Market access for your Category D Medicines.
RP Pharma was established to partner with you and to offer a cost effective and quick time-to-market solution for Category D medicines (Complementary Medicines including Health Supplements), thereby ensuring regulatory compliance to enable a sustainable business model.
RP Pharma is a pharmaceutical company licensed in terms of Section 22C of the Medicines and Related Substances Act 101 of 1965 and can act as your Applicant or Holder of the Registration Certificate (MA Holder).
Effective as of the 15th of November 2013, the SAHPRA (previously the Medicines Control Council), by virtue of powers vested in it by section 14(2) of the Act, by resolution approved by the Minister of Health, determined that Complementary Medicines (CAMS) falling in Category D and in the different pharmacological classifications are subjected to registration as per the provisions of the Act.
The SAHPRA has requested that all manufactures, importers, exporters and wholesalers of Complementary Medicines are licensed as per section 22C(1)(b) of the Medicines Act and that all category D medicines be subjected to registration (“call-up notices”) in terms of section 14 of the Medicines and Related Substance Act, 1965 (Act 101 of 1965).
The licensing and registration process must be preceded by obtaining a Pharmacy Premises Licence through the National Department of Health (NDOH) and confirmation of compliance with GPP from South African Pharmacy Council (SAPC).
No need to appoint a Responsible Pharmacist
Expertise and experience “on tap”
Ongoing administrative and technical support
Availability
Flexibility
Reducing your regulatory workload
RP Pharma is a pharmaceutical company licensed in terms of Section 22C of the Medicines and Related Substances Act 101 of 1965 and can act as your Applicant or Holder of the Registration Certificate (MA Holder).
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