GOVERNMENT GAZETTE OF THE REPUBLIC OF NAMIBIA N$2.40 WINDHOEK - 18 August 2008 No. 4103 GOVERNMENT NOTICES CONTENTS No. 196 Medicines and Related Substances Control Act, 1965: Registration of certain medicines... 1 No. 197 Regulations relating to scope of practice of oral hygiene: Medical and Dental Act, 2004... 10 No. 198 Regulations relating to ownership of pharmacy by private hospital: Pharmacy Act, 2004... 11 Government Notices MINISTRY OF HEALTH AND SOCIAL SERVICES No. 196 2008 MEDICINES AND RELATED SUBSTANCES CONTROL ACT, 1965: REGISTRATION OF CERTAIN MEDICINES In terms of section 17(a) of the Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965), I give notice that the medicines set out in the Schedule are registered subject to the following conditions: (a) (b) (c) (d) the manufacture and control of the medicine must be in accordance with the existing good manufacturing practices as required by the World Health Organization; in order to assess compliance with paragraph (a), inspections and investigations may be carried out, at such times as the council may consider necessary, by inspectors authorized in terms of section 26 of the Act to do so; the information contained in the package insert must, by the manufacturer of the medicine concerned, be updated so as to conform with the package insert approved by the Medical Control Council so as to ensure that such insert provides accurate information to the user of the medication concerned; the registration of medicine is subject to regular review regarding its quality, safety and efficacy, and the Council may, as it considers necessary, vary the conditions of registration of the medicine;
2 Government Gazette 18 August 2008 No. 4103 (e) (f) (g) the first two production batches must be validated in accordance with the detailed process validation protocol which was submitted at the time of the application for registration; a validation report must be submitted to the council within one month from the date of completion of the validation referred to in paragraph (e); and the Council may review the registration dossier at such intervals as the Council may determine. J. GAESEB REGISTRAR OF MEDICINES Windhoek, 29 July 2008 SCHEDULE
No. 4103 Government Gazette 18 August 2008 3 S/N APPLICANT REGISTERED NAME APPROVED NAME OF ACTIVE(S) DOSSAGE FORM STRENGTH/DOSE UNIT REGIST. NO. REG. DATE 1 2 3 4 5 GlaxoSmithKline S.A. Caduet 5 mg / 40 mg Caduet 5 mg / 80 mg Caduet 10 mg / 40 mg Caduet 10 mg / 80 mg Augmentin ES 600 Amlodipine Besylate, Atorvastatin Calcium Amlodipine Besylate, Atorvastatin Calcium Amlodipine Besylate, Atorvastatin Calcium Amlodipine Besylate, Atorvastatin Calcium Amoxycillin Trihydrate / Potassium Clavulanate Powder for suspension Each tablet contains Amlodipine Besylate equiv. to Amlodipine 5,0 mg, Atorvastatin Calcium equiv. to Atorvastatin 40,0 mg Each tablet contains Amlodipine Besylate equiv. to Amlodipine 5,0 mg, Atorvastatin Calcium equiv. to Atorvastatin 80,0 mg Each tablet contains Amlodipine Besylate equiv. to Amlodipine 10,0 mg, Atorvastatin Calcium equiv. to Atorvastatin 40,0 mg Each tablet contains Amlodipine