Description

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 a 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, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities.

Eligibility Criteria

Every natural or legal person 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 for human health.

Application Procedure

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 (in the "Related Documents") can be submitted either through the competent authority:

Public Health Services
Ministry of Health
1 Prodromou str.
1449 Nicosia
Tel: +357 22605575, 22605554
Fax: +357 22605482
Email : healthservices@mphs.moh.gov.cy,
Website: http://www.moh.gov.cy/moh/mphs/phs.nsf

The application form for being granted a "Food Supplements Distribution Licence" (T-Φ-073 in the "Related Documents") in the Republic of Cyprus should be accompanied by the following documents:

· copy of document from the manufacturer with the names and quantities of the ingredients of every product (Quantative 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 Labelling);
· 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 country of manufacture or in EU member state & copy of Production licence);
· raw material safety data sheet (copy of Specifications of raw materials);
· 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 applicant is informed regarding the authorisation decision within 120 days from the date that the application form and supporting documents were duly submitted.

The authorisation for the distribution of food supplements is valid for five years from the date of issue; the renewal fee is €34,17.

Notification Procedure

The form "Notification of the Distribution of Food Supplements" (T-Φ-072 in the "Related Documents") 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).
The person making the Notification is given a receipt by the Authority.

Obligations and Supervision

Authorised 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.

Related Documents.

Form for the Application