REGIONAL EXPERIENCE ON THE VETERINARY MEDICINAL PRODUCTS REGULATIONS

REGIONAL EXPERIENCE ON THE VETERINARY MEDICINAL PRODUCTS REGULATIONS IN NORTH AFRICA AND THE MIDDLE EAST Professor Lotfi El Bahri Advanced Training for OIE Focal Points on Veterinary Products, countries of North Africa and Middle East (2 ND CYCLE) … 1

PLAN INTRODUCTION I- VETERINARY MEDICINAL PRODUCTS (VMP) MARKET IN NORTH AFRICA II- CURRENT STATUS OF THE VETERINARY MEDICINAL PRODUCTS LEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST III- UPDATING OF THE VETERINARY MEDICINAL PRODUCTS LEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST CONCLUSION Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 2

Veterinary Medicinal Products: Fundamental component of any policy for development of the livestock sector and control of the health status of livestock in North Africa and the Middle East countries in order to ensure: - food self-sufficiency due to the demographic growth coverage of population needs for animal proteins (deficit of 20%) - Initially: import of veterinary medicinal products then progressive development of the local veterinary medicinal products (VMP), Hence the need of these countries to have a veterinary medicinal products legislation Advanced Training for OIE Focal Points on Veterinary Products, Countries of North Africa and Middle East (2 ND CYCLE) 3

INTRODUCTION I - VETERINARY MEDICINAL PRODUCTS MARKET IN NORTH AFRICA II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTS LEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST III- UPDATE OF VETERINARY MEDICINAL PRODUCTS LEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST CONCLUSION Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 4

I - VETERINARY MEDICINAL PRODUCTS MARKET IN NORTH AFRICA North Africa (Maghreb, Arab Maghrebin Union) consists of Algeria, Libya, Morocco, Mauritania and Tunisia. Its area is 7. 5 millions sq 2 with a population exceeding 90 million inhabitants. the three Maghreb countries, namely Algeria, Morocco and Tunisia share an animal population estimated at : Cattle: 5 million head Ovine: 43 million head Caprine: 10 million head Camels: 600 000 head Poultry: 600 million chicks per year (Bouguedour R. 2008) Livestock plays an important role and contributes to 20% of the domestic agricultural gross production. This important livestock heritage allowed a development of the veterinary drugs market both at the local manufacturing and import levels. Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 5

I - VETERINARY MEDICINAL PRODUCTS MARKET IN NORTH AFRICA The vet. drugs turnover for these 3 countries is estimated at 110 million euros in 2009 For 3 laboratories (Merial, Ceva, Intervet) >50% of the market CEVA: 3 fabrication units (Morocco, Algeria, Tunisia) The market is essentially based on poultry and ruminants sectors and is dominated by antibacterials, antiparasitics, vaccines and vitamins. The Maghrebin veterinary medicinal products industry is clearly increasing (soluble powders, oral solutions, creams, oblets, injectable solutions… ) Illicit market for veterinary products (underground circuits at the borders): 15% of turnover Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 6

I - VETERINARY MEDICINAL PRODUCTS MARKET IN NORTH AFRICA THERAPEUTIC CATEGORIES DISTRIBUTION ANTIBACTERIALS 40 -35 % ANTIPARASITICS 23 -20 % VACCINES 19 -15 % VITAMINS 14 -12 % OTHERS 13 -8 % BOUGUEDOUR R, 2008 Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 7

I - VETERINARY MEDICINAL PRODUCTS MARKET IN NORTH AFRICA Growth in turnover of 5% per year • Development of veterinary medicine practice in the private sector among new graduates working in livestock areas of dairy and slaughter cattle, and in large urban cities • More framing for ovine husbandry • Granting of sanitary mandate for veterinarians (Morocco: 1985; Tunisia: 2006). more communication with breeders • Quick development of the poultry sector (Broilers, layers and turkey): main source of animal proteins Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 8

Introduction – Importance II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTS LEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST I – VETERINARY MEDICINAL PRODUCTS MARKET IN NORTH AFRICA III- UPDATE OF VETERINARY MEDICINAL PRODUCTS LEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST CONCLUSION Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 9

There actually some VMP legislations for registration, distribution, fabrication, quality control and public health protection, similar in the 3 Maghrebin countries with some specificity that will be later indicated These Maghrebin legislations are inspired from the French legislation, especially Law No 75 -409 of May 1975 related to VMP The legislative texts were classified under the following headings: - MA (marketing authorization) procedures - Manufacturing and quality control of VMP - Consumer health protection Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 10

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 1. TUNISIAN LEGISLATION Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 11

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTS LEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 1 TUNISIAN LEGISLATION II. 1. 1 MA (marketing authorization) PROCEDURE 1 - Law No 78 -23 of March 8, 1978 organizing the veterinary pharmaceuticals 2 - Decree No 79 - 831 of September 1979 determining the rules of good practice in veterinary pharmaceuticals fabrication and quality control, labeling, denomination and the procedures for visa application. The proposed price by the manufacturer constitutes one of the conditions requested for the attribution of an MA Products locally manufactured: prices are agreed by the minister of commerce after notice of a commission (commerce+ public health) Imported products: prices agreed by a Purchase Drugs Commission (PDC) based in the central pharmacy of Tunisia (monopoly on the importation: law No 2005 -75 of August 4, 2005) 3 - Order of the Ministers of Agriculture and Public Health of January 15, 1980, establishing the composition of the commission of determining the composition of the licensing commission of processing establishments of veterinary drugs and the granting of a visa authorizing the marketing of drugs 4 - Law No 90 -79 of August 7, 1990 establishing the National Laboratory for Drugs Control (Laboratoire National de Contrôle des Medicaments) Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 12

