Volume 7: Medicines and Cosmetics
Annex 3 to Chapter 6: Veterinary medicines that did not comply with the 1989 CSM/VPC guidelines

Company	Number of products	Target 1 species	Ingredient (Bovine (b) or ovine (o) material)	Country of origin	Outcome
1	1 vaccine	avian	(1) Muscle (b)	France/	(1)+(2) Changed to US source April 1990
			(2) Casein digest (b)	US/UK
2	1 diagnostic	1 bovine	(1) Muscle (b)	UK	(1) Changed to closed herd April 1990
	1 vaccine	1 avian
	(Animal Test Certificate only)		(2) Casein digest (b)	Various	(2) Acceptable (milk)
			(3) Soup stock (b)	UK	(3) Company confirmed source is Oxoid/1
3	9 emergency vaccines each restricted to use on single farm	2 avian	Blood (o)	UK company	Oxoid/1,3
		1 bovine	Agar		All products discontinued between 1989 and 1992
		5 porcine	base
		1 simian
4	7 vaccines comprising 5 emergency vaccines and 2 vaccines (Animal Test Certificates only)	4 avian	Soup stock (b)	UK	Company confirmed source is Oxoid/1
		1 bovine
		2 simian
5	23 vaccines	6 avian	(1) Serum (b)	UK/NZ	(1) Changed to NZ source January 1990
		1 bovine
		1 porcine	(2) Milk Amine (b)	UK	(2) Acceptable (milk)
		15 small animal
			(3) Hydrolysed gelatin (b/o)	Various	(3) Acceptable heat treatment
			(4) Casein hydrolysate (b)	Various
					(4) + (5) Acceptable (milk)
			(5) Casein peptone (b)	UK
			(6) Bovine serum albumen (BSA) (b) present in 1 avian vaccine only	UK/NZ	No documentation located for the BSA component
6	18 vaccines including one Animal Test Certificate only	1 avian	(1) serum (b)	UK/NZ/Australia/	(1) Changed to non-UK source February 1990
		5 bovine		US/Canada
		1 equine
		11 small animal	(2) BSA present in 1 dog vaccine	UK/NZ	(2) No documentation located for the BSA
7	3 autogenous vaccines	2 bovine	Lung tissue (b)	UK	All production ceased in 1990
		1 ovine	Warts (b)
			Scabs (o)
8	13 vaccines	2 avian	Serum (b)	UK company	Changed to non-UK source August 1990
		2 bovine
		9 small animal
9	1 vaccine	fish (immersion)	Brain Heart Infusion	UK/US	Changed to US source 1990
			Broth (b)		Product withdrawn 1994
10	1 vaccine	fish (immersion)	Brain Heart Infusion	US	Remains under review
			Broth (b)
11	11 vaccines	1 bovine	(1) Brain Heart Infusion	(1) UK	(1) Never marketed
		1 porcine	Broth (b)
		9 small animal	(2) Serum (b)	(2) UK/NZ	(2) No documentation located for 9 small animal and 1 porcine vaccines
			(3) Soup stock (b)	(3) UK	(3) Oxoid/1
12	31 vaccines	3 bovine	(1) Serum (b)	(1) Ireland	(1) Never marketed
		4 porcine
		8 ovine	(2) Serum (b)	(2) UK/NZ	(2) No documentation located for 1 sheep and 1 bovine vaccine
		1 fish
		15 more than one species	(3) Trypsin (b)	(3) UK	(3) No documentation located for 1 sheep vaccine
			(4) Proteose peptone (b)	(4) UK/Holland	(4) Oxoid/2
			(5) Hydrolysed casein (b)	(5) UK/NZ	(5) Acceptable (milk)
			(6) Casein (b)	(6) UK/non-UK	(6) Acceptable (milk)
			(7) Liver Digest (b)	(7) UK/non-UK	(7) No documentation located for 8 multi-species vaccines
12 cont'd			(8) Heart (b)	UK/Ireland/NZ/US	(8) No documentation located for 8 multi-species vaccines
			(9) Skeletal muscle (b)	UK	(9) No documentation located for 7 multi-species vaccines
			(10) Pancreas (b)	UK	(10) No documentation located for 8 multi-species vaccines
			(11) Blood (o)	UK	(11) No documentation located for 1 porcine vaccine
			(12) Liver (b)	UK/non-UK	(12) No documentation located for 2 multi-species vaccines
			(13) Soup stock (b)		(13) Oxoid/1
13	11 vaccines	1 bovine	(1) Soup	UK	(1) Oxoid/2
		3 porcine	stock (b)
		5 ovine
		1 avian	(2) Gelatin (b/o)	UK
	3 antisera	4 more than one species			(1)+(2)+(3)Changed to US sourced medium by 1992
			(3) Bile (b)	UK
			(4) Serum (b)	UK	(4) Changed to closed herd source 1992. Replaced by horse sera 1997
			(5) Heart muscle (b)	UK	(5) Changed to milk based medium sourced from NZ/ Australia September 1990
14	8 vaccines	2 avian	(1) Serum (b)	(1) Various including UK	(1) No documentation located for 8 vaccines
		1 porcine
		5 small animal	(2) BSA was a component of 3 small animal vaccines	(2) UK	(2) No documentation located for the BSA component
15	1 plasma substitute	equine small animals	calf	Various	Changed to non-UK source April 1990
			skin (b)

1 Species to which vaccine administered

Oxoid/1	By April 1990 heat treated to 132°C for 80 mins and considered acceptable		Oxoid ensured that it sourced and processed the ingredients it supplied to the various manufacturing companies in such a way as to be acceptable to the Veterinary Medicines Directorate, thus enabling the companies if supplied to comply with the guidelines.
Oxoid/2	Proteose peptone replaced by L85: contains UK soup stock by March 1990
Oxoid/3	Used NZ source of sheep material
Source: The Veterinary Medicines Directorate (M74 tab 3)