DFS3030 - Law, Policy and Application: Definition of medical products: EC Directives

Northern Ireland maintains alignment with certain EU excise processes and rules as a result of the Northern Ireland Protocol to the Withdrawal Agreement, so the following EC Directives apply in Northern Ireland.

Council Directive/92/83/EEC - Article 27(1) and (2)

Law

1. Member States shall exempt the products covered by this Directive from the harmonised excise duty under conditions which they shall lay down for the purpose of ensuring the correct and straightforward application of such exemptions and of preventing any evasion, avoidance or abuse:

(d) when used for the production of medicines referred to in Directives 2001/82/EC and 2001/8C/EU of the European Parliament and of the Council.

2. Member States may exempt the products covered by this Directive from the harmonised excise duty under conditions which they shall lay down for the purpose of ensuring the correct and straightforward application of such exemptions and of preventing any evasion, avoidance or abuse:

(c) for medical purposes in hospitals and pharmacies

Policy and Application

Article 27(1) provides for products which shall be exempt from duty. Amongst them are products which are used for the production of medicines defined by Directive 2001/82/EC and 2001/83/EC. This is conditional on the Commissioners being satisfied that no evasion, avoidance or abuse has occurred.

Article 27(2) provides for products which may be exempt from duty. With regard to the DFS regime, this includes products which are only to be used for medical purposes in hospitals and pharmacies.

Council Directive 2001/82/EC – Article 1

Law

For the purposes of this Directive, the following terms shall bear the following meanings:

1. Proprietary medicinal product: Any ready-prepared medicinal product placed on the market under a special name and in a special pack.

2. Veterinary medicinal product: Any substance or combination of substances presented for treating or preventing disease in animals.

Any substance or combination of substances which may be administered to animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in animals is likewise considered a veterinary medicinal product.

Policy and Application

To satisfy this definition, the constituents of the product must be recognised, by the Commissioners, as having medicinal properties, or the product must be marketed/presented as being for medicinal purposes.

Although the definition does not apply in GB following the end of the transition period, we use this as a guide to what is a medicinal product.