National Policy on Traditional Medicine and Regulation of Herbal Medicines - Report of a WHO Global Survey
(2005; 168 pages) Voir le document au format PDF
Table des matières
Afficher le documentAcknowledgements
Afficher le documentExecutive summary
Afficher le documentAcronyms, abbreviations and definitions
Afficher le documentWHO Regions
Ouvrir ce répertoire et afficher son contenu1. Introduction
Ouvrir ce répertoire et afficher son contenu2. National policy on traditional medicine and complementary/alternative medicine
Ouvrir ce répertoire et afficher son contenu3. The regulatory situation of herbal medicines
Ouvrir ce répertoire et afficher son contenu4. Member States, WHO and herbal medicines
Fermer ce répertoire5. Country summaries
Afficher le document5.1 WHO African Region
Afficher le document5.2 WHO Region of the Americas
Afficher le document5.3 WHO Eastern Mediterranean Region
Afficher le document5.4 WHO European Region
Afficher le document5.5 WHO South-East Asia Region
Afficher le document5.6 WHO Western Pacific Region
Afficher le documentReferences
Afficher le documentAnnex 1. Text of survey instrument
 

5.4 WHO European Region

Countries that responded to the survey: European Region

Thirty nine of the 51 countries of the WHO European Region responded to the Global Survey. Table 7 summarizes the development of national policy and regulation of TM/CAM and herbal medicines in the European Region, with comparative figures for all of the responding countries and the global percentages. The figures and percentages represent those countries responding positively to the questions. The survey response figures represent all of the responding countries either in the region or globally as indicated.

Table 7. WHO European Region: positive responses

 

Member States in the European Region responding positively with the following

Regional survey % that responded positively
(38)

Global survey % that responded positively
(141)

National policy on TM/CAM

7

18%

32%

Law or regulation on TM/CAM

14

37%

38%

National programme on TM/CAM

3

8%

28%

National office for TM/CAM

9

24%

53%

Expert committee on TM/CAM

10

26%

43%

National research institute on TM, CAM or herbal medicines

10

26%

41%

Law or regulation on herbal medicines

36

98%

65%

Registration of herbal medicines

32

84%

61%

While a large number of countries in the WHO European Region have developed national policies and regulations on TM/CAM through different mechanisms, it is in the area of herbal medicine regulation and registration that the commitment of the countries of the Region to these issues is most evident. The high percentage of countries with herbal medicine regulation and herbal medicine registration systems demonstrates a high level of commitment to ensuring the safety, quality and efficacy of herbal medicines through strong regulatory and policy systems.

Armenia

In the Republic of Armenia, no national policy, laws or regulations on TM/CAM exist, nor are there currently plans to establish them. There is neither a national programme nor an office for TM/CAM, although there are plans to establish them. There are no expert committees set up or national research institutes on TM, CAM or herbal medicine, but research on TM takes place within a department of the National Institute of Health.

Regulation of herbal medicines in Armenia began in 1998 through the national drug law that also regulates conventional pharmaceuticals. Herbal medicines are regulated as a separate category and as dietary supplements. By law, herbal medicines may be sold with medical claims. No national pharmacopoeia exists, nor is one in the process of being developed. In its place, the British herbal pharmacopoeia is used and is legally binding. National monographs are found in the Armenian national formulary for herbal medicines (2001), which is legally binding. The WHO monographs are also used and are legally binding as well.

Regulatory requirements for herbal medicines are limited to adherence to information in pharmacopoeias and monographs; compliance is ensured through inspection by the Drug and Medical Technology Agency. Safety regulatory requirements include the same requirements as for conventional pharmaceuticals and reference to scientific research on similar products. The control mechanism for this requirement is an expert report on safety at the time of registration.

There are 130 registered herbal medicines and 60 herbal dietary supplements. The national essential drug list contains three herbal medicines, and there is a national essential herbs list. The national centre for post marketing monitoring of adverse drug reactions (including those of herbal medicinal products) was established within the Drug and Medical Technology Agency in 1997. The centre participates in the WHO Programme for International Drug Monitoring. In Armenia, herbal medicines are sold in pharmacies as over the counter medicines and by licensed practitioners without restriction. National sales of herbal medicines in 2001 were estimated to be between US$ 50 000 and US$ 60 000, based on data provided by local herbal medicine producers.

Austria

The Republic of Austria has not developed, and has no plans to develop, national policy, laws, regulations, a national programme or a national office on TM/CAM. There are no expert committees or national research institutes on TM/CAM or herbal medicines.

Herbal medicine regulation was introduced in Austria in 1989 in Law No. 541. The regulation is partly the same for herbal medicines as for conventional medicines. In Austria, herbal medicines are regulated as prescription and over the counter medicines. Medical claims may be made by law about herbal medicines.

The national pharmacopoeia, the Austrian pharmacopoeia, and the European pharmacopoeia are used and are both legally binding. The Austrian pharmacopoeia contains monographs, which are also legally binding.

Regulatory requirements for manufacturing include adherence to information in pharmacopoeias and monographs and the same rules of GMP as for conventional pharmaceuticals. Inspections ensure compliance with these requirements. Safety regulatory requirements are the same as for conventional pharmaceuticals, and compliance is ensured through the pharmacovigilance reporting system.

There is no registration system for herbal medicines, nor are any included on a national essential drug list. No national post marketing surveillance system explicitly exists for herbal medicines, nor is one being planned. In Austria, herbal medicines are sold in pharmacies as prescription and over the counter medicines and in special outlets.

Azerbaijan

The Republic of Azerbaijan does not have a national policy, laws, regulations, a national programme, a national office, or an expert committee on TM/CAM, nor are there currently any plans to establish these. No information is available about the existence of national research institutes on TM, CAM or herbal medicines.

The same laws and regulations that apply to conventional pharmaceuticals apply to herbal medicines. Herbal medicines are regulated as over the counter medicines, self medication, dietary supplements, health foods and as a separate regulatory category. By law, medical, health nutrient content and structure/function claims may be made about herbal medicines.

No national pharmacopoeia exists, and no information is available about the other pharmacopoeia that is used and considered to be legally binding. National herbal monographs are in development. Other monographs are used in their place and are considered to be legally binding; however, no information was provided about which monographs are used.

Manufacturing regulatory requirements include adherence to information in pharmacopoeias and monographs, the same GMP rules as for conventional pharmaceuticals and special GMP rules. No control mechanism exists to ensure compliance with these requirements. Safety requirements for herbal medicines are the same as those for conventional pharmaceuticals; however, no control mechanism exists to ensure compliance.

There is a registration system for herbal medicines; however, the number of registered herbal medicines is not known. Herbal medicines are included on the national essential drug list; however, the number included is not known. A post marketing surveillance system for herbal medicines is being planned. In Azerbaijan, herbal medicines are sold in pharmacies as over the counter medicines, in special outlets, by licensed practitioners and without restriction.

Belarus

The Republic of Belarus is currently developing a national policy on TM/CAM. Currently, no laws, regulations, national programme, national office, or expert committee on TM/CAM have been established, nor are there currently any plans to establish these. No national research institutes on TM, CAM or herbal medicines have been set up.

The same laws and regulations that apply to conventional pharmaceuticals also apply to herbal medicines. Herbal medicines are regulated as over the counter medicines and as dietary supplements. By law, medical claims may be made about herbal medicines.

In place of a national pharmacopoeia, the State pharmacopoeia of the USSR is used and is considered to be legally binding. No national monographs exist or are in development, and no others are used in their place.

