Starting materials

Importance of registering with the starting materials register

In the European Union, unauthorised veterinary medicinal products can end up in legal circulation. These may be products that:

• were produced illegally
• contain inferior ingredients
• do not contain any ingredients
• contain incorrectly dosed ingredients.

Consequently, they can pose a threat to human health, animal health or the environment.

Hence, Art. 95 of the Veterinary Medicinal Products Regulation lays down rules for importers, manufacturers and distributors of all active substances used as starting materials in veterinary medicinal products.

This stipulates that:

• You are to register your operations involving any active substances that could be used as starting materials in a veterinary medicinal product from with the Veterinary Medicinal Products Unit
• Manufacturers of active substances referred to above must satisfy the requirements for good manufacturing practice (GMP). The requirements are set out in Volume 4 - GMP guidelines - Part II Basic Requirements for Active Substances used as Starting Materials
• Importers or distributors must satisfy the requirements for good distribution practice (GDP). The requirements for GDP for starting materials are set out in Commission Implementing Regulation 2021/1280
• Any changes made in terms of holding starting materials intended for veterinary medicinal products mentioned in your previous registration are to be reported to the Veterinary Medicinal Products Unit on an annual basis.

The EudraGMDP database is the existing database for production and wholesale distribution. It contains all licensed manufacturers, importers and distributors of medicinal products (including veterinary medicinal products).

From 28 January 2022 onwards, this European database will also feature those companies registered in the starting materials register, under the API REG module. They will be featured once the Veterinary Medicinal Products Unit has approved the registration.

If you are a manufacturer, importer or wholesale distributor of active substances that could be used as starting materials in veterinary medicinal products, you will also be required to register if you are already featured in the database as a manufacturer or wholesale distributor of active substances intended for medicinal products and these active substances are also intended for veterinary medicinal products. 

Reporting obligation

If you hold active substances that could be used as starting materials in veterinary medicinal products, please report this here.

• If you wish to begin importing, manufacturing or distributing active substances, please report this at least 60 days prior to the point in time at which you intend to commence this activity.
• If you were engaged in importing, manufacturing or distributing active substances prior to 28 January 2022, please register by 29 March 2022 at the latest.

In addition to the registration form, please also complete the relevant appendices below and include these in your application.

• Appendix 1: Manufacturing operations using active substances
• Appendix 2: Importation of active substances
• Appendix 3: Distribution of active substances.

Your registration should: 

• specify the category of active substances to which the operations or activities pertain
• include a current extract from the Trade Register of the Dutch Chamber of Commerce
• include a floor plan for the site where the operations using active substances are taking place.

If you have multiple sites, please register for each individual site separately.
Each year, you should also submit ‘a list of the changes that have occurred vis-à-vis the information previously shared with the Veterinary Medicinal Products Unit in the registration form’. All changes that could potentially affect the quality or safety of the manufactured, imported or distributed active substances are to be reported forthwith, pursuant to Article 95(5).

You will receive an automatic confirmation of receipt upon submission of your registration.

Once your registration has been approved, your business will feature in the European database for manufacturing and wholesale distribution (the EudraGMDP database) under the API REG module. From that point onwards, your registration as a holder of starting materials will be public throughout the EU.

Your business may be inspected on the basis of a risk assessment to ensure compliance with the GDP requirements, pursuant to Article 95(8) and Commission Implementing Regulation 2021/1280. The competent authority will notify you of this in advance.

Costs

Administrative costs will be charged for:

• registration in the Register of Internet Trade in Veterinary Medicines
• a request for a variation 
• the annual fee

The amount of these costs can be found under fees and product types Veterinary Medicinal Products Unit. 

Clearance of active substances intended for veterinary medicinal products in accordance with the EU Pharmacopoeia

The current guidelines stipulate that these active substances must satisfy the version of the EU Pharmacopoeia applicable at the time of the active substance being used for the purposes of producing the human or veterinary medicinal product. Manufacturers are given ample time to prepare for Pharmacopoeia changes, which are announced at least one year before implemented.

The aforementioned rule applies to manufacturers of both human medicinal products and veterinary medicinal products.

OMS

You must register in the Organisation Management Service (OMS)-database of the European Medicines Agency (EMA), otherwise we, as the Veterinary Medicinal Products Unit (BD), cannot process your manufacturing license or certificate (MIA), your wholesale license (WDA), or your registration for the veterinary raw materials register in this database. If you are not registered with the OMS, you will not be visible in the European database for manufacturers, importers and wholesalers (EudraGMDP). More information about OMS can be found on Organisation Management Service (OMS).

More information

If you have any questions on registering active substances used as starting materials in veterinary medicinal products, please feel free to contact us using the Contact Form.

Further information on Good Distribution Practice can be found here.