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 1 TUNISIAN LEGISLATION II. 1. 1 MA PROCEDURE 5 - Circular No 67/91 of June 29, 1991 of the Minister of Public Health on the correlation between the activities of local production and drugs. Stop of imports of all veterinary drugs if these are locally manufactured (Cancelled in 2008 by the WTO) 6 - Order of the Ministers of Finance and Public Health of February 1997, fixing the rates and terms of payment of visa application fee for the sale of veterinary drugs 7 - Law No 2000 -40 of August 2000 modifying and completing the Law No 78 23 of March 78 organizing the veterinary pharmaceuticals Article 11. the visa authorizing the placing on the market is jointly delivered by the Ministers of Agriculture and Public Health after consulting the committee provided for in Article 8 of this Law 8 - give its assent to the granting of the visa and its refusal to distribute drugs and pharmaceutical specialties for veterinary use on the market The mentioned agency is The National Agency of Sanitary and Environmental Control of Products (ANCSEP). Its areas of expertise are the safety of medicines and health products, environmental security and food safety 9 - Law No 2005 -75 of August 4, 2005 relating to the importation of vaccines, sera allergens and their control 13 Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 1 TUNISIAN LEGISLATION II. 1. 2 MANUFACTURING AND QUALITY CONTROL OF VETERINARY MEDICINAL PRODUCTS (5 texts) 1 - LAW No 73 - 55 of August 3, 1973 on organization of pharmaceutical professions , modified by Law of July 12, 1976 (article 3). 2 - Decree No 79 -831 of September 1979 setting rules for good practice in manufacturing the VMP and their quality control. 3 - Order of Ministers of Agriculture and Public Health of January 15, 1980 establishing the composition of the committee for licensing the operating facilities for VMP manufacturing. 4 - Order of the Ministers of Public Health of May 29, 1997 establishing the powers of the technical pharmacist responsible for manufacturing pharmaceuticals establishments for human and veterinary medicine use, and qualification standards for the personnel called to assist him. Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 14

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 1 TUNISIAN LEGISLATION II. 1. 2 MANUFACTURING AND QUALITY CONTROL OF VETERINARY PHARMACEUTICALS article 1: The establishments for preparation of pharmaceuticals destined for human or veterinary use must assign the technical responsibility to a pharmacist in case they are not managed by a pharmacist. Article 2 - the technical pharmacist responsible for a pharmaceutical establishment must be holding: - Either a title or diploma of industrial pharmacist and one year practical experience in pharmaceutical industry or in control, higher education or inspection of pharmaceutical manufacturing fields, - Or 2 year practical experience in pharmaceuticals manufacturing or control, higher education or inspection of pharmaceuticals manufacturing fields, 5 - Law No 2000 -400 of April 5, 2000 modifying and completing the law No 78 -23 of March 1978 on veterinary medicine. article 8: Inspection report of an establishment for pharmaceutical manufacturing for veterinary use, written by competent authorities of the Public Health Ministry. Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 15

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 1 TUNISIAN LEGISLATION II. 1. 3. PURCHASE, POSSESSION AND RETAIL OF VETERINARY DRUGS (7 texts) 1 - Law No 69 -54 of July 26, 1969, on regulatory provisions governing poisons. 2 - Law No 73 -55 of August 3, 1973 on the organization of pharmaceutical professions, all its modifying or completing texts, especially the Law No 92 -75 of August 3, 1992. 3 - Law No 78 -23 of March 8, 1978 organizing the veterinary pharmacy. 4 - Order of Ministers of Agriculture and Commerce of February 1996, modifying the order of May 21, 1982 and fixing the prices of pharmaceuticals. 5 - Decree No 2000 -254 of January 31, 2000 on deontology in veterinary medicine. Article 63: The veterinarian may have on deposit in his office of toxic or not toxic drugs and biological substances necessary to his professional exercise in accordance with the provisions of the law No 73 -55 of August 3, 1973 Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 16

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 1 TUNISIAN LEGISLATION II. 1. 3. PURCHASE, POSSESSION AND RETAIL OF VETERINARY DRUGS 6 - Order of the ministers of agriculture, public health and trade of February 12, 2000, establishing the conditions for supplying pharmaceutical and bilogical products for veterinary use. Article 1: Free practice veterinarians are authorized to procure pharmaceutical and biological products for veterinary use from the Central pharmacy of Tunisia, the “Institut Pasteur “ and the National veterinary research Institute. The naming of pharmaceuticals and biologics covered by this order shall be fixed by the Ministers of Agriculture and Public Health. Article 2: The Central pharmacy of Tunisia, the “Institut Pasteur “ and the National veterinary research Institute are authorized to assign to veterinarians listed in article one of this order pharmaceuticals and biologics for veterinary use as determined in the nomenclature above. This will be done at the products sale price to the public reduced by half of the profit margin for pharmacists, as provided by the order of May 21, 1982, and modified by the order of February 29, 1996. Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 17

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 1. TUNISIAN LEGISLATION II. 1. 3. PURCHASE, POSSESSION AND RETAIL OF VETERINARY DRUGS The amounts collected in accordance with the preceding paragraph of this article shall be paid to the Central Pharmacy of Tunisia which will pay these amounts and those taken by its bias in favor of the National Employment fund. Article 3: the pharmaceuticals specified in article 1 of this order shall be delivered under a prescription written and signed by the veterinarian with mention, in addition to the prescribed medicinal products, of the price of each products. This prescription must be returned to the purchaser of these products. Free practice veterinarians are authorized to transfer these products in proportion to the number of units required and on basis of their public price 7 - Law No 2000 -40 of April 5, 2000, modifying and completing the law No 78 -23 of March 8, 1978, organizing the veterinary pharmacy. Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 18

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 1 TUNISIAN LEGISLATION II. 1. 4. CONSUMMER HEALTH PROTECTION There are risks to the consumer due to the presence of veterinary products residues (parent molecule, metabolites) in foods of animal origin: allergic reaction, bacterial resistance, aplastic anemia, cardiotoxicity… Presence of residues: constitutes barriers to export animal products and aquaculture products to the European Union Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 19

