If you import veterinary medicinal products from countries outside the EEA (European Economic Area, the EU member states plus Iceland and Norway), you will need an import licence for this. In addition, a marketing authorisation must be issued for the veterinary medicinal products you import and which are destined for a member state in the EEA.
Importation of veterinary medicinal products
When applying for a licence for the import of veterinary medicinal products from outside the EEA, the MEB Agency, Veterinary Medicinal Products Unit (BD) asks the Health Care and Youth Inspectorate (IFJ) for advice on whether the relevant licence requirements have been met.
You must apply for an import licence if you perform operations that are needed upon import to acquire the customs status of community goods as described in Regulation 952/2013/EC. This is also referred to as “putting into free circulation”.
You do not need to apply for an import licence if a veterinary medicinal product is not put into free circulation in the Netherlands but remains under customs supervision, for example, in a customs warehouse.
In addition, you do not need to apply for a licence if it is a veterinary medicinal product that is intended and used exclusively as a diagnostic agent on non-living material of animal origin, in order to identify a disease or the immunological status of animals (up to 1-1-2020).
Requirements for the import of veterinary medicinal products
Pursuant to Art. 4.17 of the Veterinary Medicinal Products Regulations, as import licence holder, you ensure that:
- a qualified person or designated individual (as stated in Art. 4.6 of the Veterinary Medicinal Products Regulations) in the Netherlands has verified or has the responsibility for verifying that the batches transported to Dutch territory have undergone:
- a complete qualitative analysis;
- a quantitative analysis of at least all active substances, and;
- all other tests or inspections required to safeguard the quality of the veterinary medicinal products. These must be in accordance with Art. 6 through 14 of Directive no. 91/412/EC as well as with the manufacturing method described in the dossier (Article 2.3 of the Veterinary Medicines Decree).
- The testing methods must also be in accordance with Art. 12 (3) (d) and (i) respectively of Directive 2001/82/EC.
- The course and result of the inspection, as described above, are recorded in a batch protocol that is dated and signed by the person performing the inspection;
- If an analysis, test or inspection, as described above, has been carried out by a third party, the QP is also responsible for the quality of that analysis, test or investigation;
- A veterinary medicine is only supplied for sale after a batch release document has been signed by the QP.
The import requirements aim to ensure that each batch of a veterinary medicinal product meets the European requirements and the marketing authorisation dossier in the country of destination.
The import requirements are described in:
- Veterinary Medicinal Products Decree (Art. 4.21 for imports);
- Veterinary Medicinal Products Regulations (Art. 4.16 - 4.18 for imports);
- The Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use
Licence requirements for import from third countries with which the EU has concluded an agreement (MRA)
After assessment of the mutual quality systems, an agreement has been concluded between the EU and a number of countries outside of the EEA (MRA: Mutual Recognition Agreement), which allows mutual recognition of licensed manufacturers.
These countries are Australia, New Zealand, Switzerland and Canada. As a result, an importer may base batch certification for batch release on a batch release document signed by the manufacturer's expert person (QP). This must show that the checks were carried out in the exporting country (Art. 4.18 of the Veterinary Medicinal Products Regulations).