PSC Cyprus: WholeSale of Medicinal Products
In order to wholesale medicinal products in the Republic of Cyprus, one needs to obtain a Wholesale Licence for medicinal products issued by the Drugs Council.
The term “medicinal product” refers to every substance or a combination of substances, that are characterised as having heeling or preventing abilities to human illness or that may be used by or given to humans in order to either restore/correct/amend normal processes or to perform medical diagnosis.
Every natural or legal person is eligible to obtain a Wholesale Licence for medicinal products, provided that the Drugs Council is satisfied that the following criteria are met:
- adequate and appropriate facilities;
- the person responsible for the wholesale of medicinal products possess the appropriate qualifications;
- one of the directors has passed the relevant examinations organised by the Drugs Council. Notably, if the applicant, or in the case of a legal entity, one of the directors of the company, is a registered pharmacist, then he/she is exempted by the obligation of undertaking the examination.
The Application for the Granting/Renewal of a wholesale licence for Medicinal Products in the Republic of Cyprus can be submitted either through the PSC Cyprus or by contacting directly the competent authority:
Registrar Drugs Council
Pharmaceutical Services, Ministry of Health
1475 Nicosia, Cyprus
Tel.: +357 22608603
Fax : +357 22608649
Email: email@example.com, firstname.lastname@example.org
The application should be accompanied by the following documents:
- letter of success in the examination for granting a Wholesale License of Medicinal Products or Pharmacist Registration in the Register of Pharmacists of the Republic of Cyprus;
- application for the Inspection of Facilities for the Wholesale of Medicinal Products;
- copy of curriculum vitae of the person responsible for the wholesale of medicinal products;
- copy of an architectural overview plan of the facilities;
- copy of Certificate of Registration from the Registrar of Companies (in case of legal entity);
- copy of Directors and Secretary (in case of legal entity);
- list of human resources and relevant responsibilities;
- list of facilities and relevant addresses (in case of more than one facilities);
- list of the main equipment to safeguard the appropriate storage and distribution of medicinal products;
- procedure for the recall of medicinal products from the market, procedure of receipt and storage, procedure for stock control, procedure for the sale of older stock by priority, procedure for the handling of returned medicinal products, procedure for cleaning and maintenance;
- licence fee of €1190 and €102 for initial inspection of facilities (payable either by cash, cheque, or bank transfer).
The applicants, wherever applicable, are required to pass written examinations organized by the Registrar Drugs Council in March, June, September and December.
On site inspections are carried out in order to ensure the appropriateness of the facilities and that the relevant above mentioned eligibility criteria are met.
The applicant is informed regarding the authorisation decision within within three months from the date that the application form and supporting documents were duly submitted.
The licence is valid for five years from the date of issue; the renewal fee is €683.
Obligations and Supervision
Licensed Wholesalers of medicinal products are obliged to comply with the provisions of the Medicinal Products for Human Use (Control of Quality, Supply and Prices) Law, as periodically amended, and to comply with Good Distribution Guidelines for Medicinal Products.
Authorized Inspectors of Registrar Drugs Council conduct regular inspections to the facilities in order to ensure among others compliance to the rules of good distribution of medicinal products.
Cyprus Association of Pharmaceutical Companies
8, Grivas Dhigenis Ave. & 3, Deligiorgis Str.,
P.O.Box 21455, 1509 Nicosia Cyprus
Tel.: +357 22889800
Fax : +357 22669048
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Ministry of Energy, Commerce and Industry, Point of Single Contact