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Greece Drugs, Vitamins and Food Supplement Registration

Articles and comments on Greece trade regulations, documentation, labeling, and product registration requirements. Share your experience here.

Greece Drugs, Vitamins and Food Supplement Registration

Postby bridgat » Mon Nov 17, 2008 12:21 am

SUMMARY

All Drugs, Vitamins or Food Supplements to be marketed in Greece must be registered with the National Drug Organization (EOF). As in most countries, the new drug approval and registration process in Greece involves well-established procedures and extensive testing. Drugs developed in Greece and in other countries are subject to the same standards as defined by European regulations.

1.REGISTRATION PROCEDURE

The National Drug Organization (EOF) is the competent authority for granting authorizations to market medical products in Greece. In general, EOF procedures on medicinal products are harmonized with the rest of the EU. EU Directives 93/39 and 93/41 were implemented as of September 1995 by Ministerial Decree Y6a/3221(published in the Government’s Gazette #782 of 12.9.1995). According to the mutual recognition provisions of this Decree, if a medicinal product is approved in another EU Member State and a separate application is submitted to EOF, EOF has the right to request a copy of the other country’s assessment report. In any case within 120 days from receipt of the assessment report, EOF must either grant a marketing authorization for the product in Greece or start the arbitration procedure via the CPMP. Explicitly, the concerned member state either recognizes the decision of the Referred Member State (RMS) and the Specific Product Characteristic (SPC) as approved; or it considers that there might be grounds for presuming that the authorization of product may present a risk to public health and therefore commence the arbitration procedure. Like in other EU Member States, the mutual recognition procedure has become mandatory from 1.1.1998.

New product licenses officially require seven months for approval, but in practice the time is much longer(at least 2 years). Marketing licenses are valid for 5 years. The same registration procedure applies to both OTC and prescription-only medicinal products. In June 1996, EOF issued guidelines concerning the submission of applications for marketing authorization based on the EU Directives. The new system had to be followed as from 14.10.1996. Price approval is obtained via publication in the Pharmaceuticals Price Control Bulletin issued by the Ministry of Development(Department of Commerce). This (price approval) procedure takes at least one year while in other EU countries the price approval procedure is much shorter. As a result, there are long delays in delivering innovative medicinal products to patients. Industry sources believe the Ministry delays the approval of pricing in order to contain prices and to control inflation rates.

Information to be submitted to EOF with the application includes the drug’s complete quantitative composition, preparation process, therapeutic indications, contraindications and side affects, mode of administration, shelf life, previous test results, and drafts of information sheets for doctors, pharmacists, and users. The application is forwarded to the Scientific Committee and Evaluation Committee both of which are part of EOF, and therefore perform their own assessment of the application to establish the efficacy, harmlessness and quality of the drug.


2. FOOD SUPPLEMENTS

For food supplements, marketing authorizations are granted by EOF following notification by the interested party. The notification may be submitted simultaneously with product launch. Food supplements of EU origin may be marketed in Greece if they contain exclusively vitamins and minerals which meet special dosage requirements laid down in the relevant Decree. If these requirements are not met or food supplements are of non-EU origin, they have to follow the EOF approval procedure, after which they may be distributed on the market. This approval procedure must be completed within 120 days from application.

Confusing packaging or labeling that will lead users to believe that the product may have a therapeutic or preventive function, will automatically alert EOF. Labeling must explicitly state that the product is not a drug and does not claim to have any therapeutic or preventive function. Terminology needs to be carefully checked, banning a number of specifically listed words, such as “cough” or “immunity”. EOF may otherwise determine that the product must follow the registration procedure for pharmaceutical products. The initial notification file must list the product’s composition by ingredient, and specific nutrition information with the indication of the Recommended Daily Allowance (RDA) as defined by the FDA.

