(2) Law on the Amendment of Law on the Management of Pharmaceuticals (2007)

Transcription

1 Cambodia 1. Principal Laws and Regulations The principal law which specifically addresses the counterfeit medicines in Cambodia is the Law on the Management of Pharmaceuticals (Royal Kram No. NS/RKM/0696/02 dated 17 June 1996 promulgating the Law on the Management of Pharmaceuticals) (1) amended by the Law on the Amendment of Law on the Management of Pharmaceuticals (Royal Kram No. NS/RKM/1207/037 dated 28 December 2007 promulgating the Law on the Amendment of the Law on the Management of Pharmaceuticals) (2). Also, Decision on Establishment of Committee for Eliminating Counterfeit Medicines, and Illegal Health Services for Poverty Reduction (Royal Government of Cambodia No. 33 SSR, Received by Ministry of Health on August 30, 2005, List No: 5025) (3) and Prakas on Roles and Responsibilities of Control Agent for Pharmaceutical, Food, Medical equipments, and Cosmetics and Private Medical, Paramedical and Medical Aid Services (No RBS.ORBS dated March 30, 2011) (4) provide provisions related to counterfeit medicines in Cambodia. 2. Website Links (1) Law on the Management of Pharmaceuticals (1996) tical%20(1996)%20eng.pdf (Cambodian Government, Ministry of Health) (English) ticals%20(1996)%20kh.pdf (Cambodian Government, Ministry of Health) (in Khmer) (2) Law on the Amendment of Law on the Management of Pharmaceuticals (2007) %20Pharmaceutical%20Management_Eng.pdf (Cambodian Government, Ministry of Health) (in English) %20Pharmaceutical%20Management_Kh.pdf (Cambodian Government, Ministry of Health) (in Khmer) (3) Decision on Establishment of Committee for Eliminating Counterfeit Medicines, and Illegal Health Services for Poverty Reduction (2005) Committee%20to%20Eliminate%20Counterfeit%20Drug%20and%20Illegal%20Health%20Services% %20Eng.pdf (Cambodian Government, Ministry of Health) (in English) Committee%20to%20Eliminate%20Counterfeit%20Drug%20and%20Illegal%20Health%20Services% %20Kh.pdf (in Khmer) or%20eliminating%20counterfeit%20medicines%20and%20illegal%20health%20service.pdf (Both in Khmer and English) (4) Prakas on Roles and Responsibilities of Control Agent for Pharmaceutical, Food, Medical equipments, and Cosmetics and Private Medical, Paramedical and Medical Aid Services (2011) 1

2 ities%20of%20control%20agent%20for%20pharmaceuticals,%20food,%20medical%20equipment% %20Eng.pdf (Cambodian Government, Ministry of Health) (in English) ities%20of%20control%20agent%20for%20pharmaceuticals,%20food,%20medical%20equipment% %20Kh.pdf (Cambodian Government, Ministry of Health) (in Khmer) 3. Extract from the laws and regulations related to counterfeit medicines (1) Law on the Management of Pharmaceuticals (1996) Article 2 A pharmaceutical is one or many kinds of substances which are primarily from chemicals, bio-products, microbes, plants combined in order to: - use for prevention or treatment of human or animal diseases, - use for medical or pharmaceutical researches or diagnosis, - change or support the functioning of the organs Article 10 Any person who committed any activities as stated below shall be fined from 1,000,000 (one million) Riels to 10,000,000 (ten million) Riels and suspend manufacturing, import, export and pharmaceutical businesses for a period of one (1) month to three (3) months, or either one of the above two punishments, however this punishment does not consider yet other offenses, 1- advertise pharmaceuticals without authorization from the Ministry of Health; 2- violate the procedure and conditions of manufacturing, import, export and pharmaceutical business; 3- the opening, closing or changing of location of pharmacies, pharmaceutical import-export companies and pharmaceutical manufacturing establishments without authorization of the Ministry of Health; 4- produced or imported or exported or stored of pharmaceuticals or raw materials for producing medicines without authorization of the Ministry of Health; 5- sold of pharmaceutical without the visas or registration or sold of pharmaceuticals that are prohibited by the Ministry of Health; In case of recidivism, the fine shall be double and suspended manufacturing or import, export or business of pharmaceutical or be subjected to either one of the two punishment. Pharmaceutical, raw materials, equipment and other materials that are relating to the offenses, as stated in point 4 and 5 shall be confiscated as State's property or destroyed. The Ministry of Health has rights to immediately suspend for temporary of the unauthorized advertisement of pharmaceutical, manufacturing, import-export and business of pharmaceutical and shall file a complaint against them to the courts. 2