Besylate equiv. to Amlodipine 10,0 mg, Atorvastatin Calcium equiv. to Atorvastatin 80,0 mg Each 5ml suspension contains; Amoxycillin Trihydrate equiv. to Amoxycillin 600,0 mg, Potassium Clavulanate equiv. to Clavulanic Acid 42,9 mg 08/7.0/0091 18/6/08 08/7.0/0092 18/6/08 08/7.0/0093 18/6/08 08/7.0/0094 18/6/08 08/20.1.2/0095 18/6/08 6 Dr Reddys Laboratories Lamitor-100 Lamotrigine Each tablet contains Lamotrigine 100,0 mg 08/2.5/0096 18/6/08 7 Dr Reddys Laboratories Lamitor-50 Lamotrigine Each tablet contains Lamotrigine 50,0 mg 08/2.5/0097 18/6/08 8 Dr Reddys Laboratories Lamitor-25 Lamotrigine Each tablet contains Lamotrigine 25,0 mg 08/2.5/0098 18/6/08 9 Dr Reddys Laboratories Cifloc 250 mg Ciprofloxacin Each tablet contains Ciprofloxacin equivalent to Ciprofloxacin 250,0 mg 08/20.1.1/0099 18/6/08 10 Dr Reddys Laboratories Cifloc 500 mg Ciprofloxacin Each tablet contains Ciprofloxacin equivalent to Ciprofloxacin 500,0 mg 08/20.1.1/0100 18/6/08 11 Serrapress 20 Paroxetine Each film coated tablet contains Paroxetine corres. to Paroxetine 20,0 mg 08/1.2/0101 18/6/08
4 Government Gazette 18 August 2008 No. 4103 12 Serrapress 30 Paroxetine Each film coated tablet contains Paroxetine corres. to Paroxetine 30,0 mg 08/1.2/0102 18/6/08 13 Carvetrend 25 Carvedilol Each tablet contains Carvedilol 25,0 mg 08/7.1.3/0103 18/6/08 14 Carvetrend 12,5 Carvedilol Each tablet contains Carvedilol 12,5 mg 08/7.1.3/0104 18/6/08 15 Carvetrend 6,25 Carvedilol Each tablet contains Carvedilol 6,25 mg 08/7.1.3/0105 18/6/08 16 Specpharm (Pty) Limited Spec-Oxytocin 10 Synthetic Oxytocin Injection Each ampoule contains Synthetic Oxytocin 10 IU 08/19/0106 18/6/08 17 Specpharm (Pty) Limited Spec-Oxytocin 5 IU Synthetic Oxytocin Injection Each 1ml ampoule contains Synthetic Oxytocin 5 IU 08/19/0107 18/6/08 18 Sandoz Clozapine-Hexal 25 mg Clozapine Each tablet contains Clozapine 25,0 mg 08/2.6.5/0108 18/6/08 19 Sandoz Clozapine-Hexal 50 mg Clozapine Each tablet contains Clozapine 50,0 mg 08/2.6.5/0109 18/6/08 20 Sandoz Clozapine-Hexal 100 mg Clozapine Each tablet contains Clozapine 100,0 mg 08/2.6.5/0110 18/6/08 21 Sandoz Clozex 25 Clozapine Each tablet contains Clozapine 25,0 mg 08/2.6.5/0111 18/6/08 22 Sandoz Clozex 50 Clozapine Each tablet contains Clozapine 50,0 mg 08/2.6.5/0112 18/6/08 23 Sandoz Clozex 100 Clozapine Each tablet contains Clozapine 100,0 mg 08/2.6.5/0113 18/6/08 24 Sandoz Parax 20 Paroxetine Each tablet contains Paroxetene Anhydrate equiv. to Paroxetene Anhydrate 40,0 mg 08/1.2/0114 18/6/08
No. 4103 Government Gazette 18 August 2008 5 25 Sandoz Parax 40 Paroxetine Each tablet contains Paroxetene Anhydrate equiv. to Paroxetene Anhydrate 40,0 mg 08/1.2/0115 18/6/08 26 Sandoz CitaloHexal 20 Citalopram Hydrobromide Each film coated tablet contains Citalopram Hydrobromide equiv. to Citalopram 20,0 mg 08/1.2/0116 18/6/08 27 Ranbaxy (S.A.) (Pty) Ltd Simayla Citalopram 40 Citalopram Hydrobromide Each film coated tablet contains Citalopram Hydrobromide equiv. to Citalopram 40,0 mg 08/1.2/0117 18/6/08 28 29 Allergan Pharmaceuticals (Pty) Ltd Allergan Pharmaceuticals (Pty) Ltd Combigan Brimodine Tartrate, Timolol