EMBAJADA ARGENTINA EN SUDAFRICA PERFIL DE · PDF filePerfil de mercado: Medicamentos para uso...

EMBAJADA ARGENTINA EN SUDAFRICA

PERFIL DE MERCADO

Medicamentos uso veterinario PRODUCTO: Medicamentos (con exclusión de los productos de las partidas 3002, 3005 o 3006) constituidos por productos mezclados o sin mezclar, preparados para usos terapéuticos o profilácticos, dosificados o acondicionados para la venta al por menor. Vacunas uso veterinario Posición Arancelaria:3004 y 3002.30 Agosto 2005 EMBAJADA ARGENTINA EN SUDAFRICA P.O. BOX 11125 SECCION ECONOMICA Y COMERCIAL HATFIELD,0028 TEL.: (2712) 342-9601 / 342-1056 SUDAFRICA FAX: (2712) 342-8969 E-MAIL: [email protected]

Perfil de mercado: Medicamentos para uso veterinario agosto 2005

Embajada Argentian en Sudáfrica 2

PERFIL DE MERCADO FECHA DE ELABORACIÓN: Agosto 2005 DESCRIPCION DEL PRODUCTO: Medicamentos para uso veterinario Medicamentos (con exclusión de los productos de las partidas 3002, 3005 o 3006) constituidos por productos mezclados o sin mezclar, preparados para usos terapéuticos o profilacticos, dosificados o acondicionados para la venta al por menor. Vacunas uso veterinario. POSICIÓN ARANCELARIA: 3004 y 3002.30 Ganado vacuno en la República de Sudáfrica Año Toros Vacas 2 años + Vacas de 1 a 2

años Terneros Bueyes Total

Lechera Demas Lechera Demas

Bueyes jovenes

En millones

1970 0,13 1,30 2,30 0,44 0,70 1,67 0,70 0,64 7,88 1971 0,12 1,14 2,42 0,36 0,80 1,51 0,84 0,65 7,84 1972 0,14 1,15 2,66 0,37 0,78 1,57 0,78 0,59 8,04 1973 0,14 1,08 2,72 0,37 0,81 1,83 0,79 0,57 8,31 1974 0,15 1,06 2,71 0,42 0,98 1,64 0,95 0,57 8,48 1975 0,18 0,93 3,06 0,35 1,08 1,63 0,97 0,61 8,81 1976 0,16 0,92 3,17 0,37 1,09 1,69 1,04 0,64 9,08 1977 0,17 0,90 3,30 0,34 1,17 1,71 1,00 0,70 9,29 1978 0,17 0,93 3,18 0,37 1,15 1,72 1,01 0,62 9,15 1979 0,17 0,89 3,07 0,38 1,09 1,66 0,99 0,48 8,73 1980 0,15 0,83 3,01 0,33 1,09 1,57 0,90 0,41 8,29 1981 0,16 0,84 3,14 0,33 1,00 1,66 0,81 0,41 8,35 1982 0,14 0,87 3,20 0,39 1,08 1,55 0,81 0,41 8,45 1983 0,16 0,91 3,07 0,37 1,08 1,51 0,78 0,32 8,20 1984 0,17 0,87 3,08 0,37 1,03 1,44 0,68 0,28 7,92 1985 0,16 0,75 3,11 0,32 1,06 1,44 0,73 0,26 7,83 1986 0,16 0,92 3,06 0,41 0,97 1,46 0,60 0,25 7,83 1987 0,18 0,85 3,13 0,36 1,00 1,46 0,66 0,27 7,91 1988 0,18 0,86 3,18 0,35 1,06 1,56 0,73 0,28 8,20 1989 0,21 0,76 3,43 0,35 1,13 1,62 0,81 0,30 8,61 1990 0,19 0,77 3,61 0,33 1,18 1,63 0,74 0,26 8,71 1991 0,18 0,89 3,42 0,37 1,17 1,64 0,68 0,28 8,63 1992 0,17 0,77 3,59 0,32 1,09 1,53 0,71 0,22 8,40



1993 0,17 0,82 3,27 0,33 1,06 1,52 0,66 0,23 8,06 1994 0,18 0,77 3,30 0,28 1,10 1,49 0,70 0,29 8,11 1995 0,20 0,82 3,46 0,31 1,14 1,54 0,69 0,20 8,36 1996 0,18 0,82 3,49 0,32 1,12 1,68 0,79 0,24 8,64 1997 0,18 0,79 3,58 0,31 1,19 1,63 0,87 0,29 8,84 1998 0,19 0,79 3,77 0,28 1,16 1,66 0,70 0,31 8,86 1999 0,20 0,76 3,87 0,32 1,22 1,60 0,61 0,18 8,76 2000 0,20 0,98 3,54 0,38 1,05 1,63 0,66 0,23 8,67 2001 0,19 0,99 3,60 0,37 1,04 1,61 0,66 0,24 8,70 2002 0,21 0,93 3,74 0,39 1,11 1,60 0,59 0,22 8,79 1) Fines de agosto Fuente: Agricultural Census by Statistics SA” Ganado ovino y caprino en la República de Sudáfrica

Ovejas Cabras Merino Karakul Demas

lanas Ovejas (carne)

Total Cabras de angora

Demas cabras

Total AÑO

1 000

1965 27.805 1.127 2.915 4.653 36.500 * * 2.990 1966 28.363 1.327 3.013 4.702 37.405 * * 2.843 1967 28.191 1.030 2.639 3.391 35.251 * * 2.750 1968 27.193 1.500 2.697 4.588 35.978 * * 2.701 1969 27.473 1.725 2.646 4.219 36.063 * * 2.774 1970 25.257 1.700 2.508 3.671 33.136 * * 2.546 1971 20.572 2.151 2.569 4.132 29.424 * * 2.135 1972 20.110 1.830 2.419 4.742 29.101 954 1.195 2.149 1973 19.711 2.215 3.161 4.520 29.607 925 1.263 2.188 1974 20.874 1.767 2.920 4.735 30.296 992 1.278 2.270 1975 20.823 1.937 3.454 4.775 30.989 1.046 1.269 2.315 1976 20.450 2.169 3.408 4.958 30.985 1.142 1.211 2.353 1977 20.873 2.156 3.813 5.119 31.961 1.199 1.261 2.460 1978 20.599 2.034 3.815 5.340 31.788 1.379 1.273 2.652 1979 20.594 1.779 3.526 5.304 31.203 1.509 1.183 2.692 1980 20.009 2.145 3.588 5.011 30.753 1.614 1.115 2.729 1981 19.335 1.936 3.824 5.648 30.743 1.676 1.082 2.758 1982 19.036 1.718 4.258 5.660 30.672 1.772 1.090 2.862 1983 17.660 1.040 4.429 5.993 29.122 1.748 1.026 2.774 1984 16.551 881 4.495 5.862 27.789 1.673 1.105 2.778 1985 16.045 691 4.586 5.787 27.109 1.961 833 2.794 1986 16.353 532 4.232 5.872 26.989 2.062 818 2.880 1987 16.087 489 4.696 5.660 26.932 2.163 826 2.989



1988 16.161 650 4.874 6.003 27.688 * * 2.944 1989 17.644 599 5.127 6.264 29.634 * * 2.885 1990 17.916 495 4.658 6.910 29.979 * * 2.842 1991 17.057 498 4.330 6.746 28.631 * * 2.482 1992 16.762 208 3.763 6.715 27.448 * * 2.375 1993 14.884 126 3.952 6.708 25.670 * * 2.237 1994 14.470 119 4.059 7.203 25.851 * * 2.353 1995 13.332 98 5.104 6.948 25.482 * * 2.369 1996 12.861 103 5.112 7.489 25.565 * * 2.406 1997 12.559 64 5.361 7.794 25.778 * * 2.394 1998 12.650 75 5.332 7.811 25.868 * * 2.360 1999 11.421 58 5.759 7.997 25.235 * * 2.325 2000 13.088 30 4.541 7.543 25.202 * * 2.355 2001 13.172 30 4.571 7.591 25.364 * * 2.427 2002 13.873 28 4.276 7.405 25.582 2.419 Al 31 de agosto Fuente: Agricultural Census by Statistics SA” COSTO DE NACIONALIZACION: Aranceles de Importacion:. P.A. 3002.30 HUMAN BLOOD; ANIMAL BLOOD PREPARED FOR THERAPEUTIC, PROPHYLACTIC OR DIAGNOSTIC USES; ANTISERA AND OTHER BLOOD FRACTIONS; AND MODIFIED IMMUNOLOGICAL PRODUCTS, WHETHER OR NOT OBTAINED BY MEANS OF BIOTECHNOLOGICAL PROCESSES; VACCINES, TOXINS, CULTURES OF MICRO- ORGANISMS (EXCLUDING YEASTS) AND SIMILAR PRODUCTS - Vaccines for veterinary medicine Unit : KG Vat : 14 % (Impuesto equivalente al IVA) Rate of Duty : Libre (Nivel general aplicable a Argentina) EU Rate : Libre (Nivel para la Union Europea) SADC Rate : Libre (Nivel para los Paises de la SADC) P.A. 3004.10 MEDICAMENTS (EXCLUDING GOODS OF HEADING 30.02, 30.05 OR 30.06) CONSISTING OF MIXED OR UNMIXED PRODUCTS FOR THERAPEUTIC OR PROPHYLACTIC USES, PUT UP IN MEASURED DOSES (INCLUDING THOSE IN THE FORM OF TRANSDERMAL ADMINISTRATION SYSTEMS) OR IN FORMS



OR PACKINGS FOR RETAIL SALE: - Containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycins or their derivatives Unit : KG Vat : 14 % (Impuesto equivalente al IVA) Rate of Duty : Libre (Nivel general aplicable a Argentina) EU Rate : Libre (Nivel para la Union Europea) SADC Rate : Libre (Nivel para los Paises de la SADC) P.A. 3004.20 MEDICAMENTS (EXCLUDING GOODS OF HEADING 30.02, 30.05 OR 30.06) CONSISTING OF MIXED OR UNMIXED PRODUCTS FOR THERAPEUTIC OR PROPHYLACTIC USES, PUT UP IN MEASURED DOSES (INCLUDING THOSE IN THE FORM OF TRANSDERMAL ADMINISTRATION SYSTEMS) OR IN FORMS OR PACKINGS FOR RETAIL SALE: - Containing other antibiotics Unit : KG Vat : 14 % (Impuesto equivalente al IVA) Rate of Duty : Libre (Nivel general aplicable a Argentina) EU Rate : Libre (Nivel para la Union Europea) SADC Rate : Libre (Nivel para los Paises de la SADC) P.A. 3004.31 MEDICAMENTS (EXCLUDING GOODS OF HEADING 30.02, 30.05 OR 30.06) CONSISTING OF MIXED OR UNMIXED PRODUCTS FOR THERAPEUTIC OR PROPHYLACTIC USES, PUT UP IN MEASURED DOSES (INCLUDING THOSE IN THE FORM OF TRANSDERMAL ADMINISTRATION SYSTEMS) OR IN FORMS OR PACKINGS FOR RETAIL SALE:- Containing hormones or other products of heading No. 29.37 (excluding those containing antibiotics): - Containing insulin Unit : KG Vat : 14 % (Impuesto equivalente al IVA) Rate of Duty : Libre (Nivel general aplicable a Argentina) EU Rate : Libre (Nivel para la Union Europea) SADC Rate : Libre (Nivel para los Paises de la SADC) P.A. 3004.39 MEDICAMENTS (EXCLUDING GOODS OF HEADING 30.02, 30.05 OR 30.06) CONSISTING OF MIXED OR UNMIXED PRODUCTS FOR THERAPEUTIC OR PROPHYLACTIC USES, PUT UP IN MEASURED DOSES (INCLUDING THOSE IN THE FORM OF TRANSDERMAL ADMINISTRATION SYSTEMS) OR IN FORMS OR PACKINGS FOR RETAIL SALE: - Containing hormones or other products of heading No. 29.37 (excluding those containing antibiotics): - Other Unit : KG Vat : 14 % (Impuesto equivalente al IVA) Rate of Duty : Libre (Nivel general aplicable a Argentina) EU Rate : Libre (Nivel para la Union Europea) SADC Rate : Libre (Nivel para los Paises de la SADC) P.A. 3004.40 MEDICAMENTS (EXCLUDING GOODS OF HEADING 30.02, 30.05 OR 30.06) CONSISTING OF MIXED OR UNMIXED PRODUCTS FOR THERAPEUTIC OR PROPHYLACTIC USES, PUT UP IN MEASURED DOSES (INCLUDING THOSE IN



