The MEB’s Veterinary Medicinal Products Unit (BD) handles and assesses applications and issues production, distribution and marketing authorisations for veterinary medicinal products. Via the Committee for the Authorisation of Veterinary Medicines (CRD), the BD issues a recommendation to the Ministry of Economic Affairs (EZ). In the Netherlands, the Minister of Economic Affairs (EZ) is responsible for the marketing authorisation of veterinary medicinal products. On behalf of the Minister of Economic Affairs, BD is also tasked with monitoring the adverse events of veterinary medicinal products, granting trial exemptions for veterinary medicinal products and feed additives and issuing batch approvals for veterinary vaccines, export certificates and licences for wholesale and retail trade.
The Dutch representatives on the Committee for Medicinal Products for Veterinary Use (CVMP) and the CMDv (Coordination Group for Mutual Recognition and Decentralised Procedures (veterinary)) work within the BD.
Draft regulation on veterinary medicinal products
As EU president in 2016, the Netherlands was responsible for rewriting the texts of the draft Regulation on veterinary medicinal products. In the new regulation, the extensive harmonisation of the legislation (Directive 2001/82/EC on veterinary medicinal products and Directive 2001/83/EC on medicinal products for human use) was abandoned. The new regulation focuses more on the specific requirements for veterinary medicinal products set by the market. The aims of the new regulation are to reduce the administrative burden, improve the availability of veterinary medicinal products, and allow for better functioning of the internal market in Europe.
The draft includes specific rules for antimicrobial veterinary medicinal products. In terms of public health, the risks of resistance form an important factor in determining the balance between efficacy and adverse reactions. Active substances classified as essential for human health may no longer be used for animals. A regulation is binding for all Member States. There is less space for national interpretation or additional criteria.
Members of the Committee for the Authorisation of Veterinary Medicines (CRD) in 2016
Dr D.G. Groothuis, Chair
Drs. M.H.C. Ambagts (appointed from 17 May 2016)
Dr R. Bouwstra (appointed from 1 March 2016)
Dr E.M. Broens
Dr D.C.K. van Doorn (appointed from 17 May 2016)
Dr H.P.M. Vijverberg
Drs. N. Wijne-Raemakers
Here is an overview of several important figures for veterinary medicinal products. This is not a complete reflection of all activities falling under veterinary medicinal products.
Appendix B: Authorised veterinary medicinal products with a new active substance in 2016
Veterinary medicinal products with a new active substance authorised via a centralised procedure
| New active substance - Centralised procedure | |
|---|---|
| 2016 | 6 |
| 2015 | 15 |
| 2014 | 21 |
| 2013 | 12 |
| 2012 | 6 |
There were 38 centralised procedures in total, with the Netherlands involved as a rapporteur or co-rapporteur in 10 procedures.
The Netherlands was a rapporteur or co-rapporteur for new Maximum Residue Limits for 2 applications.
New applications via the Decentralised procedure
| DCP RMS | DCP CMS | |
|---|---|---|
| 2016 | 15 | 63 |
| 2015 | 12 | 60 |
| 2014 | 8 | 73 |
| 2013 | 11 | 105 |
| 2012 | 3 | 105 |
The number of DCPs increased in 2016 for the applications for which the Netherlands was the Reference Member State (RMS) as well as applications for which the Netherlands was a Concerned Member State (CMS).
New applications via the Mutual recognition procedure (MRP)
| MRP CMS | |
|---|---|
| 2016 | 15 |
| 2015 | 17 |
| 2014 | 12 |
| 2013 | 19 |
| 2012 | 33 |
The long-term number of new applications via the mutual recognition procedure (MRP) consists primarily of CMS applications. They decreased slightly last year. There were no RMS applications via the MRP in 2016.
Authorised veterinary medicinal products
| Authorised veterinary medicinal products | |
|---|---|
| 2016 | 2620 |
| 2015 | 2572 |
| 2014 | 2526 |
| 2013 | 2430 |
| 2012 | 2374 |
The number of authorised veterinary medicinal products has increased over the years. The number of new marketing authorisations issued is 115.
Number of concluded cases
| Number of concluded cases | |
|---|---|
| 2016 | 5631 |
| 2015 | 5721 |
| 2014 | 5437 |
| 2013 | 5467 |
| 2012 | 4775 |