Maleate Alphagan Purite Eye drops Brimodine Tartrate Opthalmic Solution Opthalmic Solution Each 1 ml solution contains: Brimodine Tartrate 2,0 mg, Timolol Maleate equiv. to Timolol 5,0 mg Each 1 ml solution contains: Brimodine Tartrate 1,5 mg, 08/15.4/0118 18/6/08 08/15.4/0119 18/6/08 30 Enablex 7.5 mg Darifenacin Hydrobromide Each tablet contains Darifenacin Hydrobromide equiv. to Darifenacin 7,5 mg 08/5.4/0120 18/6/08 31 Enablex 15 mg Darifenacin Hydrobromide Each tablet contains Darifenacin Hydrobromide equiv. to Darifenacin 15,0 mg 08/5.4/0121 18/6/08 32 Exjade 125 mg Deferasirox Each dispersible tablet contains Deferasirox 125,0 mg 08/27/0122 18/6/08 33 Exjade 250 mg Deferasirox Each dispersible tablet contains Deferasirox 250,0 mg 08/27/0123 18/6/08 34 Exjade 500 mg Deferasirox Each dispersible tablet contains Deferasirox 500,0 mg 08/27/0124 18/6/08 35 Cleevec 100 Imatinib Mesilate Each tablet contains Imatinib Mesilate equiv. to Imatinib 100,0 mg 08/34/0125 18/6/08 36 Cleevec 400 Imatinib Mesilate Each tablet contains Imatinib Mesilate equiv. to Imatinib 400,0 mg 08/34/0126 18/6/08
6 Government Gazette 18 August 2008 No. 4103 37 Sandostatin Lar 10 mg Octreotide Acetate Injection Each vial contains Octreotide Acetate equiv. to Octreotide 10,0 mg 08/34/0127 18/6/08 38 Sandostatin Lar 30 mg Octreotide Acetate Injection Each vial contains Octreotide Acetate equiv. to Octreotide 30,0 mg 08/34/0128 18/6/08 39 Aclasta Zoledronic Acid Monohydrate Infusion Each 100 ml solution contains Zoledronic Acid Monohydrate equiv. to Zoledronic Acid 5,0 mg 08/34/0129 18/6/08 40 Zometa Concentrate for Solution for Infusion Zoledronic Acid Monohydrate Concentrate Each 5 ml vial contains Zoledronic Acid Monohydrate equiv. to Zoledronic Acid 4,0 mg 08/34/0130 18/6/08 41 Tegretol 200 Carbamazepine Each tablet contains Carbamazepine 200,0 mg 08/2.5/0131 18/6/08 42 Sandoz Sandoz Topiramate 200 Topiramate Each film-coated tablet contains Topiramate 200,0 mg 08/2.5/0132 18/6/08 43 Sandoz Sandoz Topiramate 100 Topiramate Each film-coated tablet contains Topiramate 100,0 mg 08/2.5/0133 18/6/08 44 Sandoz Sandoz Topiramate 50 Topiramate Each film-coated tablet contains Topiramate 50,0 mg 08/2.5/0134 18/6/08 45 Sandoz Sandoz Topiramate 25 Topiramate Each film-coated tablet contains Topiramate 25,0 mg 08/2.5/0135 18/6/08 46 Sandoz Fexofast 120 Fexofenadine Each film-coated tablet contains Fexofenadine 120,0 mg 08/5.7.1/0136 18/6/08 47 Sandoz Fexofast 180 Fexofenadine Each film-coated tablet contains Fexofenadine 180,0 mg 08/5.7.1/0137 18/6/08 48 inova Pharmaceuticals (Pty) Limited Duro-Tuss Linctus Bromhexine, Salbutamol Sulphate Linctus Each 5 ml liquid contains Bromhexine 4,0 mg, Salbutamol Sulphate equiv. to Salbutamol 2,0 mg 08/10.1/0138 18/6/08
