Wholesale of Veterinary Medicinal Products
In order to wholesale veterinary medicinal products in the Republic of Cyprus, one needs to obtain the license for the wholesaling of veterinary medicinal products by the Council of Veterinary Medicinal Products operating under the auspices of the Ministry of Agriculture, Natural Resources and Environment.
Who is Eligible
The Council of Veterinary Medicinal Products (VMPs) issues the license to applicants for distributing VMPs, only in cases where they pass successfully the examinations provided by the regulations ΚΔΠ133/2006. In case the applicant is a legal person, the aforementioned obligation concerns one of its directors.
If applicants are a)registered pharmacists or b)individuals who can prove that they had been practicing wholesaling activities by the date of effect of Act 10(I)/2006 for VMPs or have successfully passed the examination for wholesaling, as provided by Act of Pharmaceutical and Poisons or by Act 116(I)/2001 for VMPs, they are excluded from the above examination.
Also, the following requirements have to be met by the applicants:
- have suitable and sufficient warehouses in order to store and distribute Veterinary Medicinal Products;
- have at his disposal suitably trained staff, particularly a responsible person for wholesales and recalls of products from the market;
- have suitable equipment in order to ensure the safe storage and transportation of Veterinary Medicinal Products;
- keep detailed records in respect of each incoming or outcoming transaction, narcotics and other documents (Invoices).
Where to Apply
The application, for obtaining the license for wholesaling of Veterinary Medicinal Products in the Republic of Cyprus, can be submitted either through the PSC Cyprus or by contacting directly the competent authority:
Council of Veterinary Medicinal Products
Ministry of Agriculture, Natural Resources and Environment
Tel: +357 22805169/22805117
Fax: +357 22805122
Which Certificates must be Submitted
The application must be accompanied by the following documents:
- Copy of architectural ground plans (premises floor plan);
- Copy of list of equipment;
- Copy of list of employees with reference to their responsibilities;
- Copy of Certificate of Incorporation (issued by the Registrar of Companies);
- Copy of Certificate of Shareholders (issued by the Registrar of Companies);
- Copy of Certificate of Directors and Secretary (issued by the Registrar of Companies);
- Copy of curriculum vitae of the Responsible Wholesaler;
- a certificate of success in the wholesale examinations or evidence of exclusion from the examinations;
- standard procedure for the withdrawal of products from the market;
- in addition, an application for authorisation must be submitted for warehouse inspection, the form of which is also posted on the Veterinary Services website. The fee for the inspection is € 200 payable (in cash, by cheque, or bank order) to the Veterinary Services;
- a licence fee of €700 payable (in cash, by cheque, or bank order) to the Veterinary Services;
Before the licence is issued, an inspection shall be carried out by the inspectors of good practice for the storage and distribution of Veterinary Medicinal Products, of the Veterinary Services Control and Inspection Unit. The purpose of the inspection is to confirm the satisfaction of all the requirements of the legislation, as well as those stated in the application submitted. If necessary, a second inspection shall be carried out to monitor corrective actions. When compliance with the requirements is confirmed, inspectors shall recommend to the Veterinary Medicinal Products Council that it approve the issue of a licence.
Fees Applicable & How to Pay
The warehouse-inspection is €200 and is payable at the time of submitting the application (payable in cash, by cheque, or bank order) to the Veterinary Services.
The licence fee is €700 and is payable at the time of submitting the application (payable in cash, by cheque, or bank order) to the Veterinary Services.
For the renewal application, the fees paid amount to €600.
The applicant is informed regarding the authorization decision within 90 days from the date that the application form and supporting documents were duly submitted (this period can be extended in case the applicant does not satisfy the prerequisites for issuing the license).
Licence Validity Period
The license is valid for 5 years.
The Wholesale License is automatically renewed, as long as three months before the expiry date an application for renewal is submitted.
For the renewal application, the fees paid amount to €600.
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 a 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. However, such a 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 Veterinary Medicinal Products (Control of Quality, Registration, Supply, Manufacture, Administration and Use) Law of 2006 (10 (I) / 2006)
- The Veterinary Medicinal Products (Procedure and Content of Examination for a Wholesale License) Regulations of 2006 (Κ.Δ.Π. 133/2006) (in the “Applications & Documents”)
What are my Obligations
Licensed distributors of medicated feedingstuffs are obliged to comply with the provisions of the Veterinary Medicinal Products (Control of Quality, Registration, Supply, Manufacture, Administration and Use) Law No 10(I) of 2006 as amended and Veterinary Medicinal Products (Procedure and Content of Examinations for wholesaling licence) Regulations of 2006 as amended or replaced.
Obligations include the implementation of all provisions relating to good practice for the storage and distribution of Medicinal Products. All premises/installations, equipment, required records, registers, designated procedures and other documentation for the implementation of the procedures shall be made available, at all times, to the inspectors of the Competent Authority for inspection. Inspections in the wholesale premises of Veterinary Medicinal Products may be planned or ad hoc. An additional obligation of the holder of the Wholesale Licence is to allow inspectors to take samples either for market control purposes or as part of an investigation.