Biofaktor has joined POLPROWET

English

Since May,2015 Biofaktor Sp. z o.o. is an active member of POLPROWET, but yesterday became officially invited during The Board Meeting. All members voted for Biofaktor. We are very happy to welcome Biofaktor aboard and we count on Biofaktor's opinions and contribution into the work for our common objectives. 

At this particular moment we are very much engaged in works on two important european regulations referring to Veterinary Medicinal Products and Medicated Feed. Both will regulate our future professional life for the next 15-20 years in entire EU!!! A moment to act is NOW! Everybody is very much welcome to join one of our Working Groups especially those dealling with registrations and lobbying.

Our core objectives regarding both regulations are:

1.) innovations - we need a better political background to invest in innovations i.e. extended protection of technical data and others

2.) a single market - we need rational SmPC supported by simplification of information attached to the product i.e. pictograms instead of texts in local languages, etc to offer all existing AH products to all member states. Today there is a disprportionate distribution linked to differences in registration conditions. There are countries having 3000 products whereas others have only 300 registered. Small markets with the same high administration requirements are naturally less attractive for investors. This must change.

3.) reduction of  administration burden - dealling with 6 basic species (1 species in case of human drugs) AH business needs to adjust all requirements to multiple species covering costs of many similar researches and preparation of similar but anyhow species-speciffic parts of dossiers. These costs additional money and efforts. Bearing in mind that AH business is only 2,5% of this of human medicines and is split by many species, the whole business is double expensive (13% AH vs 7%Human Health) thus return on investment is lower. Changes must be done in order to stimulate AH business to maintain current registrations and bring innovations. We are for increase of centralized procedures versus minimizing national ones. We are for a strong pharmacovigillance support versus reduction of administrative procedures performed by reg. offices, very often repeating the same procedures in each country.

4.) antibiotics - we need wise and respectfull policy towards antibiotics based on principal: "as little as possible, as much as necesarry". A national guideliness of prudent use of antibiotics is a must and needs to be created before any regulations comes from aboves (EU). 

5.) others

Full text available in PL version.

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