If the national procedure is followed, the marketing authorisation granted is only valid for the Netherlands. The veterinary medicinal product with the relevant dossier is only marketed in the Netherlands.
Articles 46 and 47 of the Veterinary Medicinal Products Regulation provide the legal basis for the national procedure.
National procedure criteria
You can use the national procedure for:
- applying for a marketing authorisation for the Dutch market only
- as a first stage of a mutual recognition procedure. The Netherlands then acts as a reference country (RMS: Reference Member State)
A national procedure is not possible in all cases. It is not possible if:
- the veterinary medicinal product falls into the category for which a centralised procedure must be followed
- the veterinary medicinal product dossier of the same applicant has already obtained a marketing authorisation in one of the other EU/EEA Member States
- the veterinary medicinal product dossier of the same applicant is already examining an application for marketing authorisation in one of the other EU/EEA Member States
In the latter two cases, a mutual recognition procedure is mandatory.
To follow a national procedure, you submit an authorisation dossier to the Veterinary Medicinal Products Unit. The efficacy/harmfulness balance of the veterinary medicinal product shall be drawn up. The period to reach a final verdict is a maximum of 210 days. This period may be interrupted to give you as an applicant the opportunity to answer questions.
After a positive decision, the product receives a national marketing authorisation. This includes the Dutch translation of the approved SPC, package leaflet and packaging texts.
Submitting an application
Would you like to submit a national application? Please also fill in the European application form .
You can read under submission of a dossier how to submit the file to the VMPU.
Annex II of the Veterinary Medicinal Products Regulation describes the preparation and submission of the dossier. Volume 6 - Notice to Applicants contains veterinary guidelines for the application for a marketing authorisation. You also provide a proposal for the SPC text. For this you use the NL SPC template, see SPC, labelling and package leaflet.
You provide all the necessary documentation with your application.
Do you have an additional question about the national procedure? Please contact the Veterinary Medicinal Products Unit.