HISTORY, CAPACITY AND POSITION

A high level presentation for SAPRAAApril 2017

History• Founded in 1976, the HPA has efficiently supported,

promoted and protected the CAMs industry for 40 years.

• The HPA is the premier trade Association in Africa in regard to knowledge and regulatory information pertaining to the CAMs and DFS industry.

• As a founding member of the International Alliance of Dietary and Food Supplement Associations (IADSA), a world leader in Governmental advisory services, the HPA has access to state of the art research into the latest

knowledge base world wide.

HPA Mandate

As the primary voice of the health products industry, the HPA is committed to developing and maintaining standards that support and foster the quality, safety and efficacy of Natural Health Products, Nutritional Dietary Supplements and Complementary and Alternative Medicines (CAMs). The Association strives to establish an ethical, credible, relevant and vibrant health products industry in South Africa.

CAPACITY

• The HPA Exco and membership base have a wealth of experience and a depth of Scientific, Technical, Legal and Regulatory knowledge as well as access to best global practice via IADSA and the CRN (Council for Responsible Nutrition).

• The HPA is the only association which represents all modalities, and paradigms in the CAMs industry (including sports nutrition), its retailers, direct sellers, manufacturers, local agents, marketers, distributors and consultants.

• HPA has competent sub-committees (e.g. Scientific and Regulatory, SMAC, PR, IT, Marketing and Promotion).

• Communication with the entire CAMs/HS supply chain.• Access to the top consultants in the CAMs space.• Good relationships and regular liaison with other associations and

stakeholders.

Key Objectives• An appropriate and risk-related legislative and regulatory

environment for the CAMs industry without compromising safety and quality.

• Protecting the consumer and companies by pushing for a reduction in the complexity and the costs of compliance in the licensing and registration process which would ultimately drive prices up.

• Assisting HPA members in achieving GMP, Regulatory, Packaging and Advertising compliance.

• Ongoing promotion of the image, credibility and integrity of the HPA as the reliable voice of the CAMs industry.

• Building ongoing good relationships with Government, the Media other associations, stakeholders and the Consumer.

• Facilitation MCA membership for all HPA members.• Education: Workshops (internal and External) and web-based.

Key Achievements• Interface and input at the Portfolio Committee on Health.• Engaged with the MCC following the Regulations of November

2013, thus allowing companies to continue trading and improving dialogue between industry and the authorities to understand the challenges that need to be overcome.

• Precipitating amendments to Regulations, Guidelines and the Road map, wherever possible, via written comments and ongoing dialogue.

• The establishment of a separate CAMs Scientific and Regulatory working group with regular interface with the regulators via the ITG with positive outcomes to date.

• Effective self-monitoring and advisory service via SMAC (Self Monitoring Advisory Committee).

HPA Workshops• 2016 - HPA/SMASA CAMS Workshop with MCC

• 2017 – HPA Workshops of GMP & Stability in JHB & CTMore workshops are planned for

2017 so we would welcome anyone

attending

HPA Proposals• Health Supplements Roadmap vs CAMS Discipline

Specific Roadmap

VS ???

HPA Scientific Committee have requested that there be a

separate HS Roadmap. Ideally this should be from 2020, after

the CAMS DS Roadmap.The MCC is reviewing this and will give feedback via the ITG

CAMS Working Group

HPA Regulatory Reviews• HPA commented on GG40158 - General Regulations to Act

101 - Complementary Medicines

• HPA reviewed the new CAMS Guidelines and how this impacts the industry.

HPA Regulatory Reviews• HPA are finalising comments on the Draft Regulations from 27

January 2017. HPA will also be proposing alternatives to the authority to improve the system for the industry as a whole.

• Some highlights are:– Definition changes to CAMS and HS

– Labelling changes again!!

– PI improvements: English, S0 exemption etc is a positive change

– Consumer Leaflet: Immediate container

– Skills of Authority but nothing for CAMS/HS

– Advertising of medicines

MCC Rescindment Notice 40637• On 24 Feb 2017 the MCC published the following notice:

• This understandably caused confusion and concern in the industry, especially for importers

HPA then interacted with the Registrar to get clarification. Dr Joey Gouws then responded to our queries with the following answers:

• Question 1: What precipitated the change of policy regarding the 2002 call-up (which Judge Zondi ruled to be an audit)?

• The rescission of the 2002 notice is not a result of and I quote from your mail "change of policy regarding the 2002 call-up". The 2002 Call Up Notice existed in law and was rescinded to ensure clarity of its effect, which is nothing with consideration of the 2013 Regulations.

• Question 2: What is the status of the MBR 20.8?

• The MBR 20.8 is as it always was – an operational tool /acknowledgment letter of receipt to allow medicines that have been submitted to the MCC following the 2002 notice in an attempt to assist Customs and Applicants in importing medicines. The MBR 20.8 only indicates that the product existed prior to 2002 and that the MCC has been notified as such. It has not had any other legal standing according to the MCC.

• Question 3: Can companies import products that fall outside of the definition of a CAM (e.g. outside the scope of practice of the Allied Health Professions or not yet called up)?

• This has nothing to do with the rescinding of the 2002 notice. In essence all the undefined medicines not yet contained in the legal definition of a CM are regarded as illegal medicines. The MCC has been trying to advocate this since 2013. There is no further notice or permission that exists on the market that would allow for such. The only medicines for which allowance is allowed currently is those CMs that are Discipline-Specific (DS). These DS medicines of which the pharmacological classification has not yet called up but are on the market prior to the 2013 Regulations may be on the market. These are regarded CAMS.

• In addition, in accordance with the Schedules to the Act, the MCC listed Vitamin and Mineral levels relating to so called "Health Supplements". Therefore the view is that Health Supplements on the market will be tolerated as long as their claims are of LOW RISK as defined and that these products comply with the labeling requirements as prescribed-until such time as regulations and appropriate Call Ups are finalised for Health Supplements.

• Question 4: What instructions have been issued to Port Health?

• The MCC does not instruct Port Health. Our office assist Port Health on a case by case basis.

• Question 5: CAMS are medicines. Does this exempt importers from the 20% import duty?

• Our office is unable to respond on questions relating to import duty.

• Question 6: Can local companies launch products as outlined in 3 above?

• In terms of the definition of a medicine, any product purporting to treat, diagnose or prevent a disease must be registered by the MCC prior to the sale thereof. Therefore, following the 2013 call up of CAMS all new products to be launched on the RSA market need to submit an application for registration to the MCC to allow the MCC to evaluate the dossier prior to introducing the product to the market.

The Way Forward

• The HPA is ideally positioned and capacitated to protect and promote the industry, serve its current members, recruit new entrants and broaden the benefits of HPA membership.

• The HPA will be working with other local and international associations, stakeholders and Government to ensure we protect this industry and the consumer as a whole.

HPA CONTACT

Deirdre AllenTel: 011 789 4464 Email: hpasa@hpasa.co.za

Address: Canyon House, 61 Main Street, Bordeaux, Gauteng, South Africa, 2194

Website: http://www.hpasa.co.za/

Wayne RobinsonCell: 084 232 7961Email: wayne.robinson@azochem.co.za

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