3 Article 12 Shall be fined from 20,000,000 (twenty million) Riels to 50,000,000 (fifty million) Riels or imprisoned from five (5) years to ten (10) years or punishments of both for any person who deliberately engaged in producing, importing, exporting or trading of pharmaceutical containing addictive substances without authorization, counterfeit drugs, pharmaceutical of non-quality or expiry date that affected to the health or lives of the consumers. Article 13 Shall also be punished with the same terms as set forth in the Articles 10, 11 and 12 for civil servant who accomplices or abuse his/her duties when s/he implement Articles 10, 11 and 12. (2) Law on the Amendment of Law on the Management of Pharmaceuticals (2007) Article 1 Article 2, 4, 8, 9, 10, 12 and 13 of the Law on Management of Pharmaceutical which have been promulgated by Kram No. ChS/RKM/0696/02 dated on June 17, 1996 shall be amended as below Article 2-New 1. A pharmaceutical is one or many kinds of substances which are primarily from chemicals, bio-products, microbes, plants combined in order to use in the prevention or treatment of human or animal diseases, or to use in the medical or pharmaceutical research or diagnosis, or change or support the functioning of the organs. 2. A counterfeit pharmaceutical is a medication which may contain inactive ingredients or inappropriate quantities of active ingredients, or may not contain enough active ingredients as mentioned on the label, or has the packaging, design, identification similar to or the same as the original products or may be produced or packaged without licensing from the Ministry of Health. Article 10-New 1- Shall be penalized to a fine from 1,000,000 (one million) to 5,000,000 (five million) riels for any person who: - Advertised pharmaceutical and cosmetic products through radio, television, magazine, newspaper, brochure, and workshop or by other means without authorization from the Ministry of Health. - who violated the procedure and conditions for the management and preservation of pharmaceutical. - Opened, closed, or changed locations of the pharmacies, pharmaceutical depots, and establishments of cosmetic sales without authorization from the Ministry of Health. 2- Shall be penalized to a fine from 5,000,000 (five million) to 10,000,000 (ten million) riels for any person who: - Opened, closed, or relocated of pharmaceutical wholesale establishment, import and distribution pharmaceutical companies, import-export of pharmaceutical companies without authorization from the Ministry of Health. - violated the procedure and conditions of trading, import-export of pharmaceutical. - imported or exported or produced of pharmaceutical without authorization from the Ministry of Health. - Distributed, sale display or sold of pharmaceutical products and cosmetics without visa or registration from the Ministry of Health. 3

