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 (2ND 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 (2ND 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 sq2 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
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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
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I - VETERINARY MEDICINAL PRODUCTS MARKET IN NORTH
AFRICA
THERAPEUTIC CATEGORIES
DISTRIBUTION
ANTIBACTERIALS
35-40 %
ANTIPARASITICS
20-23 %
VACCINES
15-19 %
VITAMINS
12-14 %
OTHERS
8-13 %
BOUGUEDOUR R, 2008
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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
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Introduction – Importance
II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTS LEGISLATIONS IN NORTH
AND MARKET
THE MIDDLE
EAST AFRICA
I – VETERINARY MEDICINAL AFRICA
PRODUCTS
IN NORTH
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 are 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
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10
II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS
IN NORTH AFRICA AND THE MIDDLE EAST
II. 1. TUNISIAN LEGISLATION
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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
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)
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granting
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.
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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
1978on veterinary medicine.
article 8: Inspection report of an establishment for pharmaceutical manufacturing for veterinary use,
written by competent authorities of the Public Health Ministry.
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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
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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.
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Casablanca, Morocco, December 6-8, 2011
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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
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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 0f 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,
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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 0f March 17, 2008: general provisions
for surveillance plans and control plans.
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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 No200/1654 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).
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II- CURRENT STATUS OF VETERINARY MEDICINAL PRODUCTSLEGISLATIONS
IN NORTH AFRICA AND THE MIDDLE EAST
II. 2. MOROCCAN LEGISLATION
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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 0n private exercise of veterinary surgery and pharmacy, promulgated by
Dahir No1-80-3401 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.
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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.
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Casablanca, Morocco December 6-8, 2011
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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.
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Casablanca, Morocco, December 6-8, 2011
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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
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Casablanca, Morocco, December 6-8, 2011
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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…
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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
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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.
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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 and establishments of VMP.
Advanced Training for OIE Focal Points on Veterinary Products
Casablanca, Morocco, December 6-8, 2011
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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.
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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 manufactturing 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
MA PROCEDURE
3files expertise
M. Public Health
M. Public Health
& Agriculture
ORIGINAL AMM OF
MANUFACTURING
COUNTRY
YES
YES
YES
YES
AMM DECISION
M. Public Health
& Agriculture
M. Public Health
& Agriculture
NATIONAL LABORATORY
FOR PHARMACEUTICAL
CONTROL
YES
Veterinary LNCM
SANITARY VISA
YES (ANCEP)
YES
MANUFACTURING AND
QUALITY CONTROL
Pharmacist
- Veterinarian
- Pharmacist
AMM NATIONAL COMMITTEE
LOCAL VETERINARY
MEDICINAL
PRODUCTSINDUSTRIES
50
6
ALGERIA
M. Agriculture
Veterinary Services
Department
YES + AMM
IN THIRD COUNTRIES
YES
22
M. AGRICULTURE
- Veterinarian
- Pharmacist
6
TUNISIA
IMPORT authorization
PURCHASE, POSSESSION AND
RETAIL OF DRUGS
VETERINARY
PHARMACOVIGILANCE
CONSUMER HEALTH
PROTECTION
_
-Pharmacists
- Private
Veterinarians
_
TO UPDATE
MOROCCO
YES
-Pharmacists
- Private
Veterinarians
- Breeders
groups
YES
ALGERIA
YES
-Pharmacists
- Private
Veterinarians
(open pharmacy)
- Breeders groups
YES
TO UPDATE
COMPLETE
YES
_
YES
RESIDUE SURVEILLANCE
PLAN
FIXING RESIDUE MAXIMUM
LIMITS
EVALUATION OF DRUGS
ECOTOXICITY
51
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, 22February- 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 andauthorized 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
Iraq, Saudi Arabia, Jordan, Lebanon, UAE, Yemen:
1-2 Qatar, Syria: 4-5; Egypt, Kuwait: 6;
Cyprus: 7; Iran, Sudan: 8; Turkey:9
AMM FILE
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
Iran: 145; Turkey: 67; Syria: 46; Egypt and Jordan: 20;
Sudan: 13; Saudi Arabia, Lebanon, Cyprus: 3; Iraq and
Yemen: 2; UAE: 1
58
GOOD MANUFACTURING
All Middle East countries
PRACTICE
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 VNeeS 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
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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
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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,No1, 2010.
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Thank you for your attention
I - VETERINARY MEDICINAL PRODUCTS MARKET IN NORTH AFRICA
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