EU Fertilising Products Regulation 2019/1009
Fixed prices for EU FPR dossiers
Fixed prices
Choose who holds the software licence.
Prices are per dossier, in euro, excluding VAT, and include two revisions. Each further revision is quoted separately.
Notified body fees are not included. Prices for Module B and Module D.1 exclude the fees of the notified body, which you pay to the notified body directly.
We work in our licence. You get viewing rights.
RecyFert pays for the FPR app and adds all information to the system. You look in, comment and approve.
- No software to buy or maintain
- Viewing rights to your own dossier
- You can move to your own licence later
Months 0 to 6
Full access to your dossier in the Gilbert FPR app. Generate the EU declaration of conformity (DoC) and the technical documentation (TD) in different languages.
After 6 months: choose archiving
€ 100 per dossier per year. Generating the DoC and TD stays available to you.
No archiving: access closes
If you need access later, it is treated as a new dossier.
| Dossier setup | Fee |
|---|---|
| Module AInternal production control. Includes 2 revisions. | € 600per dossier |
| Module B, followed by Module CEU-type examination and conformity to type. Includes 2 revisions. | € 1,000per dossier |
| Module D.1Production process quality assurance. Includes 2 revisions. | € 1,800per dossier |
| QMS documentation setupModule D.1 onlyRecyFert writes and sets up the QMS documentation system. Includes 12 months of the QMS software licence. One price per company, regardless of the number of products. | € 9,500per company |
You buy the app. We build the dossier.
You buy your licence directly from Gilbert RegTech. RecyFert gets edit rights in your system. You keep the freedom to work in it yourself and you keep the system up to date.
- Your licence, your data, your system
- RecyFert builds the dossier inside it
- Take over editing whenever you want
- Archiving is included in your Gilbert licence
| Dossier setup by RecyFert | Fee |
|---|---|
| Module AIncludes 2 revisions. | € 300per dossier |
| Module B, followed by Module CIncludes 2 revisions. | € 700per dossier |
| Module D.1Includes 2 revisions. | € 1,500per dossier |
| QMS documentation setupModule D.1 onlyRecyFert writes and sets up the QMS documentation system. Needs the QMS licence below. One price per company, regardless of the number of products. | € 8,000per company |
You pay Gilbert RegTech directly
- Dossier licence, per dossier per month
- € 50
- QMS licence Module D.1 only, per company per month. RecyFert needs it for the QMS documentation setup
- € 250
Optional services, done by RecyFert
You do not need to build this capacity in house. Our team does the work.
One-off options
Paid once- On-premises audit preparation€ 4,500
For 1 production site + travel costs. For Module D.1. RecyFert:
- prepares your site and your team for the audit;
- attends the audit with you;
- handles the initial correspondence with the notified body.
Additional production sites: ask us for a price.
Recurring options
Paid every year- Archiving€ 100 per dossier per yearRecyFert keeps a copy of your dossier for the 5 years the regulation requires after your product is placed on the market, and supplies it to an auditor or surveillance authority within 24 hours. You can keep generating the DoC and TD in different languages.
- Quality records logging€ 300 per dossier per yearModule D.1 requires quality records. RecyFert logs and keeps them for you.
- Annual internal audit€ 3,000 per yearFor 1 production site + travel costs. RecyFert carries out the yearly internal audit of your quality system and attends the notified body's audit by conference call. In-person attendance and additional production sites: ask us for a price.
- QMS software licence€ 3,600 per company per year from month 13The first 12 months are included in the QMS documentation setup. From month 13, RecyFert keeps your QMS system active in the Gilbert FPR app. One price per company, regardless of the number of products.
All prices are in euro and exclude VAT. Prices for Module B and Module D.1 exclude the fees of the notified body, which you pay to the notified body directly.