Medicines Act
(Chapter 176, Section 9)
Medicines (Orphan Drugs) (Exemption) Order
O 12
G.N. No. S 470/1991

(31st January 2000)
[4th November 1991]
1.  This Order may be cited as the Medicines (Orphan Drugs) (Exemption) Order.
2.  In this Order, unless the context otherwise requires —
“advertisement” includes any notice, poster, circular, label, wrapper or document and any announcement made orally or by means of producing or transmitting light or sound;
“hospital” means a Government hospital or private hospital and includes a medical or dental clinic;
“orphan drug” means a medicinal product which —
(a)has been identified by any doctor or dentist as an appropriate and essential remedy with no effective substitute available for the treatment of any rare disease;
(b)has not been granted a product licence under the Act; and
(c)has been approved by the competent health authorities either of the country of the origin or of any other country where the orphan drug has been used;
“rare disease” means a life-threatening and severely debilitating illness affecting less than 20,000 persons.
Importation and supply of orphan drugs
3.  The licensing authority may permit any person to import or supply any orphan drug without a product licence if the drug is to be used by a doctor or dentist who has prescribed the drug for the treatment of a patient under his care.
Maintenance of records
4.—(1)  Every person who is permitted by paragraph 3 to import any orphan drug shall maintain written records which shall include —
(a)the quantity imported or supplied;
(b)the date received or supplied; and
(c)name and address of the person to whom the drug is supplied.
(2)  All records to be maintained under this paragraph and documents which support such entries in such records shall be open to inspection by any person authorised in writing by the licensing authority.
Custody of orphan drugs
5.—(1)  Any orphan drug imported under paragraph 3 shall be kept in a hospital and be under the charge and control of a doctor, dentist or pharmacist appointed by that hospital (referred to hereinafter as the custodian).
(2)  Where an orphan drug is urgently required for the treatment of a patient, the drug may be supplied by an importer or custodian directly to the doctor or dentist who has prescribed the drug for the treatment of the patient under his care.
(3)  Any person who imports any orphan drug under paragraph 3 shall forthwith by notice in writing notify the licensing authority of the name, quantity and other relevant particulars of the drug so imported.
Supply of orphan drugs by custodian
6.—(1)  Any doctor or dentist who requires an orphan drug for the treatment of a patient who is suffering from a rare disease may request the custodian of a hospital to supply the drug to him.
(2)  A request for any orphan drug which has not been imported before 4th November 1991 shall be made through the licensing authority.
7.—(1)  No person shall publish or cause to be published any advertisement likely to lead to the use of any orphan drug.
(2)  Paragraph (1) shall not apply to any advertisement contained in a publication intended for circulation to any person in charge of a hospital or other institution for use by persons engaged in the hospital or institution for education or research purposes.
Cessation of exemption
8.  The exemptions granted under this Order in respect of any orphan drug shall cease to apply —
(a)if, in the opinion of the licensing authority, the incidence of any rare disease for which the drug is used has increased significantly in any one year; or
(b)as soon as an application for a product licence for the drug has been approved by the licensing authority.
9.  Any person who contravenes or fails to comply with paragraph 4, 5 or 7 shall be guilty of an offence and shall be liable on conviction to a fine of $1,000.
[G.N. No.S 470/91]