Manufacturing requirements in Belarus include adherence to information in pharmacopoeias and monographs and the same GMP rules as for conventional pharmaceuticals. A control mechanism exists to ensure compliance with these requirements; however, no details are available. Safety regulatory requirements include the same requirements as for conventional pharmaceuticals and special requirements of traditional use without demonstrated harmful effects and reference to documented scientific research on similar products. To ensure compliance with these requirements, the registration procedures require reports on safety.

There are 300 registered herbal medicines in Belarus; however, none is included on a national essential drug list. The post marketing surveillance system includes a national system to monitor adverse effects of herbal medicines, which was established in 1999. In Belarus, herbal medicines are sold in pharmacies as prescription and over the counter medicines.

Belgium

National policy on TM/CAM in the Kingdom of Belgium was established in 1999, as were laws and regulations. No national programme has been issued, nor has national office have been established. However, a national office under the direction of the Ministry of Health is being planned. No expert committee exists, nor do national research institutes on TM/CAM or herbal medicines.

Regulation of herbal medicines was introduced in 1969; the regulations are partly the same as for conventional pharmaceuticals. Herbal medicines are regulated as prescription medicines, over the counter medicines and as dietary supplements. Medical and nutrient content claims may be made by law.

The European pharmacopoeia serves as the national pharmacopoeia, and is considered to be legally binding. No national monographs exist.

Regulatory requirements for manufacturing of herbal medicines include adherence to the information in pharmacopoeias and monographs and the same GMP rules as for conventional pharmaceuticals. Compliance with these requirements is ensured through inspections of the manufacturing and packaging sites. Safety requirements are the same as for conventional pharmaceuticals, and are ensured through the pharmacovigilance centre and general pharmacy inspections.

There is no registration system, nor are herbal medicines included on a national essential drug list. The national post marketing surveillance system established in 1990 includes adverse effect monitoring of herbal medicines. In Belgium, herbal medicines are sold in pharmacies as conventional and over the counter medicines without restriction.

Bulgaria

In the Republic of Bulgaria, national policy on TM/CAM is being developed. Laws and regulations on TM/CAM were established in 1995 and amended in 2000. A national programme is being planned. The national office, established in 1988 - the Department of Traditional Medicine - is administered by the Ministry of Health. An expert committee was established in 1998 as part of the Bulgarian Drug Agency. No national research institutes have yet been established to investigate TM, CAM or herbal medicines.

Herbal medicines are regulated through laws and regulations which are partly the same as for conventional pharmaceuticals; these were issued in 1995 and amended in 2001. The relevant law is Regulation No. 17 of 19 May 2001 on documentation requirements for marketing authorization for medicinal products. Herbal medicines are regulated as prescription medicines and over the counter medicines and as dietary supplements. By law, medical, health and structure/function claims may be made about herbal medicines.

No national pharmacopoeia yet exists, although one is in development. Instead, the European pharmacopoeia is used, and is considered legally binding. No national monographs yet exist, although they are also in development; in their place, the ESCOP monographs are used, although they are not legally binding.

Regulatory requirements for manufacturing are the same rules of GMP as for conventional pharmaceuticals, and are controlled through manufacturing authorization inspections. Safety requirements include those required for conventional pharmaceuticals and traditional use without demonstrated harmful effects. No control mechanism exists for these safety requirements.

A total of 113 herbal medicines have been registered, but none is included on a national essential drug list. There is a post marketing surveillance system that includes adverse effect monitoring, which was introduced in 1975.

In Bulgaria, herbal medicines are sold in pharmacies as prescription and over the counter medicines and in special outlets. Estimates of the volume of annual sales of packs of four of the most popular herbal medicines sold were provided for 1999, 2000 and 2001. In 1999, 48 814 packs were sold (figures only given for two medicines); in 2000, 134 548 packs were sold and in 2001, 127 996 packs were sold. Although the total volume decreased between 2000 and 2001, this is due to a drop in sales of one of the four medicines: sales of the other three medicines increased in the same period.

Czech Republic

Although national policy, laws, regulations and a national programme on TM/CAM do not currently exist in the Czech Republic, they are being developed. No national office exists, nor is one being planned. There is also no expert committee or national research institute on TM, CAM or herbal medicines.

National laws and regulations on herbal medicines were introduced in 1997 in Law No. 79, which is also the same law that regulates conventional pharmaceuticals. Herbal medicines are regulated as prescription and over the counter medicines. Legally, medical claims may be made about them.

The Cesky lekopis 2002 (Pharmacopoeia bohemica MMII) is the national pharmacopoeia containing two legally binding parts: the European pharmacopoeia in translation and national monographs.

Regulatory requirements for manufacturing include adherence to information contained in pharmacopoeias and monographs and the same GMP rules that are used for conventional pharmaceuticals. Compliance with these requirements is ensured by means of GMP standards. The safety requirements for herbal medicines are the same as for conventional pharmaceuticals and assessment during the registration process is guaranteed. As of November 2003, there were 230 registered herbal medicines.

No herbal medicines are included on a national essential drug list. A national post marketing surveillance system that includes adverse effect monitoring exists. Herbal medicines are sold in the Czech Republic in pharmacies as prescription and over the counter medicines and in special outlets. Data for volume and value of national market sales of herbal medicines was provided, based on reporting from herbal medicines wholesalers.

In 1999, the national sales volume was 6.17 million packs of herbal medicines, with a value of 246.6 million Czech koruna (US$ 9 million). In 2000, the volume reached 6.62 million packs, with a value of 256.55 million koruna (US$ 9.363 million). Finally, in 2001, annual sales involved 8.14 million packs with a value of 315.76 million koruna (US$ 11.524 million).

Denmark

No information is available for the Kingdom of Denmark about national policy, laws, regulations, a national programme, a national office, an expert committee or national research institutes on TM/CAM.

Regulation of herbal medicines in Denmark began in 1992, through laws and regulations separate from, but similar to, those for conventional pharmaceuticals. Herbal medicines are regulated as over the counter medicines and as a separate regulatory category. By law, herbal medicines may be sold with medical claims.

No national pharmacopoeia exists: the European pharmacopoeia is used instead and is legally binding. No national monographs exist; however, the monographs in the European pharmacopoeia are used instead, and are considered to be legally binding.

The same GMP rules used for conventional pharmaceuticals apply to herbal medicines, and compliance is ensured through inspection by the Danish Medicines Agency. Safety requirements include reference to documented scientific research on similar products and bibliographical documents; these documents are part of the application process for marketing authorization.

There are 170 registered herbal medicines; there are no herbal medicines included on a national essential drug list. A post marketing surveillance system that includes adverse effect monitoring of herbal medicines exists. In Denmark, herbal medicines are sold in pharmacies as over the counter medicines and in special outlets without restriction.

Estonia

The Republic of Estonia does not have a national policy, laws, regulations, a national programme, a national office, an expert committee or national research institutes on TM/CAM, nor are there currently any plans to establish these.

Regulation of herbal medicines began in 1998 in Estonia; herbal medicines are regulated as prescription and over the counter medicines and as dietary supplements. By law, medical, health and nutrient content claims may be made for herbal medicines.

The European pharmacopoeia is used in lieu of a national pharmacopoeia and national monographs, and is considered legally binding. In addition, the monographs in the British herbal pharmacopoeia and the WHO monographs are used.