THE FORM OF TRANSDERMAL ADMINISTRATION SYSTEMS) OR IN FORMS OR PACKINGS FOR RETAIL SALE: - Containing alkaloids or derivatives thereof (excluding those containing hormones or other products of heading No. 29.37 or antibiotics) Unit : KG Vat : 14 % (Impuesto equivalente al IVA) Rate of Duty : Libre (Nivel general aplicable a Argentina) EU Rate : Libre (Nivel para la Union Europea) SADC Rate : Libre (Nivel para los Paises de la SADC) P.A. 3004.50 MEDICAMENTS (EXCLUDING GOODS OF HEADING 30.02, 30.05 OR 30.06 CONSISTING OF MIXED OR UNMIXED PRODUCTS FOR THERAPEUTIC OR PROPHYLACTIC USES, PUT UP IN MEASURED DOSES (INCLUDING THOSE IN THE FORM OF TRANSDERMAL ADMINISTRATION SYSTEMS) OR IN FORMS OR PACKINGS FOR RETAIL SALE: - Other medicaments containing vitamins or other products of heading No. 29.36 Unit : KG Vat : 14 % (Impuesto equivalente al IVA) Rate of Duty : Libre (Nivel general aplicable a Argentina) EU Rate : Libre (Nivel para la Union Europea) SADC Rate : Libre (Nivel para los Paises de la SADC) P.A. 3004.90 MEDICAMENTS (EXCLUDING GOODS OF HEADING 30.02, 30.05 OR 30.06) CONSISTING OF MIXED OR UNMIXED PRODUCTS FOR THERAPEUTIC OR PROPHYLACTIC USES, PUT UP IN MEASURED DOSES (INCLUDING THOSE IN THE FORM OF TRANSDERMAL ADMINISTRATION SYSTEMS) OR IN FORMS OR PACKINGS FOR RETAIL SALE: - Other Unit : KG Vat : 14 % (Impuesto equivalente al IVA) Rate of Duty : Libre (Nivel general aplicable a Argentina) EU Rate : Libre (Nivel para la Union Europea) SADC Rate : Libre (Nivel para los Paises de la SADC) Fuente: Arancel de Importacion: extraído del libro Jacobsen Publishers (Pty) Ltd. (*)Sudáfrica es miembro de la Comunidad de Desarrollo del Africa Austral (SADC) junto con Angola, Botswana, República Democrática del Congo, Lesotho, Malawi, Mauricio, Mozambique, Namibia, Swazilanda, Seychelles, Tanzania, Zambia y Zimbabwe. REGULACIONES Y DOCUMENTACION Las regulaciones de importacion requieren que los medicamentos para uso veterinario sean registrados previamente a su importacion o venta. Segun la nueva legislacion, todos los importadores, exportadores, mayoristas y distribuidores de medicinas deben aplicar por una licencia conforme con GMP, GDP o GWP (Good



manufacturing or distribution or wholesaling practice). Ciertos medicamentos veterinarios pueden ser registrados con por el Departamento de Agricultura. (ver anexo 1) MEDICINE CONTROL COUNCIL www.mccza.com Documents under section: Guidelines - Veterinary Medicines Document Description GENERAL INFORMATION (Zipped MS-Word 121Kb) Document Description GUIDELINE ON PHARMACEUTICAL AND ANALYTICAL REQUIREMENTS FOR VETERINARY MEDICINES (Zipped MS-Word 43Kb) Document Description BIOAVAILABILTY AND BIOEQUIVALENCE OF VETERINARY MEDICINES (Zipped MS-Word 65Kb) Document Description VETERINARY DRUG RECALLS (Zipped MS-Word 32Kb) Document Description EFFICACY OF VETERINARY BIOLOGICALS (Zipped MS-Word 32Kb) Document Description SECTION 21 APPLICATIONS FOR UNREGISTERED VETERINARY MEDICINES (Zipped MS-Word 108Kb) Document Description EFFICACY OF AND GCP FOR VETERINARY MEDICINES (Zipped MS-Word 35Kb) Document Description GUIDELINE ON PRECLINICAL SAFETY STUDIES FOR VETERINARY MEDICINES (Zipped MS-Word 35Kb) Document Description MRLS AND WITHDRAWAL PERIODS (Zipped MS-Word 75Kb) Document Description SAFETY OF VETERINARY BIOLOGICALS (Zipped MS-Word 35Kb) South African Veterinary Council Tel: (2712) 324-2392 Fax: (2712) 324-2394 E-mail: [email protected] Pagina web: www.savc.co.za Department of Agriculture Medicine control



Ms. Mart van der Linde Tel: (2712) 546-5005 Fax: (012) 546-5066 E-mail: [email protected] Empresa Consultora Privada: Quintiles Transnational Contact: Ms. A. Vienings Tel: (2712) 671-2200 Fax: (2712) 671-2361 E-mail: [email protected] Para mayor informacion visitar las siguientes paginas web www.mccza.com www.doh.gov.za www.nda.gov.za LEYES, REGULACIONES Y SISTEMAS QUE RIGEN EL PRODUCTO IMPORTADO: Rigen leyes y regulaciones establecidas por el South African Bureau of Standard SOUTH AFRICAN BUREAU OF STANDARDS (SABS) PRIVATE BAG X191 TEL: (2712) 428-7911 / 428-6561 / 6925 PRETORIA, 0001 FAX: (2712) 344-1568 SUDAFRICA E-MAIL: [email protected] Web: www.sabs.co.za TIPO DE CAMBIO AL 11/08/05: 1 U$S = 6.50 Rand (TABLA TIPO DE CAMBIO ANEXO 3) IMPORTACIONES SUDAFRICANAS: P.A. AÑO CANTIDAD KG VALOR RAND VALOR U$S (*) 3002.30. 1997 209,812 40,587,534 8,804,237 3002.30. 1998 263,333 48,917,818 8,845,898 3002.30. 1999 287,515 64,592,283 10,571,568 3002.30. 2000 265,596 71,405,105 10,288,920 3002.30. 2001 307,476 92,902,235 10,790,039 3002.30. 2002 254,228 99,253,405 9,434,734 P.A. AÑO CANTIDAD Kg VALOR RAND VALOR U$S (*) 3004.10. 1997 278.669 75,583,530 16,395,5603004.10. 1998 231.912 81,193,784 14,682,4203004.10. 1999 217.592 80,364,945 13,153,0193004.10. 2000 211.107 75,718,289 10,910,4163004.10. 2001 279,641 103,740,891 12,048,8843004.10. 2002 191,215 103,789,392 9,865,912



3004.10. 2003 275,779 80,023,187 10,585,078 P.A. AÑO CANTIDAD Kg VALOR RAND VALOR U$S (*) 3004.20. 1997 696.727 284,432,087 61,698,9343004.20. 1998 751.864 278,456,450 50,353,7883004.20. 1999 1.157.401 323,715,167 52,981,2063004.20. 2000 1.115.835 409,369,728 58,986,9933004.20. 2001 1,108,482 477,462,010 55,454,3573004.20. 2002 1,359,904 452,098,063 42,975,1013004.20. 2003 834,179 236,486,984 31,281,347 P.A. AÑO CANTIDAD Kg VALOR RAND VALOR U$S (*) 3004.39. 1997 298.141 143,108,121 31,042,9763004.39. 1998 244.492 154,900,722 28,010,9803004.39. 1999 323.310 168,480,035 27,574,4743004.39. 2000 345.869 179,414,097 25,852,1753004.39. 2001 334,421 241,787,912 28,082,2203004.39. 2002 324,598 266,418,850 25,324,9863004.39. 2003 834,179 236,486,984 31,281,347 P.A. AÑO CANTIDAD Kg VALOR RAND VALOR U$S (*) 3004.40. 1997 63.433 22,107,437 4,795,5393004.40. 1998 37.434 19,065,903 3,447,7223004.40. 1999 34.336 17,409,049 2,849,2723004.40. 2000 20.545 12,090,944 1,742,2113004.40. 2001 22,237 15,258,080 1,772,1353004.40. 2002 16,482 29,271,063 2,782,4203004.40. 2003 21,317 18,634,152 2,464,835 P.A. AÑO CANTIDAD Kg VALOR RAND VALOR U$S (*) 3004.50. 1997 109.330 16,543,503 3,588,6123004.50. 1998 82.409 27,704,202 5,009,8013004.50. 1999 90.364 37,999,742 6,219,2703004.50. 2000 147.482 60,873,582 8,771,4103004.50. 2001 74,471 41,022,232 4,764,4873004.50. 2002 197,257 68,450,417 6,506,6943004.50. 2003 61,121 18,080,976 2,391,663 P.A. AÑO CANTIDAD Kg VALOR RAND VALOR U$S (*) 3004.90. 1997 3.197.439 1,252,107,810 271,606,9003004.90. 1998 4.313.645 1,801,653,596 325,796,3103004.90. 1999 3.924.912 2,143,695,699 350,850,3603004.90. 2000 4.887.392 2,654,515,663 382,495,0523004.90. 2001 4,955,102 3,426,381,032 397,953,6623004.90. 2002 5,787,145 3,926,172,016 373,210,2683004.90. 2003 6,875,096 3,994,158,091 528,327,790Fuente: Monthly Abstract of Trade Statistics.



(*) Valor calculado con tasa de cambio promedio anual para cada año. ESTADÍSTICAS DE IMPORTACIÓN Y EXPORTACIÓN CON PAIS DE ORIGEN Y DESTINO AÑO 2003 P.A.3002.30 Importaciones Exportaciones Pais origen Cantidad Valor Valor Cantidad Valor Valor Destino kg Rand U$S kg Rand U$S

NL 32,382 18,011,282 2,382,445 245 331,610 43,864

US 57,774 15,709,922 2,078,032 17 36,418 4,817 DE 42,669 13,421,173 1,775,287 120 34,360 4,545 FR 41,728 12,696,784 1,679,469 2 200 26

UY 38,376 8,506,340 1,125,177 0 0 0 GB 3,768 4,642,990 614,152 90 26,883 3,556

BR 6,037 3,450,126 456,366 1,112 735,692 97,314 IT 13,072 2,790,813 369,155 20,480 13,981,606 1,849,419

HU 7,841 2,671,089 353,319 9,963 827,446 109,451 NZ 15,681 2,304,874 304,878 0 0 0

AU 2,681 1,712,234 226,486 112 73,906 9,776 IL 1,634 1,165,851 154,213 1,596 355,990 47,089

AR 1,628 508,664 67,284 0 0 0 DK 591 502,165 66,424 2 200 26

ES 486 301,528 39,885 2 70 9 KE 200 124,942 16,527 4,720 1,476,670 195,327

BE 159 96,877 12,814 2 500 66 IE 1,314 92,400 12,222 15 8,458 1,119 CA 36 48,431 6,406 0 0 0

ZW 0 0 0 62,295 9,223,338 1,220,018 SA 0 0 0 6,250 4,622,641 611,460

TN 0 0 0 6,795 4,209,860 556,860 ZM 0 0 0 18,119 3,254,926 430,546

MU 0 0 0 6,934 3,252,495 430,224 AE 0 0 0 1,549 3,058,890 404,615

MW 0 0 0 6,851 2,246,656 297,177 CH 0 0 0 297 1,252,367 165,657

MR 0 0 0 6,334 1,027,991 135,978 TZ 0 0 0 2,964 990,723 131,048

UG 0 0 0 5,527 969,963 128,302 MZ 0 0 0 9,306 965,499 127,712

TR 0 0 0 164 269,520 35,651 AO 0 0 0 1,251 258,737 34,224 CM 0 0 0 550 213,302 28,215

CD 0 0 0 509 121,243 16,037



NG 0 0 0 850 115,920 15,333 RW 0 0 0 484 115,118 15,227

JO 0 0 0 205 82,545 10,919 MG 0 0 0 77 78,686 10,408

GH 0 0 0 75 39,878 5,275 GA 0 0 0 112 35,372 4,679

TH 0 0 0 240 28,823 3,813 AN 0 0 0 100 21,925 2,900 SH 0 0 0 60 21,815 2,886

SC 0 0 0 60 15,420 2,040 SG 0 0 0 2 9,828 1,300

OM 0 0 0 26 9,415 1,245 HK 0 0 0 50 8,985 1,188

SD 0 0 0 44 7,075 936 AT 0 0 0 12 1,930 255

EG 0 0 0 14 213 28 ER 0 0 0 1 50 7

KW 0 0 0 2 50 7 Total 268,057 88,758,485 11,740,540 176,587 54,421,208 7,198,572

P.A.3004.10 Importaciones Exportaciones Pais origen Cantidad Valor Valor Cantidad Valor Valor Destino kg Rand U$S kg Rand U$S

GB 35,340 38,948,908 5,151,972 109 22,824 3,019 AT 111,554 11,764,007 1,556,086 0 0 0 SI 39,114 6,645,198 878,994 0 0 0 IN 39,995 6,359,233 841,168 0 0 0 AU 8,905 4,437,229 586,935 3 2,212 293 BE 5,195 3,289,567 435,128 3 250 33 NL 9,814 2,652,664 350,881 0 0 0 IT 4,864 2,192,893 290,065 0 0 0 IE 15,889 1,815,589 240,157 3 50 7 US 1,302 839,865 111,093 100 550 73 FR 119 529,640 70,058 50 225 30 DE 3,027 362,126 47,900 0 0 0 SG 440 161,237 21,328 0 0 0 BR 217 17,252 2,282 0 0 0 CN 1 5,662 749 0 0 0 ZNC 3 2,117 280 0 0 0 ZW 0 0 0 778 903,202 119,471 NG 0 0 0 539 297,801 39,392 ZM 0 0 0 2,317 218,695 28,928 ET 0 0 0 10 83,276 11,015 AO 0 0 0 2,165 43,895 5,806



MU 0 0 0 77 39,526 5,228 TZ 0 0 0 570 24,828 3,284 MZ 0 0 0 88 22,761 3,011 MW 0 0 0 40 9,920 1,312 KE 0 0 0 60 4,860 643 MG 0 0 0 73 2,489 329 UG 0 0 0 22 1,000 132 SC 0 0 0 1 367 49 MR 0 0 0 13 100 13 PK 0 0 0 1 13 2 PT 0 0 0 1 2 0

TOTAL 275,779 80,023,187 10,585,078 7,023 1,678,846 222,070 P.A.3004.20 Importaciones Exportaciones Pais origen Cantidad Valor Valor Cantidad Valor Valor destino kg Rand U$S kg Rand U$S

IT 47,428 42,351,011 5,601,986 0 0 0 GB 177,844 35,143,575 4,648,621 2,479 1,145,543 151,527 FR 90,793 34,843,264 4,608,897 240 94,380 12,484 US 87,670 31,388,757 4,151,952 1,535 239,487 31,678 DE 9,320 21,013,077 2,779,508 1,881 7,641,191 1,010,740 IN 107,403 13,042,998 1,725,264 4 25 3 BE 14,603 11,332,302 1,498,982 0 0 0 NL 33,461 11,245,826 1,487,543 8 550 73 ES 7,061 5,850,959 773,936 0 0 0 JP 2,613 5,238,262 692,892 0 0 0 IE 11,005 4,644,156 614,306 0 0 0

ZW 136,199 3,531,223 467,093 11,637 1,255,135 166,023 AU 621 2,792,486 369,376 5 14,025 1,855 SI 11,432 2,473,665 327,204 0 0 0 DK 11,074 2,270,697 300,357 0 0 0 BR 4,406 2,211,688 292,551 0 0 0 CA 21,363 1,651,863 218,500 0 0 0 NO 37,919 1,569,936 207,663 0 0 0 PT 9,465 1,456,837 192,703 0 0 0 MX 2,393 1,225,717 162,132 0 0 0 CH 1,495 791,564 104,704 0 0 0 AT 973 300,957 39,809 0 0 0 ZA 6,177 66,370 8,779 0 0 0 CN 1,456 48,196 6,375 0 0 0 NG 0 886 117 14,000 203,315 26,894 GH 5 712 94 1,093 423,178 55,976 ZM 0 0 0 23,031 1,856,460 245,563 MU 0 0 0 21,007 1,715,385 226,903 KE 0 0 0 891 837,817 110,822