4 - sold pharmaceutical of damaged quality and expired date. 3- Shall be penalized to a fine from 10,000,000 (ten million) to 2,000,000 (twenty million) riels for any person who: - Opened, closed, or changed locations of pharmaceutical manufacturing establishment without authorization from the Ministry of Health. - violated the technical procedure and conditions of pharmaceutical production. - imported the raw materials, half-finished products, packaging materials, pharmaceutical manufacturing machine without authorization from the Ministry of Health. - Produced pharmaceutical of which its quality does not meet the standard for proposing a visa. - Stored the raw materials, packaging materials, pharmaceutical manufacturing machine, pharmaceutical products outside of their business or manufacturing establishment without authorization from the Ministry of Health. 4- Should any of the offenses above causes serious damage to public health, human or animal s life, the Ministry of Health shall suspend immediately the activities of production, import, export and trade of pharmaceutical, and prepare a file to be forwarded to the courts to impose the punishment in accordance to the law. 5- All of the offences which is penalized to a fine from 1,000,000 (one million) to 10,000,000 (ten million) riels, the Ministry of Health bears right to impose interim penalty. In case the offender does not pay interim penalty, the Ministry of Health shall prepare the file to be forwarded to the courts. Article 11-New Shall be subjected to penalize to imprison from 1 to 6 months or penalize to a fine from 2,000,000 (two million) to 10,000,000 (ten million) Riels or both of the punishment for any person who obstructed the implementation of this law. Article 12-New 1- Shall be the subject to penalize to imprison from 5 to 10 years and penalize to a fine from 20,000,000 (two million) to 10,000,000 (ten million) Riels, for any person who: - Deliberately engaged in producing, importing, storing of addictive drug, or any drug affected nervous systems, raw materials and ingredients containing addictive substance which have been specified in the Addictive Drug control Law or Prakas of the Ministry without any authorization. - Distributing, sale display or sold of any addictive drug or drug affected nervous system which are not medically beneficial or prohibited by the Ministry of Health. - Producing, importing, distributing, sale display or sale of counterfeit pharmaceutical. 2- Should any of the offenses above causes serious damage to public health, human or animal s life, the Ministry of Health shall immediately suspend activities of producing, importing, exporting and trading and prepare a file to be forwarded to the court in order to impose the punishment in accordance to the law. Article 13-New Shall be penalized in administrative penalty for civil servant who is complicity or who commits an abuse of his/her own duties during the implementation of the articles 10-new, 11-new, and 12-new. In serious case, shall prepare the file to be forwarded to the court. (3) Decision on Establishment of Committee for Eliminating Counterfeit Medicines, and Illegal Health Services for Poverty Reduction (2005) 4

5 Article 1 Establishment of Committee for Eliminating Counterfeit Medicines and Illegal Health Services for Poverty Reduction shall be applied nationwide. The committee consists of two commissions: 1.1 Inter-ministerial Commission: Inter-ministerial commission has following compositions: 1. Minister of Health President 2. Secretary of State, Ministry of Health 01 Permanent Vice-President 3. Under-Secretary of State of Ministry of Health 01 Vice-President 4. Under-Secretary of State of Ministry of Interior 01 Vice-President 5. Under-Secretary of State of Ministry of Justice 01 Member 6. Under-Secretary of State of Ministry of Information 01 Member 7. Under-Secretary of State for Ministry of Commerce 01 Member 8. Under-Secretary of State of Ministry of Education, Youth and Sport 01 Member 9. Under-Secretary of State of Ministry of Economy and Finance 01 Member 10. Under-Secretary of State of Ministry of Agriculture, Forestry and Fisheries 01 Member 11. Phnom Penh Deputy Governor 01 Member 12. Director of Department of Hospital Service, Ministry of Health Member 13. Director of Department of Drugs, Food, Medical Materials & Cosmetic, Ministry of Health Secretary 1.2 Municipal-Provincial Commission: Municipal-Provincial Commission has following compositions: 1. Deputy Municipal- Provincial Governor President 2. Director of Municipal-Provincial Health Department Permanent Vice-President 3. Deputy Director of Municipal-Provincial Health Department 01 Member 4. Prosecutor, Municipal-Provincial Court 01 Member 5. Municipal-Provincial Police Commission Member 6. Director of Municipal-Provincial Department of Information Member 7. Director of Municipal-Provincial Department of Commerce Member 8. Director of Municipal-Provincial Department of Education, Youth and Sport Member 9. Director of Municipal-Provincial Department of Economy and Finance Member 10. Director of Municipal-Provincial Department of Agriculture, Forestry and Fisheries Member 11. Director of Municipal-Provincial Department of Road Checkpoint Member 12. Head of Technical Bureau, Health Department Member 13. Head of Bureau Drugs, Food, Medical Materials & Cosmetic, Ministry of Health Secretary and Food Safety Article 2 Role and Responsibilities of Committee for Eliminating Counterfeit Medicines and Illegal Health Services for Poverty Reduction as the followings: - Strengthen inter-ministerial cooperation to eliminate counterfeit medicines and illegal health services in Cambodia - Investigate for sources of those counterfeit medicines and illegal health services - Take effective actions for regular inspection to seize, destroy, or prevent counterfeit medicines and illegal health services for future successful elimination. 5