Regulatory requirements for manufacturing include adherence to information in pharmacopoeias and monographs and the same GMP rules as are used for conventional pharmaceuticals. Compliance is ensured by inspection by the State Agency of Medicines, but only for those herbal medicines regulated as prescription medicines. Safety requirements vary according to the regulatory status of the herbal medicines; however, requirements include those laid down for conventional pharmaceuticals and special requirements of traditional use without demonstrated harmful effects and reference to documented scientific research on similar products. The control mechanism of inspection ensures compliance.

There are currently 85 registered herbal medicines in Estonia; however, none is listed on the essential drug list. A post marketing surveillance system for herbal medicines that includes a national monitoring system for adverse effects was established in 1995. Herbal medicines in Estonia are sold in pharmacies as prescription and over the counter medicines.

France

The French Republic does not have a national policy, laws, regulations, a national programme, a national office, an expert committee or national research institutes on TM/CAM, nor are there currently any plans to establish these.

Regulation of herbal medicines in France began in 1985, using the same laws and regulations as are used for conventional pharmaceuticals. Herbal medicines are regulated as over the counter medicines, and by law, medical claims may be made about them.

No national pharmacopoeia is currently used, and there is no information available about national monographs. The same GMP rules are required for the manufacture of herbal medicines as for conventional pharmaceuticals. Compliance with these requirements is ensured through inspections. Safety requirements are the same as for conventional pharmaceuticals, but also include the special requirement of traditional use without demonstrated harmful effects.

In France, 787 herbal medicines are registered; none is listed on a national essential drug list. A post marketing surveillance system that includes pharmacovigilance for herbal medicines has been established. Herbal medicines are sold in pharmacies as over the counter medicines in France.

Georgia

Georgia does not have a national policy, laws, regulations, a national programme or an expert committee on TM/CAM, nor are there currently any plans to establish these. A national office was established in 2001, and is administered by the Ministry of Health. No information is available on national research institutes on TM, CAM or herbal medicines.

In Georgia, regulation of herbal medicines was introduced in 2002 in laws and regulations similar to those that regulate conventional pharmaceuticals. Herbal medicines are regulated as over the counter medicines and as a separate regulatory category. By law, medical claims may be made about herbal medicines.

A national pharmacopoeia was published in two volumes, in 2000 and 2003; it is legally binding. National monographs on herbal medicines are being developed.

Manufacturing regulatory requirements for herbal medicines are adherence to pharmacopoeias and monographs; no information is available on the control mechanism used to ensure compliance with this requirement, if any. Safety requirements for herbal medicines are the same as those for conventional pharmaceuticals; no control mechanism exists to ensure compliance.

There are 181 registered herbal medicines in Georgia; however, none is included on a national essential drug list. No post marketing surveillance system for herbal medicines exists, nor is one currently being planned. In Georgia, herbal medicines are sold in pharmacies as over the counter medicines.

Germany

In the Federal Republic of Germany, a national policy on TM/CAM was issued in 1976. In that year, laws and regulations on TM/CAM were also issued. A national programme for TM/CAM was introduced in 1978. There is not currently a national office for TM/CAM, although there is a relevant department in the Federal Institute for Drugs and Medical Devices. The national expert committee was established in 1978. There are currently no national research institutes for TM/CAM or herbal medicines.

The national laws and regulations on herbal medicines in Germany were issued in 1976, and have been updated, for instance by several amendments to the Medicines Act. Herbal medicines are regulated as prescription medicines, over the counter medicines and as medicines for self care purposes, which are sold outside pharmacies. By law, medical claims and claims about traditional use may be made about herbal medicines.

A national pharmacopoeia, the Deutsches Arzneibuch (German pharmacopoeia, DAB) and the European pharmacopoeia are used and are considered to be legally binding. A number of additional national monographs have been issued, such as the Deutscher Arzneimittel Codex (DAC), but they are not legally binding.

Regulatory requirements for the manufacture of herbal medicines include adherence to the information in pharmacopoeias and, in the absence of pharmacopoeias, monographs, other monographs, the GMP rules for conventional pharmaceuticals and special GMP rules, the German Medicines Act, and Eudralex (the European Union rules relating to medicinal products). Compliance with these requirements is ensured through inspection and marketing authorization. Safety regulatory requirements include those required for conventional pharmaceuticals. Implementation of these requirements is ensured through pharmacovigilance and literature reviews.

There are approximately 3500 herbal medicines registered in Germany. The post marketing surveillance system, established in 1978, includes monitoring for adverse effects of herbal medicines. Herbal medicines are sold in Germany in pharmacies as prescription and over the counter medicines, in special outlets and in supermarkets. According to industry data for 2002, annual sales of herbal medicines in Germany had a value of 2.072 billion euros (US$ 2.432 billion).

Hungary

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. There is no national programme on TM/CAM. The National Institute of Pharmacy, which was established in 1962 under the Ministry of Health, has dealt with the evaluation and registration of traditional herbal medicines since about 1982. Two scientific societies and an association on TM/CAM have been established. The Research Institute for Medicinal Plants was founded in 1915.

In Hungary, herbal medicinal products may be sold as traditional herbal products, called “healing products or paramedicine” (having therapeutic effects but not considered to be medicaments), or as herbal medicines, which are considered to be conventional pharmaceutical products. Both are regulated as over the counter medicines for self medication purposes and by law, medical claims and health claims may be made.

The regulation for traditional herbal products (“healing products or paramedicine”) was issued in 1987. According to this decree, a traditional herbal product may be approved if: its composition or components are known; the quality of the components and product is determined and constantly ensured; its safety in the doses to be administered is proven; the conditions of its production meet the public health regulations; the prescribed technology for its production can be ensured; its established effect is proven through evaluation or based on scientific knowledge.

The regulations for herbal medicines (conventional pharmaceutical products which contain herbal drug(s) or herbal drug preparation(s)) were laid down in a law of 1998 and regulations, in 2000 and 2001, which refer to medicines in general. These regulations include some special quality requirements for herbal medicines.

The seventh edition of the Hungarian pharmacopoeia (1986) is the national pharmacopoeia in force. However, Hungary has signed the Convention on the Elaboration of a European Pharmacopoeia, so the standards of the European pharmacopoeia, which are included in the eighth edition of the Hungarian pharmacopoeia, are also legally binding.

The GMP rules used for conventional pharmaceuticals are also requirements for the manufacture of herbal medicines; compliance is ensured through regular GMP inspections of herbal preparation manufacturers. The safety and efficacy of a herbal medicinal product may be proved using the same requirements as those for conventional pharmaceuticals, including preclinical and clinical trials or by referring to documented scientific research on similar products. Safety and efficacy requirements are ensured through the controlled production of the product and quality assurance data.

There are currently 40 authorized herbal medicinal products and about 700 registered traditional herbal medicinal products (healing products) in Hungary. Though none of these is included on the essential drug list, there is also a traditional herbal drugs list containing 98 drugs without indication (decree 81/2003(XII.23) of Minister of Health). A post marketing surveillance system including adverse effect monitoring was established in 1970. Herbal medicines are sold in pharmacies as over the counter medicines; traditional herbal medicines are sold in pharmacies and in special shops for healing products.

Iceland

The Republic of Iceland does not have a national policy, laws, regulations, a national programme, a national office, or national research institutes on TM/CAM, nor are there currently any plans to establish these. An expert committee on TM/CAM was established in 2000 as part of the Icelandic Medicines Control Agency.

Regulation of herbal medicines in Iceland began in 1997 with the issue of Regulation No. 684, the regulation concerning marketing authorization for herbal medicinal products. This is a separate regulation for herbal medicines and is similar to the regulations on conventional pharmaceuticals. Herbal medicines are regulated as over the counter medicines, dietary supplements, health foods and as a separate regulatory category. Medical claims may be made by law only for those herbal medicines that have marketing authorization under the 1997 regulation.