TH 0 0 0 2,000 685,283 90,646 MZ 0 0 0 5,164 653,800 86,481 UG 0 0 0 167 100,500 13,294 TZ 0 0 0 448 75,872 10,036 BI 0 0 0 24 48,240 6,381

MW 0 0 0 156 40,289 5,329 CD 0 0 0 45 29,121 3,852 LK 0 0 0 100 16,581 2,193 CI 0 0 0 14 15,677 2,074 CG 0 0 0 87 9,045 1,196 SC 0 0 0 80 8,006 1,059 AO 0 0 0 37 6,912 914 RW 0 0 0 18 6,348 840 SH 0 0 0 20 5,441 720 CM 0 0 0 45 5,000 661 GQ 0 0 0 1 90 12

TOTAL 834,179 236,486,984 31,281,347 86,217 17,132,696 2,266,230 P.A.3004.39 Importaciones Exportaciones Pais origen Cantidad Valor Valor Cantidad Valor Valor destino KG Rand U$S KG Rand U$S

DK 32,720 67,206,722 8,889,778 561 102,458 13,553 CH 17,885 39,014,632 5,160,666 1 723 96 NL 11,416 25,359,904 3,354,485 699 95,400 12,619 DE 20,486 18,911,420 2,501,511 1 39,651 5,245 IN 146,719 9,217,253 1,219,213 1 56 7 BE 8,486 7,192,229 951,353 0 0 0 GB 22,444 6,683,577 884,071 707 281,583 37,246 FR 5,149 5,056,877 668,899 17 418 55 IT 1,742 4,298,379 568,569 22 22,124 2,926 IE 1,807 2,274,826 300,903 0 0 0 SE 79 1,789,418 236,696 181 6,212 822 US 318 1,752,910 231,866 973 600,671 79,454 AT 228 1,528,483 202,180 0 0 0 IS 261 311,181 41,162 0 0 0 CN 3,775 282,110 37,316 0 0 0 AU 63 235,603 31,164 781 64,313 8,507 CZ 176 184,116 24,354 0 0 0 ES 100 117,235 15,507 1 2,511 332 ZW 1,334 82,083 10,858 25,570 3,038,889 401,969 PK 341 64,398 8,518 0 0 0 FI 53 58,944 7,797 0 0 0 SA 4 4,292 568 3,205 137,773 18,224 CA 3 3,318 439 6 23,891 3,160



CY 1 3,052 404 0 0 0 NG 0 1,722 228 942 2,597,836 343,629 JP 1 1,597 211 0 0 0 BS 0 531 70 0 0 0 SG 8 405 54 127 42,999 5,688 SV 1 232 31 0 0 0 SC 0 0 0 11,452 1,872,324 247,662 KE 0 0 0 2,966 1,515,428 200,453 HK 0 0 0 17,511 1,033,646 136,726 MU 0 0 0 4,598 892,371 118,038 ZM 0 0 0 1,437 701,252 92,758 TW 0 0 0 1,846 411,281 54,402 VU 0 0 0 49 307,235 40,640 MW 0 0 0 889 306,739 40,574 KW 0 0 0 270 254,536 33,669 LK 0 0 0 3,637 238,224 31,511 MG 0 0 0 1,636 224,960 29,757 CD 0 0 0 1,708 186,433 24,660 PG 0 0 0 8,100 180,000 23,810 TG 0 0 0 199 151,800 20,079 AO 0 0 0 443 135,161 17,878 CM 0 0 0 799 134,894 17,843 MZ 0 0 0 711 71,533 9,462 TZ 0 0 0 38 56,263 7,442 UG 0 0 0 45 46,360 6,132 GH 0 0 0 17 30,391 4,020 MY 0 0 0 70 28,461 3,765 GQ 0 0 0 20 19,283 2,551 ET 0 0 0 17 14,619 1,934 RW 0 0 0 8 12,875 1,703 ML 0 0 0 40 7,383 977 NZ 0 0 0 91 5,369 710 LU 0 0 0 87 4,550 602 PT 0 0 0 5 4,300 569 IR 0 0 0 0 3,507 464 YU 0 0 0 3 2,809 372 AG 0 0 0 1 2,573 340 805 0 0 0 110 900 119 GR 0 0 0 2 500 66 AE 0 0 0 6 250 33 BJ 0 0 0 10 80 11

TOTAL 275,600 191,637,449 25,348,869 92,616 15,915,798 2,105,264 P.A.3004.40 Importaciones Exportaciones



Pais origen Cantidad Valor Valor Cantidad Valor Valor destino KG Rand U$S KG Rand U$S

CH 1,195 6,137,818 811,881 0 0 0 ES 4,604 4,738,744 626,818 203 190,208 25,160 IT 937 3,106,520 410,915 1 316 42

TW 10,070 2,975,129 393,536 0 0 0 DE 957 709,488 93,848 2 1,728 229 US 213 425,153 56,237 0 0 0 SE 3,312 325,305 43,030 0 0 0 GB 21 118,893 15,727 0 0 0 FR 3 95,292 12,605 0 0 0 CA 5 1,810 239 0 0 0 MZ 0 0 0 1,453 278,760 36,873 ZW 0 0 0 2,787 177,689 23,504 CM 0 0 0 8 48,878 6,465 SN 0 0 0 5 47,040 6,222 ZM 0 0 0 4,576 44,762 5,921 GH 0 0 0 2 35,202 4,656 MW 0 0 0 294 29,862 3,950 UG 0 0 0 13 28,957 3,830 BJ 0 0 0 12 28,594 3,782 GN 0 0 0 30 20,358 2,693 CD 0 0 0 40 5,792 766 TZ 0 0 0 55 5,040 667 BA 0 0 0 1 632 84 BE 0 0 0 1 316 42

TOTAL 21,317 18,634,152 2,464,835 9,483 944,134 124,885 P.A.3004.50 Importaciones Exportaciones Pais origen Cantidad Valor Valor Cantidad Valor Valor destino KG Rand U$S KG Rand U$S

DE 18,550 7,354,193 972,777 8,628 876,903 115,992 CH 252 3,254,837 430,534 0 0 0 GB 24,570 2,706,357 357,984 59,816 5,040,918 666,788 DK 1,546 2,211,709 292,554 130 39,206 5,186 NO 850 626,230 82,835 0 0 0 NL 1,802 498,679 65,963 881 32,846 4,345 AU 2,940 433,440 57,333 668 98,348 13,009 US 4,559 410,322 54,275 1,122 667,357 88,275 NZ 1,430 188,628 24,951 0 0 0 IN 1,986 141,629 18,734 0 0 0 FR 568 87,787 11,612 0 0 0 CA 400 68,205 9,022 2,409 3,067,268 405,723 IE 790 48,128 6,366 2 250 33



IT 727 41,858 5,537 70 10,339 1,368 CN 130 4,592 607 105 16,370 2,165 AT 2 3,417 452 6 110 15 BR 15 487 64 2 225 30 CO 0 372 49 0 0 0 ZA 4 106 14 0 0 0 MU 0 0 0 23,047 8,573,489 1,134,059 ZW 0 0 0 52,197 7,512,249 993,684 ZM 0 0 0 290,941 6,141,104 812,315 KE 0 0 0 12,555 5,911,167 781,900 MW 0 0 0 24,028 2,808,380 371,479 TZ 0 0 0 4,762 1,792,924 237,159 JO 0 0 0 5,048 1,738,253 229,928 MZ 0 0 0 3,522 1,240,561 164,095 UG 0 0 0 6,576 750,790 99,311 AO 0 0 0 6,777 573,830 75,903 SN 0 0 0 2,218 475,738 62,928 SC 0 0 0 2,725 357,491 47,287 YU 0 0 0 853 257,080 34,005 HK 0 0 0 717 193,417 25,584 NG 0 0 0 1,423 115,411 15,266 VU 0 0 0 14 107,575 14,229 MG 0 0 0 183 106,767 14,123 AE 0 0 0 278 74,152 9,808 ET 0 0 0 350 71,422 9,447 TR 0 0 0 243 64,308 8,506 CR 0 0 0 113 31,772 4,203 TW 0 0 0 105 29,452 3,896 VE 0 0 0 218 28,081 3,714 MT 0 0 0 81 23,522 3,111 GT 0 0 0 43 22,960 3,037 GA 0 0 0 66 22,271 2,946 PT 0 0 0 81 19,786 2,617 CM 0 0 0 230 19,320 2,556 SA 0 0 0 48 18,173 2,404 SG 0 0 0 39 14,144 1,871 ML 0 0 0 120 13,739 1,817 MY 0 0 0 21 11,745 1,554 CD 0 0 0 131 5,906 781 SD 0 0 0 47 5,703 754 OM 0 0 0 29 4,566 604 CG 0 0 0 8 3,641 482 GR 0 0 0 3 1,700 225 BE 0 0 0 6 753 100 BY 0 0 0 5 552 73



SB 0 0 0 0 350 46 TOTAL 61,121 18,080,976 2,391,663 513,690 48,994,384 6,480,739

P.A.3004.90 Importaciones Exportaciones Pais origen

Cantidad Valor Valor Cantidad Valor Valor

destino KG Rand U$S KG Rand U$S GB 1,127,478 631,514,036 83,533,603 113,621 10,308,645 1,363,577 DE 1,238,209 577,528,522 76,392,662 57,556 10,307,782 1,363,463 FR 798,774 456,779,295 60,420,542 6,492 1,713,700 226,680 CH 227,127 394,104,055 52,130,166 1,159 7,363 974 US 200,285 332,764,958 44,016,529 1,691 639,213 84,552 IE 135,801 272,979,208 36,108,361 20 1,626 215 BE 125,879 251,604,427 33,281,009 17,768 807,293 106,785 IT 295,865 232,112,778 30,702,748 768 204,915 27,105 IN 1,458,052 116,187,111 15,368,665 5 726 96 NL 121,260 106,687,532 14,112,107 11,455 562,986 74,469 ES 247,520 105,670,462 13,977,574 568 189,408 25,054 PR 10,579 103,645,617 13,709,738 0 0 0 SE 129,551 101,684,244 13,450,297 22 369 49 AU 223,631 60,399,789 7,989,390 28,586 2,383,345 315,257 AT 53,765 45,069,298 5,961,547 208 63,553 8,406 DK 19,035 44,463,029 5,881,353 660 358,276 47,391 JP 13,727 32,636,185 4,316,956 4,023 54,553 7,216 PT 15,458 19,095,788 2,525,898 1 316 42 CA 52,235 18,736,154 2,478,327 5,429 499,911 66,126 IR 2,529 13,221,386 1,748,861 16,890 1,751,839 231,725 IS 11,479 12,503,647 1,653,922 0 0 0 MX 153,305 9,416,969 1,245,631 0 0 0 KR 12,401 9,245,154 1,222,904 2,198 893,697 118,214 BR 19,851 9,027,712 1,194,142 489 33,356 4,412 FI 1,414 6,889,448 911,303 0 7 1

CN 51,360 4,376,099 578,849 0 0 0 NZ 10,905 4,220,704 558,294 3,129 63,226 8,363 NO 4,366 3,703,280 489,852 381 56,379 7,458 TR 7,813 3,667,080 485,063 0 0 0 IL 6,360 2,116,086 279,906 9,138 2,855,212 377,674 SI 6,505 1,714,926 226,842 0 0 0 ZA 15,635 1,536,525 203,244 0 0 0 MY 11,591 1,348,307 178,347 10,884 1,959,218 259,156 CO 3,345 1,326,672 175,486 0 0 0 SL 957 944,955 124,994 60 14,636 1,936 TW 2,634 764,212 101,086 405 88,223 11,670 ZNC 3,777 697,113 92,211 5 28,397 3,756 SO 474 634,038 83,867 0 0 0



TH 4,275 490,078 64,825 106 34,612 4,578 ZW 37,519 454,725 60,149 138,260 16,436,943 2,174,199 MA 1,000 425,949 56,342 0 0 0 AR 21 365,161 48,302 0 0 0 GR 1,792 299,848 39,662 394 47,567 6,292 SA 115 243,070 32,152 4,116 1,914,526 253,244 MZ 2,490 200,529 26,525 72,164 6,945,026 918,654 ZM 3,639 157,340 20,812 218,074 11,335,267 1,499,374 CZ 95 139,093 18,399 418 166,201 21,984 SG 1,548 80,584 10,659 10,611 1,220,916 161,497 KE 139 62,613 8,282 387,059 43,841,495 5,799,140 AZ 766 52,973 7,007 0 0 0 HK 218 47,664 6,305 12,060 5,434,895 718,901 HU 129 45,000 5,952 15,245 162,343 21,474 TZ 54 32,372 4,282 28,506 1,705,943 225,654 RE 1 18,596 2,460 0 0 0 EG 104 4,608 610 141 29,020 3,839 BD 60 4,233 560 1 316 42 CI 28 4,177 553 68 12,343 1,633 EC 3 3,922 519 1 1,898 251 TN 0 2,876 380 1 316 42 RU 0 2,528 334 0 0 0 CR 0 593 78 0 0 0 NE 1 444 59 7 43,892 5,806 PH 1 432 57 45 3,927 519 DO 0 422 56 0 0 0 NG 0 386 51 28,399 11,880,393 1,571,481 ET 6 225 30 13,121 626,296 82,843 MU 10 202 27 97,231 16,067,144 2,125,284 PK 41 171 23 155 27,810 3,679 AE 0 134 18 2,491 626,646 82,890 CD 3 122 16 154,282 1,569,040 207,545 BZ 1 106 14 0 0 0 UG 0 45 6 113,039 8,683,562 1,148,619 CY 19 35 5 107 70,648 9,345 ML 85 20 3 3,260 359,768 47,588 HN 1 14 2 2 43,008 5,689 DM 0 0 0 1,972 9,527,362 1,260,233 MW 0 0 0 1,074,397 9,147,993 1,210,052 GH 0 0 0 76,978 5,651,334 747,531 AO 0 0 0 73,399 2,089,306 276,363 IQ 0 0 0 20,120 1,661,205 219,736 HR 0 0 0 2,800 853,563 112,905 GQ 0 0 0 1,146 744,433 98,470 SC 0 0 0 7,901 660,637 87,386