The Greek market for vitamins and food supplements is currently in a period of regulatory uncertainty. The Greek Ministry of Health, upon the recommendation of Greek academics, has determined that the local diet provides an adequate supply of vitamins to the population with very few exceptions (e.g. pregnancy, specific vitamin deficiencies, etc.). Therefore, according to the Ministry of Health, the intake of vitamins beyond the RDA need not be supplemented , and in certain cases excess intake could be a health hazard. As a result, there are specific regulations on the allowable concentration of vitamins sold in Greece. It should be noted that, while such products can be sold in both pharmacies and health stores, sale of vitamins above a certain concentration is restricted to pharmacies. There are many cases where vitamins and food supplements exceeding the RDA are sold illegally in Athletic Centers and pharmacies. Despite these restrictions, the government has yet to crack down on the sale of imported vitamins which exceed these concentration restrictions. The recommendations of Greek academics are at odds with the EU pressure to open this market to international competition., which would officially allow higher concentration products. The question remains as to whether Greece will indeed crack down on this market, remain unofficially open, or comply officially to EU directives. Considering the strict regulations concerning the labeling of vitamins and food supplements, it is advisable to consult with local distributor or consultant.

For more information regarding the Drug, Vitamins and Food Supplements market, please contact:
t
The Commercial Service
American Embassy
91 Vasilissis Sophias Avenue
GR-101 60 Athens, Greece
Tel: 30/1/721-2307, Fax: 30/1/721-8660

KEY CONTACTS

GOVERNMENT

Ministry of Health
17 Aristotelous St.
GR-104 33 Athens, Greece
Tel: 30/1/523-3573
Fax: 30/1/523-5017

National Pharmaceutical Organization (EOF)
284 Messogion St.
GR-144 62 Holargos
Athens, Greece
Tel: 30/1/652-5562, 30/1/6534-5193
Fax: 30/1/654-5535

TRADE ASSOCIATIONS

Panhellenic Union of Pharmaceuticals Industrials (PEF)
12 Deligiorgi St.
GR 104 37 Athens, Greece
Tel: 30/1/523-7805, 30/1/524-7139

Association of Representatives of Pharmaceuticals Species and Specialties.
P.O. BOX 146 10
GR 528 94 Nea Erythrea
Athens, Greece
Tel: 30/1/800-9477
Fax: 30/1/807-1573

Association of Pharmaceutical Business of Greece (S.F.E.E.)
Vasilos Georgiou 30 & Mikras Asias
GR 152 33 Halandri
Athens, Greece
Tel: 30/1/689-1485, 30/1/689-1987
Fax: 30/1/682-1040



THE FOLLOWING IS A COPY OF THE LAWS AND REGULATIONS GOVERNING NUTRITIONAL SUPPLEMENTS ISSUED BY THE MINISTRY OF HEALTH AND WELFARE IN THE ENGLISH LANGUAGE.

BY DECISION OF THE GOVERNMENT

SUBJECT: AVAILABILITY OF SUPPLEMENTS

Considering the following:
1. Law 1316/83, Article 14, paragraph 3 (published 3/A/11/1/93) and Law 1965/91, Article 1 par. 2 (1b and 5) (pub.146/21.9.91)
2. Law 1558/85, Article 294 as well as L.2081/92. Article 27
3. Recommendation 0-652/10.7.95 of the board of the National Drug Organization (EOF).
4. The need to determine the terms and conditions for the availability of supplements.
5. The decision of the Prime Minister and Minister of Health and Welfare number DY 3a/987/28.9.95 concerning the Assignment of responsibilities to the Vice Ministers for Health and Welfare.

DEFINITION

Article 1
1. Nutritional supplements are products which contain one or more nutritional elements. The aim of the supplements is to supplement the daily nutritional needs of people, when their nutrition is not balanced. They do not fail in the category of common foods, and they are not medicines-according to the standing laws for medicines, and are neither product for special nutritional needs not are intended for special categories of people.

2. The medical forms that the supplements may be made available are the following: Capsules, common pills, pills (with sugar), granules, powder in sachets, ampoules, drops of drinkable, etc.

Article 2

1. The supplements are made available for sale in the Greek market in standardized from a) notification to the National Drug Organization (EOF) and b) decision of the EOF by which it is approved that these products will be available for sale, as mentioned in article 3 and 4 of this decision.

2. The supplements are to be available for sale only from pharmacies.

Article 3

NOTIFICATION PROCEDURE
1. Supplements originating from countries of the European Union (EU) and from the European Economic area, are made available in the Greek Market after notification to the EOF, provided they contain solely vitamins and minerals (as referred to the table of appendix I) and only if the recommended dosage falls into the following categories:

a) no less than 15% of RDA (Recommended Daily Allowance)

b) no more than 150% if RDA for Vitamins A and D

c) no more than 300% of RDA for the vitamins mentioned in Appendix I

d) no more than 100% of RDA for minerals.