No national pharmacopoeias or national monographs are used; instead, the European pharmacopoeia is used, and is considered to be legally binding. Regulatory requirements for manufacturing include the same GMP rules as for conventional pharmaceuticals, as well as adherence to the information in pharmacopoeias and monographs. Implementation of these requirements is ensured through the submission of GMP approval documents for manufacturers of herbal products authorized under Regulation No. 684. For other products, no control mechanism exists. Safety regulatory requirements include traditional use without demonstrated harmful effects and reference to documented scientific research on similar products, provided by manufacturers.

Eleven herbal medicines are currently registered in Iceland; none is included on a national essential drug list. The same post marketing surveillance system used for conventional pharmaceuticals, which includes adverse effect monitoring, is used for herbal medicines. In Iceland, herbal medicines are sold in pharmacies as over the counter medicines and in special outlets. The value of annual market sales of herbal medicines in 2002 was estimated at 1 billion Icelandic krona (US$ 13.175 million).

Ireland

Ireland is currently developing its national policy on TM/CAM, as well as laws and regulations. No national programme is currently being developed. There is no national office or national research institute focusing on TM, CAM or herbal medicines.

The regulation of herbal medicines was introduced in 1998 with the passage of the Medicinal Products (Licensing and Sale) Regulations, which regulate conventional and herbal medicines. Herbal medicines are regulated as prescription medicines, over the counter medicines, dietary supplements and medicines for self medication purposes. By law, medical, health, nutrient content and structure/function claims may be made.

In Ireland, the European pharmacopoeia is used in lieu of a national pharmacopoeia; it is legally binding. The monographs contained in it are also used in place of national ones.

Regulatory requirements for the manufacture of herbal medicines include adherence to the information contained in pharmacopoeias and monographs, the GMP rules for conventional pharmaceuticals and special GMP rules. Implementation of these requirements is ensured through the licensing of manufacturers and authorization of herbal products. Regarding safety, the same regulatory requirements that apply to conventional pharmaceuticals also apply to herbal medicines; compliance is likewise ensured by the same means.

There is no registration system, nor are herbal medicines included on a national essential drug list. The same post marketing surveillance system used for conventional medicines is used to monitor herbal medicines. In Ireland, herbal medicines are sold in pharmacies as prescription and over the counter medicines and in special outlets without restriction.

Israel

The State of Israel is currently developing a national policy, laws and regulations, a national programme and a national office for TM/CAM. There is currently no expert committee or national research institute on TM/CAM or herbal medicines.

There is currently no specific regulation of herbal medicines in Israel. Herbal medicines may be considered as dietary supplements, and by law no medicinal claims may be made for them. No national pharmacopoeia exists; instead, the Homeopathic pharmacopoeia, British pharmacopoeia, French pharmacopoeia and United States pharmacopoeia are used and are considered legally binding. In the place of national monographs, the ESCOP monographs, Commission E monographs and WHO monographs are used, but these are not considered legally binding.

The regulatory requirements for the manufacture of herbal medicines are the same as those for conventional pharmaceuticals, including the control mechanism to ensure compliance. As for safety, herbal medicines are screened to restrict those that are not suitable for food use. Furthermore, a list of those herbs which may be used in dietary supplements has been drawn up.

There is currently no registration system, nor are herbal medicines included on a national essential drug list. The same post marketing surveillance system used for conventional medicines, which includes adverse effect monitoring, is used for herbal medicines. There are no restrictions on the sale of herbal medicines.

Kazakhstan

In the Republic of Kazakhstan, a national policy on TM/CAM is currently being developed. Laws and regulations were issued in 1997 and 2003. The national programme was introduced in 2001. The national office is administered by the Ministry of Health. No national expert committee for TM/CAM has been established. Several national research institutes focus on the study of herbal medicines.

Regulation of herbal medicines in Kazakhstan began in 1995 with Article 8 of President’s Decree No. 2655, the same one that regulates conventional pharmaceuticals. Herbal medicines are regulated as prescription medicines, over the counter medicines, self medication and dietary supplements. By law, medical and structure/function claims may be made about herbal medicines.

In lieu of a national pharmacopoeia, the State pharmacopoeia of the USSR is used, as well as the United States pharmacopoeia, British pharmacopoeia and European pharmacopoeia. The information in these is legally binding. National monographs have been published; however, these are not legally binding.

Manufacturing regulatory requirements are limited to adherence to information in pharmacopoeias and monographs. To ensure compliance, inspection by regional departments is required. Safety regulatory requirements are the same as for conventional pharmaceuticals; compliance is ensured through laboratory testing for radioactivity, microbiological purity and pesticides.

There are 134 registered herbal medicines in Kazakhstan; five were included on the national essential drug list issued in 2003. The post marketing surveillance system includes a national system to monitor adverse effects of herbal medicines, which was established in 2003. Herbal medicines are sold in pharmacies as prescription and over the counter medicines.

Kyrgyzstan

The Kyrgyz Republic does not have a national policy, laws, regulations, a national programme or a national office on TM/CAM, nor are there currently any plans to establish these. There is no national expert committee. The National Scientific Research and Processing Centre of Balneology and Traditional Medicine of the Ministry of Health of Kyrgyzstan was founded in 1990.

The National Law on Pharmaceuticals of 1997 establishes regulations on herbal medicines that are partly the same as those for conventional pharmaceuticals. Herbal medicines are regulated as prescription medicines, over the counter medicines, dietary supplements and herbal raw materials. By law, herbal medicines must be sold with medical claims.

No national pharmacopoeia yet exists, and there are no immediate plans to develop one; meanwhile, the pharmacopoeia of the former Soviet Union is used, and is considered to be legally binding. National monographs are contained in the National medicinal remedy (1985) and the Scientific research basis of Kyrgyz national medicine (1985). Together, the two monographs contain 1 500 monographs, but they are not legally binding.

Manufacturing regulatory requirements include adherence to information contained in the pharmacopoeia and temporary instructions, such as some elements of GMP, which include instructions for the licensing and inspection of herbal medicine manufacture, as well as requirements for documentation, product marketing authorization and design of labels for herbal medicines. While a control mechanism exists to assure compliance with these requirements, details were not provided. Safety requirements for herbal medicines are the same as for conventional pharmaceuticals, which include testing for toxic elements, radioactivity and heavy metals.

There are currently 95 herbal medicines registered in Kyrgyzstan; however, none are included on the national essential drug list. A post marketing surveillance system has been established. In Kyrgyzstan, herbal medicines are sold in pharmacies as prescription and over the counter medicines. Marketing research on annual sales of herbal medicines provide details of the value and volume of herbal medicines sold in Kyrgyzstan in 2000 and 2001. In 2000, 299 892 packs of herbal medicines were sold for a value of US$ 39 495. In 2001, 247 538 packs were sold for a total value of US$ 31 862.

Latvia

Information is not available on the status of national policy, laws and regulations, national programme, national office, or expert committee on TM/CAM in the Republic of Latvia. There are no national research institutes on TM, CAM or herbal medicines.

The national laws and regulations for herbal medicines in Latvia are partly the same as those for conventional pharmaceuticals. Herbal medicines are regulated as prescription and over the counter medicines, dietary supplements and health foods. By law, medical, health and nutrient content claims may be made about herbal medicines.