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 1 TUNISIAN LEGISLATION II. 1. 4. CONSUMMER HEALTH PROTECTION 1 - Law No 78 -23 0 f March 8, 1978 organizing the veterinary pharmacy (article 12: fixing of waiting time. article 18: materials and veterinary medicinal products subject to special provisions), 2 - Order of the Ministers of Agriculture and Public Health in veterinary medicine, 3 - Order No 81 -1453 of November 10, 1981 on slaughter animals and sanitary inspection of meat and offals, 4 - Decision of Public Health Minister of October 20, 1990 on prohibiting chloramphenicol for veterinary use, 5 - Decision of Public Health Minister of May 25, 1995 on prohibiting Nitrofurans for veterinary use, 20 Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 1 TUNISIAN LEGISLATION II. 1. 4. CONSUMMER HEALTH PROTECTION 6 - Decision of Ministers of Public Health, Agriculture, Environment and Hydraulic Resources of September 2004 prohibiting use of VMP containing stilbens and/or androgens. 7 - Development of a national plan for surveillance and detecting of residues in foodstuffs of animal origin in 1999( approved by decision No 2000/159/CE of February 8, 2000, 8 - Memo of the Directorate General of Veterinary Services No 742/200 of March 28, 2006 fixing the maximal limits for VMP residues and contaminants in poultry products, farmed fish and wild feathered game. 9 - Memo of the Directorate General of Veterinary Services No 743/200 of March 28, 2006 on use of anabolics and unauthorized substances for animal use. 10 - Memo of the Directorate General of Veterinary Services No 200/773 0 f March 17, 2008: general provisions for surveillance plans and control plans. Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 21

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 1 TUNISIAN LEGISLATION II. 1. 4. CONSUMMER HEALTH PROTECTIONsha 11 - Memo of the Directorate General of Veterinary Services No 200/1626 of May 19, 2008: general provisions for surveillance plans and control plans for farmed fish. 12 - Memo of the Directorate General of Veterinary Services No 200/1654 of May 21, 2001: general provisions for wild game surveillance plans and control plans. 13 - Memo of the Directorate General of Veterinary Services No 200/1769 of June 3, 2008 general provisions for poultry meat surveillance plans and control plans. 14 - Memo of the Directorate General of Veterinary Services No 200/1814 of June 20, 2008: general provisions for consumption eggs surveillance plans and control plans. 15 - Memo of the Directorate General of Veterinary Services No 200/1093 of May 7, 2009: surveillance specific plan for residues search in cow milk surveillance plans and control plans. 16 - Memo of the Directorate General of Veterinary Services No 200/1096 of May 7, 2009: surveillance plans and control plans for honey. 17 - Decision of the European Commission on approval of residues surveillance plans submitted by Tunisia for poultry, aquaculture and wild game (2001 -2010). Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 22

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 2. MOROCCAN LEGISLATION Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 23

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 2. MOROCCAN LEGISLATION II. 2. 1. MRKETING AUTHORIZATION PROCEDURES (10 texts) 1 - Decree No 2 -72 -373 of first Rabia II 1394 (April 24, 1974) for creation of a National Laboratory for control of medicinal products and proprietary medicinal products. 2 - Law No 21 -80 0 n private exercise of veterinary surgery and pharmacy, promulgated by Dahir No 1 -80 -3401 of Safar 17, 1401 (December 25, 1980). 3 - Decree No 2 -76 -266 of Jumada I, 1397, (May 1977) on the approval of flow of proprietary medicinal products and advertising for specialty drugs at the pharmacy and proprietary medicinal products. Article 10: in the use of an approved medicinal product presents some risk for the public health, the Minister may, for good cause suspend the registration and prohibit the flow of the specialty until a final decision. The latter decision must be taken in a six month period and after inviting the holder to provide explanations ; otherwise the registration suspension and prohibition of the medicinal product become definitely effective. 24 Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco December 6 -8, 2011

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 2. MOROCCAN LEGISLATION II. 2. 1. MRKETING AUTHORIZATION PROCEDURES 4 - Dahir No 1 -80 -340 of Safar 17, 1401 (December 26, 1980) on promulgation of Law No 21 -80 on private exercise of medicine, surgery and veterinary pharmacy. Official bulletin No 3564 of Rabia II, 1401 (February 18, 1981). 5 - Decree No 2 -82 -541 of Jumada I, 1403 (March 15, 19830 ) for enforcement of law No 21 -80 on the private exercise of medicine, surgery and veterinary pharmacy. Official bulletin No 3672 of March 16, 1983. Article 13: no medicinal product for veterinary use shall be marketed without having previously obtained a marketing authorization jointly delivered by the Minister of Agriculture and Agrarian reform, and Minister of Health. Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco December 6 -8, 2011 25

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 2. MOROCCAN LEGISLATION II. 2. 1. MRKETING AUTHORIZATION PROCEDURES 6 - Joint circular No 1 -94 of October 7, 1994 of the Minister of Agriculture and Agricultural development, and Minister of Public Health, on the constitution of applications for marketing authorization of VMP. 7 - Circular Note No 005823 of November 4, 2004 on pharmacovigilance procedure for VMP. 8 - circular Note No 778/DE/DSA/LNCMV of May 22, 2006, on the authorization of biocides for livestock use, disinfectants, antiseptics, udder hygiene products) 9 - Dahir No 1 -06 -151 of Shawal 1427 on promulgation of Law No 17 -04 on Code of drugs and pharmacy. Official bulletin No 5480 of December 7, 2006 (Articles 7, 8, 9, 15 and 22) 10 - Dahir No 1 -09 -20 of Safar 22, 1430 (February 18, 2009) on promulgation of Law No 25 - 08 on creation of the National office for food safety. Article 2: Controlling and proceeding with the registration of VMP and veterinary pharmaceutical establishments. Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 26

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 2. MOROCCAN LEGISLATION II. 2. 2. VETERINARY MEDICINAL PRODUCTS MANUFACTURING AND QUALITY CONTROL (5 texts) 1 - Dahir No 1 -80 -340 of Safar 17, 1401 (December 26, 1980) on promulgation of the law No 21 -80 on the private practice of veterinary medicine, surgery and pharmacy. Official Bulletin No 3564 of Rabia II 12, 1401 (February 18, 1981). article 4: no one may prepare, import or sell by wholesale veterinary medicinal products without prior authorization. Article 5: the establishments referred to in article 4 above must be owned by a pharmacist, a veterinarian or a company whose general management is provided by a pharmacist or a veterinarian. -To ensure direct control on manufacturing, packaging and distribution of veterinary medicinal products, the establishments referred to above are required to seek the assistance of a number of pharmacists or veterinarians proportional to the importance of the establishment and the nature of activities Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 27

