Hungary

Policy

In the early 1960's the Ministry of Health identified the National Institute of Pharmacy to be in charge of the registration procedures specific to herbal medicines.

A national policy on TM/CAM was introduced in the Republic of Hungary in 1997 as part of the Law on Public Health, Chapter IV, Section 104. Laws and regulations were issued on naturopathic activities in 1987 and 1997.

Contact

Ministry of Health Hungary

1051 Budapest, Arany János u. 6-8.

Tel: (+36-1)795-1100 
Fax: (+36-1)795-0012                       
Website: http://www.eum.hu/english/

National Institute for Food and Nutrition (OÉTI)
H-1476 Budapest
Gyali ut 3/A. POB 52
Hungary
Tel: (36-1) 476-1100
Fax: (36-1) 215-1545
Website: http://www.info.antsz.hu

 

Laws & Regulations

Supplements considered to be foods must undergo a quality control and registration procedure with either OETI, or KERMI, one of the food control institutes..  Supplements considered medicines must undergo a full pharmaceutical registration process with OGYI (Drug Control Institute).  Supplements considered paramedicines (natural remedies not classified as normal medicines) go through a simplified pharmaceutical registration process.   Most botanicals are classified as paramedicines and registered with OGYI.  No disease claims may be made on nutritional products.

Fortified and Functional Foods - Fortified and functional foods considered to be foods must undergo a quality control and registration procedure with either OETI, or KERMI. Fortified and functional foods considered medicines must undergo a full pharmaceutical registration process with OGYI. Fortified and functional foods considered paramedicines (natural remedies not classified as normal medicines) go through a simplified pharmaceutical registration process.

Most fortified and functional foods containing botanicals are classified as paramedicines and registered with OGYI.

Since 1970, Hungary has a post-marketing surveillance system in place.

A national policy on TM/CAM was introduced in the Republic of Hungary in 1997 as part of the Law on Public Health, Chapter IV, Section 104. Laws and regulations were issued on naturopathic activities in 1987 and 1997.

Contact

OETI  OGYI                             

http://www.magyarorszag.hu/

National Institute for Food and Nutrition (OÉTI)
H-1476 Budapest
Gyali ut 3/A. POB 52
Hungary
Contact: Mr. Imre Rodler, Director
Tel: (36-1) 476-1100
Fax: (36-1) 215-1545
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
Internet: www.info.antsz.hu

 

Standards & Guidelines

Law of 1998 and regulations in 2000 and 2001 are the standard and guidelines for herbal medicines which include pharmaceutical products containing either herbal drug(s) or herbal preparations(s). The main focus of the regulations is for the quality requirements of herbal medicines [1]

The eighth edition of the Hungarian pharmacopoeia is the latest edition of the national pharmacopoeia in force. Since Hungary has signed the convention on the elaboration of the European Pharmacopoeia, standard of the National pharmacopoeia is adhering to the European country which also legally binding [1]

Good Manufacturing Practice (GMP) is the guidelines which applied worldwide for the process of manufacturing product. Manufacture of the herbal medicines also referring to the same guideline. The safety and efficacy of the product was examined by some procedures which include the preclinical and clinical trials. These procedures strictly should refer to the documented scientific research for the same product [1]

Good Manufacturing Practice (GMP) is technical support issued by WHO in 2007 to assure the safety and quality of herbal medicines during the manufacturing process. However, it is advisable for other countries to develop their own national GMP for manufacturing herbal medicines which suits to the country's actual situation [2]

There are about 40 authorized herbal medicine products and 700 registered traditional herbal medicine product in Hungary. This figure is not including the essential drug list but there is another traditional herbal drugs list which consist of 98 drugs without sign (decree 81/2003(XII.23) by Minister of Health. In 1970, a post marketing surveillance system which includes the adverse effect of monitoring was introduced. In Hungary, herbal medicine sold in pharmacies as over the counter medicines and traditional herbal medicines sold in special shop as healing products [1]

In Hungary, there is a system known as aerial plant protections which utilize fixed-winged airplanes to spray the fertilizers, pesticides, and fungicides on some 800 000 to 1 million hectares of crops. This system had been started since 35 years ago and proved to decrease treated to the crops. National proposal is sent to Organisation for Economic Co-operation and Development (OECD) to make best practice for pesticide aerial application [3]

In terms of guidelines for agricultural and collection of herbal medicine's plants, this country obey to the documents by WHO title "WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants" [4]

Nowadays, herbal medicines are widely used as home remedies, over-the-counter drug products and raw materials for the pharmaceutical industry. A guideline to examine the quality of these herbal medicines for the safe use known as "Quality control methods for herbal materials" is produced by WHO in 1998 [5].

Contact

Ministry of Health Hungary
1051 Budapest, Arany János u. 6-8. Phone: (+36-1)795-1100
Fax: (+36-1)795-0012
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.This email address is being protected from spambots. You need JavaScript enabled to view it.
Website: http://www.eum.hu/english

References

  1. National policy on traditional medicine and regulation of herbal medicines – Report of a WHO global survey. Available from: http://apps.who.int/medicinedocs/en/d/Js7916e/9.4.html
  2. WHO. Guidelines on good manufacturing practices (GMP) for herbal medicines. Available from: http://apps.who.int/medicinedocs/documents/s14215e/s14215e.pdf
  3. OECD. Aerial plant protection work in agriculture in Hungary. Available from: http://www.oecd.org/env/spraydrift/48402936.pdf
  4. WHO. Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants. Available from: http://whqlibdoc.who.int/publications/2003/9241546271.pdf
  5. WHO. Quality control methods for herbal medicines. Available from:http://apps.who.int/medicinedocs/documents/h1791e/h1791e.pdf