The Sector consists of pharmacists / inspectors properly trained and qualified.
Main responsibilities are:
1. Inspection of manufacturing / partial manufacturing premises of pharmaceutical products, according to Good Manufacturing Practice guidelines (GMP).
2. Inspection of wholesale premises of pharmaceutical products, according to Good Distribution Practice guidelines (GDP).
3. Issue of manufacturing / partial manufacturing authorizations of pharmaceutical products.
4. Issue of wholesale authorizations of pharmaceutical products.
5. Quality control of pharmaceutical products marketed in the Republic of Cyprus, through sampling of pharmaceutical products from the private and public sector and uploading them to State General Laboratory for laboratory analysis, to verify the quality of marketed pharmaceutical products.
6. Issue of Good Manufacturing Practice Certificates (GMP Certificates), according to Directive 2003/94/EC
7. Issue of Certificates according to the World Health Organization (WHO) standard, for pharmaceutical products manufactured in Cyprus and intended for export (Certificate of Pharmaceutical Product - CPP).
8. Examination of applications for Qualified Person’s registration.
9. Investigation and handling of incoming rapid alert (Rapid Alert notifications, according to the Rapid Alert Notification system of European countries, MRA countries, PICS members).
10. Recalls of pharmaceutical products having quality problems and issuing (when necessary) rapid alert notifications, to all Member states of the rapid alert notification system.
11. Investigation of complaints for quality problems of pharmaceutical products.
Manufacturing and partial manufacturing authorisation of pharmaceutical products.
Drugs Council is the Competent Authority for issuing manufacturing, partial manufacturing and wholesale authorizations.
Manufacturing and partial manufacturing authorizations of pharmaceutical products are issued as result of inspection of the premises and are valid for five years. According to the provisions of the new legislation, a manufacturing authorization is issued per manufacturer and states each separate pharmaceutical form that may be manufactured.
Inspections are performed periodically, at regular intervals in accordance with a predefined program and in accordance to the risk of the operations, to confirm compliance in line with Good Manufacturing Practice rules, as imposed by the law and Directive 2003/94/EK.
The Section aims that all manufacturers and partial manufacturing premises of pharmaceutical products, are inspected at least once every two years and risk operations every 12 months (although guidelines suggest 3 years intervals).
Wholesale authorization of pharmaceutical products
Wholesale authorizations are issued upon application to the Drugs Council and following inspection of the storage premises of pharmaceutical products. Wholesale licences are valid for five years and are issued if the applicant meets the following criteria:
1. Have suitable and sufficient premises, facilities and equipment to ensure proper maintenance and distribution of pharmaceutical products.
2. Have an appointed responsible person with appropriate qualifications, as defined by the Drugs Council (see below):
i. Bachelor degree in Pharmacy.
ii. Other university graduates with at least 6 months practical experience in the wholesale or retail sale of medicines.
iii. High school graduates (6-year secondary education) with at least 2 years practical experience in the wholesale or retail sale of medicines.
The applicant should undergo examination for wholesale distribution authorization. Examination include current legislation on medicines, pharmacy and narcotic/psychotropic substances. In the case that the applicant is a legal entity, the obligation lies on one of the directors. Exemptions from this obligation are:
1. Persons succeeded the examination for wholesale authorization, according to the Pharmacy and Poisons Law, Cap. 254.
2. Persons operating wholesale business, upon the entry into force of the Law No. 70 (I) of 2001.
3. Pharmacists registered in Cyprus.
The Section aims that all wholesale authorization holders are inspected every two – three years, in order to verify the compliance with Good Distribution Practice..