In place of a national pharmacopoeia, the European pharmacopoeia, British herbal pharmacopoeia, German pharmacopoeia and German homeopathic pharmacopoeia. In place of national monographs, Hagers Handbuch der pharmazeutischen Praxis is used.

Manufacturing regulatory requirements include adherence to information in pharmacopoeias and monographs and the same rules of GMP that apply to conventional pharmaceuticals. Implementation of these requirements is ensured through state pharmacy inspections. Safety regulatory requirements include the same requirements as for conventional pharmaceuticals and special requirements of traditional use without demonstrated harmful effects and reference to documented scientific research on similar products. Implementation of these requirements is not ensured by any control mechanism.

In Latvia, over 100 herbal medicines are registered; however, none is included on a national essential drug list. The post marketing surveillance system, which includes adverse effect monitoring, was established in 2000. In Latvia, herbal medicines are sold in pharmacies as prescription and over the counter medicines.

Lithuania

The Republic of Lithuania does not have a national policy, laws, regulations, a national programme, a national office, an expert committee or national research institutes on TM/CAM, nor are there currently any plans to establish these.

Lithuania regulates herbal medicine through laws and regulations, either the same as, or partly the same as, those used for conventional pharmaceuticals. Herbal medicines are regulated as prescription medicines, over the counter medicines and dietary supplements. No information is available about the claims made for herbal medicines.

In place of a national pharmacopoeia, the European pharmacopoeia is used and is considered to be legally binding. In place of national monographs, the WHO monographs are used, and are considered to be legally binding. There are no plans to develop national versions.

Manufacturing regulatory requirements are limited to adherence to information in pharmacopoeias and monographs; compliance is ensured through the manufacturer’s laboratories and the quality control laboratory of the State Drug Control Agency. Safety regulatory requirements are limited to traditional use without demonstrated harmful effects, but no control mechanism exists for this requirement.

There is a registration system, but no data are available on the number of registered herbal medicines. No information is available about the inclusion of herbal medicines on an essential drug list. No post marketing surveillance system yet exists, and none is planned. In Lithuania, herbal medicines are sold in pharmacies as prescription and over the counter medicines.

Netherlands

The Kingdom of the Netherlands does not have a national policy, laws, regulations, a national programme, a national office, an expert committee or national research institutes on TM/CAM, nor are there currently any plans to establish these.

In the Netherlands, herbal medicines are regulated under the same laws as conventional pharmaceuticals. Herbal medicines have the regulatory status of prescription or over the counter medicines. According to law, health and nutrient content claims may be made.

In place of a national pharmacopoeia, the European pharmacopoeia is used and is considered legally binding. No national monographs exist, nor are any others used in their place.

Regulatory requirements for herbal medicines are the same GMP rules used for conventional pharmaceuticals. Implementation of these requirements is ensured through inspection of nonregistered medicines and pharmaceutical inspections. Safety requirements are the same as for conventional pharmaceuticals; no control mechanism exists for these requirements.

In the Netherlands, there is no registration system for herbal medicines, nor are they included on a national essential drug list. There is no post marketing surveillance system for unregistered herbal medicines, and none is being planned. Herbal medicines are sold in pharmacies as over the counter medicines, in special outlets, droggeries and health shops.

Norway

The Kingdom of Norway issued a national policy on TM/CAM in 2002 that included a national programme. A national law or regulation on TM/CAM entered into force in January 2004. No TM/CAM national office exists, nor is the establishment of such an office being planned. There is also no expert committee for TM/CAM. At the University of Tromsø, the National Research Institute on Complementary and Alternative Medicine (NAFKAM) conducts research on TM/CAM and herbal medicines.

Regulation of herbal medicine was introduced as part of the Regulation on Medicinal Products of 22 December 1999 and is partly the same as for conventional pharmaceuticals. Herbal medicines are regulated as prescription medicines, over the counter medicines and for self medication only. Herbal medicines may be sold by law with medical claims, if they are registered. There is no national pharmacopoeia, nor is one being developed; the European pharmacopoeia is used and considered legally binding. Monographs contained in the European pharmacopoeia are also considered legally binding, since there is no national herbal monograph and one is not currently being developed.

Regulatory requirements for the manufacturing of herbal medicines involve adherence to information in pharmacopoeias and monographs and the same rules of GMP as for conventional pharmaceuticals. Inspections are performed in order to ensure that these requirements are implemented. In order to assess the safety of herbal medicines, there are special regulatory requirements, namely traditional use without demonstrated harmful effects. If herbal medicines meet these requirements, they are then approved by the health authorities. This serves as the control mechanism to ensure implementation of the safety requirements.

There are 28 registered herbal medicines in Norway, none of which are included on the national essential drug list. The documentation required for the quality of natural remedies is essentially the same as for other proprietary medicinal products, whereas the requirements for the documentation of safety and efficacy are much less comprehensive and based on bibliographical documentation on traditional uses in folk medicine. The post marketing surveillance system for herbal medicines includes a system to monitor adverse effects of herbal medicines; however, there is no information about when it was established. Herbal medicines in Norway are sold in both pharmacies and health food stores and may also be sold in ordinary food stores.

Portugal

The Portuguese Republic does not have a national policy, laws, regulations, a national programme, a national office, an expert committee or national research institutes on TM/CAM, nor are there currently any plans to establish these.

Portugal has introduced regulation of herbal medicines in the same laws as those covering conventional pharmaceuticals. Herbal medicines are regulated as prescription and over the counter medicines. Medical claims may be made about herbal medicines.

There is a national pharmacopoeia, Farmacopeia portuguesa; however, no national monographs exist, or are being planned. The same GMP rules used for conventional pharmaceuticals are used for herbal medicines; although a control mechanism exists for these requirements, no detailed information is available. Safety requirements for herbal medicines are also the same as for conventional medicines; a control mechanism exists, but again, no detailed information is available.

There is no registration system for herbal medicines, and none is included on a national essential drug list. The post marketing surveillance system, which includes adverse effect monitoring, was established in 1995. In Portugal, herbal medicines are sold in pharmacies as prescription and over the counter medicines.

Republic of Moldova

The Republic of Moldova does not have a national policy, laws, regulations, a national programme, a national office, an expert committee or national research institutes on TM/CAM; information is not available about whether there are currently any plans to establish these.

Herbal medicines are not regulated in the Republic of Moldova; they have the status of over the counter medicines. Medical claims may be made about herbal medicines. The State pharmacopoeia of the USSR is used and is considered legally binding while the Moldovan national pharmacopoeia is in preparation. There are also national monographs that are considered legally binding.

Regulatory requirements for the manufacture of herbal medicines are limited to adherence to the information in pharmacopoeias and monographs; implementation is ensured through analysis of samples by the State Pharmaceutical Inspectorate. Safety requirements are limited to traditional use without demonstrated harmful effects; implementation is ensured by laboratory testing requirements for certification by the State Pharmaceutical Inspectorate.

There are currently 58 herbal medicines registered in the Republic of Moldova; none is included on a national essential drug list. The post marketing surveillance system, including adverse effect monitoring, was established in 1999. In the Republic of Moldova, herbal medicines are sold in pharmacies as over the counter medicines.

Romania

Romania does not have a national policy, laws, regulations, a national programme, a national office or an expert committee on TM/CAM, nor are there currently any plans to establish these. A national institute on herbal medicines has been established.

Regulation of herbal medicines was introduced in 2002 in the same law governing the regulation of conventional pharmaceuticals. Herbal medicines are regulated as prescription medicines, over the counter medicines and dietary supplements. By law, medical and health claims may be made concerning herbal medicines.

