Good Manufacturing and Distribution of Pharmaceutical Products
This Sector has the aim of ensuring the quality of pharmaceutical products circulating in the Republic of Cyprus. It consists of pharmacists / inspectors appropriately educated and trained.
The main responsibilities of the sector are:
1. Good Manufacturing Practice (GMP) Inspections of facilities engaging in the manufacture / partial manufacture of pharmaceutical products (Good Manufacturing Practice Guidelines)
2. Good Manufacturing Practice (GMP) inspections of third country importers of pharmaceutical products
3. Good Distribution Practice (GDP) inspections of pharmaceutical product wholesale facilities (Good Distribution Practice Guidelines)
4. Inspections of Brokers
5. Quality control of pharmaceutical products circulating in the Republic of Cyprus through the sampling of pharmaceutical products from the private and public sector and providing these samples to the General State Chemistry for laboratory analyses, in order to verify the quality of the pharmaceutical products on the market.
6. The issue of GMP certificates for pharmaceutical product manufacturing facilities
7. The issue of GDP certifications for pharmaceutical wholesale facilities
8. Examination of applications for registration in the Qualified Persons Register
9. Investigation and handling of incoming Rapid Alert notifications, in accordance with the EU, MRA countries, PIC/S members Rapid Alert Notification communication system
10. Recall of pharmaceutical products presenting with quality issues and the issuing of Rapid Alerts to all countries that are members of the Rapid Alert Notifications system, when required.
11. Investigation of reports and complaints (from citizens, hospitals or clinics) about quality problems with pharmaceutical products.
12. Pharmacovigilance inspections (GVP) of systems maintained by Marketing Authorisation Holders of pharmaceutical products or their local representatives in Cyprus.