POISONS AND THERAPEUTIC GOODS REGULATION 2008 - REG 166 Consideration of applications

POISONS AND THERAPEUTIC GOODS REGULATION 2008 - REG 166

166 Consideration of applications

(1) After considering an application under this Division, the Secretary may issue the licence for which the application is made or may refuse the application.

(2) In particular, the Secretary may refuse an application if of the opinion that the applicant is not a fit and proper person to hold the licence for which the application is made.

(3) A licence may not be issued unless the Secretary is satisfied that the premises to which the application relates are appropriate for the manufacture or supply of drugs of addiction.

(4) The Secretary is not empowered to issue a licence under this Division for the supply, under the program known as the New South Wales Opioid Treatment Program, of methadone or buprenorphine to drug dependent persons (as defined in section 27 of the Act) unless--

(a) the licence is a replacement licence, or

(b) the application for the licence is made by or on behalf of an agency that--

(i) provides drug treatment services at premises under that Program to no more than 50 drug dependent persons who are resident at the premises while they are being treated, and

(ii) is a member of the Network of Alcohol and Other Drug Agencies Incorporated.

(5) To avoid doubt--

(a) subclause (4) does not affect the validity or operation of any licence to supply methadone or buprenorphine that was in force immediately before 30 June 2006, and

(b) the Secretary may--

(i) add conditions to, or vary or revoke the conditions of, such a licence, or

(ii) vary the premises to which such a licence relates, on the application of the licensee.

(6) In this clause--


"replacement licence" means a licence to supply methadone or buprenorphine that replaces such a licence which is in force immediately before the replacement licence is issued.