No. 4103 Government Gazette 18 August 2008 7 49 Trileptal 150 Oxcarbazepine Each tablet contains Oxcarbazepine 150,0 mg 08/2.5/0139 18/6/08 50 Adcock Ingram Ltd Adco-Nevirapine Nevirapine Each tablet contains Nevirapine 200,0 mg 08/20.2.8/0140 18/6/08 51 Adcock Ingram Ltd Adco-Lamivudine Lamivudine Each tablet contains Lamivudine 150,0 mg 08/20.2.8/0141 18/6/08 52 Adcock Ingram Ltd Adco-Efavirenz Efavirenz Each tablet contains Efavirenz 600,0 mg 08/20.2.8/0142 18/6/08 53 Adcock Ingram Ltd Adco-Zidovudine Zidovudine Each tablet contains Zidovudine 300,0 mg 08/20.2.8/0143 18/6/08 54 Benylin Children s Diphenhydramine, Ammonium Chloride Syrup Each 5ml syrup contains Diphenhydramine 12,5 mg, Ammonium Chloride 125,0 mg 08/10.1/0144 18/6/08 55 Dalacin VC Clindamycin Phosphate Vag. Cream Each 1 g cream contains Clindamycin Phosphate equiv. to Clindamycin 20,0 mg 08/20.1.1/0145 18/6/08 56 Xalacom Latanoprost, Timolol Maleate Eye Drops Each 1ml solution contains Latanoprost 50,0 µg, Timolol Maleate equiv. to Timolol 5,0 mg 08/15.4/0146 18/6/08 57 Sutent 25 mg Capsules Sunitinib Maleate Capsules Each capsule contains Sunitinib Maleate 25,0 mg 08/26/0147 18/6/08 58 Sutent 12,5 mg Capsules Sunitinib Maleate Capsules Each capsule contains Sunitinib Maleate 12,5 mg 08/26/0148 18/6/08 59 Sutent 50,0 mg Capsules Sunitinib Maleate Capsules Each capsule contains Sunitinib Maleate 50,0 mg 08/26/0149 18/6/08 60 Lyrica 25 mg Pregabalin Capsules Each capsule contains Pregabalin 25,0 mg 08/2.5/0150 18/6/08
8 Government Gazette 18 August 2008 No. 4103 61 Lyrica 50 mg Pregabalin Capsules Each capsule contains Pregabalin 50,0 mg 08/2.5/0151 18/6/08 62 Lyrica 75 mg Pregabalin Capsules Each capsule contains Pregabalin 75,0 mg 08/2.5/0152 18/6/08 63 Lyrica 100 mg Pregabalin Capsules Each capsule contains Pregabalin 100,0 mg 08/2.5/0153 18/6/08 64 Lyrica 150 mg Pregabalin Capsules Each capsule contains Pregabalin 150,0 mg 08/2.5/0154 18/6/08 65 Amlodipine Besylate 5 mg Amlodipine Besylate Each tablet contains Amlodipine Besylate equiv. to Amlodipine 5,0 mg 08/7.1/0155 18/6/08 66 Amlodipine Besylate 10 mg Amlodipine Besylate Each tablet contains Amlodipine besylate equiv. to Amlodipine 10,0 mg 08/7.1/0156 18/6/08 67 Abbott Laboratories Aluvia 100/25 Lopinavir, Ritonavir Each film-coated tablet contains Lopinavir 100,0 mg, Ritonavir 25,0 mg 08/20.2.8/0157 18/6/08 68 Dr Reddys Laboratories DRL-Omeprazole 40 Omeprazole Capsules Each capsule contains Omeprazole 40,0 mg 08/11.4.3/0158 18/6/08 69 70 AstraZeneca Pharmaceuticals (Pty) Ltd AstraZeneca Pharmaceuticals (Pty) Ltd Pulmicort Nebulising Suspension 0,25 mg/ml Pulmicort Nebulising Suspension 0,5 mg/ml Budesonide Suspension Each 1 ml suspension contains Budesonide 0,25 mg 08/21.5.1/0159 18/6/08 Budesonide Suspension Each 1 ml suspension contains Budesonide 0,5 mg 08/21.5.1/0160 18/6/08 71 Pharmaplan Dazit s Desloratadine Each tablet contains Desloratadine 5,0 mg 08/5.7.1/0161 18/6/08 72 Servier Laboratories SA Coralan 7,5 mg s Ivabradine Each tablet contains Ivabradine equiv. to Ivabradine 7,5 mg 08/7.6/0162 18/6/08
