Welcome to the new PHARMAPACT archives. Here you will find the latest correspondence between PHARMAPACT and the relevant authorities, plus new reports on pertinent issues.
CALL UP NOTICE FOR MEDICINES FREQUENTLY REFERRED TO AS COMPLEMENTARY MEDICINES IN TERMS OF THE MEDICINES AND RELATED SUBSTANCES CONTROL ACT, 1965 (ACT 101 OF 1)
refuse to waste our time commenting on this imbecilic drivel.
For our detailed critique on the unconstitutionality of the principles involved,
click here, or visit our current and or archived material.
PHARMAPACT COMMENTS ON DRAFT COMPLEMENTARY MEDICINES LEGISLATION
22 FEBRUARY 2002
RELATED SUBSTANCES CONTROL ACT, 1965 (ACT 101 OF 1965)
No. R 204
NOTICE FOR MEDICINES FREQUENTLY REFERRED TO AS COMPLEMENTARY MEDICINES IN TERMS
OF THE MEDICINES AND RELATED SUBSTANCES CONTROL ACT, 1965 (ACT 101 OF 1965)
Medicines Control Council (MCC) has noted that there are increasing numbers of
medicines frequently called complementary medicines being sold in South Africa
for which claims of safety, quality and efficacy are being made without the
approval of the MCC. The
Complementary Medicines Working Group of the MCC, after consultation with
stakeholders, recommended to Council that a call up of the following categories
of medicinal products be undertaken, for purposes of which certain specified
exemptions in the application for registration of a medicine (MBR1) form will be
categories of the medicines frequently referred to as complementary medicines
submission of an application in response to this call up would not constitute
product registration but should be considered a primary step in the registration
data compiled from this call up will enable Council to compile an audit of all
products currently available in the market place.
Council will review the claims of safety, quality and efficacy for all
identified products and will determine whether any such claims constitute a
public health hazard and act accordingly.
all products, Council will at a later stage determine which additional Annexures
of the MBR1 form will be required for registration purposes
person who contravenes this call up notice shall be subjected to the provisions
of Section 14 read with Section 29 (b) and (h) and Section 30 of Act 101, 1965.
also noted that similar unsubstantiated claims of safety, quality and efficacy
are being made with respect to African traditional medicines that are widely
available in the market place. The
MCC’s African Traditional Medicines Working Group will be asked to consider
whether a similar approach to a call up for the purposes of preparing an audit
of these products could be gainfully undertaken at this time.
(b) The Medicines
Control Council established in terms of Section 2 of the Medicines and Related
Substances Control Act, 1965 (Act 101 of 1965) by virtue of the powers vested in
it by section 14 (2) of the Act has by resolution approved by the Minister of
Health, determined that, with effect from the date of publication of this notice
preparations or mixtures of substances that fall under the definition of a
medicine, including all dilutions, mixtures or derivations of any substances
that are anthroposophical medicines, aromatherapeutic medicines, ayurvedic
medicines, Chinese traditional medicines, energy substances, homeopathic
medicines, nutritional substances that purport to have therapeutic or medicinal
effects, Western herbal medicines, Unani-Tibb medicines, combination
homeopathic/flower essences, and combination complementary medicines,
be subject to a call-up process instituted as a primary step towards
registration of such as medicines and shall be submitted to the MCC within six
(6) months of the date of publication of this notice.
is further notified that, under section 14 (2)(b) of Act 101 of 1965, the
above-mentioned resolution shall relate to medicines available for sale or
distribution in the Republic on the date on which it comes into operation and
shall relate also to medicines that become available after the said date.
resolved that –
medicines called up for registration in terms of the call-up notice number
…… dated ……… issued in terms of Section 14 (2) of the Medicines and
Related Substance Control Act, 1965 (Act 101 of 1965) shall by unanimous
decision of Council and approved by the Minister of Health be exempted from
complying with the provisions of application as contained in the application for
registration of a medicine (MBR1) form.
of the MBR1 form that are required:
Front page (cover sheet),
Annexure 1, (all information except 1, 5 and 12),
Annexure 2 (except the chemical name if not available)
call up shall not be applicable to medicines for which registration application
has already been made under the listed call up notices and for which a reference
number has already been issued to the applicant by the MCC.
424 3815 23/03/1973 Old – Herbal drugs 34
2186 4512 22/11/1974 Old and New – 25 special foods for which medicinal
claims are made
1029 6029 26/05/1978 Old and New – any medicine which purports to be a
medicine by using the terms…medicated, medicinal,
for medical use or similar connotation
559 9620 15/03/1985 Old and New – oral preparations containing vitamins,
alone or in combination with other pharma-
cologically active ingredients, including minerals,
medicinal claims are made or not…
It is hereby further notified that this call up notice supersedes all previous call up notices for preparations of this nature.