register

If the MEB Agency – Veterinary Medicinal Products Unit – has made a decision about granting, changing or withdrawing an authorisation for the:

• preparation, packaging, labelling or supplying of veterinary medicines under the Veterinary Medicines Act (1) or;
• the manufacture, importation, wholesale or retail of veterinary medicines under the Animals Act (2);

then the information from the authorisation will also:

a. be processed in the authorisation register - last update February 2013 [3]
The authorisation register contains data about the location where the marketing authorisation holder may perform certain activities as listed in the authorisation, combined with the application number and the category of veterinary medicines to which the authorisation relates.

This register also lists those parties who have obtained an authorisation for the importation of a veterinary medicine from outside the European Economic Area (EEA): countries located outside the EU, plus Iceland, Liechtenstein and Norway. The importation of a veterinary medicine from outside the EEA into the Netherlands is prohibited without such an authorisation. The customs office enforces this ban.

b. be published in the Government Gazette [3];

c. be processed in the EudraGMP database (in the event of an authorisation for manufacture and importation [4])

[1] Stipulations regarding the Veterinary Medicinal Products Act expired on 01.01.2013.

[2] Stipulations under the Animals Act came into effect on 01.01.2013.

[3] Taking into consideration article 4.16, section 1 and 5.6, sections 1 and 2 of the Decree on veterinary medicinal products.

[4] As intended in article 4.16, section 2 of the Decree on veterinary medicinal products.