COMPANY PROFILE
CO-DEVELOPING CUSTOMER SPECIFIC SOLUTIONS IN PARTNERSHIP WITH YOUR COMPANY’S GOALS TO ACHIEVE SUCCESSFUL MARKET ENTRY INTO THE SOUTH AFRICAN AND SUB-SAHARAN PHARMACEUTICAL AND HEALTHCARE MARKET
MC Pharma (Pty) Ltd., is a pharmaceutical company licensed in terms of Section 22C of the Medicines and Related Substances Act 101 of 1965, and offers the services of an Applicant and Holder of the Registration Certificate (Marketing Authorisation Holder), on behalf of a Principal or product owner.
In addition, MC Pharma has the expertise to distribute's product on behalf of a Principal (who is at all times deemed to be the owner of the medicinal product(s)). Commercialisation activities are delegated, by means of agreements, to competent and licensed companies in South Africa, with the approval of the Principal or product owner.
​
MC Pharma is proud to represent and to service global customers and Principals from such countries as Australia, the USA, Brazil, EU, and the UK.
MC PHARMA (PTY) LTD. ACTS AS:-
APPLICANT
For pre-registered medicinal product applications: MC Pharma will submit an application for the registration of a medicinal or health product and act as Applicant for the duration of the Regulatory Authority’s evaluation and review processes and until registration (marketing authorisation) has been granted by the Regulatory Authority.
HOLDER OF THE REGISTRATION CERTIFICATE
As the Marketing Authorisation Holder, MC Pharma (Pty) Ltd will take responsibility for a medicinal or health product in a relationship that is free from commercial conflicts of interest, whilst allowing the “Principal” the freedom to be involved in the distribution and marketing of the medical products, if they wish (otherwise it may be delegated to VP Medical). MC Pharma will be responsible for all regulatory aspects of the medicine including compliance with the conditions of registration and regulations.
Technical agreements with all contract acceptors (manufacturers; packers; analytical laboratories; warehouse, distribution facilities, and marketing agents) enable MC Pharma to carry out and fulfill its regulatory obligations.
