XVI.App1.5. Classification of the medicinal product (legal status)

When a marketing authorisation is granted, the competent authorities shall specify the classification of the medicinal product (legal status) into a medicinal product subject to medical prescription (see XVI.App.1.5.1.), or a medicinal product not subject to medical prescription [DIR Art 70(1)]. When new facts are brought to their attention, the competent authorities shall examine and, as appropriate, amend the classification of a medicinal product [DIR Art 74].

The competent authorities may provide sub-categories, including subject to special medical prescription (see XVI.App.1.5.2.) and subject to restricted medical prescription (see XVI.App.1.5.3.) [DIR Art 70(2)]. If a competent authority does not designate medicinal products into sub-categories, it shall nevertheless take into account the criteria in determining whether any medicinal product shall be classified as a prescription-only medicine [DIR Art 71(5)]. For centrally authorised products, the Guideline on Legal Status for the Supply to the Patient of Centrally Authorised Medicinal Products38 applies. Where the Commission Decision granting a marketing authorisation requires the legal status of a medicinal product to be subject to special and/or restricted medical prescription, Member States must find suitable ways to allow marketing authorisation holders of centrally authorised products to fulfil all the conditions laid down in the Commission Decision.

A competent authority may waive application above criteria for sub-categories of the legal status of a medicinal product, having regard to the maximum single dose, the maximum daily dose, the strength, the pharmaceutical form, certain types of packaging and/or other circumstances of use which it has specified [DIR Art 71(4)].

XVI.App1.5.1. Subject to medical prescription

Medicinal products shall be subject to medical prescription where:

• The medicinal product is likely to present a danger either directly or indirectly, even when used correctly, if utilised without medical supervision; or
• The medicinal product is frequently and to a very wide extent used incorrectly, and as a result is likely to present a direct or indirect danger to human health; or
• The medicinal product contains (a) substance(s) or preparations thereof, the activity and/or adverse reactions of which require further investigation; or
• The medicinal product is normally prescribed to be administered parenterally [DIR Art 71(1)].

XVI.App1.5.2. Subject to special medical prescription

When considering classification of a medicinal product as subject to special medical prescription, the following shall be taken account:

• The medicinal product contains, in a non-exempt quantity, a substance classified as a narcotic or a psychotropic substance within the meaning of the international conventions in force, such as the United Nations Conventions; or
• The medicinal product is likely, if incorrectly used, to present a substantial risk of medicinal abuse, to lead to addiction or be misused for illegal purposes; or
• The medicinal product contains a substance which, by reason of its novelty or properties, could be considered as belonging to the group envisaged in the second indent as a precautionary measure [DIR Art 71(2)].

XVI.App1.5.3. Subject to restricted medical prescription

This legal status can be used to control who may initiate treatment, prescribe the medicinal product and the setting in which the medicinal product can be used.

When considering classification of a medicinal product as subject to restricted medical prescription, the following shall be taken into account:

• The medicinal product, because of its pharmaceutical characteristics or novelty or in the interests of public health, is reserved for treatments which can only be followed in a hospital environment; or
• The medicinal product is used in the treatment of conditions which must be diagnosed in a hospital environment or in institutions with adequate diagnostic facilities, although administration and follow-up may be carried out elsewhere; or
• The medicinal product is intended for outpatients but its use may produce very serious adverse reactions requiring a prescription drawn up as required by a specialist and special supervision throughout the treatment [DIR Art 71(3)].