Pharmacy Ownership Regulations: GNR.553

• These notes outline the ownership and licensing regulations for pharmacies, according to GNR.553 of 25 April 2003.

Ownership Regulations

• Regulations 2, 5, and 6 define who may own a pharmacy.

Manufacturing or Wholesale Pharmacy

• The State or any person can own or have a beneficial interest in such a pharmacy, as per regulation 7(a).

Consultant Pharmacy

• Any person can own or have a beneficial interest in this type of pharmacy.

Community Pharmacy

• Ownership is allowed for any person or body corporate, adhering to regulation 7.
• The owner must not be prohibited from owning a pharmacy due to any legislation.
• The owner must not be an authorized prescriber.
• The owner must not have direct/indirect beneficial interest on behalf of an unauthorized person.
• The owner must not own or have beneficial interest in a manufacturing pharmacy.

Institutional Public Pharmacy (Regulation 3 & 4)

• States that the State or a person referred to in regulation 4 can own/have beneficial interest in an institutional pharmacy in a public health facility.
• The State can arrange with the private sector to manage an institutional pharmacy in a public health facility.

Institutional Private Pharmacy

• Any person can own or have beneficial interest in an institutional pharmacy within a private health facility, in accordance with regulation 7.
• The person or body corporate must not be prohibited by law from owning a pharmacy.
• The person or body corporate must not be an authorized prescriber.
• The person or body corporate must not have any direct or indirect beneficial interest on behalf of a person contemplated in paragraphs (a) and (b).
• The person or body corporate must not be the owner or holder of any direct or indirect beneficial interest in a manufacturing pharmacy.

Conditions for Pharmacy Ownership (Regulation 7)

• Must provide proof of ability to comply with Good Pharmacy Practice standards.
• Where applicable, compliance with Good Manufacturing Practice or Good Distribution Practice is needed.
• An undertaking to comply with the standards is required.
• The pharmacy’s location.
• The benefits provided to the specific serving community.
• The nature and extent of pharmaceutical services to be provided.
• Meeting statutory requirements for the location of a pharmacy within a private or public health facility.
• The approximate number of the population whom pharmaceutical services will be provided to.
• The relationship between proposed services and existing services and facilities.
• The breadth of services to those outside the service area, and the extent/nature of available pharmaceutical services nearby.
• Addressing any special care needs within the community.
• An inspection report by the council of the premises.

Pharmacy Licensing Procedure

• Licensing involves both registration and recording.
• Registration application is submitted to the Director-General, involving the NDOH and SAPC.
• Once approved, a license is issued by the NDOH.
• Licensing recording application is submitted to SAPC with the NDoH license.
• If approved, the pharmacy, its owners, and the responsible pharmacist are recorded.

Licensing of Pharmacy Premises (Regulation 8)

• To own a pharmacy based on section 22A of the Act, one must apply to the Director-General.
• A completed application form approved by the Director-General is required.
• Providing documentary evidence of compliance with regulations 2, 3, 4, 5, 6, and 7, paying the application fee.
• The council's assistance may be requested to assess compliance.
• If satisfied, based on the application, documents, and inspection report, the Director-General may issue a license with conditions.
• The license holder must inform the council within 30 days of license issuance before providing pharmaceutical services, using the Director-General approved form.
• Upon notification and payment of a recording fee, the council records the pharmacy's details, license date, and number.
• The license is not transferable to unauthorized parties.

Licence Withdrawal (Regulation 9)

• Conditions that could lead to licence withdrawal include: failed compliance with ownership or licensing conditions, disposal of interest to an unauthorized person, contravention of relevant acts/legislation, sequestration or liquidation and failure to pay fees.
• Additional conditions: failure to comply with registration/recording requirements, suspension from practicing as a pharmacist, ceasing pharmacy business operations.
• Failure to comply with Good Pharmacy Practice or Good Manufacturing or Distribution Practice could also lead to withdrawal.

Overview of pharmacy ownership and licensing, based on GNR.553 of 2003. Covers manufacturing, consultant, community, and institutional public setups. Details specific ownership rules forbidding prescribers and manufacturers from owning community pharmacies.