The national pharmacopoeia, the Romanian pharmacopoeia, was published in 1993; it is considered to be legally binding. It also contains 85 monographs that are legally binding.

The regulatory requirements for herbal medicines are the same GMP rules as for conventional pharmaceuticals; implementation is ensured through pharmaceutical inspections in the production and distribution channels. Herbal medicines have the same safety requirements as conventional pharmaceuticals. Implementation of these safety requirements is ensured by means of assessment of the safety aspects included in the product dossier and by monitoring the safety of the product on the market through the pharmacovigilance network.

In Romania, 96 herbal medicines have been registered; none is included on the national essential drug list. The post marketing surveillance system, which includes adverse effect monitoring, was established in 1976. Herbal medicines are sold in Romania in pharmacies as prescription and over the counter medicines.

Russian Federation

In the Russian Federation, the national policy on TM/CAM was issued in 1991 and national laws and regulations in 1993. Development of the national programme began in 2001 and is currently scheduled for completion in 2005. A TM/CAM national office was established in 1991, but there is no information about the ministry which administers it. The expert committee was established in 2001. A national research institute on TM was established in 1991.

The law or regulation on herbal medicines is the same as for conventional pharmaceuticals, but the year of issue is unknown. The regulatory status used for herbal medicines is prescription medicines, over the counter medicines or dietary supplements. Herbal medicines are legally sold with medical, nutrient content, and structure/function claims in the Russian Federation.

Eleven editions of the State pharmacopoeia of the USSR have been published, the most recent dating from 1990. The information in the pharmacopoeia is legally binding. The previous edition that was published in 1968 is also used to supplement the current edition. The title of the national monograph is translated as Pharmacopoeia monograph, technical requirements, and is considered legally binding.

Manufacturing regulatory requirements include adherence to information in pharmacopoeias and monographs and the same GMP rules as those required for conventional pharmaceuticals. The implementation of manufacturing requirements is ensured through licensing of the manufacturing process, compliance with established regulations and certification of products. The requirements for the assessment of safety of herbal medicines are same as for conventional pharmaceuticals, with additional requirements, namely radioactivity control.

There are approximately 260 herbal medicines registered in the Russian Federation and they are almost all included in the essential drug list, which is issued annually. There is a post marketing surveillance system and a national system to monitor adverse effects of herbal medicines. Herbal medicines are sold in pharmacies as over the counter drugs, in special outlets as biologically active supplements or without restriction.

Serbia and Montenegro

In Serbia and Montenegro, no national policies, national programmes, national office or expert committee on TM/CAM have been established, nor are there currently any plans to establish them. Laws and regulations on TM/CAM are in development. A national institute on herbal medicines has been set up.

Regulation of herbal medicines was established in 1993 in a law partly the same as that used to regulate conventional pharmaceuticals. Herbal medicines are regulated as dietary supplements and as supportive medicines, a category similar to over the counter medicines. Herbal medicines may be sold with nutrient content and structure/function claims according to law.

The European pharmacopoeia is used as a national pharmacopoeia and is considered to be legally binding. Regulatory requirements for the manufacture of herbal medicines include adherence to information in pharmacopoeias and monographs and the same rules of GMP that apply to conventional pharmaceuticals. Implementation is ensured by inspection. Safety requirements for herbal medicines are the same as for conventional pharmaceuticals and involve laboratory testing; no details of the control mechanism used are available.

There is a registration system for herbal medicines in Serbia and Montenegro, but no information about the number of registered medicines is available. No herbal medicines are included on a national essential drug list. A post marketing surveillance system is being planned. In Serbia and Montenegro, herbal medicines are sold in pharmacies as over the counter medicines and in special outlets.

Slovakia

In the Slovak Republic, there is no national policy on TM/CAM, and there are currently no plans to establish one. The national medicines law that applies to TM/CAM was issued in 1998. No national programme has been issued and no national office, expert committee or national research institutes on TM/CAM have been established.

The regulation of herbal medicines was introduced in 1997, with a separate law or regulation for herbal medicines. Herbal medicines are regulated as prescription medicines, over the counter medicines, self medication, dietary supplements and as a separate regulatory category. By law, medical, health and nutrient content claims may be made about herbal medicines.

The national pharmacopoeia, Pharmacopoea slovaca, was published in 1997; it is legally binding. The Codex pharmaceuticus slovacus, published in 1997, contains 110 national monographs; these are legally binding.

Manufacturing regulatory requirements include adherence to information in pharmacopoeias and monographs and the same GMP rules as for conventional pharmaceuticals. If the product is registered, compliance with these requirements is part of the procedure including national inspection and GMP requirements. Safety requirements include those used for conventional pharmaceuticals and special requirements of traditional use without demonstrated harmful effects, reference to documented scientific research on similar products and laboratory testing for heavy metals, radioactivity and microbiological contamination. The implementation of these safety requirements is ensured through manufacturing requirements, standards and in process controls.

There are nine national registered herbal medicines in Slovakia; however, none is included on a national essential drug list. The post marketing surveillance system includes monitoring of adverse effects of herbal medicines. In Slovakia, herbal medicines are sold in pharmacies as prescription and over the counter medicines and in special outlets.

Slovenia

The Republic of Slovenia does not have a national policy, laws, regulations, a national programme or a national office; however, all are currently in the process of being established. There is no expert committee on TM/CAM. No national research institutes on TM/CAM or herbal medicine have been established.

The regulation of herbal medicines is part of the Medicinal Products and Medical Devices Act of 1999, which regulates conventional pharmaceuticals. Before a herbal medicine is placed on the market, there should be a marketing authorization issued by the Agency for Medicinal Products and Medical Devices. Herbal products are regulated as over the counter medicines, foods and cosmetics. The claims allowed by law vary according to the regulatory status under which a product is classified. By law, herbal medicinal products may make medical claims; however, other herbal products such as cosmetics and foods may only make cosmetic and nutritional claims, respectively.

The official pharmacopoeia in Slovenia is the European pharmacopoeia. The Formularium slovenicum is the national addendum to the European pharmacopoeia and contains national monographs that are not included in the European pharmacopoeia. Both are considered legally binding.

Regulatory requirements for the manufacture of herbal medicines include adherence to the European pharmacopoeia and Formularium slovenicum and the same GMP rules as for conventional pharmaceuticals. Implementation of these requirements is ensured by means of GMP inspections. Safety requirements for herbal medicines include those used for conventional pharmaceuticals. Implementation of these requirements is ensured through toxicopharmacological documentation that is required as part of the application for marketing authorization.

There are 69 herbal medicines registered in Slovenia. None are included on the essential drug list. The post marketing surveillance system, which includes adverse effect monitoring, was established in 2000. In Slovenia, herbal medicines are sold in pharmacies as over the counter medicines and in special outlets; for those products classified as foods and cosmetics, there are no restrictions. In 2000, the value of herbal medicines sold over the counter in Slovenia was US$ 2 301 000; in 2001, the value of these sales was US$ 2 158 000. First quarter sales in 2002 were US$ 594 000. These values are estimated to be 20% below the actual sales of herbal medicinal products.

Spain

The Kingdom of Spain does not have a national policy, laws, regulations, a national programme, a national office, an expert committee or national research institutes on TM/CAM, nor are there currently any plans to establish these.

The Spanish Medicinal Products Act No. 25 of 1990 regulates both herbal medicines and conventional pharmaceuticals. Herbal products are regulated as prescription and over the counter medicines, self medication and health foods. By law, medical and health claims may be made, but only for products authorized as medicines.

