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 does not own, wholesale or distribute
product and the Principal 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 licenced 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 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. (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 place,
and reassign the distribution rights for the medicinal
product. MC Pharma will be responsible
for all regulatory
aspects of the medicine including compliance with the conditions of
registration.
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.
MC PHARMA REGULATORY
LICENCES
| Authority | Type of Licence and date of Issue | Licence No |
| The Department of Health | Manufacturing Pharmacy dd 30/03/2006 | GP00093M |
| The Medicines Control Council | Licence to manufacture medicines dd 07/08/2009 | 0000000253 |
| Licence to Import dd 07/08/2009 | 000000253.-.5 | |
| SA Pharmacy Council | Certificate of recording of a Manufacturing Pharmacy dd 16/04/2006 | Y50668 |