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 2. MOROCCAN LEGISLATION II. 2. 2. VETERINARY DRUGS MANUFACTURING AND QUALITY CONTROL 2 - Decree No 2 -82 -541 of Jumada I, 1403 (March 15, 1983) for the enforcement of law No 21 - 80 on the exercise of private veterinary medicine, surgery and pharmacy. Official bulletin No 3672 of March 16, 1983; Article 9: prior authorization for manufacturing, preparation, wholesale or distribution of VMP, as provided by article 4 of law No 21 -80 above, is delivered when necessary by the Secretary General of the government on assent of the Minister of Agriculture and agrarian reform, and Public Health Minister, issued after a survey carried by a commission composed of one veterinary inspector and one pharmacy inspector. For this purpose the responsible veterinarian or pharmacist of the establishment send to the Secretary General of the government an application indicating in particular… Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 28

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 2. MOROCCAN LEGISLATION II. 2. 2. VETERINARY DRUGS MANUFACTURING AND QUALITY CONTROL Article 11: pursuant to the provisions of article 5 of law No 21 - 80 above, the number of veterinarians or pharmacists that the establishment will ensure their contribution is as follows: 1 - for the establishments of manufacturing, packaging and eventually the medicinal drug distribution: - one veterinarian or pharmacist for every 15 -30 workers or employees, - one additional veterinarian or pharmacist for every 30 workers or employees performing a pharmaceutical activity; 2 -for the establishments exclusively ensuring the production and distribution of medicinal products: - one veterinarian or pharmacist for every 50 -100 workers or employees performing a pharmaceutical activity; - one additional veterinarian or pharmacist for every 50 workers or employees performing a pharmaceutical activity Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 29

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 2. MOROCCAN LEGISLATION II. 2. 2. VETERINARY DRUGS MANUFACTURING AND QUALITY CONTROL 3 - Dahir No 1 -06 -151 of Shawal 30, 1427 on promulgation of law No 17 -04 on medicinal products and pharmacy code. Official bulletin No 5480 of December 7, 2006. Article 20: Every drug must be prepared in respect of good practice rules of manufacturing and distribution as enacted by the administration, after consultation with the National Council of the college of pharmacists. Each batch of drugs, is subject to compliance testing before being marketed by the pharmaceutical establishment to ensure quality of said lot and certify that it is safe for use. 30 Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 2. MOROCCAN LEGISLATION II. 2. 2. VETERINARY DRUGS MANUFACTURING AND QUALITY CONTROL 4 - joint circular No 834 of June 7, 2007 of the Minister of Agriculture, Rural Development and Marine Fishing, and Public Health on good practice in preparing and wholesale distribution of veterinary medicinal products (Annex 1, Annex 2, Annex 3, Annex 4 ); Annex 1: “ veterinary drugs assessment inspection for compliance with principles of good manufacturing practice, performed every 18 -24 months by the veterinarians of Livestock Department, and pharmacy inspectors of Pharmacy and drug department (Ministry of Health) to verify compliance with the repositories of good manufacturing practice of VMP” ; 5 - Dahir No 1 -09 -20 of Safar 22, 1430 (February 18, 2009) promulgating the Law No 25 -08 on creation of the Food Safety National Board and establishments of VMP. Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 31

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 2. MOROCCAN LEGISLATION II. 2. 3. PURCHASE, POSSESSION AND RETAIL OF VETERINARY DRUGS (9 texts) 1 - Dahir of 12 Rabia II, 1342 (December 2, 1922) on regulations for import, trade, detention and use of poisons, extemporaneous preparation and detention for assignment to users. 2 - order of the Minister of Public Health No 465 -69 of September 18, 1969 on setting for approval of the calculation method for prices of pharmaceuticals manufactured and packaged in Morocco for human and veterinary use, and determining the safety stock to be established by manufacturers. 3 - Decree No 2 -76 -266 of 17 Jumada I 1397 (May 6, 1977) on the approval of the pharmaceutical flow and advertising for pharmaceutical specialties. 4 - Law No 21 -80 on private exercise of medicine, surgery and veterinary pharmacy, promulgated by Dahir No 180 -3401 of 17 Safar 1401 (December 25, 1980) official bulletin No 3564 of 12 Rabia II 1401 (February 18, 1981) 5 - Dahir No 1 -8— 340 of 17 Safar 1401 (December 26, 1980) on promulgation of Law No 21 -80 on private exercise of medicine, surgery and veterinarian pharmacy. Official bulletin No 3564 of 12 Rabia II 1401 (Feb 18, 1981). Article 7 – free or at price delivery of veterinary pharmaceuticals reserved to: - pharmacists: the retail supply of veterinary pharmaceuticals is subjected to a prescription delivered by a veterinarian licensed to practice, or by an official veterinary inspector. - veterinarians licensed for private practice, veterinary medicine and surgery without running open pharmacy in places of their practice at home or that of their customers, provided that the drug is administered by the veterinarian himself or under his control. • Article 8: cooperatives, corporations or associations of livestock owners legally constituted and approved, can under the control of a veterinarian participating effectively in the management, hold and deliver to their members for the exclusive exercise of their activities veterinary drugs at exclusion. 32 Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 2. MOROCCAN LEGISLATION II. 2. 3. PURCHASE, POSSESSION AND RETAIL OF VETERINARY DRUGS 6 - Decree No 2 -8 -541 of 29 Jumada I, 1403 (March 15, 1983) issued to implement the law No 21 – 80 on the private practice of veterinary medicine, surgery and pharmacy. Official bulletin No 3672 of March 16, 1983. 7 - Order of the Minister of public health No 2365 – 93 of 16 Jumada II, 1414 (December 1, 1993) setting for their approval the method of calculating prices of pharmaceuticals of foreign origin allowed to be imported for human and veterinary use. 8 - Dahir No 1 -94 -115 of 7 Ramadan 1414 (Feb 18, 1994) modifying and completing the law No 21 -80 on private exercise of veterinary Medicine, surgery and pharmacy. 9 - Dahir No 1 -06 -151 of 30 Shawal 1427 promulgating the law No 17 -04 on drug and pharmacy code. Official bulletin No 5480 of December 7, 2006. Article 34: when the prescription concerns a veterinary drug the pharmacist must equally check that such prescription indicates the identity and address of the animal owner and species. Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 33