CM 0 0 0 3,195 625,766 82,773 LK 0 0 0 399 425,416 56,272 GM 0 0 0 1,191 396,273 52,417 YU 0 0 0 1,227 370,674 49,031 RW 0 0 0 573 318,370 42,112 KY 0 0 0 15,000 269,542 35,654 KW 0 0 0 1,004 268,728 35,546 CG 0 0 0 72 259,710 34,353 GT 0 0 0 1,077 206,889 27,366 MG 0 0 0 919 152,608 20,186 BH 0 0 0 619 140,985 18,649 MT 0 0 0 493 129,339 17,108 HV 0 0 0 89 97,271 12,867 SN 0 0 0 450 90,558 11,979 BJ 0 0 0 29 81,013 10,716 TG 0 0 0 340 56,100 7,421 BG 0 0 0 581 55,813 7,383 GA 0 0 0 44 54,378 7,193 TD 0 0 0 342 51,788 6,850 JO 0 0 0 28 47,450 6,276 LU 0 0 0 381 46,460 6,146 BA 0 0 0 120 34,420 4,553 AN 0 0 0 462 27,575 3,647 GN 0 0 0 19 25,874 3,422 OM 0 0 0 278 19,467 2,575 LY 0 0 0 350 15,110 1,999 SH 0 0 0 459 14,861 1,966 UZ 0 0 0 2 13,984 1,850 YE 0 0 0 50 12,284 1,625 VN 0 0 0 30 11,643 1,540 BI 0 0 0 181 11,199 1,481 CV 0 0 0 6 10,559 1,397 ID 0 0 0 2 9,487 1,255 PL 0 0 0 39 6,872 909 GE 0 0 0 56 6,174 817 PE 0 0 0 76 4,710 623 SV 0 0 0 1 1,580 209 MK 0 0 0 1 1,450 192 BB 0 0 0 1 949 126 DJ 0 0 0 8 936 124 NP 0 0 0 1 633 84 PA 0 0 0 1 633 84 SR 0 0 0 1 633 84 VE 0 0 0 1 633 84 NI 0 0 0 1 632 84



MH 0 0 0 162 578 76 AM 0 0 0 1 316 42 DZ 0 0 0 1 316 42 MM 0 0 0 1 316 42 UA 0 0 0 1 316 42 GP 0 0 0 0 283 37 EE 0 0 0 10 221 29

TOTAL 6,875,096 3,994,158,091 528,327,790 2,882,063 199,855,539 26,435,918 Fuente: Customs & Excise Codigo de Paises: Ver anexo 2 ESTADISTICAS DE IMPORTACION Y EXPORTACION CON PAISES DE ORIGEN Y DESTINO AÑO 2004

P.A.3002.30 Importaciones Exportaciones Pais origen Cantidad Valor Valor Cantidad Valor Valor destino kg Rand U$S kg Rand U$S

AE 0 0 0 257 362,626 56,221 AL 0 0 0 4 3,645 565

AO 0 0 0 6,142 857,338 132,921 AR 988 696,865 108,041 0 0 0

AU 2,310 1,065,481 165,191 46 26,943 4,177 BI 0 0 0 4 2,680 416

BJ 0 0 0 15 16,890 2,619 BR 5,872 3,296,974 511,159 1 7 1 CA 19 32,541 5,045 0 0 0

CD 0 0 0 2,247 157,014 24,343 CG 0 0 0 140 9,962 1,544

CH 0 0 0 22 2,051 318 CM 0 0 0 388 113,823 17,647

CO 0 0 0 10 1,075 167 CV 0 0 0 2 5,787 897

DE 37,001 14,768,731 2,289,726 102 35,255 5,466 DZ 0 0 0 3 1,730 268

EG 0 0 0 11 34,320 5,321 ES 1,452 3,785,918 586,964 1,560 1,908,617 295,910

FR 65,989 23,489,427 3,641,772 249 271,000 42,016 GA 0 0 0 239 38,872 6,027

GB 9,857 5,098,569 790,476 35 44,138 6,843 GH 0 0 0 556 91,372 14,166 GM 0 0 0 8 24,085 3,734

GN 0 0 0 6 28,483 4,416 GY 559 16,560 2,567 0 0 0

HK 0 0 0 1 780 121



HU 12,832 5,084,991 788,371 4,800 336,000 52,093 ID 0 0 0 2 871 135

IE 3,497 539,261 83,606 2 300 47 IL 1,523 2,485,398 385,333 1,021 296,410 45,955

IN 170 19,310 2,994 150 54,842 8,503 IT 12,868 3,718,812 576,560 6,992 49,196,346 7,627,340

KE 0 0 0 3,511 965,648 149,713 KG 0 0 0 43 20,349 3,155 KW 0 0 0 805 115,354 17,884

LR 0 0 0 4 1,035 160 MA 0 0 0 36 223,540 34,657

MD 0 0 0 42 132,233 20,501 MG 0 0 0 386 279,822 43,383

MK 0 0 0 5 655 102 ML 0 0 0 3 1,308 203

MR 0 0 0 1,834 299,262 46,397 MU 0 0 0 3,830 1,259,766 195,313

MW 0 0 0 5,262 1,832,240 284,068 MY 4 398 62 0 0 0

MZ 0 0 0 829 755,594 117,146 NC 0 0 0 42 65,388 10,138

NE 0 0 0 5 5,166 801 NG 0 0 0 77 134,415 20,840 NL 45,184 18,458,626 2,861,802 172 256,517 39,770

NO 10 39,287 6,091 0 0 0 NZ 9,221 1,376,392 213,394 40 70,692 10,960

OM 0 0 0 15 6,756 1,047 PK 0 0 0 300 321,000 49,767

RU 0 0 0 4 3,600 558 RW 0 0 0 547 134,346 20,829

SA 0 0 0 4 1,517 235 SC 0 0 0 23 150,658 23,358

SD 0 0 0 89 30,152 4,675 SH 0 0 0 32 5,662 878

SL 0 0 0 7 8,059 1,249 SN 0 0 0 11 18,796 2,914

TD 0 0 0 39 35,164 5,452 TM 0 0 0 13 20,687 3,207 TN 0 0 0 3,160 2,512,565 389,545

TZ 0 0 0 2,772 1,666,330 258,346 UG 0 0 0 3,210 559,672 86,771

US 93,162 18,892,137 2,929,013 7 15,288 2,370 UY 42,943 7,823,321 1,212,918 0 0 0

YE 0 0 0 8 8,449 1,310 ZA 10 6,182 958 0 0 0



ZM 0 0 0 82,203 5,627,319 872,453 ZW 0 0 0 21,020 7,406,647 1,148,317

Total 345,471 110,695,181 17,162,044 155,405 78,874,913 12,228,669


AE 0 0 0 1,318 152,505 23,644 AO 0 0 0 284 164,592 25,518

AT 70,900 12,027,845 1,864,782 0 0 0 AU 1,724 1,292,909 200,451 14,037 195,235 30,269

BE 5,651 3,592,575 556,988 0 0 0 BR 3,996 726,895 112,697 2,273 175,645 27,232

CA 0 1,461 227 0 0 0 CD 0 0 0 1,371 320,883 49,749

CH 113 192,675 29,872 0 0 0 DE 23,211 2,808,957 435,497 0 0 0

ET 0 0 0 27 19,852 3,078 FI 3 9,561 1,482 0 0 0

FR 6,335 7,967,698 1,235,302 0 0 0 GB 123,289 30,344,940 4,704,642 632 14,934 2,315

GQ 0 0 0 21 19,415 3,010 HK 0 0 0 1,625 498,933 77,354 ID 0 0 0 1 51 8

IE 16,487 1,582,096 245,286 0 0 0 IN 75,952 9,101,645 1,411,108 0 0 0

IT 5,448 2,067,818 320,592 24 12,349 1,915 JP 1 1,111 172 0 0 0

KE 0 0 0 287 108,252 16,783 MU 0 0 0 86 5,752 892

MW 0 0 0 8 4,595 712 MZ 0 0 0 9 1,502 233

NG 0 0 0 110 25,595 3,968 NL 12,562 4,240,105 657,381 0 0 0

SE 0 0 0 70 9,457 1,466 SI 52,583 8,663,809 1,343,226 0 0 0

TZ 0 0 0 9 4,005 621 US 7,868 8,770,265 1,359,731 0 0 0 ZA 669 23,753 3,683 0 0 0

ZM 0 0 0 1,747 203,555 31,559 ZNC 235 48,330 7,493 0 0 0

ZW 0 0 0 913 663,050 102,798 805 0 0 0 0 1,421 220

Total 407,027 93,464,448 14,490,612 24,852 2,601,578 403,345



P.A.3004.20 Importaciones Exportaciones

Pais origen Cantidad Valor Valor Cantidad Valor Valor destino kg Rand U$S kg Rand U$S

AE 7 831 129 0 0 0 AF 3,230 3,066,973 475,500 0 0 0

AO 0 0 0 26 11,331 1,757 AT 442 326,640 50,642 1,353 447,411 69,366 AU 2,962 6,597,646 1,022,891 6 25,573 3,965

BE 42,154 5,862,847 908,969 0 0 0 BI 0 0 0 2 50 8

BR 25,290 3,276,118 507,925 0 0 0 CA 24,251 2,030,990 314,882 0 0 0

CD 0 0 0 0 250 39 CH 970 921,098 142,806 0 0 0

CL 0 0 0 2,251 1,008,788 156,401 CN 305 26,635 4,129 0 0 0

CO 0 0 0 750 335,539 52,022 CY 443 367,661 57,002 0 0 0

DE 14,203 13,121,569 2,034,352 480 2,736,481 424,261 DK 905 1,451,255 225,001 0 0 0

ER 0 0 0 19 157,358 24,397 ES 436 687,796 106,635 0 0 0 FR 82,749 36,460,016 5,652,716 0 0 0

GB 227,204 44,049,019 6,829,305 1,242 559,196 86,697 GH 0 0 0 18 4,775 740

GQ 0 0 0 1 273 42 GR 846 263,997 40,930 507 43,195 6,697

HU 753 181,421 28,127 2,600 306,906 47,582 ID 0 0 0 2 55,388 8,587

IE 9,719 2,526,999 391,783 0 0 0 IN 190,981 21,352,428 3,310,454 0 0 0

IT 89,422 43,518,100 6,746,992 0 0 0 JP 4,983 19,834,292 3,075,084 0 0 0

KE 0 0 0 14,101 1,962,817 304,313 KG 0 0 0 12 24,308 3,769

MA 0 0 0 1 50 8 MU 0 0 0 7,998 627,772 97,329 MW 0 0 0 1,936 128,543 19,929

MX 3,102 962,522 149,228 0 0 0 MY 0 0 0 2,329 822,711 127,552

MZ 0 0 0 531 65,952 10,225 NE 0 0 0 7 13,564 2,103

NG 0 0 0 1 7,153 1,109 NL 30,452 6,975,230 1,081,431 1 316 49



NO 30,000 619,256 96,009 0 0 0 NZ 781 79,749 12,364 0 0 0

PE 0 0 0 255 120,830 18,733 PT 10,823 1,722,004 266,977 0 0 0

RW 0 0 0 234 453,646 70,333 SC 0 0 0 222 7,614 1,180

SG 0 0 0 186 48,296 7,488 SL 0 0 0 7 1,838 285 TH 0 0 0 4,859 1,760,842 272,999

TW 0 0 0 3 226,262 35,079 TZ 0 0 0 76 25,698 3,984

UG 0 0 0 31,404 1,288,731 199,803 US 196,926 29,401,375 4,558,353 1,579 195,681 30,338

VU 0 0 0 147 108,787 16,866 ZA 9,975 338,861 52,537 0 0 0

ZM 0 0 0 6,633 2,209,880 342,617 ZNC 1,473 445,854 69,125 0 0 0

ZW 16,279 687,918 106,654 7,296 1,904,283 295,238 805 0 0 0 50 40,910 6,343

Total 1,022,066 247,157,100 38,318,930 89,125 17,738,998 2,750,232


CA 0 1,771 275 0 0 0 CD 0 0 0 2 995 154

CH 5 19,128 2,966 0 0 0 DE 191 293,072 45,438 0 0 0

DK 103,023 129,371,419 20,057,584 0 0 0 EG 14,393 12,210,416 1,893,088 0 0 0

FR 13,345 44,548,053 6,906,675 0 0 0 GB 4 66,188 10,262 0 0 0

HK 20 22,898 3,550 0 0 0 KE 0 0 0 8 17,390 2,696

MU 0 0 0 5,144 6,879,465 1,066,584 MW 0 0 0 617 1,030,791 159,813 MZ 0 0 0 649 915,472 141,934

SD 0 0 0 96 61,775 9,578 US 93 81,898 12,697 0 0 0

ZM 0 0 0 393 609,257 94,458 ZW 0 0 0 3,743 5,232,603 811,256

Total 131,074 186,614,843 28,932,534 10,652 14,747,748 2,286,473





AT 13 50,244 7,790 0 0 0 BE 55,071 67,342,527 10,440,702 0 0 0

CH 48 159,159 24,676 0 0 0 DE 7,407 14,056,649 2,179,325 0 0 0 ES 1,094 718,467 111,390 0 0 0

FR 93,341 4,712,284 730,587 0 0 0 GB 1,473 1,374,539 213,107 104 17,640 2,735

IT 12,777 18,146,376 2,813,392 0 0 0 KE 0 0 0 682 457,154 70,877

MT 0 0 0 42 56,990 8,836 MW 0 0 0 3 1,554 241

MZ 0 0 0 1 708 110 NL 3,578 3,618,978 561,082 0 0 0

PH 0 0 0 144 76,500 11,860 PT 886 1,406,648 218,085 0 0 0

SE 7,056 7,770,077 1,204,663 0 0 0 US 5,927 4,410,761 683,839 0 0 0

ZW 0 0 0 323 102,617 15,910 Total 188,671 123,766,709 19,188,637 1,299 713,163 110,568



