GOVERNMENT GAZETTE OF THE REPUBLIC OF NAMIBIA. N$2.40 WINDHOEK - 18 August 2008 No CONTENTS

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1 GOVERNMENT GAZETTE OF THE REPUBLIC OF NAMIBIA N$2.40 WINDHOEK - 18 August 2008 No 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, No. 198 Regulations relating to ownership of pharmacy by private hospital: Pharmacy Act, Government Notices MINISTRY OF HEALTH AND SOCIAL SERVICES No 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 2 Government Gazette 18 August 2008 No (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

3 No Government Gazette 18 August S/N APPLICANT REGISTERED NAME APPROVED NAME OF ACTIVE(S) DOSSAGE FORM STRENGTH/DOSE UNIT REGIST. NO. REG. DATE 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/ /6/08 08/7.0/ /6/08 08/7.0/ /6/08 08/7.0/ /6/08 08/20.1.2/ /6/08 6 Dr Reddys Laboratories Lamitor-100 Lamotrigine Each tablet contains Lamotrigine 100,0 mg 08/2.5/ /6/08 7 Dr Reddys Laboratories Lamitor-50 Lamotrigine Each tablet contains Lamotrigine 50,0 mg 08/2.5/ /6/08 8 Dr Reddys Laboratories Lamitor-25 Lamotrigine Each tablet contains Lamotrigine 25,0 mg 08/2.5/ /6/08 9 Dr Reddys Laboratories Cifloc 250 mg Ciprofloxacin Each tablet contains Ciprofloxacin equivalent to Ciprofloxacin 250,0 mg 08/20.1.1/ /6/08 10 Dr Reddys Laboratories Cifloc 500 mg Ciprofloxacin Each tablet contains Ciprofloxacin equivalent to Ciprofloxacin 500,0 mg 08/20.1.1/ /6/08 11 Serrapress 20 Paroxetine Each film coated tablet contains Paroxetine corres. to Paroxetine 20,0 mg 08/1.2/ /6/08

4 4 Government Gazette 18 August 2008 No Serrapress 30 Paroxetine Each film coated tablet contains Paroxetine corres. to Paroxetine 30,0 mg 08/1.2/ /6/08 13 Carvetrend 25 Carvedilol Each tablet contains Carvedilol 25,0 mg 08/7.1.3/ /6/08 14 Carvetrend 12,5 Carvedilol Each tablet contains Carvedilol 12,5 mg 08/7.1.3/ /6/08 15 Carvetrend 6,25 Carvedilol Each tablet contains Carvedilol 6,25 mg 08/7.1.3/ /6/08 16 Specpharm (Pty) Limited Spec-Oxytocin 10 Synthetic Oxytocin Injection Each ampoule contains Synthetic Oxytocin 10 IU 08/19/ /6/08 17 Specpharm (Pty) Limited Spec-Oxytocin 5 IU Synthetic Oxytocin Injection Each 1ml ampoule contains Synthetic Oxytocin 5 IU 08/19/ /6/08 18 Sandoz Clozapine-Hexal 25 mg Clozapine Each tablet contains Clozapine 25,0 mg 08/2.6.5/ /6/08 19 Sandoz Clozapine-Hexal 50 mg Clozapine Each tablet contains Clozapine 50,0 mg 08/2.6.5/ /6/08 20 Sandoz Clozapine-Hexal 100 mg Clozapine Each tablet contains Clozapine 100,0 mg 08/2.6.5/ /6/08 21 Sandoz Clozex 25 Clozapine Each tablet contains Clozapine 25,0 mg 08/2.6.5/ /6/08 22 Sandoz Clozex 50 Clozapine Each tablet contains Clozapine 50,0 mg 08/2.6.5/ /6/08 23 Sandoz Clozex 100 Clozapine Each tablet contains Clozapine 100,0 mg 08/2.6.5/ /6/08 24 Sandoz Parax 20 Paroxetine Each tablet contains Paroxetene Anhydrate equiv. to Paroxetene Anhydrate 40,0 mg 08/1.2/ /6/08

5 No Government Gazette 18 August Sandoz Parax 40 Paroxetine Each tablet contains Paroxetene Anhydrate equiv. to Paroxetene Anhydrate 40,0 mg 08/1.2/ /6/08 26 Sandoz CitaloHexal 20 Citalopram Hydrobromide Each film coated tablet contains Citalopram Hydrobromide equiv. to Citalopram 20,0 mg 08/1.2/ /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/ /6/ 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/ /6/08 08/15.4/ /6/08 30 Enablex 7.5 mg Darifenacin Hydrobromide Each tablet contains Darifenacin Hydrobromide equiv. to Darifenacin 7,5 mg 08/5.4/ /6/08 31 Enablex 15 mg Darifenacin Hydrobromide Each tablet contains Darifenacin Hydrobromide equiv. to Darifenacin 15,0 mg 08/5.4/ /6/08 32 Exjade 125 mg Deferasirox Each dispersible tablet contains Deferasirox 125,0 mg 08/27/ /6/08 33 Exjade 250 mg Deferasirox Each dispersible tablet contains Deferasirox 250,0 mg 08/27/ /6/08 34 Exjade 500 mg Deferasirox Each dispersible tablet contains Deferasirox 500,0 mg 08/27/ /6/08 35 Cleevec 100 Imatinib Mesilate Each tablet contains Imatinib Mesilate equiv. to Imatinib 100,0 mg 08/34/ /6/08 36 Cleevec 400 Imatinib Mesilate Each tablet contains Imatinib Mesilate equiv. to Imatinib 400,0 mg 08/34/ /6/08