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 2. MOROCCAN LEGISLATION II. 2. 4. CONSUMER HEALTH PROTECTION (10 texts) 1 - Joint decree of Ministers of Agriculture and Public Health No 2 -63 -253 of 29 Safar 1383 (July 22, 1963) on prohibition of use of arsenicals, antimonials and estrogens for feeding or breeding of some animals. Official bulletin No 2649 of August 24, 1968. 2 - Decree No 2 -82 -541 of 29 Jumada I 1403 (March 15, 1983) issued for th application of the law No 21 -80 on the private exercise of veterinary medicine, surgery and pharmacy. Official bulletin No 3672 of March 16, 1983. (article 13: determination of a waiting time) 3 - Joint decision of the Minister of agriculture and agricultural development and the Minister of Public Health of August 19, 1996, on suspension of approvals granted to VMP containing chloramphenicol. 4 - Joint order of the Minister of Agriculture and Agricultural Development and the Minister of Public Health No 619 - 96 of 13 Shawal 1417 (Feb 21, 1997) on the withdrawal of approvals and prohibition of the flow of VMP containing chloramphenicol. Article 3: "Import by pharmaceutical companies of pure chloramphenicol as raw material is strictly prohibited for veterinary use” 5 - Joint decision of Minister of Agriculture, rural development and maritime fishing and Minister of Health, issued on July 29, 1998 on the suspension of licenses granted to VMP containing nitrofurans Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 34

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 2. MOROCCAN LEGISLATION II. 2. 4. CONSUMER HEALTH PROTECTION 6 - Joint order of the minister of Agriculture, rural development and maritime fishing, and the Minister of health No 39 - 99 of 26 Ramadan 1419 (January 14, 1999) on the withdrawal from the national market of nitrofurans drugs for veterinary use and veterinary pharmaceuticals containing nitrofurans. article 2: "The importation by pharmaceutical companies of pure nitrofurans raw material for veterinary use is strictly prohibited, unless jointly waived by the Minister of agriculture, rural development and maritime fishing, and the Minister of Health“. 7 - Decree of Ministers of agriculture and public health No 2 -00 -1022 of 6 Dhu-al-Qada 1421 (January 31, 2001) modifying the Decree No 2 -63 -253 of 29 Safar 1383 (July 22, 1963) on prohibiting the use of arsenicals, antimonials or estrogens for feeding and breeding of some animals: official bulletin No 4874 of Feb 15, 2001 8 - Developing a surveillance plan for VMP residues in marine and inland fish farms since 2002 9 - Dahir No 1 -09 -20 of 22 Safar 1430 (Feb 18, 2009) promulgating the law No 25 -08 for establishing a Food Safety National Office. 10 - Decision of the European Commission of June 11, 2010, approving the surveillance plans for residues presented by Morocco for aquaculture. Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 35

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 2. MOROCCAN LEGISLATION II. 2. 5. EVALUATION OF POTENTIAL RISK TO THE ENVIRONMRNT OF THE VETERINARY MEDICINAL PRODUCT Assessment obligation of possible risk to environment in the marketing authorization (MA) application for a VMP. Drug residues (parent molecule, excreted environmental metabolites) are found in the environment - directly: antiparasitic dips, aquaculture indirectly: manure spreaders, poultry droppings. Drugs residue toxicity for earthworms, algae, daphnia, fish, dung beetles. MA withdrawal: Ivomec SR bolus in France (2004): Ivermectin intra-rumen bolus is nocive to the environment. Non degradation of cattle dung: disruption of grasslands growth cycle and multiplication of flies Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 36

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 2. MOROCCAN LEGISLATION II. 2. 5. EVALUATION OF POTENTIAL RISK TO THE ENVIRONMRNT OF THE VETERINARY MEDICINAL PRODUCT 1 - Circular note No 778/DSA/LNCMV of May 22, 2006 on the authorization of livestock biocidal products (disinfectants, antiseptics, udder hygiene products ). Annex 4: required data for the technical file: toxicological studies: - Acute toxicity to fish - effect on algal growth (inhibition test) - Acute toxicity on other non- target aquatic organism - Pathogenicity and infectivity for honey bees and earthworms. - Acute toxicity and/ or pathogenicity and infectivity for other non-target organisms likely to be threatened - (Possible) effects on other flora and fauna. Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 37

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 3. MAURITANIAN LEGISLATION Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 38

1 - Law No 2004 – 024 of July 13, 2004 on code of livestock in Mauritania. Official journal of October 30, 2004, 1081 Article 26: No veterinary medicinal product can be released or delivered to the public unless it has received prior permission for marketing issued by the Minister of Livestock after notice of the National Commission on marketing authorizations stipulated in Article 27 below. However, unregistered drugs can be imported by a special authorization when provided under an international aid, or when they are introduced for experimentation under supervision of the veterinary services. Article 27: There shall be established a National Commission on authorizations of marketing responsible for advising on applications for marketing authorizations. The rules, organization and operation of the commission and the terms and conditions for granting the authorization of marketing are set by decree of the Council of Ministers responsible for livestock. Article 28: the institutions engaged in the manufacture, importation and wholesale or retail of veterinary drugs are subject to approval of the Minister of livestock, after consultation of the concerned technical ministries. the institutions engaged in the manufacture, importation and wholesale or retail of veterinary drugs are subject to approval of the Minister of Livestock, after consultation with the ministries concerned. The conditions and procedures for granting permission will be specified by decree of the Council of Ministers on a report of the responsible Minister for livestock. Article 29: any establishment of preparation, sale or wholesale distribution of veterinary drugs must be under the technical responsibility of a veterinarian. 39 Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011

