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Duty Free Spirits Guidance

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

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 defined by Directive 65/65/EEC.

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 65/65. 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/65/65 – Article 1

Law

For the purposes of this Directive, the following shall have the meanings hereby assigned to them:

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

2. Medicinal product: Any substance or combination of substances presented for treating or preventing disease in human beings or animals.

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