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 characterized 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.
Who is Eligible
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.
Where to Apply
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: firstname.lastname@example.org, email@example.com
Which Certificates must be Submitted
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.
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.
Fees Applicable & How to Pay
The fee for the initial inspection of facilities is €102.
The licence fee is €1190.
The renewal fee is €683.
All fees are payable by cash, cheque, or bank transfer.
The applicant is informed regarding the authorization decision within within three months from the date that the application form and supporting documents were duly submitted.
Licence Validity Period
The licence is valid for five years from the date of issue; the renewal fee is €683.
Dispute with the Competent Authority's Decision
How to File an Administrative Action
Administrative Action Against a Competent Authority’s Decision
Any person may file an Administrative Action at the Administrative court against a decision, act or omission of any competent authority or body.
Pursuant to Article 146 of the Constitution, an Administrative Action may be lodged within 75 days from the date of the decision or act or omission or from the day when such decision or act or omission was notified to the applicant.
The Administrative Court acts as a cassation Court and not as a substantive Court. In other words, the Administrative Court may:
I. Dismiss the Administrative Action
II. Annul wholly or partially the contested decision or act
III. Compel the relevant authority or body to take a certain action
After a decision is annulled, the authority and/or public body must reverse things back to the state prior to when the concerned decision and/or act was executed and reexamine.
How to Appeal
An Appeal may be filed against the Administrative Court’s first-instance decision within a period of 42 days from the date such decision was given.
At the Supreme Court (Court of Appeal Section) hearing, the contested issue of the appeal remains the legality of the decision or act already adjudicated for. However, such revision of the legality of the decision or act is solely examined on the matters and the extent that the two parties have limited the reasons in the relevant notice of appeal.
The decision adopted by the Supreme Court is considered final in relation to the matter that has been judged.
Legislation & Obligations
Which Laws and Regulations Apply
- The Medicinal Products for Human Use (Control of Quality, Supply and Price) Law of 2001 (70 (I) / 2001)
- The Medicinal Products for Human Use (Procedure and Content of Examination for a Wholesale License) Regulations of 2004 (Κ.Δ.Π. 144/2004) (in the “Applications & Documents”)
What are my Obligations
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.