Veterinary (Medicated) Feedingstuffs Market Distribution
Distribution of Medicated Feedingstuffs
In order to distribute and place on the market medicated feedingstuffs in the Republic of Cyprus, one needs to obtain an authorization for the distribution of medicated feedingstuffs by the Council of Veterinary Medicinal Products, operating under the auspices of the Ministry of Agriculture, Rural Development and Environment.
The term “medicated feedingstuffs” refers to any mixture of a veterinary medicinal product or products and feed or feeds which is ready prepared for marketing and intended to be fed to animals without further processing, because of its curative or preventive properties or other properties as a medicinal product.
In parallel, the term ‘placing on the market’ refers to the holding in the territory of the European Community for sale or disposal in any other form to third parties, either for consideration, and actual sale or disposal according to the EC Directive of 1990.
Who is Eligible
Every physical or legal person is eligible to obtain the medicated feedingstuffs licence, provided that the Veterinary Services is satisfied that the following criteria are fulfilled:
- availability of suitable and adequate facilities and equipment for storing medicated feedingstuffs;
- appropriate control mechanisms are in place;
- personnel with sufficient knowledge and sufficient skills and finally is employed;
- the premises, personnel and equipment used in the process of disposal, are subject to the rules and principles of health production.
Where to Apply
The application form for issue / renewal of authorisation for the distribution of medicated feedingstuffs can be submitted either through the PSC Cyprus or by contacting directly the competent authority:
Council of Veterinary Medicinal Products
Ministry of Agriculture, Rural Development and Environment
Tel.: +357 22805112, +357 22805114
Fax: + 357 22805122
E-mail: [email protected]
Which Certificates must be Submitted
The application must be accompanied by the following documents:
- application form for the inspection of the establishment of preparation of medicated feedingstuffs/ intermediate products or of distribution of medicated feedingstuffs;
- certified copy of the certificate of Incorporation of the Company (in case of legal person);
- certified copy of the certificate of Directors and Secretary of the Company (in case of legal person);
- certified copy of the certificate of Registered office address of the Company (in case of legal person);
- flow – diagram for Deliver / Storage and Placing on the market;
- description of technical equipment / control programme and maintenance;
- pest Control Programme;
- cleaning Programme;
- details of Personnel;
- organization Chart /Responsibilities of Personnel;
- organizational technical measure ensuring the quality / safety / recall;
- records of complaint for recall;
- records for documentation;
- receipt of fee of €800,00.
On-site inspections are carried out in order to ensure that all the prerequisites, mentioned are met.
Fees Applicable & How to Pay
The combined application and inspection fee is €800,00 (€400,00 for the application + €400 for inspection) and is payable either by cash, cheque or bank transfer.
Upon approval, the applicant must pay to Veterinary Services the licence fee of €170,86 (payable either by cash, cheque or bank transfer).
The renewal fee is €250 (payable either by cash, cheque or bank transfer).
The applicant is informed regarding the authorization decision within three months from the date that the application form and supporting documents were duly submitted.
Licence Validity Period
The authorization for the distribution of medicated feeding stuffs is valid for five years from the date of issue. The renewal fee is €250.
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
- Council Directive (90/167/EEC)
- The Veterinary Medicinal Products (Control of Quality, Registration, Supply, Manufacture, Administration and Use) Law of 2006 (10 (I) / 2006)
- The Veterinary Medicinal Products (Medicated Feedingstuffs) Regulations of 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 of 2006 (10(I) / 2006) as amended and Veterinary Medicinal Products (Medicated Feedingstuffs) Regulations of 2006 as amended or replaced, and specifically, among others, to:
- keep daily records of the holding or disposal of medicated feeding stuffs for last three years; such as the type and quantity of the medicated feeding stuffs, the name and address of the individuals or legal entities to which the medicated feeding stuffs have been disposed to, the name and address of the veterinary that has issued the veterinary recipe.
Authorized Inspectors of the Veterinary Services conduct planned as well as unplanned inspections to the premises of the licensed medicated feedingstuffs distributors to ensure compliance with the provisions of the relevant Laws and Regulations and perform sampling testing to examine the quality and consistency of medicated feedingstuffs.