2. The notification is given to the EOF at the same time that the product is made available to the Greek market after formal request which should include the following:

a) Full name and address of the person making the request and of the person responsible for the product.

b) Name of the product.

c) The label and the package in which the product is made available to the Greek market, together with direction for use, pamphlets and advertising pamphlets.

d) License for production or packaging for those that are produced inside the country.

e) Fee of 150,000 drachmas, or as ordained by future decision, for any form and content which concerns notification or significant alteration.

3. Any significant alteration of the elements of the present article should be notified to the EOF.

4. The elements of notification are examined by the EOF in order to be established if the terms of articles 1,2,3,5,6,7,8, of the present decision are followed, otherwise the penalties of article 9 are applied.

5. A dossier with the full name of the product, quantity synthesis, method of control, specifications for the use of the basic elements (purity criteria, toxicity, origin, etc.) should be made available to the official authorities.

Article 4

PROCEDURE OF APPROVAL

1. The supplements which are imported from other countries and those that originate form E.U countries and E.E.A countries, but do not fall in the categories of Articles 3, are subject to the procedure from EOF which issues a document approving the sale of the product at the market. The procedure must be concluded within 120 days from the date of filling all the necessary documentation. All the necessary documents to be submitted for approval by the EOF are the following:


1.1 Full name and address of the applicant and of the person responsible for the circulation of the product: Responsible for the circulation of the product is considered a person or a company, which is named in the decision of approval, based on official documentation, and is responsible to the authorities of the country for following all the legal conditions and the correct circulation-sale of the product.

1.2 Name of the product.

1.3 Quality and quantity synthesis.

1.4 Ingredients-in detail-of the product.

1.5 Method of control.

1.6 Specifications for basic ingredients.

1.7 Label, direction for use, pamphlets and advertising pamphlets of the product.

1.8 Two samples.

1.9 A certificate for legal circulation in the country of origin or in a E.U. or a country of the E.E.A

1.10 License for production or packaging for those that are produced in the country or other, third countries.

1.11 Fee of 500,000 drachmas or as ordained by future decisions for any form and content which concerns approval, renewal or alteration of the decision of approval.

2. Any alteration of the above should be made known to the EOF.

3. The decision for the approval of circulation is valid for five years and for its renewal, all the documentation mentioned in article 4 should be submitted.

4. The decision of the EOF not to permit or to renew a decision of approval is reasonably justified and the appellant is duel notified. The appellant may appeal against the decision to the High Council of Science.

Article 9

In case of violation of the terms of this Ministerial Decision, all the terms of article 19 of P.O. 96/73 are applied “on the sale in general of pharmaceutical, dietary and cosmetic products” as modified by law 1316/83, article 33 (3/1983) and Law 1965/91, article 10.

Article 10

The persons responsible for nutritional supplements which are already in circulation in the Greek market should in a period of six months from the publishing of this decision, comply with the terms of this decision. In particular for products for which particulars have been submitted to the EOF in accordance with past laws, additional particulars should be submitted in accordance with this ministerial decision.

Article 11

This Ministerial Decision includes following Appendix as an inseparable part.
In this regulation there are additional changes as follows:
a) Fee for authorization 250.000 drachmas

b) Fee for notification 150.000 drachmas

c) Fee for parallel import 60.000 drachmas(parallel importers have to submit notification)

APPENDIX I
Table for Recommended Daily Allowance for vitamins and minerals.

1. VITAMINS

Vitamin A 0,700 MG
B1 Thiamin 1,1 MG
B2 Riboflavin 1,6 MG
Niacin(equivalent to Niacin) 18 MG
Pantothenic acid 6 MG
Vitamin B6(Pyridoxine) 1,5 MG
Phallic acid 0,200 MG
Vitamin C 45 MG
Vitamin D 0,005 MG
Vitamin E(equivalent a-tockoferol) 10 MG
Biotin 0,150 MG
Vitamin B12 1,4 MG

2. MINERALS

Calcium 700 MG
Iodine 0,130 MG
Magnesium 300 MG
Ferrum 14 MG
Phosphorus 550 MG
Zinc 9,5 MG

Article 12

VALIDITY

The validity of this Ministerial Decision starts from the moment of its publication in the Government paper.

THE VICE MINISTER
bridgat
 
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