Posted 31 January 2017
The Minister of Health has published two sets of regulations on 27 January 2017
- General Regulations to the Medicines and Related Substances Act (GoN 50, GG. 40577, 27 January 2017), for comment by 27 February 20167 according to the gov.za web site, but within 3 months according to the text – http://www.gov.za/sites/www.gov.za/files/40577_gon50.pdf
This is a comprehensive set of proposed regulations to accompany the launch of SAHPRA and allow for the promulgation of the 2008 and 2015 Amendment Acts. The ToC is as follows (and includes 25A. Sub -categories of complementary medicines):
LIST OF CONTENTS
Regulation No. Title
- Requirements for therapeutic equivalence.
- The manner and conditions for allowing international tendering.
- Conditions for compounding medicine.
- Time frames for considering applications.
- Particulars to be published in the Gazette in respect of applications received for registration in terms of section 14(3).
- Importation of medicines in terms of section 15C.
- Labelling of medicines intended for human use.
- Professional Information for medicines for human use.
- Consumer Information,
- Prescription book or permanent record.
- Importation of medicines into the Republic.
- Transmission of medicines through the Republic.
- Permits and authorisation in terms of section 22A of the Act.
- Importation or exportation of specified Schedule 5. Schedule 6, Schedule 7 or Schedule 8 substances.
- Personal medicinal use by persons entering the Republic.
- Information to be furnished annually to the Chief Executive Officer.
- Licence to dispense or compound and dispense medicines.
- Licence to manufacture, import, export, act as a wholesaler or distribute medicines or scheduled substances.
19A. Exemption in terms of Section 22H
- Period of validity of licence issued in terms of regulations 18 and 19 and renewal of licences.
- Appeal against the decision of the Director -General.
21A. Appeal against the decision of the Authority.
- Application for the registration of a medicine.
- Information that must appear in the register for medicines.
23A. Transfer from the register for medicines to the register for medical devices or IVDs.
- Application for an amendment to the register for medicines.
- Categories and classification of medicines.
25A. Sub -categories of complementary medicines.
- Certificate of registration.
- Destruction of medicines.
- Particulars which must appear on a prescription for a medicine.
28A. Particulars which must appear on an order for a Schedule 6 medicine.
- Returns to be furnished in respect of specified Schedule 5 and Schedule 6, 7 or 8 substances.
- Register of specified Schedule 5 or Schedule 6 medicines.
- Method of taking samples, the certificate to be issued and the reporting of analysis results.
- Seizure of medicines.
- Repackaging of medicines.
- Conduct of clinical trials for humans and animals.
34A. Authorisation of sale of unregistered medicine for certain purposes.
- Skills of staff of the Authority.
- Control of medicines in hospitals.
- Pricing Committee.
- Professional information for veterinary medicines.
- Labelling for veterinary medicines.
- Offences and Penalties.
- Compliance with Requirements.
- Batch release for biological medicines.
- Advertising of medicines.
- Obtaining pain control medicines by registered midwives.
- Acquisition and use of medicines by masters of ships and officers in charge of any aircraft.
- Use of medicines for exhibition purposes.
- Medicines and Related Substances Act: Regulations: Transparent pricing system: Dispensing fee for pharmacists (GoN 48, GG. 40577, 27 January 2017) – http://www.gov.za/sites/www.gov.za/files/40577_gon48.pdf or on CamCheck
This is the revised dispensing fee for pharmacists, signed by the Minister on 21 December 2016, which stipulates:
” 10. (1) The appropriate dispensing fee as contemplated in Section 22G (2)(b) of the Act to be charged by a pharmacist, must be calculated as
(a) where the single exit price of a medicine or scheduled substance is less than ninety seven rand and six cents (R97.06), the dispensing fee shall not exceed R9.25 plus 46% of the single exit price in respect of that medicine or scheduled substance;
(b) where the single exit price of a medicine or scheduled substance is greater than or equal to ninety seven rand and six cents (R97.06) but less than two hundred and fifty eight rand and eighty eight cents (R258.88), the dispensing fee shall not exceed R22.50 plus 33% of the single exit price in respect of that medicine or scheduled substance;
(c) where the single exit price of a medicine or scheduled substance is greater than or equal to two hundred and fifty eight rand and eighty eight cents (R258.88) but less than nine hundred and six rand and ten cents (R906.10), the dispensing fee shall not exceed R69.00 plus 15% of the Single Exit Price in respect of that medicine or scheduled substance;
(d) where the single exit price of a medicine or scheduled substance is greater than or equal to nine hundred and six rand and ten cents (R906.10), the dispensing fee shall not exceed R160.00 plus 5% of the Single Exit Price in respect of that medicine or scheduled substance.
This fee which is exclusive of VAT represents a maximum dispensing fee and doesn’t preclude dispensers from charging a lower fee to be added to the SEP of a medicine or scheduled substance thus resulting in a final price to be paid by the consumer.