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Regulatory Affairs
2 weeks ago
The Responsible Pharmacist contemplated in regulation 25(3) must:
- Ensure that they continuously supervises the pharmacy in which they have been appointed.
- Have appropriate qualifications and experience in the services being rendered by such pharmacy.
- Ensures that persons employed in such pharmacy and who provide services forming part of the scope of practice of a pharmacist are appropriately registered with council.
- Notify council immediately upon receiving knowledge that he /her services as responsible pharmacist have been or will be terminated.
LEGAL
- To ensure registration of RP and licensing of the company with Authorities.
- To ensure name of RP is prominently displayed over entrance.
- To ensure that the pharmaceutical facility is conducted under the continuous supervision of a pharmacist (legal requirement).
- To ensure that a Designated Deputy RP (DDRP) is in control of the facility should the RP be absent.
- To ensure that contracts exist between Holder of Registration Certificate and 3rd party contractors stipulating where all responsibilities lie.
- To approve and sign off all advertising material and to ensure that the material is legal.
- To ensure that directors (when applicable) are au fait with the latest ethical rules of SAPC, the SA Guide to GMP and sign agreements to abide thereby.
COMPLAINTS
- To ensure that all product complaints are investigated and identified as to the nature of the problem and is given the necessary attention.
- To ensure that product complaints involving "adverse drug reactions" are reacted upon and followed up without delay.
- To ensure that product complaints are noted and kept on file and followed up in procedurally correct manner.
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