6 - Disseminate, educate and promote public awareness of risks of consumption of counterfeit medicines and illegal health services. - Prepare the file to be forwarded to the court for jurisdiction on the offenders. Article 3 Inter-ministerial Commission for Eliminating of Counterfeit medicines and Illegal Health Services for Poverty Reduction has the rights to use seal of MoH to undertake their mission. Municipal-Provincial Commission for Eliminating Counterfeit Medicines and Illegal Health Services for Poverty Reduction bear the rights to use seal of municipal-provincial halls to undertake their mission. Article 4 Inter-ministerial Commission for Eliminating of Counterfeit Medicines and Illegal Health Services for Poverty Reduction has its secretariat at MoH. Municipal-Provincial Commission for Eliminating of Counterfeit Medicines and Illegal Health Services for Poverty Reduction has its secretariat at municipal-provincial health department. Article 5 All members of Inter-ministerial and Municipal-Provincial Commission shall participate in meetings upon calls of their Presidents to report of their activities and outcomes to Royal Government of Cambodia. Article 6 All expenses of the committee are the responsibility of MoH. Article 7 Any provision which is contrary to what stipulated in this decision shall be deemed as abrogated. Article 8 Minister in charge of the Cabinet of Council of Ministers, Minister of Health, Co-Ministers, Minister, Secretary of State of Ministries, Institutions, and all Municipal-Provincial Governors, and other relevant compositions as embodied in Article 1 shall implement based on the decision from this signing date hereafter. (4) Prakas on Roles and Responsibilities of Control Agent for Pharmaceutical, Food, Medical equipments, and Cosmetics and Private Medical, Paramedical and Medical Aid Services (2011) (1) Article 3, A, Point 5; 2) Article 3, A, Point 8, 3) Article 3, A, Point 9; 4) Article 3, B, Point 2 and 5) Article 5, A, Point 9 are directly related to counterfeit medicines.) Article 3 Division of responsibilities of Control Agent for Pharmaceuticals, Medical Equipment and Cosmetics at central level: 6