AE 0 0 0 1 3,670 569 AO 0 0 0 887 419,005 64,962

AT 113 895,482 138,834 0 0 0 AU 1,597 801,391 124,247 240 18,060 2,800

AW 0 0 0 4 6,464 1,002 BE 9,584 5,604,413 868,901 0 0 0

BI 0 0 0 1,186 73,025 11,322 BJ 0 0 0 1 2,108 327

BR 200 17,084 2,649 0 0 0 CA 1 885 137 0 0 0 CD 0 0 0 766 26,564 4,118

CH 21,610 33,621,209 5,212,591 1 2,100 326 CN 2,136 135,509 21,009 0 0 0

CO 0 633 98 0 0 0 CY 0 0 0 2 23,500 3,643

CZ 292 279,370 43,313 0 0 0 DE 31,741 37,285,930 5,780,764 8 22,743 3,526



DK 20,867 51,060,191 7,916,309 0 0 0 ES 100 124,745 19,340 0 0 0

ET 0 0 0 5 3,856 598 FR 2,088 6,268,939 971,929 0 0 0

GB 18,021 12,588,307 1,951,676 44,843 742,910 115,180 GH 0 0 0 45 67,145 10,410

GQ 0 0 0 1 92 14 HK 1 504 78 15,054 407,282 63,144 IE 1,545 1,412,349 218,969 3 300 47

IN 151,921 8,734,044 1,354,115 1 50 8 IT 2,416 1,736,779 269,268 18 2,818 437

JM 0 2,743 425 0 0 0 KE 0 144 22 10,098 1,953,223 302,825

KR 1 10,246 1,589 0 0 0 KW 0 0 0 115 177,098 27,457

LK 0 0 0 661 338,561 52,490 MG 0 0 0 3,787 336,700 52,202

MO 0 0 0 218 13,931 2,160 MU 0 0 0 4,178 531,350 82,380

MW 0 0 0 758 56,406 8,745 MX 1 1,884 292 0 0 0

MY 8 7,139 1,107 59 35,836 5,556 MZ 0 0 0 1,335 1,111,656 172,350 NG 0 0 0 359 966,978 149,919

NL 9,295 19,995,524 3,100,081 111 40,017 6,204 NO 0 0 0 1 4,210 653

NZ 2 2,363 366 369 502,436 77,897 PK 1,100 119,420 18,515 0 0 0

SC 0 0 0 6,260 575,450 89,217 SD 0 0 0 167 67,020 10,391

SE 146 1,631,071 252,879 0 0 0 TR 0 0 0 78 8,855 1,373

TW 0 0 0 8,484 1,947,943 302,007 TZ 0 0 0 91 6,548 1,015

UA 0 566 88 0 0 0 UG 0 0 0 87 35,869 5,561

US 5,071 4,317,448 669,372 41 74,065 11,483 VU 0 0 0 4 17,600 2,729 ZA 19 6,816 1,057 0 0 0

ZM 0 0 0 3,863 997,990 154,727 ZW 0 0 0 40,480 1,921,635 297,928

805 0 0 0 436 17,516 2,716 Total 279,876 186,663,128 28,940,020 145,106 13,560,585 2,102,416





AO 0 0 0 7 18,440 2,859 BE 675 242,633 37,618 0 0 0

CA 30 2,038 316 0 0 0 CH 367 3,495,954 542,008 0 0 0

DE 1,331 2,126,177 329,640 0 0 0 ES 3,325 2,724,833 422,455 0 0 0 FR 20 37,802 5,861 0 0 0

GB 152 1,150,967 178,444 0 0 0 IT 653 1,831,186 283,905 0 0 0

KE 0 0 0 4,023 19,202 2,977 MW 0 0 0 11 20,159 3,125

PH 3,534,792 7,207,723 1,117,476 0 0 0 SL 0 0 0 50 16,868 2,615

TW 8,178 2,527,136 391,804 0 0 0 TZ 0 0 0 5 117 18

US 59 1,745,394 270,604 0 0 0 ZM 0 0 0 3,000 11,760 1,823

ZW 606 100,680 15,609 2,535 57,871 8,972 805 0 0 0 19 10,032 1,555

Total 3,550,188 23,192,523 3,595,740 9,650 154,449 23,946


AE 0 0 0 95 15,606 2,420

AO 0 0 0 3,469 1,552,249 240,659 AT 210 163,086 25,285 2 1,496 232

AU 480 94,540 14,657 133 30,436 4,719 BE 2,084 532,878 82,617 90 192,451 29,837

BG 0 0 0 162 33,745 5,232 BR 182 6,324 980 0 0 0

CA 660 57,118 8,856 31 2,968 460 CD 0 0 0 1,655 39,328 6,097

CG 0 0 0 500 6,460 1,002 CH 468 646,554 100,241 7 1,126 175 CM 0 0 0 118 6,402 993

CN 320 4,925 764 0 0 0 CZ 0 0 0 71 26,630 4,129

DE 13,322 6,319,025 979,694 4,352 435,878 67,578 DK 1,318 2,836,868 439,824 36 28,392 4,402

ES 8,375 816,419 126,577 0 0 0 ET 0 0 0 910 274,280 42,524



FR 298 32,027 4,965 30 63,881 9,904 GB 25,558 2,185,406 338,823 486 107,279 16,632

GQ 0 0 0 14 5,338 828 GR 0 0 0 8 4,434 687

HK 0 0 0 136 3,749 581 IE 698 726,858 112,691 7 750 116

IN 295 59,399 9,209 12 1,692 262 IR 2,707 72,906 11,303 0 0 0 IT 17 12,755 1,978 23 18,238 2,828

KE 0 0 0 13,840 7,591,934 1,177,044 MG 0 0 0 2 4,789 742

MU 0 0 0 3,259 1,088,759 168,800 MW 0 0 0 3,680 1,786,845 277,030

MX 3,466 574,890 89,130 0 0 0 MY 0 0 0 63 69,440 10,766

MZ 0 0 0 1,651 733,546 113,728 NG 0 0 0 14,748 670,951 104,023

NL 7,513 1,977,016 306,514 943 196,095 30,402 NO 142 138,105 21,412 0 0 0

NZ 2,956 492,054 76,287 211 16,993 2,635 PL 0 0 0 19 7,765 1,204

PT 0 0 0 202 52,464 8,134 RW 0 0 0 32 4,131 640 SA 0 0 0 4 202 31

SC 0 0 0 1,145 152,869 23,701 SG 0 0 0 61 87,991 13,642

SH 0 0 0 60 189 29 TD 0 0 0 191 107,342 16,642

TW 0 0 0 753 167,532 25,974 TZ 0 0 0 4,445 1,342,555 208,148

UA 0 0 0 1 1,000 155 UG 0 0 0 5,330 2,202,355 341,450

US 481 72,027 11,167 157 69,837 10,827 VE 0 0 0 107 13,755 2,133

VU 0 0 0 21 157,860 24,474 YU 0 0 0 526 137,889 21,378

ZM 0 0 0 173,106 8,222,414 1,274,793 ZNC 839 52,023 8,066 0 0 0 ZW 0 0 0 29,551 3,665,718 568,328

805 0 0 0 0 503 78 Total 72,389 17,873,203 2,771,039 266,455 31,406,531 4,869,230

P.A.3004.90 Importaciones Exportaciones Pais origen Cantidad Valor Valor Cantidad Valor Valor



destino kg Rand U$S kg Rand U$S AE 18 74 11 3,419 343,987 53,331

AF 2,722 1,093,967 169,607 2 20 3 AN 0 0 0 894 126,804 19,660

AO 0 0 0 5,105 1,381,708 214,218 AR 16 16,418 2,545 466 40,367 6,258

AT 131,011 46,699,849 7,240,287 195 52,813 8,188 AU 324,030 80,460,787 12,474,541 23,164 1,768,755 274,226 BA 0 0 0 112 9,840 1,526

BB 15 10,661 1,653 25 33,365 5,173 BE 108,307 105,592,051 16,370,861 13,735 481,287 74,618

BH 0 0 0 341 45,768 7,096 BI 0 0 0 2,342 77,665 12,041

BJ 0 0 0 1,167 320,670 49,716 BR 99,785 28,414,159 4,405,296 921 52,013 8,064

CA 113,900 47,833,260 7,416,009 3,697 256,404 39,753 CD 0 0 0 9,230 685,455 106,272

CG 273 91,890 14,247 2,130 226,769 35,158 CH 222,632 307,718,221 47,708,251 1,009 304,504 47,210

CI 0 0 0 10,764 240,253 37,249 CL 4 1,722 267 0 0 0

CM 0 0 0 1,535 232,225 36,004 CN 84,571 6,528,533 1,012,176 10 513 80 CO 2,702 979,023 151,787 0 0 0

CV 0 0 0 126 63,821 9,895 CY 0 402 62 20 15,337 2,378

CZ 0 0 0 13,754 1,236,260 191,668 DE 2,083,620 611,767,387 94,847,657 41,639 7,222,080 1,119,702

DK 31,249 71,425,742 11,073,758 1,546 636,539 98,688 DM 0 0 0 624 3,000,000 465,116

EG 0 0 0 1,366 314,295 48,728 ER 0 0 0 277 4,759 738

ES 243,641 144,235,380 22,362,074 38,420 5,187,238 804,223 ET 1 4,135 641 3,909 1,866,397 289,364

FI 2,830 7,776,320 1,205,631 0 0 0 FR 609,597 387,540,620 60,083,817 33,511 5,959,334 923,928

GA 0 0 0 348 51,897 8,046 GB 1,285,627 527,006,789 81,706,479 48,841 6,951,201 1,077,706 GE 0 0 0 6 3,250 504

GH 4 47 7 75,013 5,413,900 839,364 GM 0 0 0 8 216,030 33,493

GN 0 0 0 663 307,585 47,688 GP 30 36,787 5,703 0 0 0

GQ 0 0 0 3,296 1,374,447 213,093 GR 861 105,134 16,300 1,815 148,413 23,010



GT 0 0 0 2,182 480,989 74,572 HK 182 94,086 14,587 10,661 1,566,138 242,812

HR 180 88,454 13,714 0 0 0 HT 0 0 0 30 561,816 87,103

HU 1,505 634,500 98,372 610 53,000 8,217 HV 0 0 0 74 13,908 2,156

ID 3 72 11 1 95 15 IE 150,621 291,021,957 45,119,683 19 1,530 237 IL 2,738 2,623,856 406,799 6,215 722,522 112,019

IN 2,125,081 180,834,814 28,036,405 1,172 51,207 7,939 IQ 0 0 0 12,600 1,621,585 251,409

IS 16,337 12,948,515 2,007,522 0 0 0 IT 357,920 294,239,141 45,618,471 273 218,886 33,936

JO 105 24,936 3,866 0 0 0 JP 4,414 18,661,290 2,893,223 3,627 1,624,121 251,802

KE 909 1,011,693 156,852 432,974 34,445,599 5,340,403 KH 0 0 0 59 1,508,184 233,827

KR 14,004 9,448,393 1,464,867 1,639 978,562 151,715 KW 0 0 0 563 183,379 28,431

LB 0 0 0 260 9,348 1,449 LK 0 0 0 205 162,728 25,229

LU 1,316 594,847 92,224 0 0 0 LV 5 7,981 1,237 0 0 0 LY 0 0 0 1,438 138,122 21,414

MG 0 0 0 2,114 295,841 45,867 ML 0 0 0 5,841 935,313 145,010

MR 0 0 0 1,823 385,680 59,795 MT 0 0 0 152 23,844 3,697

MU 161 45,504 7,055 112,499 12,000,309 1,860,513 MW 24 22,523 3,492 228,896 6,935,341 1,075,247

MX 182,290 9,888,877 1,533,159 0 0 0 MY 3,912 325,331 50,439 7,337 1,105,717 171,429

MZ 0 0 0 82,643 5,623,440 871,851 NG 6 503 78 223,599 17,072,339 2,646,874

NL 104,242 105,725,835 16,391,602 2,585 168,880 26,183 NO 4,956 4,117,695 638,402 0 0 0

NZ 15,947 14,114,182 2,188,245 16,124 352,317 54,623 OM 0 0 0 24 2,037 316 PA 0 0 0 22 1,259 195

PE 0 0 0 148 68,669 10,646 PH 17 35,756 5,544 1 316 49

PK 537 11,038 1,711 0 0 0 PL 3,658 1,580,701 245,070 0 0 0

PR 43,896 276,251,499 42,829,690 0 0 0 PT 22,112 18,543,732 2,874,997 156 2,434 377



QA 0 0 0 122 21,795 3,379 RE 0 0 0 4 415 64

RW 0 0 0 3,262 2,824,112 437,847 SA 3 106 16 40,098 1,972,704 305,846

SC 0 0 0 8,481 949,677 147,237 SD 0 0 0 117 107,524 16,670

SE 93,514 111,268,098 17,250,868 0 0 0 SG 3,965 333,353 51,683 1,396 121,242 18,797 SH 0 0 0 584 29,113 4,514

SI 10,469 4,520,225 700,810 971 112,952 17,512 SL 822 1,022,661 158,552 11,878 32,833 5,090

SM 1,139 1,240,639 192,347 0 0 0 SN 0 0 0 5 4,177 648

ST 0 0 0 128 21,100 3,271 SY 0 0 0 2 910 141

TD 0 0 0 161 133,323 20,670 TG 0 0 0 4 20,000 3,101

TH 151 34,464 5,343 514 70,449 10,922 TM 0 0 0 8 37,714 5,847

TR 10,735 4,348,388 674,169 1,787 632,230 98,020 TW 6,486 1,482,545 229,852 1,192 241,500 37,442

TZ 48 1,172 182 40,086 10,397,556 1,612,024 UA 1 25,862 4,010 0 0 0 UG 1 3,285 509 302,367 29,670,709 4,600,110

US 322,561 420,983,892 65,268,820 16,359 1,849,156 286,691 UY 862 65,802 10,202 0 0 0

UZ 0 0 0 10 32,772 5,081 VG 0 0 0 60 4,650 721

VU 0 0 0 116 499,961 77,513 YE 0 0 0 455 64,193 9,952

YU 0 0 0 1,244 118,080 18,307 ZA 3,110 507,174 78,632 0 0 0

ZM 1 619 96 502,325 51,247,175 7,945,298 ZNC 2,950 1,537,312 238,343 0 0 0

ZW 47,271 2,370,896 367,581 205,706 14,469,656 2,243,358 805 0 0 0 837 67,874 10,523

Total 8,908,613 4,167,983,562 646,199,002 2,644,290 251,724,975 39,027,128

Fuente: Customs & Excise Codigo de Paises: Ver anexo 2 EXPORTACIONES SUDAFRICANAS: P.A. AÑO CANTIDAD KG VALOR RAND VALOR U$S (*)



