifications for Pharmaceutical Products for Human Use, for Pharmaceutical Products for Veterinary Use, for Cosmetics, for Dietary Supplements and Special Nutrition products, for Medical Devices, for Biocidal Products, Μanagement of Inspections, Management of Scientific Events & Conferences, National Formulary, NewRS - Electronic Submission CESP System, IDEM - UPD and SPOR Terms Management System
Pricing
Pricing System for Pharmaceutical Products for Human Use
Market monitoring
Market (Sales, Stock & Shortages) Monitoring System, Authenticity Tape Inventory System, Intra-Community Traffic and Exports System, Customs Clearance for Pharmaceutical Products for Human or Veterinary Use System
Pharmacovigillance
Adverse Reactions Yellow Card System
Online pharmaceutical applications
For pharmaceutical companies, health professionals and the public:
- Sales Submission System for Pharmaceutical Products for Human Use
- Veterinary Pharmaceutical Sales Submission System
- Notification of final/temporary suspension of circulation or 1st circulation of Pharmaceutical Products for Human Use
- Verification and Cancellation of Authenticity Tape from public Hospitals
- Declaration of Stocks of Pharmaceutical Products for Human Use
- Yellow Card
- Search of Pharmaceutical Products for Human Use Information (Substances, Prices, SPC, PL)
Drug Usage Tool
Calculation of DDD and Cost of Day Treatment for Pharmaceutical Products for Human Use
Integrated electronic submissions management system through CESP
The multilingual NewRS web-based system serves the receipt, processing and storage of electronic documentation files for pharmaceutical products for human or veterinary use.
It receives, processes and stores these files in a digital repository, in the context of the procedures of the pharmaceutical companies to the relevant Auditing Authority:
- Application for a marketing authorization
- Modification of marketing authorization
- Renewal of marketing authorization
- Withdrawal of marketing authorization