No. 4103 Government Gazette 18 August 2008 9 73 Servier Laboratories SA Coralan 5 mg s Ivabradine Each tablet contains Ivabradine equiv. to Ivabradine 5,0 mg 08/7.6/0163 18/6/08 74 Biogaran South Africa Caranor 7,5 mg s Ivabradine Each tablet contains Ivabradine equiv. to Ivabradine 7,5 mg 08/7.6/0164 18/6/08 75 Biogaran South Africa Caranor 5 mg s Ivabradine Each tablet contains Ivabradine equiv. to Ivabradine 5,0 mg 08/7.6/0165 18/6/08 76 Sandoz Sandoz Cefpodoxime 100 Cefpodoxime Proxetil Each tablet contains Cefpodoxime Proxetil equiv. to Cefpodoxime 100,0 mg 08/20.1.1/0166 18/6/08 77 Sandoz Sandoz Cefpodoxime 40mg/ 5ml Cefpodoxime Proxetil Suspension Each 5ml suspension contains Cefpodoxime Proxetil equiv. to Cefpodoxime 40,0 mg 08/20.1.1/0167 18/6/08 78 AstraZeneca Pharmaceuticals (Pty) Ltd Zoladex 10,8 Goserelin Acetate Injection Each Zoladex Depot contains Goserelin Acetate equiv. to Goserelin Base 10,8 mg 08/21.10/0168 18/6/08 79 Adcock Ingram Ltd Rilace 1.25 Ramipril Capsules Each capsule contains Ramipril 1,25 mg 08/7.1.3/0169 18/6/08 80 Adcock Ingram Ltd Rilace 2.5 Ramipril Capsules Each capsule contains Ramipril 2.5 mg 08/7.1.3/0170 18/6/08 81 Adcock Ingram Ltd Rilace 5 Ramipril Capsules Each capsule contains Ramipril 5 mg 08/7.1.3/0171 18/6/08 82 Adcock Ingram Ltd Rilace 10 Ramipril Capsules Each capsule contains Ramipril 10 mg 08/7.1.3/0172 18/6/08 83 Adcock Ingram Ltd Tramgesic Flashtabs Tramadol Each tablet contains Tramadol 50,0 mg 08/2.9/0173 18/6/08 84 Adcock Ingram Ltd Adco-Fem 35 Cyproterone Acetate, Ethynyloestradol Each tablet contains Cyproterone Acetate 2,0 mg, Ethynyloestradiol 0,035 mg 08/21.8.2/0174 18/6/08
10 Government Gazette 18 August 2008 No. 4103 MINISTRY OF HEALTH AND SOCIAL SERVICES No. 197 2008 REGULATIONS RELATING TO SCOPE OF PRACTICE OF ORAL HYGIENE: MEDICAL AND DENTAL ACT, 2004 Under section 59 of the Medical and Dental Act, 2004 (Act No. 10 of 2004), and on the recommendation of the Medical and Dental Council of Namibia, I have made the regulations set out in the Schedule. R. N. KAMWI MINISTER OF HEALTH AND SOCIAL SERVICES Windhoek, 29 July 2008 Definitions SCHEDULE 1. In these regulations, unless the context otherwise indicates, a word or expression defined in the Act has that meaning, and - the Act means the Medical and Dental Act, 2004 (Act No. 10 of 2004). Scope of practice of oral hygiene 2. an oral hygienist may perform the following acts - (a) (b) (c) (d) (e) (f) (g) (h) (i) (j) (k) (l) (m) the provisional examination and charting of conditions of the mouth, with particulars reference to the face, soft tissues, teeth, occlusion and periodontium; the scaling, roof planning and polishing of teeth, including the trimming and polishing of restorations; the performing of dental radiography; the topical application of agents appropriate to the practice of oral hygiene, including caries preventive agents, tooth-desensitizing agents, surface anaesthetics and plague-controlling agents; the application and removal of periodontal packs; the taking of impressions and the casting of study and primary work models: the placement of temporary fillings as an emergency measure prior to the referral to a dentist or dental therapist; the temporary cementing of inlays, crowns and bridges; the placement of glass ionomers cement on sensitive dentine abrasion lesions; the placement of soft lining in dentures as tissue conditioners; the taking of cytological smears, including for the purpose of testing for candida infection; the discussion of treatment options with, and the explaining of treatment procedures to patients; the discussion of treatment fees;