3002.30. 1997 45,884 7,319,625 1,587,771 3002.30. 1998 81,509 11,684,021 2,112,843 3002.30. 1999 71,985 10,912,087 1,785,939 3002.30. 2000 45,900 11,753,729 1,693,621 3002.30. 2001 210,305 54,082,829 6,281,397 3002.30. 2002 104,435 117,117,189 11,132,813 P.A. AÑO CANTIDAD Kg VALOR RAND VALOR U$S (*) 3004.10. 1997 153.057 1,739,445 377,3203004.10. 1998 68.324 3,580,289 647,4303004.10. 1999 36.772 4,618,635 755,9143004.10. 2000 70.511 11,581,236 1,668,7663004.10. 2001 27,318 4,062,032 471,7813004.10. 2002 8,351 3,094,530 294,1573004.10. 2003 7,023 1,678,846 222,070 P.A. AÑO CANTIDAD Kg VALOR RAND VALOR U$S (*) 3004.20. 1997 58.797 9,889,598 2,145,2493004.20. 1998 106.381 20,967,488 3,791,5893004.20. 1999 85.678 18,790,865 3,075,4283004.20. 2000 209.115 39,545,554 5,698,2073004.20. 2001 127,791 10,396,927 1,207,5413004.20. 2002 156,642 27,050,183 2,571,3103004.20. 2003 86,217 17,132,696 2,266,230 P.A. AÑO CANTIDAD Kg VALOR RAND VALOR U$S (*) 3004.39. 1997 272.519 32,462,518 7,041,7613004.39. 1998 237.030 39,600,537 7,161,0373004.39. 1999 180.178 34,182,799 5,594,5663004.39. 2000 222.653 30,835,150 4,443,1053004.39. 2001 592,268 50,544,333 5,870,4223004.39. 2002 169,135 29,201,200 2,775,7793004.39. 2003 92,616 15,915,798 2,105,264 P.A. AÑO CANTIDAD Kg VALOR RAND VALOR U$S (*) 3004.40. 1997 329.750 9,923,855 2,152,6803004.40. 1998 35.205 15,644,260 2,828,9803004.40. 1999 35.789 3,650,713 597,4983004.40. 2000 4.204 154,805 22,3063004.40. 2001 91,589 1,790,550 207,9623004.40. 2002 13,924 1,472,602 139,9813004.40. 2003 9,483 944,134 124,885 P.A. AÑO CANTIDAD Kg VALOR RAND VALOR U$S (*) 3004.50. 1997 167.872 7,324,144 1,588,7513004.50. 1998 111.840 10,435,840 1,887,1323004.50. 1999 307.306 39,717,895 6,500,474



3004.50. 2000 344.620 45,568,020 6,565,9973004.50. 2001 247,540 57,256,845 6,650,0403004.50. 2002 309,261 94,703,237 9,002,2093004.50. 2003 513,690 48,994,384 6,480,739 P.A. AÑO CANTIDAD Kg VALOR RAND VALOR U$S (*) 3004.90. 1997 2.303.798 106,574,804 23,118,1793004.90. 1998 3.325.855 203,204,040 36,745,7583004.90. 1999 2.988.133 165,907,801 27,153,4863004.90. 2000 3.291.771 375,889,763 54,162,7903004.90. 2001 4,324,310 197,314,893 22,916,9453004.90. 2002 3,752,724 242,548,773 23,055,9673004.90. 2003 2,882,063 199,855,539 26,435,918Fuente: Monthly Abstract of Trade Statistics. (*) Valor calculado con tasa de cambio promedio anual para cada año. CAMARAS DE COMERCIO SUDAFRICANAS DURBAN CHAMBER OF COMMERCE Mr. J. Naidoo P.O. Box 1506 TEL: (2731) 335-1000 Durban, 4000 FAX: (2731) 322-1288 Sudáfrica E-MAIL: [email protected] JOHANNESBURG CHAMBER OF COMMERCE Ms. Leticia Schutte Private Bag 34 TEL: (2711) 726-5300 Auckland Park, 2006 FAX: (2711) 482-2000 Sudáfrica E-MAIL: [email protected] CAPE CHAMBER OF COMMERCE AND INDUSTRY Ms. Jeannie Taljard P.O. Box 204 TEL: (2721) 418-4300 Cape Town, 8000 FAX: (2721) 418-1800 Sudáfrica E-MAIL: [email protected] PRETORIA CHAMBER OF BUSINESS Mr. G. Herbert P.O. Box 40653 TEL: (2712) 342-3236 Arcadia, 0007 FAX: (2712) 342-1486 Sudáfrica PORT ELIZABETH REGIONAL CHAMBER OF COMMERCE AND INDUSTRY Ms. Samantha Barnes P.O. Box 1137 TEL: (2741) 484-4430 North End, 6056 FAX: (2741) 487-1851 Sudáfrica E-mail: [email protected] DESPACHANTES DE ADUANA:



Translink Mr. Mike Weeks Tel: (2711) 396-1325/6 P.O. Box 1168 Fax: (2711) 396-3221 / 2111 Kempton Park, 1620 E-mail: [email protected] Sudafrica Pagina Web: http://www.translink.co.za Renfreight P.O. Box 4281 Tel: (2711) 407-3500 Johannesburg, 2000 Fax: (2711) 339-6889 Sudafrica E-mail: [email protected] Hansefracht Africa Projects P.O. Box 8096 Tel: (2711) 969-4924 Putfontein, 1513 Fax: (2711) 969-4939 Sudafrica E-mail: [email protected] Safcor Freight P.O.Box 707 Tel: (2711) 377-7000 Johannesburg, 2000 Fax: (2711) 377-7111 Sudafrica E-mail: [email protected] LISTADO DE EMPRESAS SUDAFRICANAS IMPORTADORAS Y/O DISTRIBUIDORAS DE MEDICAMENTOS PARA USO VETERINARIO. Transfarm Ltd Contacto: Mr. D. Coetzee Tel: (2712) 377-9000 / 3441 Fax: (2712) 377-0929 / 0144 E-mail: [email protected] Tipo de empresa: Mayorista farmaceutico Establecido:1980 Empleados 200 IPS Ltd Contact: Mr B. Madeleyn Tel: (2716) 981-8285 Fax: (2716 933-1863 E-Mail: [email protected] [email protected] CEVA Ancherpharm Animal Health Ltd Contacto: Mr. H. Stassen Tel: (2711) 882-1516 / 17 Fax: (2711) 882-1526 E-mail: [email protected] Pagina Web: www.ceva.com Tipo de empresa: Importador y distribuidor de productos veterinarios Establecido: 1973 Empleados 20 Pet Care Distributors & Exporters



Contact: Mr. M. Mercer Tel: (2731) 569-9100 Fax: (2731) 569-2074 E-Mail: [email protected] [email protected] Tipo de emprea: Importador, exportador y distribuidor de productos veterinarios. Empleados: 40 Pro-Ditsributors Contact: Mr. H. Ridder Tel: (2711) 392-4651 Fax: (2711) 392-4650 E-Mail: [email protected] Kaplor Trade International Contact: Mr. Peter Loram Tel: (2711) 396-4383 Fax: (2711) 396-4707 E-mail: [email protected] The Big Five Veterinary & Pharmaceuticals Mr. Frans Schutte Tel: (2712) 546 5005 Fax: (2712) 546 5066 E-mail: [email protected] Bedson African Business Group Contact: Mr. Oscar Bupo Tel: (2712) 803-4376 Fax: (2712) 803-1685 E-Mail: [email protected] Strider Distributors Contact: Dr. Glynn Catton Tel: (2711) 803-3553 Fax: (2711) 803-7490 E-mail: [email protected] MCP Contact: Mr. Mark Samson Tel: (2721) 447-4806 E-mail: [email protected] E-mail: [email protected] Anchorpharm Animal Health Contact: B. Lee Tel: (2711) 882-1516 Fax: (2711) 882-1526



E-Mail: [email protected] General Veterinary Supplies Contact: Ms. L. Shepherd Tel: (2711) 974-2532 Fax: (2711) 974-2553 E-Mail: [email protected] Tipo de empresa: Distribuidor medicamentos y productos veterinarios Establecidos: 1997 Empleados 24 Immuno Vet Services CC Contact: D. Hewson Tel: (2711) 699-6240 Fax: (2711) 462-0869 E-Mail: [email protected] Tipo de empresa: Importador y distribuidor medicamentos y productos veterinarios Establecidos: 1986 Empleados 30 Swavet Ltd Contact: Mr. J. schoeman Tel: (264- 61) 23 7356 Fax: (264-61) 22 6058 E-Mail: [email protected] Tipo de empresa: Distribuidor de medicamentos veterinarios en NAMIBIA Establecidos: 1969 Empleados: 12 ANEXO 1

MEDICINES CONTROL COUNCIL



GUIDELINE ON PHARMACEUTICAL AND ANALYTICAL REQUIREMENTS FOR VETERINARY

MEDICINES

This document has been prepared to serve as a recommendation to applicants wishing to submit applications for registration of veterinary medicines. It represents the Medicines Control Council’s current thinking on pharmaceutical and analytical aspects of veterinary medicines. It is not intended as an exclusive approach. The Council reserves the right to request for additional information to establish the safety, quality and efficacy of any medicine for which an application is submitted for registration. Alternative approaches may be used but these must be scientifically and technically justified. The MCC is committed to ensure that all medicines gaining market approval will be of the required quality, safety and efficacy and, in doing so, reserves the right to make amendments in keeping with the knowledge which is current at the time of consideration of data accompanying applications for registration of veterinary medicines. These guidelines should be read in conjunction with Regulations 2, 22, 24, 42, 43, 44 and 48. REGISTRAR OF MEDICINES



MS M.P. MATSOSO DATE: 13 JANUARY 2004 INDEX: PAGE 1. THE ACTIVE PHARMACEUTICAL INGREDIENT 3 - 4 2. FORMULATION 4 - 5 3. RAW MATERIAL SPECIFICATIONS AND CONTROL PROCEDURES 6 -7 4. CONTAINERS AND PACKAGING MATERIALS 8 5. THE MANUFACTURING PROCEDURES 9 6. THE FINISHED PRODUCT 10 - 11 7. STABILITY 12 8. PHARMACEUTICAL DEVELOPMENT 13 - 14 9. GUIDELINE ON SUBMISSION OF VALIDATION PROTOCOLS 15 - 18 AND VALIDATION REPORTS 10. EXEMPTION FROM POST – IMPORTATION IDENTIFICATION AND 19 - 21 TESTING OF REGISTERED MEDICINES



1. THE ACTIVE PHARMACEUTICAL INGREDIENT 1.1 The approved name (INN) or chemical description of the active pharmaceutical

ingredient(s) must be stated including the structural formula, the empirical formula and the molecular mass.

1.2 The solubility of each active pharmaceutical ingredient must be stated in terms of a unit part of the substance per number of parts of the solvent, or in unit mass of substance in a given volume of solvent, at a specific temperature. The solvents must include water and the solvent(s) relevant to the formulation. Storage requirements of the raw material and retesting period must be stated

. 1.3 The name and physical address of each manufacturer and vendors being applied

for must be stated. No active ingredient from any source other that the approved source(s) may be used.

1.4 Active Pharmaceutical Ingredient File (APIF) should include the following information: * The name and physical address of the manufacturer (Including any intermediate manufacturer) * The approved name of the relevant active pharmaceutical ingredient * The chemical name and chemical structure of the active pharmaceutical ingredient – *The processes carried out by any intermediate manufacturer must be identified *Evidence of /GLP compliance of the laboratory where relevant or possible, for all tests and analyses must be submitted. * Evidence occurrence of isomers and polymorphism where applicable * Structure elucidation for New Chemical Entities (NCE) * A description of impurities. Distinguish between actual and possible impurities * A description of possible degradation products * The physical and chemical properties of the active pharmaceutical ingredient



* The detailed methods used for identification and assay, including chromatograms wherever relevant * CoA results of at least two batches * Results of stability studies performed on the active pharmaceutical ingredient obtained by the above method of syntheses. The conditions under which degradation products are formed must be included. A stability- indicating assay method must be used in these studies, and must be described in full. Supporting chromatograms wherever relevant must be included. Stability data on new chemical entity active pharmaceutical ingredient must be generated according to the stability guidelines.



1.5 Certificates of analyses (CoA) A valid CoA (a), of a batch of active pharmaceutical ingredient, purchased and received by the specified in Part 2C must be performed by or on behalf of the manufacturer of the final product. A valid CoA must be on the letterhead of the manufacturer of the active pharmaceutical ingredient. 1.6 Requirements for proof of chemical and physical equivalence of Active Pharmaceutical Ingredient: When more than one manufacturer is being applied for or when different methods of synthesis are used in the manufacture of active pharmaceutical ingredient the following must be submitted in lieu of each manufacturer: A. An Active Pharmaceutical Ingredient File (APIF) Note that if the identical method of synthesis is used by each manufacturer (or the same parent company) or at different sites of the same manufacturer, a statement to this effect will suffice. B. A communication pointing out the differences in the methods used, and the differences with regard to the impurity profiles. C. A valid CoA issued by each manufacturer and the analytical reports issued by or on behalf of the manufacturer of the final product. For new sources the valid CoA is required. D. Comparative critical tests e.g. Identification, assay, solubility, particle size, optical rotation, residual solvents and impurity profiles, performed on samples from each source to demonstrate physical and chemical equivalence, must be performed by the same laboratory (either the laboratory of the manufacturer or an independent laboratory). The same analytical methods and equipment must be used for these tests. These results must be presented in tabulated format. 2. FORMULATION 2.1 The formula must show the approved names (INN) and/or chemical names of all active pharmaceutical ingredients and approved names of excipients (inactive ingredients) including those that do not necessarily remain in the final product after manufacturing, such as granulating agents and gasses used for flushing, etc.



