Wholesale licences for pharmaceutical products or active ingredients which are used in the manufacture of pharmaceutical products means every activity consisting of the procuring, possession, supply or export of pharmaceutical products or active ingredients which are used in the manufacture of pharmaceutical products, apart from the supply of pharmaceutical products or active ingredients which are used for the preparation of pharmaceutical products for the general public.
Wholesaling of pharmaceutical products or active ingredients which are used in the manufacture of pharmaceutical products is forbidden without a wholesale licence issued by the Drugs Council.
Wholesale licences are issued following an application to the Drugs Council and the inspection of the applicant’s premises.
The application must be accompanied by the prescribed assessment fees for the application along with the inspection fees.
The licence is issued if the applicant meets the following:
1. Has suitable and sufficient premises, systems, facilities and equipment to ensure that the pharmaceutical products are maintained and distributed appropriately.
2. Has appointed a person with suitable qualifications as has been defined by the Drugs Council (see below):
The Drugs Council requires that the applicant be subjected to examination for a wholesale licence. In the case that the applicant is a legal person, this requirement falls to one of the directors of the legal entity. The following are exempt from this requirement:
(a) University degree in Pharmacy
(b) Other university degree with at least 6 months of practical experience in wholesaling or the retail sale of pharmaceutical products
(c) has a graduation diploma from high school (following a 6-year secondary education) with at least two (2) years of practical experience in wholesaling or the retail sale of pharmaceutical products.
The wholesale licence is issued as soon as is possible and not later than 90 days from the receipt of the appropriately completed application by the drugs Council.
(a) Registered pharmacists in the Republic of Cyprus
(b) Proven activities in wholesaling prior to the implementation of the Law No. 70(i) of 2001
(c) Persons who have successfully passed the wholesale examinations that had been conducted in accordance with the Pharmacy and Poisons Law Chapter 254
In the case that the Drugs Council requests necessary supplementary information pertaining to the issue of the licence, the above deadline may be suspended until all the required supplementary information is submitted.
The wholesale licence is valid for a period of five (5) years and is renewed with the payment of the prescribed renewal fees and the submission of a renewal application.
Each wholesale licence issued by the Drugs Council is recorded, consecutively, in the Register for Wholesale Licensees.
Following the issuance of the Wholesale Licence, all licensees are regularly inspected by the Inspectorate based on a risk assessment frequency so as to establish whether the guidelines for Good Distribution Practice are being implemented and followed.