Home Page Service Sectors Other Services Wholesale and Retail Trade WholeSale of Medicinal Products

WholeSale of Medicinal Products


Description

In order to wholesale medicinal products in the Republic of Cyprus, one needs to obtain a Wholesale Licence for medicinal products by the Registrar Drugs Council, operating under the auspices of the Pharmaceutical Services of the Ministry of Health.

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.


Hide details for Eligibility CriteriaEligibility Criteria

Every natural or legal person is eligible to obtain a Wholesale Licence for medicinal products, provided that the Registrar 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 Registrar 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.


Hide details for Application ProcedureApplication Procedure

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: phscentral@phs.moh.gov.cy, apaphitou@phs.moh.gov.cy
Website: http://www.moh.gov.cy/phs

The application should be accompanied by the following documents:
  • application for examination for the Granting of a Wholesale Licence of Medicinal Products (wherever applicable);
  • 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.


Hide details for Obligations and SupervisionObligations 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) Laws of 2001 until 2012 and The Medicinal Products for Human Use (Procedure and Content of Examination for a Wholesale Licence) Regulations of 2001, as periodically amended, and specifically, among others, to conform with the following:
  • book keeping of invoices, narcotics, purchases and sales;
  • rules of good distribution.

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.


Hide details for Other AssociationsOther Associations

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
Email: marianne@ccci.org.cy
Website: http://www.ccci.org.cy



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Related Links

Pharmaceutical Services
The Medicinal Products for Human Use (Control of Quality, Supply and Prices) Law and Amendments
The Medicinal Products for Human Use (Procedure and Content of Examination for a Wholesale License) Regulations of 2004
Operating a pharmacy
Business Setup Procedures
Application for issuance of Certificates of Companies by the Registrar of Companies

Related Documents

Download the Acrobat fileApplication for the Inspection of facilities for the Wholesale of Medicinal Products.pdf
Download the Acrobat fileApplication for examination for the Granting of a Wholesale Licence of Medicinal Products.pdf
Download the Acrobat fileApplication for the Granting - Renewal of a Wholesale Licence for Medicinal Products.pdf



Last Update on: 19/07/2019 02:49:02 PM


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