2.2 The name and the amount of the active pharmaceutical ingredient must correspond to that given under Composition in the package insert. a) For excipients that do not appear in the final product, this must be so indicated b) Each raw material must be listed together with its quantity per dosage unit. This would include the vehicle(s), solvent(s) or base(s). In the absence of an approved name (INN) or chemical name, a chemical description or characterization of the substance must be given. Special technical characteristics of the excipient, where applicable, must be indicated such as “lyophilised”, “micronised”, “solubilised”, “emulsified”, etc. the technical grade of excipients, where relevant, must be indicated. Some excipients are single chemical entities while others are combinations. Some are chemically transformed, e.g. modified starch. For excipients that are mixtures of chemically related or unrelated components, e.g. Polyol esters (mixture of mono-, di- and trimesters), direct compression excipients or film coating material, or excipients that are chemically modified, the dossier must specify the nature and quantity of each component, where possible



2.3 A product may contain more than one active pharmaceutical ingredient provided that i) each active pharmaceutical ingredient makes a contribution to the claimed indications; ii) the effect of combining the active pharmaceutical ingredients in one product does not decrease the safety, stability or efficacy of the product; and iii) the product provides rational concurrent therapy for a significant proportion of the target species 2.4 The purpose of each inactive ingredient must be stated briefly. If the excipient is used for multiple purposes in the formulation, each purpose must be mentioned. 2.5 Any overages for the active pharmaceutical ingredient must be stated separately and the reasons for it must be given. The label claim quantity must be stated and the excess quantity indicated as the actual amount or as a percentage. For example, 500mg* *Use the asterisk to explain the amount, percentage and purpose of the overage. 2.6 Where a potency adjustment for the active pharmaceutical ingredient has to be made, a statement to the effect that the actual quantity of the active will depend on the potency, and the excipient(s) that will be used to adjust the bulk quantity must be included, as well as the manner in which the adjustment will be made. Potency calculations, formulae where applicable, must be included and must also be shown in the manufacturing procedure. 2.7 Where the vehicle is added up to the required volume or mass of the product, the actual or estimated quantity of that vehicle may be stated. However, expressions such as “add up to” and “q.s.” are acceptable. Solutions added to adjust the pH must be described in terms of composition and strength (normality, molarity, etc) but it is not necessary to state the actual quantity added as none may be added or only minute quantities may be needed. For biological medicines the details of any solution supplied by the manufacturer for the reconstitution before use of a dried biological medicine that is offered for sale in a dried form shall be supplied. 2.8 Toxicity levels per dosage unit must be indicated for all solvents and for other ingredients when required by Council.



3. RAW MATERIAL SPECIFICATIONS AND CONTROL PROCEDURES 3.1 Specifications and the limits of all raw materials, including the active ingredient(s) must be listed and must at least be at the level of the latest editions of recognized pharmacopoeia reference books, (BP, USP, EP). Any deviation from such specif ications and limits must be fully substantiated. More than one pharmacopoeia may be used for the raw materials, provided that each individual reference is used fully and not partially or selectively. For example, USP may be used for starch, and BP for lactose, etc One ingredient may be tested in accordance with alternative pharmacopoeias, depending on the site of manufacture. 3.2 In-house specifications must at least be at the level of an approved pharmacopoeia. Any in-house specifications that are at a lower quality standard than that of an approved pharmacopoeia must be fully motivated, subject to approval by the Council. (Cross-reference to a Pharmacopoeia is necessary). 3.3 Additional specification parameters, over and above those stipulated in the official compendia, such as a very accurate description of isomers, polymorphs, etc., must be submitted for all active ingredient(s) where required by the Council. 3.4 Control procedures for all raw material specifications shall be fully described, unless performed - in accordance with a recognised -pharmacopoeia. In the latter instance, reference to the - pharmacopoeia must be made as indicated in 3.1 above. 3.5 Specification limits and the control procedures for particle size of active pharmaceutical ingredients, which have a solubility of less than 1 part in 200 parts water, and for those which the Council may request, must be submitted. Particle size must be stated in SI units (µm). If the particle size is stated in sieve sizes, the corresponding size in SI units should be included. Exemption from this requirement may be applied for if the active ingredient is reconstituted into, or is administered as, a complete solution, or for any reason determined by the Council. 3.6 The following minimum requirements must be confirmed: i) Identification and assay of the Active Pharmaceutical Ingredient will be performed irrespective of the possession of a certificate of analysis from the supplier;



ii) Identification of the inactive Ingredient will be performed irrespective of the possession of a certificate of analysis from the supplier; and that iii) Any test not included in a valid* certificate of analysis will be performed. * valid as defined by c GMP 3.8 For those inactive ingredients for which a conclusive identification test is not included, all those parameters, which are specific to the identification of that raw material, must be performed irrespective of the possession of a Certificate of Analysis from the supplier. 3.9 For all natural raw materials of organic origin, microbial limits and test procedures must be included. 3.10 Frequency of testing of water, if applicable shall be included. Water must be tested at least once a week for microbiological contaminants, and daily or just before use for conductivity, pH and oxidizing substances.



3.11 For biological medicines: a) Specifications for the primary production lot used in the manufacture of the final filling lot of a biological medicine and specifications for all raw materials for the diluent must be listed. b) Tests of a biological source material must include tests to confirm the identification, safety and potency of the primary production or bulk lot used in the manufacture of the final filling lot. c) Parameters and criteria of acceptance to confirm the identification, safety and potency of the product must be provided.



4. CONTAINERS AND PACKAGING MATERIALS 4.1 Full details of the immediate container specifications and limits, including nature of material, dimensions and sketches where applicable, as well as those of applicators and administration sets, the closure system, wadding and any other component in direct contact with the product, where applicable, and the control procedures thereof must be supplied. 4.2 A brief description of the outer container, if any, must also be given. At least the nature of the material must be mentioned e.g. Outer cardboard carton. 4.3 The type of container described here must correspond to that described in the package insert under “Presentation” and in the stability studies. 4.4 If product is packed in bulk containers, the type of material of the container must be stated. 4.5 All pack sizes must be included.



5. THE MANUFACTURING PROCEDURES 5.1 The Inspection Flow Diagram must be included. 5.2 The batch manufacturing formula and the batch size(s) must be included. Where more than one batch size is indicated, the batch formula of the smallest batch size only may be given. 5.3 A copy of the Batch/Master manufacturing document or a comprehensive flow diagram and a description of the manufacturing procedures detailing the various stages of manufacturing must be submitted. Indicate the type of equipment (including sieve sizes in µm), duration of treatment, temperature, light and humidity conditions, machine settings (e.g. Rotation speed or rpm) etc. 5.4 All in-process controls (analytical, microbiological and physical) shall be shown in the flow diagram. 5.5 A copy of the Batch/Master Packaging document or a comprehensive description of the packaging procedures, detailing the various stages of packaging and labelling must be submitted. Indicate the type of equipment used in the packaging process. The in-process tests and control procedures carried out during the packaging process shall be included. 5.6 A process validation protocol must be submitted, and subsequent to this a validation report when available.



6. THE FINISHED PRODUCT 6.1 Final product specifications and limits must be listed for in-process controls, final product controls, stability tests and the manipulated final product (if applicable). 6.2 The description of the final product must correlate to the description given under identification in the package insert. 6.3 Content uniformity must be specified and a control procedure must be submitted if the quantity of the active pharmaceutical ingredient is less than 2mg or less than 2 % mass per mass of the total mass of the dosage unit (e.g. tablet, capsule, etc), unless otherwise requested by Council. The active content assay need not be performed separately in the case where Uniformity of Content has already been performed for batch release purposes. 6.4 For quality control and batch release purposes, final product specifications for all solid oral dosage forms and suspensions shall include a requirement for dissolution of active pharmaceutical ingredient/s unless otherwise requested by Council. 6.5 Disintegration time, where relevant, for example for chew tablets, matrix tablets and soft gelatine capsules will be determined as a lot release requirement on all batches on which dissolution is not determined as a criterion for lot release. Disintegration time can be used as a lot release requirement for multivitamins and mineral preparation, unless a dissolution requirement for a specific product is included in the USP, in which case dissolution must be done as a lot release requirement. 6.6 For imported products, at least the identification and assay of the active pharmaceutical ingredient content must be performed after importation. This is intended to verify that the product has not been affected adversely during the transfer process. Exemption from this requirement may be applied for according to Addendum C (Guide on applying for exemption from re-identification and re-assay of imported products). 6.7 The final non-analytical release criteria must include the checking of the appearance of the dosage form, the container, the package insert, the label, the batch number, the expiry date of the product, the certificate of analysis and the batch release documents (FPRR functions).



6.8 All control procedures other than those from a recognized pharmacopoeia must be described in full. 6.9 A complete analysis report or certificate of analysis for one batch (pilot- or production) of the fin ished product must be submitted with the application. 6.10 The full validation data of the assay method of the active pharmaceutical ingredient related to batch release must be submitted. Chromatograms confirming the separation of the active from the degradation products, if relevant, must be included (See Addendum on Stability) It must be demonstrated that the assay method is stability indicating, i.e. it must distinguish between the active pharmaceutical ingredient/s and the degradation product/s. If the assay method used to determine the active pharmaceutical ingredient content is not stability indicating, then the validation data of the method/s used to determine the degradation product content must be submitted. If the assay method (chromatographic) is taken from one of the latest recognized pharmacopoeias, then other validation data may be requested, e.g., system suitability where applicable.



If different assay method/s are used for stability testing, then a full description of the method and the validation thereof must be submitted. Chromatograms confirming the separation of the active from the degradation products, if relevant, must be included. 6.11 All other quantitative assay methods (for preservatives, related substance, antioxidants etc) must be validated and the validation data included, except where such methods are from approved pharmacopoeias.. 6.12 For a product from a non-biological origin, which has endotoxin levels, the validation data as required by the USP/BP/EP must be submitted, except where the dose is less than 2 m /10kg, or standard LAL test is employed. 6.13 For products with a biological origin or any other products for which no endotoxin levels have been specified in a pharmacopoeia, the validation data must be submitted for evaluation.



7. STABILITY 7.1 All applications for registration of a medicine must be submitted with stability data in accordance with the minimum requirements stated in the Guidelines for Stability. 7.2 The stability program must be described in detail and must include the following information: i) Conditions (temperature, humidity) ii) Time points for testing e.g. 3 months, 6 months etc. iii) - Tests to be determined iv) How often - stability testing will be performed on future batches (should be in accordance with c GMP guidelines.) 7.3 Stability data must be presented in a tabulated format and must include the following: i) Batch No. (Confirm that the formula is the same as the one applied for) ii) Date of manufacture iii) Date of commencement of stability study iv) Name of manufacturer v) Source of Active Pharmaceutical Ingredient (manufacturer not the supplier) vi) Indicate whether production/pilot/experimental batch vii) Container (Confirm that the container is the same as the one applied for) viii) Storage conditions (must be controlled according to guidelines) ix) Tests - and limits x) Stability results 7.4 Discussion and conclusion of shelf life for each type of container must be provided.



8. PHARMACEUTICAL DEVELOPMENT 8.1 Any change or differences in the formulation during the development history must be indicated clearly. 8.2 A separate Pharmaceutical Expert Report (of not be more than 25 pages of A4 paper) must be submitted with each application and must include at least the following: 8.2.1 Active Pharmaceutical Ingredient(s): a) Comment on the synthesis of the active pharmaceutical ingredient(s); b) Discuss all physico-chemical properties, e.g. Solubility, water content, particle size, crystal properties, polymorphs, chirality, stability, etc. Reference may be made to the APIF; 8.2.2 Formulation: a) Motivate and explain the function of the inactive ingredients; b) Indicate the safety/toxicity profile of the inactive ingredients; c) State any interactions likely to occur or that may occur under given circumstances; d) Motivate/explain all overages; e) discuss relevant physico-chemical parameters separately, e.g. pH, etc.; f) Include pre-formulation studies and motivate; g) Novel formulations and excipients must be discussed/explained. 8.2.3 Production/Manufacture: a) Describe how the manufacturing method was derived; b) Describe how in-process controls and validation plans were developed. 8.2.4 Stability a) Discuss the stability of the final product formulation and the parameters used during stability and to confirm quality for lot release; b) Discuss the containers used during stability studies; c) Discuss dissolution; d) Conclusion on stability. 8.2.5 Conclusion in Expert Report



8.2.6 Name, CV, Date and Signature of responsible person 8.2.7 A reference list used in the compilation of the report.



8.3 Details relating to the premises on which primary production is undertaken and to the staff involved in production and testing of a biological medicine. A description of the premises where preparation of the primary production or bulk batch are carried out, names, qualifications, field and experience of the persons involved in preparation of the primary production and the final lot and details of the facility where the imported final filling lot is stored must be recorded. i) A floor plan of the premises must be included. ii) If the premises are used for other purposes such details must be supplied. iii) Conditions under which the product is stored must be described.



9. GUIDELINES ON SUBMISSION OF VALIDATION PROTOCOLS AND VALIDATION REPORTS This guideline intends to communicate to Industry, the policy and requirements in respect of validation protocols and validation reports to be submitted to the Medicines Control Council. 9.1 Important References: Chapter 9 of the SA Guide to Good Manufacturing Practice (1996 edition) Circulars United States Pharmacopoeia (USP) British Pharmaceutical Codex (BPC) FDA Guidelines on Validation ICH & VICH 9.2 Council resolution: The standard to be used to assess compliance with current Good Manufacturing Practice, is the South African Guide to Good Manufacturing Practice (latest edition). 9.3 What is validation: 9.3.1 The SA Guide to GMP defines “validate” as follows: “VALIDATE To provide documented evidence that an item of equipment, process, system or method is in a state of control (i.e. That all assignable causes of variation have been eliminated) and is able to consistently deliver specified results.” 9.3.2 Validation is an integral part of current good manufacturing practice; it is, therefore, also an element of the quality assurance programme associated with a particular product or process. 9.3.3 There should be levels where validation and qualification should be performed, and the level should determine the intensity of these products. It should be least for liquid preparations (solutions) and most for parenteral medicines, and for solid dosage forms it should depend on the criticality of the product as far as the patient is concerned. 9.4 When should validation be done? 9.4.1 Validation should be considered in the following situations: * totally new processes * new equipment * processes and equipment, which have been altered to suit changing priorities * processes where the end product test if poor and an unreliable indicator of product quality



9.4.2 When any new manufacturing formula or method of preparation is adopted, steps should be taken to demonstrate its suitability for routine processing. The defined process, using the materials and equipment specified, should be shown to yield a product consistently of the required quality.