No. 4103 Government Gazette 18 August 2008 11 (n) the performing of the following functions in orthodontics - (i) (ii) (iii) (iv) cephalometric tracing; the relief of trauma caused by intra- and extra-oral appliances, including the cutting of the distal arch wires and the removal of the complete arch wire; the placement of pre-activated orthodontic appliances and the removal of orthodontic attachments, bands, appliances and arch wires; the fitting of orthodontic retainers; and (o) the administering of applicable local analgesia appropriate to the scope of the profession of oral hygiene. Performing of professional acts by student in oral hygiene 3. A student in oral hygiene may perform, as part of his or her education, tuition and training, and on the instructions, and under the direct supervision, of a dentist or an oral hygienist, any of the acts prescribed by regulation 2. MINISTRY OF HEALTH AND SOCIAL SERVICES No. 198 2008 REGULATIONS RELATING TO OWNERSHIP OF PHARMACY BY PRIVATE HOSPITAL: PHARMACY ACT, 2004 Under section 66 of the Pharmacy Act, 2004 (Act No. 9 of 2004), read with section 37 of that Act, on the recommendation of the Pharmacy Council of Namibia, I have made the regulations set out in the Schedule. R. N. KAMWI MINISTER OF HEALTH AND SOCIAL SERVICES Windhoek, 30 July 2008 Definitions SCHEDULE 1. In these regulations, unless the context otherwise indicates, a word or expression defined in the Act has that meaning, and - hospital means a state hospital established under section 2 of the Hospitals and Health Facilities Act, or a private hospital registered under section 23 of that Act; Hospitals and Health Facilities Act means the Hospitals and Health Facilities Act, 1994 (Act No. 36 of 1994); Medicines and Related Substances Control Act means the Medicines and Related Substances Control Act, 2003 (Act No. 13 of 2003); and the Act means the Pharmacy Act, 2004 (Act No. 9 of 2004). Person other than pharmacist, private company or close corporation who may own pharmacy 2. Subject to the Act, a hospital may own a community pharmacy.
12 Government Gazette 18 August 2008 No. 4103 Conditions subject whereto private hospital may own and conduct pharmacy 3. (1) A community pharmacy referred to in subregulation (2) must - (a) (b) be licensed as a private health facility under section 31 of the Hospitals and Health Facilities Act; and situate on the premises where the hospital is situated. (2) A hospital referred to in regulation 2 (a) must conduct its community pharmacy in accordance with the Act, the Medicines and Related Substances Control Act and the Hospitals and Health Facilities Act; and (b) may not - (i) (ii) have any financial or other interest in any community pharmacy other than the community pharmacy of which it is the owner; or conduct business as a wholesale pharmacist referred to in section 35(26) of the Act or as a manufacturer as defined in section 1 of the Medicines and Related Substances Control Act, or have any financial or other interest in such wholesale pharmacy or manufacturer.