The Royal Spanish pharmacopoeia was published in 2003, and is considered legally binding. National monographs also exist, and are considered legally binding.

Regulatory requirements for the manufacture of herbal medicines include adherence to information in pharmacopoeias and monographs, the same GMP rules as for conventional pharmaceuticals and special GMP rules. Implementation of these requirements is ensured through quality control of manufacturers and systematic campaigns of market control. Safety requirements include those used for conventional pharmaceuticals as well as special requirements of traditional use without demonstrated harmful effects and reference to documented scientific research on similar products. If the product has a history of traditional safe use, the requirements are less strict. Compliance with requirements is ensured through the national pharmacovigilance system.

In Spain, there are 2 277 registered herbal medicines; however, none is included in an essential drug list. The same post marketing surveillance system used for conventional pharmaceuticals, including adverse effect monitoring, is used for herbal medicines; it was established in 1985. In Spain, herbal medicines are sold in pharmacies as prescription and over the counter medicines.

Sweden

The Kingdom of Sweden does not have a national policy, laws, regulations or a national programme on TM/CAM and there are no plans to establish them. There is also currently no national office, expert committee or national research institute for TM/CAM.

Regulation of herbal medicine was first introduced in 1978. In 1993, a new act was put into force in Sweden. As part of this regulation, the product group “natural remedy” was defined. It includes herbal medicinal products and medicinal products where the active constituent is a bacterial culture, mineral, salt or salt solution. Furthermore, under the act, the Medical Products Agency should assess the chemical pharmaceutical, safety and efficacy documentation and decide to approve or reject the product. The requirements for the chemical pharmaceutical documentation are partly the same as for conventional medicinal products, with due consideration of the special characteristics of herbal material. Concerning safety and efficacy, applications including bibliographical documentation are more common with natural remedies than conventional medicinal products. Natural remedies are regulated as over the counter medicines for self medication, but only for certain approved medical indications. Herbal medicines may be sold, by law, with medical claims for the approved indications only. With the new directive on traditional herbal medicine products, 2004/24/EC, the legislation in Sweden and the rest of the European Union will be revised during 2005.

A national pharmacopoeia exists, but monographs contained in the European pharmacopoeia are legally binding and take precedence over national monographs. If there is no monograph in the European pharmacopoeia, adherence to national pharmacopoeias is accepted.

Regulatory requirements for the manufacture of herbal medicines involve adherence to information in the European pharmacopoeia, where applicable, and to the same GMP rules as those used for conventional pharmaceuticals. Implementation of these requirements is ensured through inspection of the manufacturing site by the competent medical authority. Safety requirements pertain to the active constituent or the finished product, and include special requirements of traditional use without demonstrated harmful effects and reference to documented scientific research. Implementation of these requirements is ensured as part of the pharmacovigilance system for conventional medicines. In this regard, the number of defined daily dosages of the product sold is taken into account.

There are 103 approved natural remedies in Sweden; none is included on a national essential drug list. The post marketing surveillance system, which includes adverse effect monitoring, was first applied to natural remedies in 1980.

In Sweden, natural remedies may be sold by anyone with a wholesale trade certificate, i.e. they may be sold not only in pharmacies but also in supermarkets, by mail order, etc. In 1999, annual sales of natural remedies were 980 million Swedish krona (US$ 127 million), in 2000 and 2001 1.1 billion krona (US$ 143 million) and in 2002 and 2003 close to 1 billion krona (US$130 million).

Switzerland

There is no official national policy on TM/CAM in the Swiss Federation. A new law on therapeutic products, specifically mentioning regulations for conventional medicine and TM/CAM, was adopted in December 2000. No national programme has been issued, nor is there information about any such programme in preparation. The Swiss Agency for Therapeutic Products (Swissmedic) serves as the national office for TM/CAM. It is administered by the Federal Department of Home Affairs; it was established in 2002. No national research institutes on TM, CAM or herbal medicines have been established.

Herbal medicines had already been authorized as medicinal products before the Federal Law on Medicinal Products and Medical Devices, which also regulates conventional pharmaceuticals and technologies, was adopted in 2000. In some cases, simplified procedures for marketing authorizations for TM/CAM apply; but only when the procedures are compatible with quality, safety and efficacy requirements. New regulations for some TM/CAM (for example homeopathic, anthroposophic and traditional Chinese medicines) are currently in elaboration. Therefore expert committees, including medical doctors, therapists, quality experts and members of CAM industry associations, were set up in 2000 to advise in these matters. Herbal medicines are regulated as prescription and over the counter medicines. Medical, health, nutrient content and structure/function claims may be made by law.

The Swiss pharmacopoeia and the European pharmacopoeia are used. The Swiss pharmacopoeia also contains monographs on herbal medicines, which are legally binding.

Regulatory requirements for manufacturing include adherence to information in pharmacopoeias and monographs and the same GMP rules used for conventional pharmaceuticals. Implementation of these requirements is ensured by licensing of manufacturing firms for production and wholesale trade. Periodic inspections are also made at these sites. Safety requirements, which are part of the licensing system, include those used for conventional pharmaceuticals and special requirements of traditional use without demonstrated harmful effects and with reference to documented scientific research on comparable products. The licensing system is overseen by Swissmedic.

There are 1 000 registered herbal medicines in Switzerland; there is no essential drug list. The post marketing surveillance system includes adverse effect monitoring and was established in 1990. In Switzerland, herbal medicines are sold in pharmacies as prescription and over the counter medicines, by licensed practitioners and drogueries. Data on annual national sales was provided for 1998 2000. In 1998, sales were 227 million Swiss francs (US$ 171 million), in 1999, they were 228 million francs (US$ 172 million) and in 2000, they were 227 million francs (US$ 171 million).

Tajikistan

In the Republic of Tajikistan, a national policy on TM/CAM is in development. Laws and regulations were issued in 1997. A national programme on TM/CAM is being developed. In the Ministry of Health, the Centre for Oriental Medicine was established in 1995. The Attestation Commission of the Ministry of Health serves as the expert committee on TM/CAM. No national research institutes on TM, CAM or herbal medicines have been founded.

Regulation of herbal medicines was introduced in 2001 in Tajikistan; it comprises the same laws and regulations as for conventional pharmaceuticals. Herbal medicines have no regulatory status. Structure/function claims may be made about herbal medicines.

No national pharmacopoeia is being developed; in its place, the State pharmacopoeia of the USSR is used. The information contained therein is legally binding. Several national monographs exist, although they are not legally binding.

Manufacturing regulatory requirements in Tajikistan are limited to adherence to information in pharmacopoeias and monographs; no specific details of the structure of the control mechanism are available. Safety requirements for herbal medicines are the same as for conventional pharmaceuticals; again, no specific details are available about the specifics of the control mechanism.

There are 12 registered herbal medicines; two herbal medicines are included on the national essential drug list issued in 2003. A post marketing surveillance system is being developed. In Tajikistan, herbal medicines are sold in pharmacies as over the counter medicines.

The former Yugoslav Republic of Macedonia

In the former Yugoslav Republic of Macedonia, no national policy on TM/CAM has been issued or is in preparation. Laws and regulations on TM/CAM were issued in 1998. No national programme has been issued, nor is one currently being planned. The national office is the Pharmaceutical Agency and is administered by the Ministry of Health; it was founded in 1998. The expert committee on TM/CAM was established in 1992. The Institute for Pharmacology serves as the national research institute for TM/CAM and herbal medicines; it was founded in 1977.

