Frequently Asked Questions:
1. How long is the membership commitment?
Membership is for 3 years.
2. Does PanGenerika have or accept members from countries outside of Europe?
Yes. PanGenerika accepts members from all countries that accept EU CTD dossiers.
3. Where does PanGenerika get our dossiers/products?
- We are in contact with a large number of dossier developers/manufacturers in Europe. If they have their own production facilities they can decide to put their dossiers on PanGenerika’s list.
- We are approached by a number of companies to put there products on our product list.
4. Why are companies putting their products on the list?
- Easy access to a large part of the European Market
- Supply security for five years
When we put products on the product list we inform our members and ask them to let us know if they are interested in a product. If an interest is shown, we give the producer a forecast and price-window.
5. When do we get into product/supply negotiations?
After a member shows interest in a product we negotiate a five year supply agreement with the producer. The agreement is between PanGenerika and the supplier. We always try to get the best price for our members. If they agree on the supply price, we finalize the supply agreement. We believe that this is the best business strategy for all parties involved.
6. What about regulatory affairs?
Our regulatory affairs department screens all dossiers to make sure that the content and format meet all current regulations (GMP requirements, NeeS-guidance, xml format). Naturally, we will need the input and support of the members for national requirements concerning the box and the package inserts.