Occupational Certificate: Health Products Code Compliance Officer

Purpose

The purpose of Occupational Certificate: Health Products Code Compliance Officer is to prepare a learner to operate as a Health Product Code Compliance Officer.

A Health Product Code Compliance Officer conducts compliance activities in a health product regulatory environment. They ensure compliance of promotional and educational material and activities to applicable industry code regulations.

A qualified learner will be able to

• Conduct/perform code compliance activities on health products.

Achieving this part-qualification will provide several benefits to the learner, including

• Being able to carry out a range code compliance activities with respect to promotional material and activities related to health products.
• Acquiring in-depth knowledge of code compliance activities and processes for health products
• Taking an important step into the health products sector with the prospect of acquiring higher or related qualifications in the field.
• Acquisition of a formal qualification in health products environment if they do not already have a qualification
• Increasing the opportunity of gaining employment with companies that manage health product applications for registration and licensing. Considering South Africa's huge unemployment rate, a qualification like this has the potential to get learners into meaningful employment.

Typical graduate attributes include proficiency, efficiency, and effectiveness in preparing dossiers for registration and renewal of health products. The Health Products Code Compliance Officer (HPCCO) is a person of integrity and high ethical standards as they ensure that all promotional material and activities designed for health products meet the requirements of the regulatory framework.

Rationale

No health product may be sold in South Africa unless it has been registered with an appropriate regulatory body. This qualification covers medicines, medical devices and in vitro devices (IVDs), complementary medicines, personal care products and veterinary products. Currently, the South African Health Products Authority (SAHPRA) registers health products as defined by the Medicines Act 101 of 1965 and its Amendments - whether they are manufactured local or abroad - to ensure safety, efficacy, and quality

The marketing or promotion of health products is very strictly controlled through application of the relevant sector codes by the Health Products Code Compliance Officer (HPCCO) or a Responsible Pharmacist (RP) or an Authorised Representative (AR) as long as they are trained as a HPCCO. The qualification plays a very critical role in ensuring that sector codes are applied to all promotional and educational materials and activities.

Unfair promotional practices carried out impact negatively on other companies promoting their products through fair practices.

In spite of their critical role, there is no qualification registered on the NQF for this much-needed part-qualification. This is the first time a qualification for this occupation is being developed. Current training is disparate and carried out by companies that register, license and market health products. There is a need to standardise such disparate training and set the benchmark for the occupation.

As the number of health products grows significantly in view of scientific advancement (the plethora of health products being a case in point), this qualification becomes critical to ensure that the public is exposed to promotional material for health products that has been subject to regulatory scrutiny prior to approval. The challenges stemming from misinformation regarding health products will always be there and this emphasises the responsibility of the Health Products Code Compliance Officer (HPCCO).

The safety of the public is paramount when it comes to using or consuming health products and the application of the relevant compliance codes will strengthen the public's confidence in products that have been approved.

Additionally, ensuring that promotional activities for health products occur within the ambit of the regulatory framework maintains fairness in the sector and companies abiding by the compliance codes are not affected negatively. Hence, this part-qualification ensures that the interests of the health product sector are protected.

The part-qualification has the potential of creating employment as it is needed in the industry and there is a potential uptake of the qualification by significant number of learners. Increased employment will translate into increased benefits for the economy.

Typical learners will be those currently practising as Health Products Code Compliance Officers who have been operating without training on a formal qualification. Other learners could include matriculants or those with a relevant higher education qualification wishing to enter the health products regulatory field.

Learners working towards this part-qualification will find that the acquisition of competencies embedded in the modules will either enable them to either obtain employment or add value to their job performance if they are already employed.

In the development of this qualification, the following stakeholders were consulted

• Training providers.
• Regulator.
• Employers/employer organisations.

There are no similar Qualification(s) and Part-Qualifications registered on the NQF, and no Skills Programmes approved by the QCTO.

Recognition of Prior Learning (RPL)

RPL for Access to Training

Learners may use the RPL process to gain access to training opportunities for a part-qualification if they do not meet the formal, minimum entry requirements for admission. RPL assessment provides an alternative access route into a part-qualification.

Such an RPL assessment may be developed, moderated and conducted by the accredited Skills Development Provider which offers that specific part qualification. Such an assessment must ensure that the learner is able to display the equivalent level of competencies required for access, based on the NQF level descriptors.

RPL for Access to the External Integrated Summative Assessment (EISA)

For exemption from modules through RPL, learners who have gained the stipulated competencies of the modules of a part-qualification through any means of formal, informal or non-formal learning and/or work experience, may be awarded credits towards relevant modules, and gaps identified for training, which is then concluded.

Entry Requirements

An NQF Level 4 qualification, with Mathematics and Science.

This qualification is made up of compulsory Knowledge, Practical Skill and Work Experience Modules

Knowledge Modules

• 242213-001-00-KM-01, Overview of Current Health Products Industry/Sector, NQF Level 5, 5 Credits.
• 242213-001-00-KM-03, Health Products, NQF Level 5, 8 Credits.
• 242202-001-00-KM-05, Codes of Practice for HPRAs, NQF Level 5, 3 Credits.
• 242213-001-00-KM-08, Professional Conduct, NQF Level 4, 3 Credits.

Total number of credits for Knowledge Modules: 19

Practical Skill Modules

• 242213-001-00-PM-02, Conduct Compliance Activities on Health Products, NQF Level 5, 6 Credits.
• 242213-001-00-PM-03, Conduct Oneself Professionally and Ethically, NQF Level 5, 3 Credits.

Total number of credits for Practical Skill Modules: 9

Work Experience Modules

• 242213-001-00-WM-04, Processes to Conduct Code Compliance Activities on Health Products, NQF Level 5, 6 Credits.

Total number of credits for Work Experience Modules: 6

1. Interpret and apply appropriate procedures and criteria to conduct/perform code compliance activities on health products.

Associated Assessment Criteria for Exit Level Outcome 1

ELO 1: Interpret and apply appropriate procedures and criteria to conduct/perform code compliance activities on health products

• Check the contents and artwork of promotional and educational materials for a health product for compliance to relevant codes and standard operating procedures (SoPs).
• Check promotional activities for compliance with the relevant codes and SoPs and make recommendations for activities that do not comply.
• Complete checks and corrections to promotional and educational materials and appropriately file/save and update activities and administrative records as per regulatory requirements.
• Receive and lodge and escalate incoming and outgoing complaints pertaining to promotional and educational materials and activities if required according to SoP.
• Handle and escalate unethical practices regarding promotional and educational materials and activities if required according to SoP.

Integrated Assessment

Integrated Summative Assessment

Integrated Assessment involves all the different types of assessment tasks required for a particular part qualification, such as written assessment of theory and practical demonstration of competence. To achieve this, the Internal Assessment Criteria (IAC) for all modules as found in the QCTO curriculum document must be followed.

An accredited SDP should implement a well-designed, formal, relevant, final internal Summative Assessment strategy for all modules to prepare learners for the EISA. These assessments evaluate learning achievements relating to the achievement of each module of the relevant components of the part-qualification.

Internal Summative Assessments are developed, moderated, and conducted by the SDP at the end of each module or after integration of relevant modules, e.g., applied knowledge tests, workplace tasks, practical demonstrations, simulated tasks/demonstrations, projects, case studies, etc.