National procedure

If the national procedure is followed, the marketing authorisation issued will only be valid for the Netherlands. The veterinary medicinal product and the related dossier will only be marketed in the Netherlands.

In the Netherlands the decision on the authorisation of a veterinary medicinal product is taken by the Chief Veterinary Officer (CVO) of the Ministry of Agriculture, Nature and Food Quality (LNV), who decides on behalf of the Minister of LNV, following consultations with the Minister of Health, Welfare and Sport (VWS).

National procedure criteria

Besides issuing a marketing authorisation for the Dutch market, the national procedure can also be conducted as an initial phase of a mutual recognition procedure, when the Netherlands acts as  Reference Member State in the latter procedure.

A national procedure is not possible in all cases. If the veterinary medicinal product falls into the category for which a centralised procedure is obligatory, the centralised procedure must be followed. What is more, if the veterinary medicinal product dossier of the same applicant has already acquired a marketing authorisation in one of the other member states of the EU/EEA, or the veterinary medicinal product dossier is already being used to process an application for a marketing authorisation in one of the other member states of the EU/EEA, a national procedure will not be possible. In this case a mutual recognition procedure is obligatory.

Submission and assessment of the authorisation dossier

In order to complete a national procedure, an authorisation dossier has to be submitted to the Veterinary Medicinal Products Unit. The benefit-risk balance of the veterinary medicinal product will then be drawn up. The maximum period allowed in order to reach a final judgement is 210 days. This period can be interrupted in order to give the applicants the opportunity to answer questions.

In the event of a positive judgement the summary of product characteristics, the label and the package leaflet will be established when the marketing authorisation is issued. Details of the national marketing authorisations issued are kept in the Veterinary Medicines Information Bank.

The packaging of veterinary medicinal products which have acquired a marketing authorisation via the national procedure must bear the national number of the marketing authorisation, which begins with ‘REG NL’.

Application forms and documents

You can use the European application form for a national application for a marketing authorisation.

Various requirements can be imposed on the authorisation dossier for national procedures to be submitted, depending on the nature of the procedure. National procedures are subject to the rules in accordance with Directive 2001/82/EC with possible amendments in line with the Dutch situation. More information can be found in the Animals Act [Wet Dieren], the Veterinary Medicines Regulations [Regeling diergeneesmiddelen] and the Veterinary Medicines Decree [Besluit diergeneesmiddelen].

A description of all the requirements relating to the structure and submission of the dossier can be found in Volume 6 Notice to Applicants. This also contains all the veterinary guidelines. In addition to this there is an NL SPC-template, see SPC, labelling and package leaflet.