Pharmacy Registration GNR.1160

• Registration of Persons and Maintenance of Registers are covered under GNR.1160 of 20 November 2000.

Categories of Persons That May Be Registered

• Pharmacy student
• Pharmacist intern
• Pharmacist
• Specialist pharmacist
• Pharmacist's Assistant
• Company entitled to carry on the business of a pharmacist
• Close Corporation entitled to carry on the business of a pharmacist
• Manager
• Nominee
• Provider
• Assessor
• Pharmacy owner
• Responsible pharmacist
• Managing director

Common Requirements for Registration

• Registration: Dually completed registration form, certified copy of ID, and payment of registration fee are needed.
• Annual Renewal: Payment of an annual fee is required.
• Removal: Non-compliance with requirements, death, or cancelled registration necessitates removal.
• Restoration: Duly completed application, acceptable evidence of compliance, and payment of a restoration fee are needed.

Pharmacist Student (Regulation 3-7)

• Registration Requirement: Must be registered with a provider and the council as a pharmacy student.
• Must provide documentary evidence from the provider of admission to the second or subsequent year of study.
• Removal Condition: Must have complied with all requirements for a qualification in pharmacy.
• Students who interrupt studies may have their name retained on the register for up to two years from the end of the interrupted year, with annual written application to the registrar.
• Restoration Requirement: Must provide documentary evidence of re-admission to the second or subsequent year of study.

Pharmacy Intern (Regulation 8-12)

• Registration Requirement: A duly completed and signed contract approved by the council for the internship.

  -Provide approval by the council of the tutor and qualification in pharmacy.

  -Provide registration with a council-approved provider for a course leading to a master's degree.

• Removal Condition: Completion of the internship to the council's satisfaction.

  - Not completing the internship to the council's satisfaction.

  -Discontinuing the internship with the council's consent.

• Restoration Requirements: Must comply with the conditions for pharmacist intern registration.

• Must have acceptable documentary evidence from a tutor indicating resumption of internship.

Pharmacist - Qualification from South Africa (Regulation 13, 14, 15, 16)

• Registration Requirements: Qualification in pharmacy and completion of internship.
• The individual must have passed all exams or evaluations.
• Provide the name and date of service at a public health facility.
• Registration allows practice for community service for up to two years.
• The council may revoke imposed conditions after report of satisfactory pharmaceutical community service completion.

Pharmacist - Qualification from Outside South Africa (Regulation 13, 17, 18, 19, 20)

• Need a qualification in pharmacy from outside the Republic, allowing practice where the qualification was awarded.
• Must be registered as a pharmacist where the awarding institution is located.
• They must be a fit and proper person in good standing.
• They must have practical training, if any was required.
• They must have passed an exam that was approved by the council, if any was required.
• Registration options: pharmacist’s assistant (post basic), pharmacist intern, or pharmacist
• Pharmacist registration stipulations: performing pharmaceutical community service, for a max of two years, and subject to restrictions.
• Council can revoke conditions after successful completion of pharmaceutical community service, with possible re-examination.

Specialist Pharmacist (Regulation 23-27)

• Must submit documentary evidence of practical experience in their field.
• Must give notice of the specialty they are going to practice.
• It is possible to register for more than one specialty, but practice is limited to only one.

Additional Qualifications or Supplementary Training (Regulation 44-46)

• The applicant must be entitled to register for additional qualifications or training.

Pharmacists' Assistant or Pharmacy Technician (Regulation 28-33)

• The applicant must be registered for council approved programmes.
• Proof must be shown from the provider of registration for an education and training programme approved by the council.
• Documentation of approval by the pharmacy council is needed for in-service training.
• Documentary evidence of tutor in approval is required where training is required during education.
• These people must meet certificate standards to be removed.

Pharmacists' Assistant (Basic or Post-Basic) (Regulation 34-36)

• They must have finished a a council approved training program.
• Documentary evidence is required:
  • Holds a certificate entitling registration
  • Complete the in-service training
  • Passed the exams

Pharmacy Technician (Regulation 56)

• Documentary evidence:
  • Provide the evidence that they are admitted into the education and training program.
• Removal:
  • Must comply with the terms of qualifications.

