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Fees for manufacturing and wholesale authorisations and variations

Dossier fees

- Manufacturing and wholesale authorisations (Article L. 5142-1 of the Public Health Code)

Type

Amount payable

Opening authorisation 

€2,000

Transfer

€200

Substantial variation (of a technical nature) 

€500

Non-substantial variation (of an administrative or technical nature) 

€200

The opening authorisation is granted by establishment, while the fee due in the event of an administrative declaration by a company or its establishments shall be charged on each establishment concerned by the variation.

Thus, the declaration of a variation by a company with N establishments would lead to N variations and N fees being due.

References: Articles L. 5141-8 and D. 5142-64 of the Public Health Code

 

- Premises preparing autogenous vaccines

Type

Amount payable

Authorisation for preparing an autogenous vaccine

€2,000

Renewal 

500

References: Articles L. 5141-8 and D. 5141-142 of the Public Health Code

 

Annual fees

- Manufacturing and wholesale authorisations (Article L. 5142-1 of the Public Health Code)

An annual fee is payable for each valid authorisation on 1 January of the assessment year. The amount is calculated according to the nature of the activity performed as defined in Article R. 5142-1 of the Public Health Code.

For the manufacture and import of veterinary medicinal products and veterinary medicinal products subject to clinical trials, the amount is calculated on the basis of the number of staff assigned to the activity.

For the other activity categories, it is a fixed amount.

If an establishment engages in multiple activities, the amount due is based on the activity generating the highest fees.

Manufacturer or importer of veterinary medicinal products

Amount payable

- Workforce less than 10

€2;200

- Workforce between 10 and 100

€6;600

- Workforce greater than 100

 

Distributor, depository, wholesaler of veterinary medicinal products, wholesaler specialised in exports, wholesaler of antiparasitic veterinary medicinal products intended for the external treatment of pets, distributor of veterinary medicinal products subject to clinical trials, wholesaler of medicated premixes or wholesaler specialised in exports of medicated premixes.

€22,000

Manufacturer, importer, distributor of medicated feed or export distributor for medicated feed.

€2,200

Reductions granted for multiple activities:

€2,200

1/ Manufacture or import of veterinary medicinal products and other veterinary pharmaceutical activities:

 

- Workforce less than 10

€2,200

- Workforce between 10 and 100

€6,600

- Workforce greater than 100

€22,000

2/ Multiple activities excluding the manufacture or import of veterinary medicinal products

€2,200

References: Articles L. 5141-8 and D. 5142-65 of the Public Health Code