2 - Decree No 2009 -102 of April 6, 2009 on veterinary pharmacy regulations Article 5 - no veterinary medicinal product or VETERINARY MEDICINAL PRODUCTS specialty locally manufactured or imported can be released or delivered to the public unless it has received a prior marketing authorization issued by decision of the Minister of Livestock after notice of the National Commission on marketing authorizations. Article 6 - Each request for a marketing authorization of a veterinary medicinal product must enclose an administrative and technical file. Authorization is given only after the applicant proves the following: - that the manufacturer has started the verification of pharmacological properties and safety of the drug to animals, humans and environment in normal conditions of use; -A maximal residue limit is set for medicinal products used for animals producing food for human consumption with regard to the active ingredients in the drug and their residues potentially dangerous for humans. - The manufacturer has a method for detection of these residues; -The waiting time is justified Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 40

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 4. ALGERIAN LEGISLATION Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 41

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 4. ALGERIAN LEGISLATION II. 4. 1. MA PROCEDURE 1 - Law No 85 – 05 of Feb 16, 1985 on health protection and promotion 2 - Law No 88 – 08 of 2 Jan 26, 1988 on veterinary medicine activities and animal health protection. Official journal of Republic of Algeria No 004 of January 27, 1988 (article 33 and 34) 3 - Decree No 90 -240 of August 4, 1990, establishing the conditions for manufacturing, marketing and control of VMP. 4 - Ministerial order No 204 of April 10, 1994 on constitution and condition for functioning of the commission provided by the article 3 of Decree No 90 – 240 of August 4, 1990 5 - Decision No 3 of Jan 27, 1996 on designation of members of the inter-ministerial commission responsible for investigating the requests for prior agreement and administrative authorizations of manufacturing establishments and wholesale of VMP 6 - Decree No 02 – 216 of June 20, 2002 defining the medicinal products for veterinary use submitted to 7 % rate of value added. 7 - Decision No 557 of May 31, 2004 establishing the list of approved experts with the inter 3 - Decree No 90 – 240 of August 4, 1990 setting condition for manufacturing, putting in sale and control of vet. Med. Products. 8 - Executive decree No 09 – 102 of 13 Rabia El Awal 1430, (March 10, 2009) setting the applicable measures to import and export of vet. Med. Products. Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 42

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 4. ALGERIAN LEGISLATION II. 4. 1. MA PROCEDURE (9 texts) 9 - order of 1 Rabia II, 1432 (March 6, 2011) setting the approval procedures for VMP importers. Algeria official journal No 26 of 5 Jumada II, 1432 (May 8, 2011). article 2 – the approval of veterinary medicinal products importers will be issued by the Minister in charge of the veterinary authority after examination by an “inter-ministerial committee that will be established for this purpose called "inter ministerial committee in charge of examining the approval requests for import of VMP". Article 6: Every importer of V. M. P. must ensure that he has the technical assistance of a technical manager holding a vet. medicine or pharmacist degree. Article 15: there shall be established, for each approved establishment for import of VMP, a register numbered and initiated by the veterinary authority, maintained by the technical manager, where are recorded the information for each imported and sold product, especially… Article 18: the importer is responsible for the quality of imported and marketed VMP. He must keep for each imported batch of VMP a certificate of compliance issued by an approved laboratory by the state and held by the veterinary authority. 43 Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 4. ALGERIAN LEGISLATION II. 4. 1. MA PROCEDURE (9 texts) Article 21: the approval of VMP importers will be issued for a 24 month period, renewed every 2 years at request of the importer and submitted for renewal no later than 30 days before expiration Article 23: the importer must comply with the requirements of the manufacturer for transport and storage of VMP including under customs. Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 44

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 4. ALGERIAN LEGISLATION II. 4. 2. VETERINARY DRUGS MANUFACTURING AND QUALITY CONTROL (4 texts) 1 - Executive decree No 90 – 240 of August 4, 1990, setting the conditions for processing, marketing and control of VMP article 2: "On the quality of all vet. med. products manufacturer, all veterinarians, every pharmacist or mentioned establishment in the article 46 of the law No 88 – 08 of January 26, 1988 afore mentioned and engaged for sale, entire or partial manufact turing of VMP, As such, division, packaging change or presentation of drugs are regarded as preparations subjected to associated control obligations" 2 - Ministerial order No 204 of April 10, 1994 on composition and work conditions of the commission provided by article 3 of decree No 90 – 240 of August 4, 1990 3 - Decree No 02 – 216 of June 20, 2002, defining VMP under 7 % rate of value added 4 - Executive decree No 09 – 261 of 3 Ramadan 1430 (August 24, 2009) on the exemption from duties and taxes of chemical and organic products imported by manufactures of vet. med. products. 45 Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 4. ALGERIAN LEGISLATION II. 4. 3. PURCHASE, POSSESSION AND RETAIL OF VETERINARY DRUGS 1 - Law No 88 – 08 of Jan. 26, 1988 on vet. medicine activities and animal health protection. Article 42: "Free delivery or expensive retail of vet. med. products referred to in article 41 above mentioned, except in case of drugs containing toxic or poisonous substances at tolerated doses, is subjected to a prescription delivered by a veterinarian and necessarily given to the user. Article 49: “Veterinarians only, during exercise of their profession, may sell vet. med. products at home, at fairs and public events Article 50: "Groups of producers, agricultural professionals, approved associations for defense sanitation, whose action contributes to organize the animal production and justifies a technical and sanitary training, can buy in bulk, keep and deliver to their members for the exclusive exercise of their activities, vet. med. products other than those covered by the particular obligations of article 41 above. However, the groups and associations referred to in the preceding paragraph may equally buy in bulk and keep drugs necessary to implement livestock health programs approved by the national veterinary authority and their implementation in under effective surveillance and responsibility of a veterinarian visiting livestock facility personally and regularly. 46 Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 4. ALGERIAN LEGISLATION II. 4. 3. PURCHASE, POSSESSION AND RETAIL OF VETERINARY DRUGS article 51: "Acquiring, keeping and delivery of pharmaceuticals detained by groups and associations referred to in article 50 above must be under a veterinarian control". article 52: Without prejudice to the provisions or article 42 above, delivery without a prescription is prohibited for vet. med. products containing substances mentioned in points c, e, f and g of article 41 of this law when the marketing decision authorization specifies this prohibition. The mentioning of compulsory presentation of a prescription shall be regulated. 47 Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 4. ALGERIAN LEGISLATION II. 4. 4. CONSUMER HEALTH PROTECTION (4 texts) 1 - Law No 88 – 08 of January 26, 1998 on veterinary medicine activities and animal health protection. article 34: fixing of a waiting time article 41: substances subject to special provisions article 52: compulsory prescription for vet. med. products subjected to special provisions 2 - Order of ministers of agriculture and agrarian reform, of health and population, and economy of August 18, 1993. article 6: "A milk fit for human consumption must not contain any antibiotic residues". 3 - Decision of minister of agriculture and agrarian reform on chloramphenicol prohibition of use in veterinary medicine 4 - Decision of minister of agriculture and agrarian reform on nitrofurans derivatives prohibition of use in veterinary medicine. Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 48