9.4.3 The validation in the production unit mainly comprises the determination and evaluation of the process parameters of the facilities applied for the scale -up to final batch size. The control of all critical process parameters, the results of the in-process controls, final controls and stability tests should prove the suitability of the important individual steps of a procedure. 9.4.4 At least three batches (including at least two production batches in the final batch size) should be validated, to show consistency. Worst-case situations should be considered. 9.4.5 When certain processes or products have been validated dur ing the development stage, it is not always necessary to re-validate the whole process or product if similar equipment is used or similar products have been produced, provided that the final product conforms to the in-process control and final product specifications. 9.4.6 There should be a clear distinction between in-process controls and validation. In-process tests are performed each time on a batch-to-batch basis using specifications and methods devised during the development phase. The objective is to monitor the process continuously. 9.5 What does validation involve: Validation involves the accumulation of documentary evidence relating to a process, item of equipment, of facility. This is achieved by means of validation protocol which should exist for every product and which details the tests to be carried out, the frequency of testing, and the results anticipated (acceptance criteria). 9.6 The Validation Protocol (VP) The Validation protocol should clearly describe the procedure to be followed for performing validation. The protocol should include at least: * the objectives of validation and qualification study; * site of the study; * the responsible personnel; * description of equipment to be used (including calibration before and after validation); * SOP’s to be followed; * standards and criteria for the relevant products and processes; * the type of validation; * time/frequency should be stipulated; * processes and/or parameters to be validated (e.g. Missing times, drying temperatures, particle size, drying times, physical characteristics, content uniformity etc) should be clearly identified.



9.7 The Validation Report (VR) 9.7.1 A written report should be available after completion of the validation. The results should be evaluated, analysed and compared with acceptance criteria. All results should meet the criteria of acceptance and satisfy the stated objective. If necessary, further studies should be performed. If found acceptable, the report should be approved and authorized (signed and dated). 9.7.2 The report should include at least: * the title and objective of the study; * refer to the protocol; * detail of material; * equipment; * programmes and cycles used * details of procedures and test methods * results (compared with the acceptance criteria) * recommendations on the limits and criteria to be applied to all future production batches (which could form part of the basis of a batch manufacturing document). 9.8 Re-validation: As a rule re-validation is required under the following circumstances: * change of formulae, procedures or quality of raw materials * change of equipment, installation of new equipment, major revisions to machinery or apparatus and breakdowns. Re-validation in the case of breakdowns is only required if a motivation cannot be supplied that justifies that such breakdown will not influence product, quality, safety or efficacy. * major changes to process parameters * changes to facilities and installations, which influence the process * on appearance of negative quality trends * on appearance of new findings based on current knowledge, e.g. Sterilisation where the frequency of checking is dependent on sophistication of in-process methodology NOTE: The extent of re-validation will depend on the nature and significance of the changes. 9.9 General notes 9.9.1 The following aspects could be considered during the validation of specific dosage forms. 9.9.2 Validation of tableting: In the case of an oral tablet manufactured by granulation and compression, the critical process parameters may include (but not be limited to): * particle size distribution of the active * blending time for the powder



* granulating time and speed * amount of granulating fluid-binder concentration * drying time – final moisture content * granule partic le size distribution * granule active content and homogeneity * blending time of external phase * tablet hardness with respect to water content, friability, disintegration and dissolution * lubrication level with respect tablet hardness, disintegration, dissolution and die -ejection force * tablet weight and thickness control uniformity of content If the tablet is film coated, the following additional parameters may require validation: * spray rate of coating solution * inlet and outlet air temperatures * coating weight of polymer with respect to table appearance, friability, disintegration and dissolution



9.10 Requirements 9.10.1 Each applicant should have a Validation Master Plan (VMP) (See SA Guide to GMP, Chapter 9) 9.10.2 Each product must have a Validation Protocol (VP), (where validation is required, i.e. for inter alia solid dosage forms, certain suspensions, sterile products etc or where major changes in formulation or manufacturing method is envisaged). 9.10.3 There should be a Validation Report (VR) following the complete validation. 9.10.4 Validation Protocols and Validation Reports should be available for inspection purposes by the inspectorate. The following is applicable: A New Applications for registration: A VP must be included in Annexure 11. (The VR should only be submitted when requested by the inspectorate). B Applications for change in applicant/manufacturer/packer/laboratory A VP must be submitted with each application for a change in manufacturer or laboratory, or change in applicant where it also involves a change in manufacturer. [If the validation had already been done, it should be indicated as such in the application. A VR should only be submitted when requested by the inspectorate]. 9.10.5 Applications will not be accepted if the Validation Protocol should be found to be incomplete. 9.10.6 Applicants should note that the submission of the VP or VR does not imply that the council or secretariat had approved the VP or VR.



10. EXEMPTION FROM POST IMPORTATION IDENTIFICATION AND TESTING OF REGISTERED MEDICINES Imported veterinary medicines must be identified chemically, assayed through a stability-indicating method, and other relevant tests conducted before release, to prove that the product integrity has not been prejudiced during transport from sources in other countries. 10. Exemption from these requirements will be considered in the following circumstances: 10.1.1 When very small quantities are imported for “selected” patients, or groups of patients. 10.1.2 Any other reason deemed by the applicant as being of such nature as to qualify for consideration for this exemption. 10.1.3 Any exemption approved will be valid for three years, provided that all the requirements are complied with during the period of validity. Initially, post importation testing must be done and subsequently at specific intervals. 10.2 When requesting exemption the following must be submitted.: 10.2.1 A suitable motivation for the request, that is, a suitable projection as to the annual usage of the relevant project 10.2.2 Validation of transport, that is, evidence that the conditions during transport are continuously monitored by temperature and, where relevant, humidity recorders. A tabulated summary indicated the method of transport utilized and the conditions during transport as indicated below must be submitted. A minimum of five printouts are required, giving an account of the same product or, five different products, provided that the products require the same storage conditions, and provided that the products are dispatched from the same site but by different shipments. 10.2.3 A copy of the accelerated stability data of the formulation being applied for, packed in the final container as specified in Part 2D [Annexure8] (to determine if the humidity must be monitored). 10.2.4 A copy of Part 2B [Annexure 2] as per the MRF 1.0 (Form. 10.2.5 An indication as to whether the request is for bulk products or for the product packed in the final container.



10.2.6 A certificate of GMP compliance, not older than 2 years, issued by a competent regulatory authority or in terms of the WHO certification scheme 10.2.7 A copy of the proposed master release document in accordance with Part 2F reflecting the specifications pertaining to the product in question (example attached). a) The type of recorder used in transit b) Specify that the received certificate of analysis: is valid, is complete (reflects the actual results of the tests performed) and reflects compliance with the registration requirements. c) Visual identification of the product and dosage form d) A consignment reference e.g. GRN (goods received notice) or invoice, etc. (Batch numbers on the invoice must concur with the batch numbers of the products). e) Confirmation of the integrity of the containers, seals, and labels. Each aspect must be specified and controlled to ensure that no damaged articles are accepted. 10.3 Furthermore, the following must be ensured: * The transport conditions (temperature and humidity, where relevant) of each shipment are recorded by a suitable device, which provides a printout that will form a permanent record of the specific shipment and is filed with the batch release documents. * An SOP, specifying the details of inclusion of the recorders, must be available for inspection. The procedure must include amongst others, the number of recorders, position of placement, date of activation and inactivation (on leaving the place of dispatch i.e. Factory and or receipt by the applicant i.e. Warehouse) and evaluation of the printout with the reference to the stability data. * The monitor must be validated and the validation data must be available for inspection. * Please note that exemption is applicable only if each future shipment is monitored and subsequently evaluated for compliance with the stability profile. * The submission must include the necessary supportive stability data. If previously submitted, a statement to this effect will suffice. * The transport monitoring method, or transport conditions must be specified in the master release document. Applicants should note that any shipment received, not complying with these



transport specifications, does not qualify for the exemption. These shipments must be assayed and identified as if exemption was not granted in the first instance. NB1) The Medicines Control Council reserves the right to withdraw the exemption, should the applicant give cause. 2) Applicants who have obtained permission for exemption previously from the MCC for their products must re-apply for exemption. 3) NAME OF PRODUCT: REGISTRATION NUMBER: DOSAGE FORM: APPROVED STORAGE CONDITION: QC FUNCTION TO BE AUTHORISED (point (v) below): ASSURANCE: TEMPERATURE RECORDED IN EACH SHIPMENT Name of product

Batch Number

Maximum and minimum temperature recorded

Maximum humidity recorded (where relevant)

Duration of transport (Date commenced and date terminated)

Mode of transport

Signature of MD/responsible pharmacist who verified the printouts



MASTER RELEASE DOCUMENT Test Specification Result Signature Temperature printout (storage conditions)

Present, attached , conforms to stability profile submitted

Certificate of Analysis Present, valid (batch specific) , conforms to MBR1, complete

Visual Identification E.g. Product description, labelling, container , batch number, expiry date

Shipping containers’ condition

Clean, undamaged Number approved Number rejected

Shipping container label Untempered Shipping container seal Present , intact Position/ Function

Signature Date

ANEXO 2 CODIGOS DE PAISES Afganistan AF Kenia KE Albania AL Kiribati KI Alemania DE Kuwait KW Algeria DZ Kyrgyzstan KG American Samoa AS Lao Peoples Dem. Rep LA Andorra AD Latvia LV Angola AO Lebanon LB Anguilla AN Lesotho LS Antartica AQ Liberia LR Antigua y Barbuda AG Libyan Arab Jamahiriya LY Antillas Holandesas AN Liechtenstein LI Arabia Saudita SA Lithuania LT Argentina AR Luxemburgo LU



Armenia AM Macau MO Aruba AW Macedonia MK Australia AU Madagascar MG Austria AT Malawi MW Azberbaijan AZ Malaysia MY Bahamas BS Maldives MV Bahrain BH Mali ML Bangladesh BD Malta MT Barbados BB Marruecos MA Belarus BY Marshall Island MH Belgica BE Martinique MQ Belize BZ Mauritius MU Benin BJ Mautitania MR Bermuda BM Mayotte YT Bhutan BT Mejico MX Bolivia BO Micronesia Fed. States FM Bosnia & Herzgovina BA Moldova Rep. de MD Botswana BW Monaco MC Bouvet Island BV Mongolia MN Brasil BR Montserrat MS British Indian Ocean IO Mozambique MZ Brunei Darussalam BN Myanmar NM Bulgaria BG Namibia NA Burkina Faso BF Nauru NR Burundi BI Nepal NP Cabo Verde CV Nicaragua NI Cambodia KH Niger NE Cameroon CM Nigeria NG Canada CA Niue NU Cayman Islands KY Norfolk Isla NF Central African Republic CF Northern Mariana Is land MP Chad TD Noruega NO Chile CL Nueva Caledonia NC China CN Nueva Zelandia NZ Christmas Island CX Oman OM Cocos Islands CC Outlyng Islas UM Colombia CO Paises Bajos NL Comoros KM Palau PW Congo CG Panama PA Congo Rep. Democratica CD Papua Nueva Guinea PG Cook Islands CK Paquistan PK Corea Dem.Peop. Dem. KP Paraguay PY Corea Republica de KR Peru PE Costa de Marfil CI Pitcairn PN Costa Rica CR Polinesia Francesa PF



Croatia HR Polonia PL Cuba CU Portugal PT Cyprus CY Puerto Rico PR Czech Republic CZ Qatar QA Dinamarca DK Reino Unido UK Djtbouti DJ Republica Dominicana DO Dominica DM Reunion RE East Timor TP Romania RO Ecuador EC Rusia RU Egipto EG Saint Kitts and Nevis KN El Salvador SV Saint Vincent &

Grenadines VC

Emiratos Arabes Unidos AE Samoa WS Eritrea ER San Marino SM España ES Santa Helena SH Estados Unidos US Santa Lucia LC Estonia EE Senegal SN Ethiopia ET Seychelles SC Falkland Islands (Malvinas) FK Sierra Leone SL Faroe Islands FO Singapur SG Fiji FJ Slovakia SK Filipinas PH Slovenia SI Finlandia FI Soa Tome & Principe SB Francia FR Solomon Islas SB French Guyana GF Somalia SO French Southern Territories TF Sr. Pierre & Miquelon PM Gabon GA Sri Lanka LK Gambia GM Sudafrica ZA Georgia GE Sudan SD Georgia Sur & Islas Sandwich GS Suecia SE Ghana GH Suiza CH Gibraltar TI Suriname SR Grecia GR Svalbard& Jan Mayen SJ Greenland GL Swazilandia SZ Grenada GD Syrian Arab Rep. SY Guadeloupe GP Taiwan Prov. de China TW Guam GU Tajikistan TJ Guatemala GT Tanzania TZ Guayana GY Thailandia TH Guinea GN Togo TG Guinea Bissau GW Tokelau TK Guinea Ecuatoriana GQ Tonga TO Haiti HT Trinidad Tobago TT Holy See VA Tunisia TN Honduras HU Turkmenistan TM



Iceland IS Turks & Caicos Islas TC India IN Turquia TR Indonesia ID Tuvalu TV Iran Rep. Islamica de IR Uganda UG Iraq IQ Ukrania UA Irlanda IE Uruguay UY Islas Heard & McDonald HM Vanuatu VU Islas Virgenes US VI Venezuela VE Israel IL Vietnam VN Italia IT Wallis & Futuna WF Jamaica JM Western Sahara EH Japon JP Yemen YE Jordania JO Yugoslavia YU Kazakhstan KZ Zambia ZM

Zimbabwe ZW ANEXO 3

TIPO DE CAMBIO VALOR PROMEDIO ANUAL

AÑO 1USD = RAND 1991 2,76 1992 2,85 1993 3,27 1994 3,55 1995 3,63 1996 4,30 1997 4,61 1998 5,53 1999 6,11 2000 6,94 2001 8,61 2002 10,52 2003 7,56 2004 6,45 2005 - Enero 5,97 2005 - Febrero 6,02 2005 - Marzo 6,01 2005 - Abril 6,15 2005 - Mayo 6,33

Fuente: Banco de la Reserva de Sudáfrica

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