Pharmacy Act, 1974 (Act No. 53 of 1974)

Board Notices

Purchase

DOMAIN 5: GOVERNANCE AND REGULATION OF MEDICINES AND MEDICAL DEVICES

INTRODUCTION

The competencies required in the domain to ensure governance and regulation of medicines and medical devices are:

5.1	Development of medicine, medical devices and IVDs dossiers and technical files.

5.2	Medicine registration, medical devices and IVD listing.

5.3	Professional practice.

DOMAIN 5: GOVERNANCE AND REGULATION OF MEDICINES AND MEDICAL DEVICES

COMPETENCIES

BEHAVIOURAL STATEMENTS

5.1	Development of medicine, medical devices, IVDs, dossiers and technical files.

5.1.1

Compile and maintain medicine dossiers and technical files in accordance with relevant legislation.

5.1.2

Effectively engage with regulatory authorities.

5.2	Medicine registration and medical devices and IVD listing.

5.2.1

Compile and submit dossiers and technical files for registration of medicines and/or listing of medicines, medical devices and diagnostics.

5.2.2

Demonstrate an in-depth knowledge of all applicable medicines and device regulatory guidelines.

5.3	Professional practice

5.3.1

Develop and monitor protocols to ensure that the industrial pharmacy operates in line with the current GxP.

5.3.2

Contribute to the review and development of legislation.

5.3.3

Develop and monitor protocols to ensure post-marketing surveillance and law enforcement can be carried out.

5.3.4

Develop and monitor protocols to ensure ongoing compliance with industrial pharmacy related legislation, regulations and regulatory bodies.

5.3.5

Develop and monitor protocols ensure ongoing compliance with post-marketing surveillance requirements.