Company or Closed Corporation Carrying on the Business of a Pharmacist

• Registration process involves carrying on the business of a pharmacist, registering the pharmacy, and involving the company, close corporation, and registered pharmacy.

Company Entitled to Carry on the Business of a Pharmacist (Regulation 47-51)

• Applying to the registrar involves providing necessary paperwork:
  • A completed form
  • Certificate of incorporation
  • CM22 and CM29 forms
  • A written guarantee of GPP practice compliance
  • Category of the pharmacy
  • Any needed information for the registrar
• The registration fees must be paid for.

Removal of a Company Entitled to Carry on the Business of a Pharmacist (Regulation 52-54)

• Grounds for removal involve companies that:
  • Fail to comply with Act 22 or 22A.
  • Contravene regulation protocols.
  • The managing director's issues.
  • GPP noncompliance.
  • Contravention of council findings.

Restoration of a Company Entitled to Carry on the Business of a Pharmacist (Regulation 55; 56)

• Reapply to the registrar by:
  • Supplying a request for a restoration
  • Showing documentary evidence that it complies with the regulations for registration
  • Pay restoration fees
• They must prove that the people involved are suitable to conduct business.

Close Corporation Entitled to Carry on the Business of a Pharmacist (Regulation 57-61)

• Apply to the registrar by:
• Duly completed application
• Founding statement certification
• Association agreement certification
• Undertaking in written form of GPP compliance
• Provide the name by council in the pharmacy
• Provide the fee as determined.

Close Corporation Entitled to Carry on the Business of a Pharmacist Removal (Regulation 62-64)

• A close corporation is removed if it:
  • Does not comply with Act 22A
  • Contravening regulations
  • Manager fails to be accountable
  • Doesn't comply with GPP
  • The council finds contravention.

Close Corporation Entitled to Carry on the Business of a Pharmacist Restoration (Regulation 65-66)

• Apply to the registrar by:
  • Duly completed application
  • Documentary evidence for the compliance
  • Restoration fees are paid
  • Furnish proof that the involved people are suitable

Requirements and Conditions for the Registration of a Pharmacy (Regulation 67-71)

• Registration conditions require:
  • Having a pharmacist in charge
  • Duly completed forms need to be submitted for the registration
  • Registration needs to provide:
  • Pharmacy category
  • Responsible pharmacist
  • As the pharmacy owner
  • A copy of lease
  • A site plan
  • A floor plan/pharmacy layout
  • Copies all the agreements relating to the operation
  • Pay fees as required
• A registrar takes actions to refuse register, subject conditions, or to just register.
• Business spaces of pharmacists are inspected.
• The pharmacy is issued a written report, with a finding report that includes any noncompliance.

Requirements and Conditions for the Registration of a Pharmacy Removal (Regulation 72-74)

• The registrar will remove pharmacies that:
  • Don't comply with registration.
  • If the pharmacist cannot do as prescribed.
  • If the direct or nominee can't the duties prescribed.
  • Fails to comply with rules.

Requirements and Conditions for the Registration of a Pharmacy Temporary Closure

• Complaints of Medicine Act or the Act constitute risk, and can have temporary closure.
• Magistrate will assist if that's the case.

Requirements and Conditions for the Registration of a Pharmacy Restoration (Regulation 75)

• Restore pharmacy, and complete an application
• Must say pharmacy compliance
• Pay rates
• Give the evidence of operating the pharmacy
• Get a council decision.

Requirements and Conditions for registers maintenance and keeping (Regulation 100)

• Must provide addresses to the registrar:
  • Postal
  • Place of business
  • Telefax
  • eMail

Keeping of registers entails

• Comparing application in registration for information in a category.
• A register of pharmacy students must have their name, compliance, number, date, pharmacy provider.

Keeping of registers involves as relates to Pharmacy (Regulation 104)

• The name and address of the pharmacy
• Owners' name and address
• The responsible pharmacist in charge
• Director, manager running the pharmacy
• Nominee details, if any
• Registration category
• Additional info

Maintenance of Registers requires (Regulation 107)

• Closure of a pharmacy

• Must notify the council in 30 days

• Changes in ownership, or interest

• Shareholder changes

• Member changes

• Location changes

• Responsible pharmacist changes

• Address changes

• Designating manager and director is to be notified with seven days.