S.L. 458.34 Art. 27Medicinalproducts subject to medical prescription.

(1) Medicinal products shall be subject to medical prescription where they -

(a) are likely to present a danger either directly or indirectly, even when used correctly, if utilized without medical supervision, or

(b) are frequently and to a very wide extent used incorrectly, and as a result are likely to present a direct or indirect danger to human health, or

(c) contain substances or preparations thereof, the activity and any adverse reactions of which require further investigation, or

(d) are normally prescribed by a doctor to be administered parenterally.

(2) For the sub-category of medicinal products subject to special medical prescription, the Authority shall take account of the following factors:

(a) 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 of 1961 and 1971, or

(b) 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

(c) the medicinal product contains a substance which, by reason of its novelty or properties, could be considered as belonging to the group envisaged in paragraph (b), as a precautionary measure.

(3) For the sub-category of medicinal products subject to restricted prescription, the Authority shall take account of the following factors:

(a) 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;

(b) 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

(c) the medicinal product is intended for out-patients 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.

(4) The Authority may waive application of subregulations (1),

(2) and (3) having regard to:

(a) the maximum single dose, the maximum daily dose, the strength, the pharmaceutical form, certain types of packaging; and, or

(b) other circumstances of use which it has specified.