The law establishing regulation of herbal medicines and conventional pharmaceuticals in The former Yugoslav Republic of Macedonia was issued in 1998. Herbal medicines are regulated as over the counter medicines. By law, medical claims may be made about herbal medicines.

In place of a national pharmacopoeia and national monographs, the European pharmacopoeia is used and is considered legally binding. Manufacturing requirements for herbal medicines are the same GMP rules required for conventional pharmaceuticals; implementation is ensured by regular routine inspections. Safety requirements for herbal medicines include reference to documented scientific research on similar products. Implementation of these requirements is ensured by renewal of registration status every five years.

There are 300 registered herbal medicines; none is included on a national essential drug list. The post marketing surveillance system, which also includes adverse effect monitoring, was established in 1992. Herbal medicines are sold in pharmacies as over the counter medicines.

Turkey

In the Republic of Turkey, a national policy on TM/CAM is being developed. Laws and regulations on TM/CAM were issued in 1985 in the “Permanent Notice concerning Shops, Spice Shops and Similar Stores”. The national programme on TM/CAM is being planned, as is the national office. The expert committee was established in 1985. There are no national research institutes on TM/CAM or herbal medicines.

National regulation of herbal medicines in Turkey was introduced in 1986 and was updated in 1999. The law or regulation for herbal medicine is partly the same as for conventional pharmaceuticals. Herbal medicines are regulated as over the counter medicines; by law, health claims may be made about them.

The Turkish pharmacopoeia was published in 1974 in its second edition; however, the European pharmacopoeia is legally binding. The Turkish pharmacopoeia also contains legally binding monographs.

The regulatory requirements for manufacturing are special GMP rules; the specific details of the control mechanism for these requirements are not available. Safety regulatory requirements for herbal medicines are the same as those for conventional pharmaceuticals. Again, details of the control mechanism for these requirements are not available.

There are 41 registered herbal medicines in Turkey; none is included on a national essential drug list. The post marketing surveillance system was established in 1985 and includes adverse effect monitoring of herbal medicines. Herbal medicines in Turkey are sold in pharmacies as over the counter medicines.

Ukraine

The national policy on TM/CAM in Ukraine was established in 1992; laws and regulations were issued in 1998. A national programme is currently in development. The national office, the Committee on National and Nontraditional Medicine, is administered by the Ministry of Health; it was established in 1998. The expert committee was established in 2001. There are national research institutes focused on traditional medicine and herbal medicine; they were established in 1992.

The regulation of herbal medicines in Ukraine was introduced in 1992; these laws and regulations are partly the same as those governing conventional pharmaceuticals. Herbal medicines are regulated as prescription and over the counter medicines. According to the law, medical, health and structure/function claims may be made.

In lieu of a national pharmacopoeia, which is in development, the State pharmacopoeia of the USSR is used and is considered legally binding. National monographs are currently in development.

Regulatory requirements for manufacturing include adherence to information in pharmacopoeias and monographs and the same GMP rules required for conventional pharmaceuticals. No specific information is available about the control mechanisms used. Safety requirements are the same as for conventional pharmaceuticals; again, although a control mechanism is reported to exist, no details are available.

There is a registration system for herbal medicines; however, no information is available on the number of registered medicines. Herbal medicines are included on the essential drug list, but the number is not known. A post marketing surveillance system, which includes adverse effect monitoring, was established in 1992. In Ukraine, herbal medicines are sold in pharmacies as over the counter and prescription medicines.

United Kingdom of Great Britain and Northern Ireland

The Osteopaths Act 1993 and Chiropractors Act 1994 provided a legal framework for self regulation of the practice of osteopathy and chiropractic. Although the United Kingdom has no single national office, the Medicines and Healthcare Products Regulatory Agency and the Department of Health in England have several teams to develop policy on the safe use and practice of CAM, working with representatives of the Government offices of Scotland, Wales and Northern Ireland. As is often the case in the United Kingdom, the voluntary sector plays an important facilitating role, and for CAM, this is done by the Prince of Wales’s Foundation for Integrated Health. The Department of Health in England has a programme to develop research expertise in CAM and to strengthen the evidence base. It also commissions periodic surveys of the use of CAM in the United Kingdom.

Herbal medicines are regulated under the Medicines Act 1968 (2001/83/EC also applies). This currently provides two regulatory routes for herbal medicines to reach the United Kingdom market. The first is the category of “licensed herbal medicines”: to receive a marketing authorization, herbal medicines are required to meet safety, quality and efficacy criteria in a similar manner to any other licensed medicines. Medicinal claims are permitted. The second category is “herbal remedies exempt from licensing requirements”: the exemption applies where herbal remedies meet the conditions set out in Section 12 of the Medicines Act 1968. Medicinal claims are not permitted.

Regulatory requirements for licensed herbal medicines include the same GMP rules required for conventional pharmaceuticals. This is enforced through the licensing of herbal medicines and manufacturers and inspections by the Medicines and Healthcare Regulatory Agency. Safety requirements for licensed herbal medicines are the same as for conventional pharmaceuticals and are enforced by the same control mechanisms mentioned above. Unlicensed herbal remedies do not currently have to meet any specific requirements of safety or quality. In accordance with the new European Union directive on traditional herbal medicinal products (2004/24/EC), the legislation will be revised by the end of 2004. This will coincide with the introduction of a simplified registration scheme, under which traditional herbal medicines will have to meet the same specific standards of safety and quality as licensed products. The normal requirement for medicines to demonstrate efficacy will be replaced by evidence of traditional use.

The latest edition of the British pharmacopoeia was published in 2002; it is legally binding. The pharmacopoeia contains 124 national monographs.

There are between 300 and 500 licensed herbal medicines in the United Kingdom; however none are included on a national essential drug list. The post marketing surveillance system, which includes adverse effect monitoring, was established in 1964. It was expanded to cover unlicensed herbal medicines in 1996.

In the United Kingdom, herbal medicines are sold in pharmacies as prescription and over the counter medicines, by practitioners (who are not currently licensed) and without restriction. Although the unregulated nature of the herbal medicines market makes estimation of sales figures difficult, an Office of Fair Trading publication indicates the 2000 sales figure to be about 72.7 million pounds sterling (US$ 123 million).

Uzbekistan

In the Republic of Uzbekistan, a national policy on TM/CAM is being developed. No national laws, regulations or programme have been issued, nor are they currently being planned. A national office is being planned; however, no expert committee or national research institutes have yet been established.

The regulation of herbal medicines began in 1997; it is governed by the same laws and regulations as for conventional pharmaceuticals. Herbal medicines are regulated as prescription and over the counter medicines. By law, medical, health, nutrient content and structure/function claims may be made.

A national pharmacopoeia and national monographs are in development; however, no information is available about any others currently being used.

Regulatory requirements for the manufacture of herbal medicine are limited to adherence to information in pharmacopoeias and monographs. No specific information is available about the control mechanism in use to enforce these requirements. Safety requirements for herbal medicines are the same as those for conventional pharmaceuticals; pharmaceutical inspections of laboratories for quality control are used to ensure the implementation of these requirements.

Currently, there are 45 registered herbal medicines in Uzbekistan; 20 herbal medicines are included on the national essential drug list. No post marketing surveillance system has yet been established. Herbal medicines are sold in pharmacies as prescription and over the counter medicines, by licensed practitioners and without restriction.

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Le Portail d'information - Médicaments essentiels et produits de santé a été conçu et est maintenu par l'ONG Human Info. Dernière mise à jour: le 25 juin 2014