7 A. Control Agent for Pharmaceuticals, Medical Equipment and Cosmetics at central level shall have the following responsibilities: 1. Inspects and monitors the implementation of the Law on the Management of Pharmaceuticals and other regulations of MOH at manufacturers of pharmaceuticals, traditional medicines, psychotropic and addictive drugs, medical equipment and cosmetics, in the Kingdom of Cambodia every one year by using evaluation checklists. Urgent inspection shall be conducted only in compulsory case with permission from MOH; 2. Inspects and monitors the implementation of the Law on the Management of Pharmaceuticals and other regulations of MOH at imports and exports establishments of medicines and cosmetics, imports and exports branch offices of medicines and cosmetics, pharmacies, depots, traditional medicines stores, cosmetic stores and centers by using evaluation checklist. Urgent inspection shall be conducted only in compulsory case with permission from MOH; 3. Monitors distribution of pharmaceuticals and other medical products at markets. Sale or distribution of medicines and these concerned products shall be suspended in case of suspicion. Reports on these suspicious medicines or sample products shall be made for the examination of their quality, and then submitted to the ministry for their decision; 4. Inspects and monitors the implementation of the decentralization and the deconcentration of the ministry by municipal-provincial health departments every trimester by using evaluation checklist; 5. Participates in investigation and elimination of counterfeit medicines within the Kingdom of Cambodia; 6. Inspects and monitors the commercial marketing of modern medicines, traditional medicines, supplementary products, all kinds of traditional wine, medical and dental equipment, reagents for medical laboratories, pharmacy, dentistry and cosmetics, and preventive or curative medicines, and beauty care centers on televisions, radios, newspapers and magazines, journals of medicine, pharmacy, dentistry and by any other means, which does not comply with the permission or without permission from MOH; 7. Monitors and evaluates the procedures in relation to opening, closing, relocation of pharmacies, substitution of responsible pharmacists, and renews the licenses for pharmaceuticals manufacturers, pharmaceuticals exports and imports establishments, cosmetic exports and imports establishments, pharmaceuticals imports and exports branch offices, cosmetics imports and exports branch offices, representative offices of foreign medicine manufacturers, cosmetic stores, and beauty care centers by using evaluation checklist; 8. When undertaking the inspection at business locations as embodied in article 2, Control Agent for Pharmaceuticals, Medical Equipment and Cosmetics is entitled to temporarily seize counterfeit medicines, medicines which are banned by MOH, medicines without license, expiry medical equipment, reagents, cosmetics, raw materials, compositional materials, and other suspicious exhibits. The Control Agent shall report the cases, through the Secretariat, to Chief of Inter-ministerial Committee for Elimination of Counterfeit Drugs and Illegal Health Services for Poverty Reduction for decision; and 9. Examines all complaints of counterfeit medicines, banned medicines, medicines without license, expiry medical equipment, reagents, cosmetics, raw materials, compositional materials and other suspicious exhibits, and reports the cases to MOH for decision. B. Control Agent for Pharmaceuticals, Medical Equipment and Cosmetics at municipal- provincial level: 7

8 1. Monitors the implementation of the Law on Pharmaceuticals and other regulations of MOH that pharmacies and depots, traditional medicine stores, and beauty care centers in the capital city and all provinces shall follow. The inspection shall be carried out at one of the aforementioned places at least every trimester by using evaluation checklist; 2. When undertaking the inspection of medical vans, pharmacies, depots, traditional medicine stores, cosmetic stores, and beauty care centers, the Control Agent for Pharmaceuticals, Medical Equipment and Cosmetics is entitled to temporarily seize counterfeit medicines, medicines which are banned by MOH, medicines without license, expiry medicines, suspicious medicines, and undeclared cosmetics. The Control Agent shall report the cases, through the Secretariat, to Chief of Municipal-Provincial Commission for Elimination of Counterfeit Drugs and Illegal Health Services for decision; 3. Monitors the commercial marketing of modern medicines, traditional medicines, supplementary medicines or products, all kind of traditional wine, medical and dental equipment, reagent equipment for medical laboratories, pharmacy, dentistry and cosmetics, preventive and curative medicines, and beauty care centers on televisions, radios, newspapers and magazines, journals of medicine, pharmacy and dentistry and by any other means, which does not comply with the permission or without permission from MOH; 4. Monitors and evaluates the procedures of opening, closing, relocation, substitution of person in charge, and renews licenses of pharmacies, depots, traditional medicine stores, as stipulated in Prakas 0014 ABS/MABS dated 13 January 2009 on the procedures and conditions for opening, closing or relocation of pharmacy. However, for exports and imports branch offices of pharmaceuticals and cosmetics as well as for provincial beauty care centers, inspection shall be undertaken through provincial health departments by using the checklist. The result of the evaluation shall be submitted to Department of Pharmaceuticals, Food, Medical Equipment, Cosmetics, MOH; 5. Monitors and takes appropriate action to eliminate unauthorized pharmaceuticals; 6. Shall send reports of activities of Control Agent for Pharmaceuticals, Food, Medical Equipment, and Cosmetics to Department of Pharmaceuticals, Food, Medical Equipment, Cosmetics, MOH every trimester. Article 4 Roles and Responsibilities of Control Agent for Food A. Scope: 1. Control Agent for Hygiene and Food Safety at central level has an inspection scope on hygiene and food safety nationwide; and 2. Control Agent for Hygiene and Food Safety at municipal-provincial level has an inspection scope on hygiene and food safety within their respective territories. B. Roles and Responsibilities: Control Agent for Hygiene and Food Safety are responsible for advising, inspecting, and monitoring the implementation of regulations related to hygiene, food safety, content, logo and imitative cases of products for infant and young child feeding or other similar products at: 8

