# Presentation: 380712

## MUMS

**Swiss ****Perspective**

**Dr. ****Flurina Stucki****, ****Swissmedic ****Swiss Agency for Therapeutic Products**** **

## Marketing Authorization for veterinary drugs - Swiss Requirements

- Administrative
- Quality
- Efficacy
- Safety

- Science driven

- „Guidelines“- VICH- EU/EMEA- FDA/CVM

**Federal law on Medicinal Products and Medical Devices 15.12.2000, LTP**

## Drugs approved in a foreign country

- Law on Therapeutic Products
**Art. 13****	**Medicinal products and proceduresauthorized in foreign countries:
- If a medicinal product or procedure is already authorized in a country having equivalent medicinal product control, the results of tests (*of the other Agency*) carried out for this purpose shall be taken into account.

*Several countries recognize Swissmedic decisions*

## Increasing requirements for quality, security and efficacy
Demand of vets to have access to a good supply of veterinary drugs 
Adoption of the regulation demanding MRLs for all active substances applied in food producing animals ...

- Demand of vets to have access to a good supply of veterinary drugs
- Adoption of the regulation demanding MRLs for all active substances applied in food producing animals ...

- Availability problem – vet. drugs

## USA

**Switzerland**

- difference

## off-label use    

- risk 			food safety
- 	Use of drugs without MRL
- 	Missing data concerning residues
- 	Unknown withdrawal periods

## task force „MUMS“

- May 2002
- Lead by Swissmedic
- Representatives of different federal authorities
- Representatives of cantonal authorities
- Veterinary organizations
- Livestock breeding organizations
- Goal: to find		**methods and solutions**

## no veterinary medicines authorized examples

- no veterinary medicines authorized examples

- cattle: 			imidocarb
- goat: 			eprinomectin
- swine: 			doxapram
- rabbit:			antibiotics
- farmed fish: 		tetracycline
- horse: 			thiobarbiturate
- etc.

## solutions: implemented – to be done

**Swiss cascade**** **– pet and farm animal

***„******MUMS“ decree***

***Limited permission*** -  availability

***Notification requirement*** – exotic pet animals

**Exceptional rule for horses** – sport horse

## implemented 	    swiss cascade				  TAMV 1.9.04, art. 6,12,13

***implemented***** ****	****    **swiss cascade**	****	****	****	****  TAMV 1.9.04, art. 6,12,13**

**If there is no drug available according to 1°**

**Swissmedic- approved veterinary drug**

**1******

**2******

**If there is no drug available according to 2°**

**3******

**Swissmedic - approved human drug**

**4******

**Magistral formulae intended for animals**

**changes to another indication **
**in the same species or to another species**

**Restrictions:  **
**only substances with defined MRL **
**(****~ ****Annex I and II)**

**If there is no drug available according to 3°**

**Import from abroad – ****	****permission needed ****	****	****	****for each single case**

## Horses can be declared as sport horses 
Like pet animals –    range of veterinary drugs
Registration in passport (lifetime)
Products containing substances without established MRLs (no forbidden substances - SR 817.021.24) can be used in all horses requiring a withdrawal period of six months
Documentation of all veterinary drugs used in non-sport horses in a individual file! 

- Horses can be declared as sport horses
- Like pet animals –    range of veterinary drugs
- Registration in passport (lifetime)
- Products containing substances without established MRLs (no forbidden substances - SR 817.021.24) can be used in all horses requiring a withdrawal period of six months
- Documentation of all veterinary drugs used in non-sport horses in a individual file!

- exceptional rule for horses

## developing a new MUMS decree

- developing a new MUMS decree

- Swissmedic is discussing guidelines for a simplified approval
- 	„MUMS decree“   (similar to human orphan drugs‘)
- Definition of „MUMS“ ?
- Simplified procedures available?
- Support granted by the authority ?

##  						all other species
cattle (dairy and meat animals)	in particular: 	
pigs			       	
sheep (meat animals)		goats
chicken				sheep (milk)
horses 				laying hens 	
dogs 				rabbits
cats 					fish
						honey bees etc.		

-  						all other species
- cattle (dairy and meat animals)	in particular:
- pigs
- sheep (meat animals)		goats
- chicken				sheep (milk)
- horses 				laying hens
- dogs 				rabbits
- cats 					fish
- 						honey bees etc.

-                                     mums decreemajor species – minor species

## Seldom occurring indications or 
limited applications in major species

- Seldom occurring indications or
- limited applications in major species

-                                               mums decreeminor use

- e.g.
- Bovine babesiosis / equine babesiosis
- Pain control in swine (oral application)
- Penicillin for intravenous application in horses
- Respiratory stimulant (analeptic agent) for all species

##                                                                                       mums decree some perspectives 

- Only substances with a defined MRL (annex I resp. annex II)
- 	Extrapolation of MRLs is established
- Simplification
- 	mainly part IV: data from literature
- 	Case-by-case decision
- Scientific advice by Swissmedic
- To waive fees
- etc.

##                                                                                     mums decreelimited permission

-                                                                                     mums decreelimited permission

- To make missing veterinary drugs available in a short time
- Safety components evaluated first
- Reduced documentation
- Time to collect necessary data
- Transition to a simplified approval

## 						mums decreenotification requirement

- 						mums decreenotification requirement

- Special exotic animals (only pets)
- 	e.g. ornamental fish, birds
- Will differ from a simplified approval
- Only for special products
- 	(e.g. no antibiotics)
- Improve availability of legal products in this field

## subproject (I)

- Eprinomectin for goats (wt milk)
- Extension of an existing drug (cattle)
- Cooperation between swiss goat association, Swissmedic and a pharmaceutical company
- PK-data from literature (incl. withdrawal time)
- Monitored release (field study)

## Antibiotics for rabbits 
	no approved product at the moment
	need for: sulfonamide, trimethoprime (Pasteurella)
		      colistin sulphate (E.coli)
Extension of an existing product (calves, pigs)
Two field studies to establish the efficacy and the withdrawal period
Cooperation between university (bacteriology), the farm rabbit organization and a pharmaceutical company

- Antibiotics for rabbits
- 	no approved product at the moment
- 	need for: sulfonamide, trimethoprime (Pasteurella)
- 		      colistin sulphate (E.coli)
- Extension of an existing product (calves, pigs)
- Two field studies to establish the efficacy and the withdrawal period
- Cooperation between university (bacteriology), the farm rabbit organization and a pharmaceutical company

- subproject (II)

## critical points

- Industry?
- Funding?
- 	No financial support from public authorities
- Substances without established MRL?
- Cooperation?
- 	between vets – breeding organizations....

## Slide 21