Medicine Act: General Regulation 42 – 18 C Marketing of medicines

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Posted 04 May 2018

Section 18C of the Medicines Act has been amended to read as follows:

“18C. Marketing of medicines, medical devices or IVDs.-The Minister shall, after consultation with the relevant industries and other stakeholders, make regulations relating to the marketing of medicines, medical devices or IVDs and such regulations shall also provide for Codes of Practice for relevant industries.”

The new General Regulation 42 (see below) is obviously insufficient:

“ADVERTISING OF MEDICINES

(1) Medicines which contain a Schedule 0 substance or a substance listed as Schedule 1 may be advertised to the public.

(2) Medicines which contain a substance listed as Schedule 2, Schedule 3, Schedule 4, Schedule 5 or Schedule 6 may be advertised-

(a) only for the information of pharmacists, medical practitioners, dentists, veterinarians, practitioners, and other authorised prescribers; or

(b) in a publication which is normally or only made available to persons referred to in paragraph (a).

(3) Subregulation (2) shall not be so construed as to prohibit informing the public of names, pack sizes and strengths of medicines which contain a substance appearing in Schedule 2, Schedule 3, Schedule 4, Schedule 5 or Schedule 6 provided that no reference or inference is made to the registered indication.

(4) No advertisement for a medicine may contain a statement which deviates from, with or goes beyond the evidence submitted in the application for registration of such medicine with regard to its safety, quality or efficacy where such evidence has been accepted by the Authority in respect of such medicine and incorporated into the approved professional information of such medicine.

(5) An advertisement for a medicine shall contain –

(a) the proprietary name of such medicine;

(b) in the case of a written advertisement-

(i) the approved name and quantity of each active ingredient of such medicine in lettering having minimum legibility: Provided that, in the case of a medicine containing only one active ingredient, such lettering shall be not less than one half the size of the largest lettering used for the said proprietary name;

(ìì) of a registered medicine, the registration number allocated to it in terms of section 15(5) of the Act;

(iii) of a medicine in respect of which an application for registration has been submitted in terms of section 14 of the Act, the reference number allocated to such application by the Authority, followed by the words “Act 101 of 1965 “; and

(iv) where a name other than the proprietary name is also used, such other name shall be in lettering one half the size of the largest type size in which the proprietary name appears in such advertisement; and

(c) in the case of a –

(i) veterinary medicine, an indication that the medicine is for veterinary use; and

(ii) complementary medicine –

(aa) a statement identifying the discipline of the medicine where relevant;

(bb) an indication that the medicine must be used in accordance with the applicable complementary discipline and principles where relevant; and

(cc) if the medicine has not received registration with the Authority the following disclaimer: “This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use. “;

(6) In the case of an advertisement for a medicine which contains more than one active ingredient, no specific reference shall be made to the specific properties of any individual active ingredient unless a reference of this nature has been approved by the Authority for inclusion in the professional information of such medicine.

(7) When a medicine is advertised verbally for the first time to persons contemplated to in subregulation 2(a), written information, which shall include at least the information referred to in regulation 11 or regulation 14, shall simultaneously be given to the person to whom the oral advertisement is directed, and when the medicine is advertised orally on subsequent occasions such information shall be available on request.”

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