9 - Restaurants, Food Stalls, Markets, Public Places, Food Product Stores and Distribution Chains; - Pharmacies, depots, or health care or education systems, both direct and indirect, for mothers and pregnant women, including nursery and day care centers. C. Procedures of Inspection: In every inspection, the Control agent for Hygiene and Food Safety shall: - Possess mission statement issued by respective agency; and - Wear Control Agent s uniform. Article 5 Division of Responsibilities of Control Agent for Food Safety and Hygiene at central, and municipal-provincial levels: A. Responsibilities of Control Agent for Food Safety and Hygiene at central level: 1. Inspects and monitors the implementation of regulations related to food hygiene and safety, content, logo and imitative case of products for infant and young child feeding or other similar products every trimester by using evaluation checklist. Urgent inspection shall occur only in compulsory case with permission from MOH; 2. Monitors the distribution flow of food products and, in case of suspicion, report the case to MOH for decision; 3. Inspects and monitors the implementation of the decentralization and the deconcentration of the ministry at municipal-provincial health departments four times per year by using evaluation checklist; 4. Collaborate with concerned ministries in monitoring hygiene at various food manufacturers; 5. Participate with concerned ministries to control illegal food, products for infant and young child feeding or other similar products nationwide; 6. Monitor the commercial marketing of products for infant and young child feeding and other similar products on radios, television, newspapers and magazines, journals of medicine, pharmacy, dentistry, workshops and by other means to sell products for infant and young child feeding at markets, public places or pharmacies, depots or other health care systems; 7. Stops all the marketing of products for infant and young child feeding and other similar products which are contrary to the MOH s permission or Sub Decree 133 ANKr, BK; 8. Examines all complaints from consumers of products for infant and young child feeding and other similar products nationwide; 9. When undertaking inspection at business locations as embodied in article 4, Control Agent for Food Safety and Hygiene is entitled to temporarily seize counterfeit products for infant and young child feeding and other similar products, which are suspicious of bad quality or expiry, and contain food additives prohibited by MOH or relevant ministries. The Control Agent shall report the case to MOH. 9

10 10. In the case restaurants and food stalls do not comply with hygiene and safety guidelines issued by MOH or cause health or life-threatening impacts on citizens, the Control Agent shall report to MOH and concerned ministries for decision. B. Responsibilities of Control Agent for Food Safety and Hygiene at municipal-provincial level: 1. Inspects and monitors the implementation of regulations of MoH related to hygiene and food safety at municipal-provincial level every trimester by using evaluation checklist; 2. Monitor locations requesting the issuance of certificate of food hygiene. However, for food product manufacturers at municipal-provincial level, the inspection shall be done by municipal-provincial health departments by using the evaluation checklist, following which the report shall be sent to Department of Pharmaceuticals, Food, Medical Equipment and Cosmetics, MoH; 3. When undertaking inspection at places as embodied in article 4, the Control Agent for Food Safety and Hygiene at municipal-provincial level shall collaborate closely with those involved to achieve a smooth inspection process; 4. Monitor the commercial marketing of products for infant and young child feeding and other similar products on televisions, radios, newspapers and magazines, journals of medicine, pharmacy, dentistry, workshops and by other means, without the permission from MoH; and 5. All reports from Control Agent for Food Safety and Hygiene at municipal-provincial level shall be summited to Department of Pharmaceuticals, Food, Medical Equipment and Cosmetics, MoH in every trimester. 10