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 5. SUMMARY TABLES OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN THE MAGHREB 1 - Cooperation Agreement in the veterinary field adopted by the council of presidency of Arab Maghreb Union on March 10, 1991: harmonization of regulations in the field of veterinary pharmacy 2 - Guidelines defining: - Manufacturing and import conditions for veterinary medicinal products - Sale and distribution conditions for veterinary medicinal products. Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 49

TUNISIA MOROCCO ALGERIA M. Public Health & Agriculture M. Agriculture Veterinary Services Department YES + AMM IN THIRD COUNTRIES YES AMM DECISION M. Public Health & Agriculture M. AGRICULTURE NATIONAL LABORATORY FOR PHARMACEUTICAL CONTROL YES Veterinary LNCM SANITARY VISA YES (ANCEP) YES MANUFACTURING AND QUALITY CONTROL Pharmacist - Veterinarian - Pharmacist - Veterinarian - Pharmacist LOCAL VETERINARY MEDICINAL PRODUCTSINDUSTRIES 6 MA PROCEDURE 3 files expertise ORIGINAL AMM OF MANUFACTURING COUNTRY AMM NATIONAL COMMITTEE 50 YES 22 6

IMPORT authorization TUNISIA _ PURCHASE, POSSESSION AND -Pharmacists RETAIL OF DRUGS - Private Veterinarians MOROCCO YES -Pharmacists - Private Veterinarians - Breeders groups VETERINARY PHARMACOVIGILANCE CONSUMER HEALTH PROTECTION FIXING RESIDUE MAXIMUM LIMITS EVALUATION OF DRUGS ECOTOXICITY 51 YES -Pharmacists - Private Veterinarians (open pharmacy) - Breeders groups _ YES TO UPDATE COMPLETE YES _ YES RESIDUE SURVEILLANCE PLAN ALGERIA Poultry, Aquaculture, wild game YES _ aquaculture _ _ TO UPDATE _

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 6. LEGISLATION IN THE MIDDLE EAST 1 - OIE Regional Conference on the veterinary medicinal products in the Middle East: “ Harmonization and improvement of registration, distribution and quality control of veterinary medicinal products”, Damascus (Syria), 2 -4 December 2009; 2 - Decree No 2008 -3166 of September 29, 2008 on ratification of an agreement related to standardization and import authorizations rules of veterinary products and vaccines locally manufactured between the government of the Tunisian Republic and the Syrian Republic government. 3 - Audit report of the Food and veterinary Office made in Turkey, 22 February- 4 March 2011. Reference D. G (SANCO)/2011 - 8863. Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 52

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 6. LEGISLATION IN THE MIDDLE EAST II. 6. 1. LEBANON Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 53

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 6. LEGISLATION IN THE MIDDLE EAST II. 6. 1 LEBANON Law No 367 of August 1, 1994, on exercise of pharmacist profession Article 32: Every physician, veterinarian or dentist, residing in a place without a pharmacy, may obtain from the minister of public health a permit to own a medicine cabinet, each according to his specialization, in order to provide with drugs and specialties that he is permitted to prescribe to persons or animals he treats, provided that this is free from pharmacies at a distance of 5 kms. This authorization doesn’t give the beneficiary the right to open a pharmacy or to hold drugs outside his pharmacy whatever the case. The drugs provided to patients must be in advance by a pharmacist who owns a pharmacy whose scientific name and titles appear on these products. Article 34: The authorization granted in the cases listed above will be automatically considered void of the opening of a regulatory pharmacy in the same locality or at a distance of 5 kms or less. The beneficiary of the withdrawn authorization will have a six months non-renewable delay to liquidate the drugs he holds. Article 54: It is prohibited to manufacture or to import from abroad any drug or pharmaceutical specialty to Lebanon without authorization from the Ministry of Public Health. 54 Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 6. LEGISLATION IN THE MIDDLE EAST II. 6. 1 LEBANON To the application for authorization must be attached six samples of the product, and in case in importation from abroad, an official statement issued by the competent authority in the country of origin certifying that the medicinal product is registered and marketed locally, mentioning the date of its circulation. Also must be attached to the application the following information: 1 - The complete composition of the product regarding categories and quantities of substances used in its composition, in addition to its properties and side effects, 2 - Detailed description of the specific analytical table of its active principles, 3 - Detailed information on the product name, pharmacological and clinical effects and instructions for use. The requests and samples are sent to a technical committee… : Article 63: Every manufacturing operation must have a responsible technical manufacturing director. This technical director must be a pharmacist working full-time and authorized to exercise the profession 55 Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 6. LEGISLATION IN THE MIDDLE EAST II. 6. 1 LEBANON Article 65: the pharmacist who oversees the testing laboratory must: 1 - Carefully check each batch of products, and specialty items manufactured in the factory prior to sale or distribution, and before leaving the factory. 2 - Check the raw materials to ensure that their natural substance or chemical composition is consistent with the adopted Pharmacopoeia, scientific books and other references. In case of non-compliance, he shall immediately notify the Department of Public Health and retain such materials for destruction by the Ministry of Public Health or are returned to the country of origin under the supervision of Ministry of Public Health. 3 - Keep a register in which are recorded under serial number and stating the date, the results of the analysis of raw materials and each batch. 4 - Keep samples of each batch even after the sale so they can be reviewed periodically as recommended by the World Health Organization. The results of these tests are recorded in the special register in accordance with the preceding paragraph. Article 80: The Minister of Public Health shall, by order, set the pricing of the selling price of manufactured pharmaceutical products. The bases for pricing are established by a Commission to be formed by decree of the Minister of Health after consultation with the ministries concerned, the College of Pharmacists, the Union of Importers of Drugs and druggists and drug manufacturers. Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 56

