Distribution of Food Supplements
In order to distribute food supplements in the Republic of Cyprus that are not (legally) distributed in any other European Union Member State and/or contain more vitamins and minerals than the ones specified in the annexes of the “Regarding Food Supplements Regulations of 2004 (Regulation 5)”, one needs to obtain a “Food Supplements Distribution Licence” by the Director of Medical and Public Health Services, of the Ministry of Health.
Food supplements that are legally distributed in any other European Union Member State can be distributed in the Republic of Cyprus, after the Responsible for Distribution (natural person (individual) or legal person/entity) submits a “Notification of the Distribution of Food Supplements” to the Director of Medical and Public Health Services, of the Ministry of Health. The basic prerequisite for filing notification is that the product contains vitamins and/or minerals that are included in the annexes of the “Regarding Food Supplements Regulations of 2004 (Regulation 5)”. Otherwise, the food supplements are subject to the application procedure for obtaining a “Food Supplements Distribution Licence” even if the product is legally distributed in any other EU Member State.
The term ‘food supplements’ means foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities.
Who is Eligible
Any physical person or legal entity established in the Republic of Cyprus is eligible to obtain a “Food Supplements Distribution Licence” or submit a “Notification of the Distribution of Food Supplements” provided that the Medical and Public Health Services is satisfied that the food supplements:
- comply with the provisions of all relevant EU and National Food Laws;
- do not contain any pharmaceutical or doping substances or other substances and ingredients that are harmful to human health.
Where to Apply
The application form for obtaining a “Food Supplements Distribution Licence” or the form for submitting a “Notification for the Distribution of Food Supplements” in the Republic of Cyprus can be submitted either through the PSC Cyprus or by contacting directly the competent authority:
Public Health Service
Ministry of Health
1 Prodromou str.
Tel: +357 22605575, 22605554
Fax: +357 22605482
Email : firstname.lastname@example.org,
Which Certificates must be Submitted
The application form for being granted a “Food Supplements Distribution Licence” (T-Φ-073) in the Republic of Cyprus should be accompanied by the following documents:
- copy of the document from the manufacturer with the names and quantities of the ingredients of every product (Quantitative and Qualitative synthesis of the product);
- copy of laboratory analysis, from an accredited laboratory of the manufacturer or other private laboratory, of the qualitative characteristics of every product (Methods of analysis of the product constituents, e.g. microbiological analysis);
- a sample of the model Product label (including a Greek Label) of the product (on A4 or A3 sheet), User Instructions, Information and advertising Leaflets (if available) (copy of the product Labeling);
- copy of Certificate of legal production and distribution of the product from the country of production or the manufacturer (copy of Certificate of legal distribution in the country of manufacture or in EU member state & copy of Production licence);
- raw material safety data sheet (copy of Specifications of raw materials);
- receipt of fee of €50 for each Food Supplement (payable by the applicant or a representative (i.e. Cyprus Distributor of the Products, payable either by cash, cheque, or bank transfer at the Ministry of Health of Cyprus).
The form “Notification of the Distribution of Food Supplements” (T-Φ-072) in the Republic of Cyprus should be accompanied by the following documents:
- a sample of the model Product label (including a Greek Label) of the product (on A4 or A3 sheet), direction circular, information leaflets and advertising texts for the product (if available);
- copy of Certificate of legal distribution as a Food Supplement from an EU Member State (e.g. copy of a Notification to a Competent Authority of another EU Member State).
Fees Applicable & How to Pay
The application fee for “Food Supplements Distribution Licence“ is €50 for each Food Supplement and is payable by the applicant or a representative (i.e. Cyprus Distributor of the Products, payable either by cash, cheque, or bank transfer at the Ministry of Health of Cyprus).
The Authorization Renewal fee is €34,17.
There are no fees applicable for submitting the “Notification of the Distribution of Food Supplements“.
The applicant is informed regarding the authorization decision within 120 days from the date that the application form and supporting documents were duly submitted.
Licence Validity Period
The authorization for the distribution of food supplements is valid for five years from the date of issue.
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
- Directive 2002/46/EC
- The Food (Control and Sale) Law of 1996 (L.54(I)/1996)
- Food Supplements Regulations
What are my Obligations
Authorized distributors of food supplements are obliged to comply with the provisions of the Food (Control and Sale) laws of 1996 (N. 54 (I)/1996) and the Food Supplements Regulations of 2004, as periodically amended or replaced.