GOVERNMENT NOTICE
DEPARTMENT OF HEALTH
R No
16 JANUARY 2003
MEDICINES AND RELATED SUBSTANCES ACT, 1965
(ACT NO 101 OF 1965)
REGULATIONS RELATING TO A
TRANSPARENT PRICING SYSTEM FOR MEDICINES AND SCHEDULED SUBSTANCES MADE IN TERMS OF SECTION 22G OF THE MEDICINES AND RELATED SUBSTANCES ACT, 1965 (ACT NO 101 OF 1965)
The Minister of Health intends to make the regulations in the Schedule.
Interested persons are invited to submit written comments or representations on the proposed Regulations to the Director-General: Health, Private Bag X828, Pretoria, 0001 (for attention of the Cluster Manager: Pharmaceutical Policy and Planning), within three months of the date of publication of this Notice.
SCHEDULE
Definitions
"the Act" means the Medicines and Related Substances Act, 1965 (Act 101 of 1965), as amended and includes the General Regulations made thereunder;
"Blue Book" means the electronic publication known as the Pharmaceutical Blue Book published by Pharmaceutical Printers and Publishers, a wholly owned subsidiary of Alex White Holdings Limited;
"CPI" means the Consumer Price Index as determined and published by Statistics South Africa from time to time;
"distributor" means a person, other than a manufacturer, wholesaler or retailer, who supplies a medicine or Scheduled substance to a retailer;
"exporter" means a person within the Republic who sells medicines to a person outside of the Republic;
"importer" means a person importing medicines for the purpose of sale in the Republic from a manufacturer or other person outside of the Republic and includes a parallel importer as defined in the Act;
"PPI" means the Production Price Index for pharmaceutical products as determined and published by Statistics South Africa from time to time;
"Pricing Committee" means the Pricing Committee appointed by the Minister in terms of section 22G of the Act;
"purchasing power parity" means the comparative purchasing power of the currencies of two countries with respect to a predetermined basket of goods and services;
"retailer" means a person who is not a wholesaler, importer, exporter, manufacturer or distributor who sells a medicine or Scheduled substance to a user and includes a person licensed in terms of section 22C(1)(a) of the Act;
"single exit price" includes all costs associated with the manufacture and sale of the medicine or Scheduled substance;
"supply chain" includes any two or more of the following-
"user" means a natural person to whom a medicine or Scheduled substance is sold for use and excludes a manufacturer, importer, exporter, wholesaler, distributor, retailer and any other person selling medicines or Scheduled substances in the Republic;
(b) The prevalence of the disease or condition as established by the applicant;
(c) The names of other manufacturers who sell medicines and scheduled substances and who, in the perception of the applicant, would be in direct or indirect competition with the applicant with respect to the medicine or Scheduled substance;
ME TSHABALALA-MSIMANG
MINISTER OF HEALTH
DATE: