NEGOTIATING MANDATES
MEDICINES AND RELATED SUBSTANCES AMENDMENT BILL [B6B-2014]
COMMENTS AND QUESTIONS FROM THE MEMBERS OF COMMUNITIES DURING THE PUBLIC HEARINGS
Provincial
legislator
GAUTENG
Comments from Stakeholders
National Department of Health Rationale
The consequences put in place for cases wherein there is resistance to be
licensed whilst selling medication. What measures are in place to ensure that
there is compliance?
The integration of traditional medication into the current process, as well as
intensive research on the matter
The regulation of addictive medication since it is not covered by the proposed
amendments to the Bill.
The purpose of cheaper medication is common in society due to the
economic factors surrounding the communities. Thus regulation of cheap
acne or pimple medication sold on the streets should be taken into
consideration by the Bill.
The lack of implementation of all relevant Medical Acts is a serious concern
within the society since there is still shortage of medication being experienced
in most health establishments.
What is the intention of the Department to look deeper into the issue of side
effects, through extensive research, especially side effects caused by
HIV/AIDS Medication?
1
The Medicines Act provides for Offences (Section 29) and Penalties
(Section 30) against any aspects of the Act where non compliances have
been identified. A person found guilty of operating without a valid license
will therefore be liable in terms of Section 29 and Section 30.
Medicines containing African Traditional ingredients being sold for
commercial purposes will be subjected to the medicines act for
registration. African Traditional Medicines (ATMs) prescribed by the
African Traditional Healer is taken care of and will be controlled in terms
of the proposed Traditional Health Practitioners Act, Act 22 of 2007 which
intends to regulate the product prescribed by the Healer, the practitioner
and the practises of the Traditional Healer.
All narcotic medication that may be regarded addictive medicines is
already controlled as Schedule 6 or Specified Schedule 5 medicine in
terms of the Medicine Act. Access to these medicines and healthcare
oversight is taken care of by the provisions of Section 22A of the Act.
The Medicine Act prohibits the sale of any medicines on the streets. Acne
and pimple creams are sometimes regarded by the communities as
cosmetics. The Cosmetic Act prohibits the inclusion of a number of
substances in any cosmetic such as mercury or hydroquinone with the
Medicines Act classifying any product containing the substance
hydroquinone a medicine and list these medicines in certain Schedules to
the Act. The scheduling of these medicines requires the intervention of a
healthcare practitioner before these products may be prescribed or
obtained.
Regretfully shortage of medicines is not addressed by the Medicines Act.
Shortage may have various reasons which may include the inability of the
medicine manufacturer to deliver medicines due to identified quality
problems on the manufacturing floor, unavailability of certain raw material
to manufacture the medicine, financial constrains etc.
The Medicine Act requires all manufacturers or sellers of medicine to
report any side effects identified to the MCC. MCC collects all these
reports and send it to the WHO office in Upsala, Sweden. By collecting all
the data on side effects caused by a certain medicine, the MCC may
NEGOTIATING MANDATES
MEDICINES AND RELATED SUBSTANCES AMENDMENT BILL [B6B-2014]
COMMENTS AND QUESTIONS FROM THE MEMBERS OF COMMUNITIES DURING THE PUBLIC HEARINGS
Provincial
legislator
Comments from Stakeholders
National Department of Health Rationale
resolve to cancel the registration of these medicines, or add additional
warnings to the medicine labelling or limit the use of the medicine to
certain types of patients. This is happening continuously such as in the
case where the MCC cancelled the registration of some medicines
intended for slimming and containing the active substance “Sibutramine”
due to the side effects out weighing the benefit of the medicine.
WESTERN
CAPE
To substitute the wording on pg 2, line 7 of the long title of the Bill with the
wording: “to replace the words “product” and “products” wherever they occur
with the words “medicine” and “medicines” respectively, or to replace the word
“product” with the expression “medicine, Scheduled substance” as the case
may be, in order to correctly reflect the subject matter of the said Act
On page 5 line 25 after “or” to insert “,”
To correct the numbering of the sub clauses throughout the clause in that sub
clause (2) is duplicated on pg 15 in line 12 and 21e
The Bill was initially published in 2012, whereupon comments were submitted
and substantial changes were made to the Bill. The substantially changed Bill
was not published for comment, and the Committee is concerned that there
may have been inadequate opportunity for the public to comment on that
version of the Bill.
2
Proposed technical corrections to the wording in the title of the Act Bill are
noted and the Legal advisors will be requested to consider.
Proposed technical correction is noted the Legal advisors will be
requested to consider
Proposed technical correction is noted the Legal advisors will be
requested to consider
The intention of B6 of 2014 was published in Government Gazette no.
37361 on 20 February 2014. During the Portfolio Committee on Health
public hearings took place on Wednesday 29 October 2014, Friday 31
October 2014 and Wednesday, 5 November 2014 with representation
received from 18 stakeholders. It is the view of the Department that the
hearings gave sufficient opportunity for Stakeholders to comment on the
Bill. In addition the proposed amendments under discussion as per Bill 6
of 2014 were not regarded substantial but related mainly to technical
corrections, clarification and the transitional process of Staff from the
Department to SAHPRA.
NEGOTIATING MANDATES
MEDICINES AND RELATED SUBSTANCES AMENDMENT BILL [B6B-2014]
COMMENTS AND QUESTIONS FROM THE MEMBERS OF COMMUNITIES DURING THE PUBLIC HEARINGS
Provincial
legislator
Comments from Stakeholders
National Department of Health Rationale
Medical devices and in vitro diagnostics are not registered in South Africa.
The Committee is of the view that registration of these devices is of great
importance to patient safety and that registration and control of these items
are necessary. The Committee is concerned that the Medicines Control
Council may not have the capacity to review these items for registration.
The draft MRSA 101 General Regulations of 1965, relating to medical devices
and in vitro diagnostic medical devices, makes provision for transitional
arrangements with a phased-in approach to registration. It is imperative that
adequate time and resources be allocated to implementation.
Careful consideration must be given to the implications of these provisions,
and cognisance must be given to existing medical devices that cannot be
readily replaced in the event that they are not registered within the required
time frames.
The Committee is concerned about the budgeting and staffing of the new
entity (SAHPRA) and about the potential financial impact on the Provincial
Budget Allocation.
The Province recommends thorough consultation with provincial governments
on the budget and resources of the South African Health Products Regulatory
Authority (SAHPRA).
3
Proposed Regulation to the Medicines Act on the control of Medical
Devices and IVDs was published in 2014. Following the inclusion of the
public comment, the proposed Regulations were again published on 14
July 2015 to allow the public for a second round of comment. In addition
for clarification and implementation purposes a number of Guidelines (5
sets of Guidelines) on the proposed regulatory oversight of Medical
Devices and IVDs were published on the MCC website which calls for
public consultation with the closing date November 2015. This will allow
for a staggered approach on the review and subsequent registration of
Medical Devices and IVDs based on risk and also allowing the Regulator
to develop capacity in this new area of responsibility.
The comment from the Committee is valid. The Department accepts that
the implementation of the regulatory oversight of Medical Devices and
IVDs can only be done in a staged approach over time ensuring adequate
financial and human resources. In addition, National Treasury is aware of
the new added responsibilities of the regulator and additional budgeting
has been requested to support the activity.
The proposed Regulations and Guidelines that will address the regulatory
oversight of Medical Devices and IVDs will take care and address the
availability of existing Medical Devices and the sale of new Medical
Devices that will come onto the market. The Regulations allow for the
transition of these products from one status of registration to another.
The Department wishes to clarify the concerns raised by the Committee in
that according to the annual budget process, the Department has been
receiving budget from National Treasury for the specific work of the MCC.
In addition, the Department has been collecting fees for the registration
and regulatory oversight of medicines since 2003. To date all these fees
collected are being transferred to National Treasury. The proposed
budget of SAHPRA will call for the retention of these fees / ring fence of
these fees in addition to the annual Treasury budget process. The
Department does not foresee any on the provincial Budget allocation.
NEGOTIATING MANDATES
MEDICINES AND RELATED SUBSTANCES AMENDMENT BILL [B6B-2014]
COMMENTS AND QUESTIONS FROM THE MEMBERS OF COMMUNITIES DURING THE PUBLIC HEARINGS
Provincial
legislator
Comments from Stakeholders
National Department of Health Rationale
KWAZULU
NATAL
Definition of Inspector be amended to be specific on qualification of the
inspector as the Medicines Act only provides that the Director-General may
authorize persons as inspectors
It is proposed that as the deletion of “cosmetic” and “foodstuff” indicates that
these will be regulated under the Foodstuffs, Cosmetics and Disinfectants Act
54 of 1972, this Act must be amended to make it more robust to cater for the
regulatory shift
It is proposed that clause 1(g) which defines “medicine” must include
traditional medicine, supplementary medicine, complementary medicine and
alternative medicines
Clause 2 C: the composition of the Board must include a person who has
expertise in traditional healing
Clause 21: The Minister must be given powers to dismiss a member of the
Board without dissolving the Board
Clause 26(3) the transfer of various employees into a “central agency” which
is SAHPRA must exclude the transfer of the Food Safety Directorate staff to
the Agency as these functions have been deleted in the Bill.
4
The qualification of an inspector is as per the Departmental Human
Resource policy requires a person to be appointed as an Inspector with a
natural science degree (including a Pharmacy degree) and experience in
a specific area of either medicine manufacturing, wholesaling, conduct of
clinical trials, or alternative the qualification of a Law Enforcement
inspector as a person with a natural science degree, pharmacy degree,
law degree, environmental etc depending on the specific identified skills
required.
Cosmetics and Foodstuffs have always been regulated in terms of the
Foodstuffs, Cosmetics and Disinfectants Act 54, 1972.
It is the intention of the Department to regulate African Traditional
Medicines prescribed by the African Traditional Health Practitioner in
terms of the African Traditional Health Practitioners Act, 2007 with
medicine containing African traditional ingredients but available on a
commercial basis in terms of the Medicines Act. In addition, the definition
of complementary and alternative medicine has been included to the
Regulations to the Medicines Act as these type of products are regarded
sub-species of a medicine.
The view of the Committee is valid. The Department will request the
Legal office to expand the composition of the Board to allow for the
inclusion of a person with expertise in African Traditional Healing on the
Board.
The Department wishes to clarify the concerns of the Committee as Section
2F of the Bill deals with disqualification of a member from membership of
Board and vacation of office. This section allows the Minister to dismiss a
member without dissolving the Board.
The Department notes and agrees with the comment. It was an omission
from the Department not to delete reference to “food control”. The Legal
office will correct the inscription.
NEGOTIATING MANDATES
MEDICINES AND RELATED SUBSTANCES AMENDMENT BILL [B6B-2014]
COMMENTS AND QUESTIONS FROM THE MEMBERS OF COMMUNITIES DURING THE PUBLIC HEARINGS
Provincial
legislator
Comments from Stakeholders
National Department of Health Rationale
The KZN local government proposed that the local authorities’ role be
considered in the Bill as they consider themselves to be well resourced and
are the sphere of government closest to the people and more attuned to local
development.
NORTH
WEST
PROVINCE
Section 2C that representation of Religious groups and Traditional Healers to
form part of the Board
Section (D) appointment of Board members to include representation from all
Provinces
Proposal that Traditional medicines to be regulated, controlled and tested by
the Department of Health
A portion of licensing fees to be retained by SAHPRA to ensure selfsustainability
LIMPOPO
The Bill should be considered with the use of the words “humans and
animals”
The Bill should be consistent with the definition of [product] wherein
“Scheduled substance” is omitted
5
The Department welcomes the assistance that the local authority could
provide. In addition the Department wishes to confirm that the MCC is
already making use of the expertise within the province through the
appointments of various Technical Experts from the KZN University on the
Technical Expert Committees of the MCC and as MCC Council members.
The Department has taken care of the requirement and intends to
address representation of Religious Groups and Traditional Healers in
terms of the African Traditional Health Practitioners Act, 2007
The Board will be responsible exclusively for governance of SAHPRA
which will include oversight of financial statements, performances etc. As
the regulatory oversight of medicines and Medical Devices / IVDs is of
national importance, expertise will be seek from all provinces.
Medicines containing African traditional ingredients being sold for
commercial purposes will be subjected to the Medicines act for
registration. African Traditional Medicines prescribed by the African
Traditional Healer will be controlled in terms of the Traditional Health
Practitioners Act, 2007 which intends to regulate the product, the
practitioner and the practise of the Traditional Healers.
The concerns of the Committee are noted. This will be taken care of as
per the proposed business model of SAHPRA, fees collected by SAHPRA
will be retained with additional funding to be obtained from National
Treasury in terms of the annual budgeting processes to address the
deficit to run the regulatory authority.
The Department welcomes the input from the Committee. In order to
clarify the concern raised by the Committee, the Department wishes to
advise that the Principle Act that defines a medicine includes veterinary
medicines. In addition separate regulations are available that address
specifically the labelling of veterinary medicines and the conduct of clinical
trials in animals. The Department is of the view that the current principle
act addresses the concerns of the Committee satisfactory.
The Department agrees with the Committee that the use of the word
“product” only in those areas where appropriate and where relevant
NEGOTIATING MANDATES
MEDICINES AND RELATED SUBSTANCES AMENDMENT BILL [B6B-2014]
COMMENTS AND QUESTIONS FROM THE MEMBERS OF COMMUNITIES DURING THE PUBLIC HEARINGS
Provincial
legislator
Comments from Stakeholders
National Department of Health Rationale
Section 2C (2)(a) Composition of the Board not more than 10 persons who
have expertise in the fields of medicine, medical devices, IVD, vigilance,
clinical trials, good manufacturing practises, public health, epidemiology,. The
Committee is proposing to include reference to Pharmacology, and
pharmaceutics and (g) one person on account of his or her knowledge of
traditional health practice
NORTHERN
CAPE
The Bill should address the traditional healers intellectual property and
indigenous knowledge before the appointment of the Board
The government must assist in facilitating a benefit sharing agreement
between western medicine and traditional processing of medicine
MPUMALAN
GA
The Bill must have good regulations to ensure the Board and SAHPRA work
effectively
6
should refer to scheduled substances. The Department will ensure that
the replacement of the word “product” be in line with the specific area that
needs to be addressed such as when the legislation should refer to
medicine, medical devices, IVDs or Scheduled substances.
The Board is intended to be a governance Board. The Department agrees
to include persons with expertise in the fields of pharmacology /
pharmaceutics. In addition, the Department agrees to expand the
composition of the Board to include one person with on account of his/her
knowledge of Traditional Health Practices.
The Department notes the concerns raised by the Committee and wishes
to clarify that the work underway with the Department of Science and
Technology on Ingenious Knowledge Systems (IKS) is able to address
this matter. This work also includes provisions for benefit sharing and bio
prospecting.
The Department welcomes the proposal by the Committee.
The
Department will ensure that SAHPRA will cooperate with the Interim
Traditional Practitioners Council through the council’s representation on
the SAHPRA Board to allow for benefit sharing between western and
traditional processing of medicine. In addition the Department wishes to
report that roadshows on the Traditional Healers Practitioners Act, the
provisions and the requirements is being conducted across the country.
The Department will follow up with the province in the roadshows and
distribute current documentation that has been translated in 9 of the local
languages.
The Department welcomes the Committee report which provides specific
comments on products versus medicines, versus medical devices and
Scheduled substances. The Department wishes to clarify the concerns of
the Committee and confirms that enabling regulations will be published for
each of the clauses as proposed in the Bill. As per the legislative
process, Regulations are published for public comment prior to
promulgation by the Minister
NEGOTIATING MANDATES
MEDICINES AND RELATED SUBSTANCES AMENDMENT BILL [B6B-2014]
COMMENTS AND QUESTIONS FROM THE MEMBERS OF COMMUNITIES DURING THE PUBLIC HEARINGS
Provincial
legislator
Comments from Stakeholders
National Department of Health Rationale
Professionals from Mpumalanga should sit on the Board
SAHPRA must assist to close gaps in the high pricing of medicines in the
private sector and generally high cost of private healthcare
The Bill must strengthen the testing and approval of traditional medicines
The Bill should clarify the roles and functions of the structure when the offices
are established at national and provincial level
SAHPRA must continually run programmes to educate the public on
medicines and also conduct awareness campaigns on the side effects of
medicines and dangers of taking medicines not prescribed by a doctor
SAHPRA must also have measures to counteract the practice that people
seek conventional medicine and medical help after consulting traditional
healers without success
7
The Department acknowledges to comments from the Committee and
wishes to clarify that appropriately skilled candidates will be identified and
selected through a transparent process by advertising in the national
media and selection is based on required expertise as per the provisions
of Section 2D of the Bill
The Department supports the views of the Committee and wishes to
clarify that pricing is a function of the Medicine Pricing Committee as per
Section 22G of the Principle Act. The Department wishes to confirm that
SAHPRA will be tasked with the responsibility for approving the
registration of a medicine or medical device / IVD based on the criteria of
safety, quality and efficacy.
The Department wishes to confirm that medicines containing African
traditional ingredients being sold for commercial purposes will be
subjected to the Medicines act for registration. African Traditional
Medicines (ATM) prescribed by the African Traditional Healer will be
controlled in terms of the proposed Traditional Health Practitioners Act,
2007 which intends to regulate the product, the practitioner and the
practise of the Traditional Healers.
The Department notes the concern of the Committee and wishes to
confirm that as SAHPRA’s functions develop, offices may be established
if the need arises at various locations across the country. It would be
restrictive to identify exact locations of SAHPRA offices in the Bill as this
would be an operational matter which the Board would be required to
consider from time to time.
The Department welcomes the view of the Committee and supports the
view. The Department wishes to confirm that this mandate to ensure
healthcare workers and consumers are educated regarding the safety of
medicines already exists in the current principle act and legislation and
SAHPRA intends to expand this role.
The Department notes the concern of the Committee and wishes to
advise that this is a matter which the Traditional Health Practitioners Act
(Act 22 of 2007) will address as it has the responsibility to regulate the
practice of traditional medicine.
NEGOTIATING MANDATES
MEDICINES AND RELATED SUBSTANCES AMENDMENT BILL [B6B-2014]
COMMENTS AND QUESTIONS FROM THE MEMBERS OF COMMUNITIES DURING THE PUBLIC HEARINGS
Provincial
legislator
Comments from Stakeholders
National Department of Health Rationale
The package insert and information on medicines should be in all the eleven
official languages
The Bill should assist in coming up with a plan to address criminal activities
identified on medicines and related substances
EASTERN
CAPE
Requirements that the regulatory pathways for medical devices and IVDs
must be different from that of medicines
Clause 14 of the Bill seeks to prescribe the conditions for the manufacture of
medical devices or IVDs and this will limit innovative methods required for the
manufacture of such devices and their accessibility to the public
Clause 12 assumes that medical devices and IVD are also dispensed like
medicines i.e. through prescription and this is generally not the case as such
prescription stipulations in the clause will limit accessibility of such medical
devices to the public
The Department acknowledges the need for informing to the public to
appear in all 11 official languages. The current legislation and regulations
already requires the labelling of a medicine to appear in at least two of the
official languages. SAHPRA will have the responsibility to ensure
expansion of these legal requirements.
The Department acknowledges the concerns of the Committee and
wishes to confirm that it is the intention of SAHPRA to retain the current
law enforcement unit which liaises, interacts and assists key agencies
such as commercial crime, directorate for priority crime investigations,
SARS, Interpol, SAPS, national regulator for compulsory specification and
the CIPC on various law enforcement matters dealing with medicines and
related substances.
The Department agrees with the comment from the Committee and
wishes to confirm that this has been taken care of as the MCC together
with the Department has developed a separate piece of Regulation and
Guidelines to address specifically the registration of medical devices and
IVDs. The latter is currently published for public comment.
All manufacturers of medical devices and IVDs will require a license to
manufacture a medical device and IVD in the case that the product will be
available and sold to the public in order to protect the public against
substandard devices of bad quality. It is the view of the Department that
this will not limit innovative methods for the manufacture of a medical
device as the quality system that the manufacturer will require to be
implemented on site will support the development of innovative medical
devices.
The Department wishes to clarify that Clause 12 calls for a mandatory
requirement that any information available to the manufacturer of a
medicine, medical device or IVD to make that information available to the
Authority in the case the Authority calls for the information.
In addition, the Authority will also register so called “combination medical
devices” where the device includes an active substance such as in the
case of an Estrogen patch the need for a prescription will be required as
8
NEGOTIATING MANDATES
MEDICINES AND RELATED SUBSTANCES AMENDMENT BILL [B6B-2014]
COMMENTS AND QUESTIONS FROM THE MEMBERS OF COMMUNITIES DURING THE PUBLIC HEARINGS
Provincial
legislator
Comments from Stakeholders
National Department of Health Rationale
Medical devices and IVDS which are manufactured for “research purposes”
only is not covered by the Bill and it appears that there is a regulatory gap
with these “research only” devices. It is the submission that devices
manufactured purely for medical research are clearly different from clinical
trials conducted for medicines which the Bill sufficiently covers. The
submission is therefore that provision must be made in the Bill to regulate the
manufacture of medical devices purely for research use only as well.
Clause 9 of the Bill provides that registration of any medicine, medical device
and IVD may be denied in the public interest. The denial in the public interest
will create uncertainty and invite unnecessary legal challenges and litigation
arising from the usage of the term in the Bill. It is proposed that the denial of
registration of medicines, medical devices and IVDs must be informed by
clearly ascertainable terms such as considerations of safety, quality and
efficacy /performance only.
the device (patch) will have a Scheduled substance (Estrogen) combined
with the substance (Estrogen) listed in one of the Schedules to the Act
that require a prescription from a healthcare provider.
The Department wishes to clarify that the Principle Act already makes
provision for the use of an unregistered medicine, medical device and
IVDs under certain conditions and including for research purposes. In
addition, regulations and guidelines prepared by the MCC are already in
place to define the framework for the conduct of clinical research involving
medicine or medical devices and IVDs.
At from the time of the enactment of the Medicine Act in 1965 the
registration of a medicine was approved based on the criteria of safety,
quality, efficacy and if it is in public interest. This requirement has stood
the test of time. With the drafting of Act 72 of 2008 this section was
omitted. The intention of Bill 6 of 2014 is to correct this omission.
Appointment of Registrar. Under clause 6 the Committee proposes the
appointment of separate and technically qualified registrars to deal with
registration of separate products i.e. one registrar for registration of medicines
and one registrar for the registration of Medical devices and IVDs
The Department wishes to clarify that Clause 6 deals with the
establishment of Registers. These Registers record the names of all the
medicines registered by the MCC as well as the names of all the
Manufacturers and Wholesalers licensed by the MCC.
To ensure compliance with legislation, active enforcement, inspections and
investigations it is proposed that SAHPRA has branches in all the provinces.
The Department wishes to clarify that the position of Registrar of
Medicines will be replaced by the position of CEO. However, the
Department wishes to confirm that as per the intended operational
activities of SAHPRA the CEO will oversee the running of the business of
SAHPRA which will include various Business Units and Business
managers which will oversee the running of the specific business unit i.e.
the Business unit for Medicines, Complementary Medicines, Medical
devices etc.
The Department notes the view of the Committee and wishes to advise
that as SAHPRA’s functions develop, offices may be established if the
9
NEGOTIATING MANDATES
MEDICINES AND RELATED SUBSTANCES AMENDMENT BILL [B6B-2014]
COMMENTS AND QUESTIONS FROM THE MEMBERS OF COMMUNITIES DURING THE PUBLIC HEARINGS
Provincial
legislator
Comments from Stakeholders
National Department of Health Rationale
To minimise the backlog, the Bill must stipulate turnaround times for
responses to all applications submitted for the registration of medicines,
medical devices and IVDs
The Bill to provide for more regulatory monitoring and control of generic
medicines so that the drugs of the same generic makeup must be of the same
price on the market. Pharmaceutical companies currently manufacture the
principle drug and move onto manufacture its generic with the same active
ingredient but the price differs on the market.
FREE
STATE
SAHPRA to have an interactive website
Substitution in Section 2B(c) of “periodic re-evaluation” for the words
“regularly review”
Amendment in Section 2G relating to the convening of the first meeting of the
Board
Amendment in Section 2F relating to the disqualification of a Board member
and inclusion of the legislative framework upon which a person is convicted
10
need arises at various locations across the country. It would be restrictive
to identify exact locations of SAHPRA offices in the Bill as this would be
an operational matter which the Board would be required to consider from
time to time.
The Department notes the concern of the Committee on the development
of a backlog on the registration of medicines, medical devices and IVDs
and the turnaround times for responses. The Department confirms that
the operational and administrative activities of SAHPRA to be addressed
in the Guidelines supporting the activities of the authority and not being
addressed in legislation.
The concerns raised by the Committee are noted and valid. The Pricing
Committee established in terms of Section 22G of the Medicines Act and
the supportive Regulations provides for the Pricing Committee to take
care of the prices of medicines.
The website of SAHPRA not to be addressed in legislation but be part of
the operational activities of SAHPRA and the activities of the institution.
The Department notes the view of the Committee and wishes to advise
that the term “periodic re-evaluation” is widely used by other international
health product regulatory authorities and is linked to the review as
prescribed by Section 15(7) of the principle Act which requires the
Authority to review a medicine every 5 years.
The Department notes the view of the Committee and wishes to advise
that Section 2G makes provision for the Board to meet as per the rules of
the Board. The department will request the Legal office to include
reference to the first meeting of the Board in legislation if not able to
address the matter in the rules of the Board.
The Department notes the concerns of the Committee and wishes to
clarify that in order not to avoid restriction or exclusivity of any of the
applicable legislation for which a person may be convicted, the view of the
Department is not to be specific in the legislation.