II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN NORTH AFRICA AND THE MIDDLE EAST II. 7. SUMMARY TABLES OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS IN THE MIDDLE EAST Work of the OIE Regional Representation for the Middle East (Dr. G. Yehia) OIE Regional Conference on veterinary medicinal products in the Middle East Detailed questionnaire on the VETERINARY MEDICINAL PRODUCTSlegislation in the Middle East. 14 out of 20 countries answered to the questionnaire: Cyprus, Egypt, Iran, Iraq, Jordan, Saudi Arabia, Kuwait, Lebanon, Qatar, Sudan, Syria, Turkey, UAE and Yemen Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 57

LEGISLATION ON VETERINARY PHARMACY AMM FILE Iraq, Saudi Arabia, Jordan, Lebanon, UAE, Yemen: 1 -2 Qatar, Syria: 4 -5; Egypt, Kuwait: 6; Cyprus: 7; Iran, Sudan: 8; Turkey: 9 Ministry of Agriculture: Lebanon, Syria, Jordan, Yemen, Ministry of Public Health and Agriculture: Egypt, Koweit, UAE; Ministry public Environment: UAE Governmental Agency: Saudi Arabia, Cyprus ORIGINAL AM OF MANUFACTURING COUNTRY Lebanon, Syria, Turkey, Yemen AM NATIONAL COMMISSION All countries of Middle East DECISION AM Ministry of Agriculture: Lebanon, Syria, Jordan, Yemen, UAE, Kuwait Ministry of Public Health: Egypt NATIONAL LABORATORY FOR DRUGS CONTROL Saudi Arabia, Jordan, Lebanon, Syria LOCAL VETERINARY MEDICINAL PRODUCTSINDUSTRIES 58 Iran: 145; Turkey: 67; Syria: 46; Egypt and Jordan: 20; Sudan: 13; Saudi Arabia, Lebanon, Cyprus: 3; Iraq and Yemen: 2; UAE: 1

GOOD MANUFACTURING PRACTICE All Middle East countries DIAGNOSTIC TESTS LEGISLATION Most of Middle East Countries IMPORT authorization All countries except Qatar and UAE DRUG PURCHASE, POSSESSION AND RETAIL Iraq, Turkey: state veterinarians Egypt: veterinarians, pharmacists, veterinary assistants, breeders groups COSUMER HEALTH PROTECTION Turkey FIXING MAXIMUM LIMITS OF RESIDUES Turkey RESIDUE SURVEILLANCE PLAN Turkey: Decision 2004/432/CE: poultry, eggs, milk, honey, aquaculture: Cyprus, Egypt, Iraq, Saudi Arabia, Lebanon, Sudan, Yemen: surveillance plan for antibiotic residues EXPORT TO EU Turkey: aquaculture and honey products (2010) Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 59

PLAN INTRODUCTION I- VETERINARY MEDICINAL PRODUCTS MARKET IN NORTH AFRICA II- ACTUAL STATUS OF VETERINARY MEDICINAL PRODUCTS III- UPDATING OF LEGISLATIONS IN NORTH AFRICA AND THE MIDDLE AST CONCLUSION Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 60

III- UPDATING OF LEGISLATIONS IN NORTH AFRICA AND THE MIDDLE AST 1 - Legal definitions to complete: immunological veterinary product, auto vaccine for veterinary use, veterinary antiparasitic product, veterinary homeopathic product, residue maximal limits. 2 - electronically submitted veterinary MA dossiers VNee. S Checker. Tool for electronic-format technical validation of MA applications (Collaboration Anses AMNV, Belgian agency FAGG-AFMPS) set on the first of January 2010. Quality verification of electronic format of MA applications before transmission to assessment bodies. Human drugs: submission of application information for AM by Common Technical Document (ICH 2000) Summary of the product characteristics (SPC): official data more complete than the notice, approved by country competent authorities: basis of information about the drug. 4 - Authorization for MA common to North Africa. 5 - Dossier of pharmacotoxicological expertise: * generic drugs with antibiotics: bioequivalence compared to the original medecines, assessed by 3 pharmacocinetic parameters: Cmax, Tmax, under curve surface * Setting of a waiting time with regard to medicinal product formulation, route of administration. 6 - Dossier of clinical expertise: specific clinical dossier for each animal species 7 - Assessment of VMP ecotoxicity to include in the AM applications. VICH EMEA/CVMP/ERA/418282/2005 -Corr Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 61

III- UPDATING OF LEGISLATIONS IN NORTH AFRICA AND THE MIDDLE AST 8 - To complete the legislation on medicinal food (Manufacturing, delivery) Guideline No 90/167/CEE. 9 - Technical responsibility for the VMP manufacturing plants entrusted to a veterinarian holding a degree in industrial pharmacy and one year practical experience in the field of pharmaceutical industry, 10 - Legislation on diagnostic tests, 11 - Legislation on livestock records, 12 - creation of pharmaceutical wholesale distributors plants led by veterinary surgeons in Tunisia, 13 - To comply with the new European legislation on maximum residue limits (MRLs): EU Regulation No 37/2010 on pharmacologically active substances and their classification concerning the MRLs in foods of animal origin, 14 - Prohibition of use of anabolics (antithyroid agents, beta-agonists, steroids …) for livestock, 15 - creation under the aegis of the OIE of a center for veterinary pharmacovigilance and post MA surveillance for North Africa and the Middle East Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 62

CONCLUSION Updating and harmonization of VETERINARY MEDICINAL PRODUCTS legislations In North Africa and Middle East countries must be considered as a real to public health in all its components: animal health, food safety, human health and environment protection. “It is worldwide recognized that VMP use must be strictly framed, and conversely, in absence of official controls, their risks associated with their imprudent use can be more important than the profits associated with their use”. B. Vallat. OIE Bulletin, No 1, 2010. Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 63

Thank you for your attention I - VETERINARY MEDICINAL PRODUCTS MARKET IN NORTH AFRICA Advanced Training for OIE Focal Points on Veterinary Products Casablanca, Morocco, December 6 -8, 2011 64