Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)RegulationsGeneral RegulationsPermits, Licensing and Authorisation23. Licence to manufacture, import, export, act as a wholesaler or distribute medicines or scheduled substances |
| (1) | An application for a licence referred to in section 22C(1)(b) of the Act, shall— |
| (a) | be made on a Form obtainable from the Authority for a licence— |
| (i) | to manufacture, import or export a medicine or Scheduled substance; |
| (ii) | to import a medicine or Scheduled substance; |
| (iii) | to export a medicine or Scheduled substance; or |
| (iv) | to act as a wholesaler of or distribute a medicine or Scheduled substance; |
| (b) | be submitted to the Chief Executive Officer; |
| (c) | be accompanied by documentary proof of— |
| (i) | the particulars of the owner of the business; |
| (ii) | registration of the responsible pharmacist with the South African Pharmacy Council; |
| (iii) | qualifications of key personnel responsible for the manufacture, storage, distribution and sale of medicines or Scheduled substances in terms of the Act; |
| (iv) | the ability to comply with good manufacturing, wholesaling or distribution practices as determined by Authority, which must include— |
| (aa) | a copy of a local area plan of the location of the business premises indicating all adjacent properties and the nature of the business being carried on, on such properties; |
| (bb) | a floor plan of the building in which the business premises are situated; |
| (cc) | a plan of the actual layout of the business premises; |
| (dd) | an inventory of equipment to be used in conducting the business; and |
| (ee) | a manual of procedures and practices to be implemented to ensure the safety, efficacy and quality of medicines, or Scheduled substances to be manufactured or distributed and sold; |
| (v) | of the payment of the prescribed application fee; |
| (vi) | any other information as may be requested by the Authority; and |
| (d) | specify the medicines or Scheduled substance to be manufactured, imported, exported or distributed and sold. |
| (2) | The applicant contemplated in subregulation(1) shall— |
| (a) | appoint, and designate as such a responsible pharmacist who will control the importation, exportation, manufacturing, wholesaling, or distribution of medicines or Scheduled substances; and |
| (b) | appoint and designate a natural person who resides in the Republic, who shall be responsible to the Authority for compliance with the Act. |
| (3) | The Authority shall inspect the business premises specified in the application. |
| (4) | The Authority may issue a licence contemplated in subregulation (1) once the Authority is satisfied that the requirements of the Act and this regulation have been complied with. |
| (5) | The Chief Executive Officer shall— |
| (a) | keep a separate register for each of the categories of licensees contemplated in section 22C(1)(b) of the Act; and |
| (b) | enter the licence number, the name of the licensee and his or her physical and postal addresses, in the register contemplated in paragraph (a). |
| (6) | Notwithstanding the period of validity of the licence, the licensee must pay the prescribed annual fee for continued registration. |
| (7) | A holder of a licence in terms of subregulation (1) shall submit to the Chief Executive Officer an application, on a Form obtainable from the Authority, accompanied by the prescribed fee, in order to amend any of the following details of the licence: |
| (a) | Name of the licence holder; |
| (b) | responsible pharmacist; |
| (c) | natural person in terms of subregulation (2)(b); |
| (d) | site address; |
| (e) | activities provided for by the licence; or |
| (f) | the medicines or Scheduled substances to be manufactured, imported, exported or distributed and sold. |
| (8) | Following an application referred to in subregulation (7) the Authority may issue a new licence: Provided that— |
| (a) | the Authority is satisfied that the application complies with provisions of subregulation (1) or any other conditions determined by the Authority; |
| (b) | either— |
| (i) | the original licence is returned to the Authority; or |
| (ii) | an affidavit is submitted to the Authority stating that the original licence has been lost, if this is the case; and |
| (c) | the applicable licence fee is paid. |
| (9) | An applicant shall notify the Chief Executive Officer in writing of any change to any of the particulars furnished in the application contemplated in subregulation (1) within 30 days of such change. |
| (10) | Any entry into the register in terms of subregulation (5) which is proved to the satisfaction of the Authority to have been made in error or through misrepresentation or in circumstances not authorised by the Act, may be removed from the register. |
| (11) | A person in respect of whose entry a removal as contemplated in subregulation (10) has been made shall be notified of such removal and any licence issued in respect of this regulation shall be deemed to be cancelled as from the date on which notice has so been given. |
| (12) | The Director -General or Chief Executive Officer, as the case may be, may make known to the public any information that pertains to the suspension or revocation of any licence referred to in this regulation in a manner which he or she thinks fit. |