6 6 Government Gazette 18 August 2008 No Sandostatin Lar 10 mg Octreotide Acetate Injection Each vial contains Octreotide Acetate equiv. to Octreotide 10,0 mg 08/34/ /6/08 38 Sandostatin Lar 30 mg Octreotide Acetate Injection Each vial contains Octreotide Acetate equiv. to Octreotide 30,0 mg 08/34/ /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/ /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/ /6/08 41 Tegretol 200 Carbamazepine Each tablet contains Carbamazepine 200,0 mg 08/2.5/ /6/08 42 Sandoz Sandoz Topiramate 200 Topiramate Each film-coated tablet contains Topiramate 200,0 mg 08/2.5/ /6/08 43 Sandoz Sandoz Topiramate 100 Topiramate Each film-coated tablet contains Topiramate 100,0 mg 08/2.5/ /6/08 44 Sandoz Sandoz Topiramate 50 Topiramate Each film-coated tablet contains Topiramate 50,0 mg 08/2.5/ /6/08 45 Sandoz Sandoz Topiramate 25 Topiramate Each film-coated tablet contains Topiramate 25,0 mg 08/2.5/ /6/08 46 Sandoz Fexofast 120 Fexofenadine Each film-coated tablet contains Fexofenadine 120,0 mg 08/5.7.1/ /6/08 47 Sandoz Fexofast 180 Fexofenadine Each film-coated tablet contains Fexofenadine 180,0 mg 08/5.7.1/ /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/ /6/08

7 No Government Gazette 18 August Trileptal 150 Oxcarbazepine Each tablet contains Oxcarbazepine 150,0 mg 08/2.5/ /6/08 50 Adcock Ingram Ltd Adco-Nevirapine Nevirapine Each tablet contains Nevirapine 200,0 mg 08/20.2.8/ /6/08 51 Adcock Ingram Ltd Adco-Lamivudine Lamivudine Each tablet contains Lamivudine 150,0 mg 08/20.2.8/ /6/08 52 Adcock Ingram Ltd Adco-Efavirenz Efavirenz Each tablet contains Efavirenz 600,0 mg 08/20.2.8/ /6/08 53 Adcock Ingram Ltd Adco-Zidovudine Zidovudine Each tablet contains Zidovudine 300,0 mg 08/20.2.8/ /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/ /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/ /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/ /6/08 57 Sutent 25 mg Capsules Sunitinib Maleate Capsules Each capsule contains Sunitinib Maleate 25,0 mg 08/26/ /6/08 58 Sutent 12,5 mg Capsules Sunitinib Maleate Capsules Each capsule contains Sunitinib Maleate 12,5 mg 08/26/ /6/08 59 Sutent 50,0 mg Capsules Sunitinib Maleate Capsules Each capsule contains Sunitinib Maleate 50,0 mg 08/26/ /6/08 60 Lyrica 25 mg Pregabalin Capsules Each capsule contains Pregabalin 25,0 mg 08/2.5/ /6/08

8 8 Government Gazette 18 August 2008 No Lyrica 50 mg Pregabalin Capsules Each capsule contains Pregabalin 50,0 mg 08/2.5/ /6/08 62 Lyrica 75 mg Pregabalin Capsules Each capsule contains Pregabalin 75,0 mg 08/2.5/ /6/08 63 Lyrica 100 mg Pregabalin Capsules Each capsule contains Pregabalin 100,0 mg 08/2.5/ /6/08 64 Lyrica 150 mg Pregabalin Capsules Each capsule contains Pregabalin 150,0 mg 08/2.5/ /6/08 65 Amlodipine Besylate 5 mg Amlodipine Besylate Each tablet contains Amlodipine Besylate equiv. to Amlodipine 5,0 mg 08/7.1/ /6/08 66 Amlodipine Besylate 10 mg Amlodipine Besylate Each tablet contains Amlodipine besylate equiv. to Amlodipine 10,0 mg 08/7.1/ /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/ /6/08 68 Dr Reddys Laboratories DRL-Omeprazole 40 Omeprazole Capsules Each capsule contains Omeprazole 40,0 mg 08/11.4.3/ /6/ 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/ /6/08 Budesonide Suspension Each 1 ml suspension contains Budesonide 0,5 mg 08/21.5.1/ /6/08 71 Pharmaplan Dazit s Desloratadine Each tablet contains Desloratadine 5,0 mg 08/5.7.1/ /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/ /6/08

9 No Government Gazette 18 August Servier Laboratories SA Coralan 5 mg s Ivabradine Each tablet contains Ivabradine equiv. to Ivabradine 5,0 mg 08/7.6/ /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/ /6/08 75 Biogaran South Africa Caranor 5 mg s Ivabradine Each tablet contains Ivabradine equiv. to Ivabradine 5,0 mg 08/7.6/ /6/08 76 Sandoz Sandoz Cefpodoxime 100 Cefpodoxime Proxetil Each tablet contains Cefpodoxime Proxetil equiv. to Cefpodoxime 100,0 mg 08/20.1.1/ /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/ /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/ /6/08 79 Adcock Ingram Ltd Rilace 1.25 Ramipril Capsules Each capsule contains Ramipril 1,25 mg 08/7.1.3/ /6/08 80 Adcock Ingram Ltd Rilace 2.5 Ramipril Capsules Each capsule contains Ramipril 2.5 mg 08/7.1.3/ /6/08 81 Adcock Ingram Ltd Rilace 5 Ramipril Capsules Each capsule contains Ramipril 5 mg 08/7.1.3/ /6/08 82 Adcock Ingram Ltd Rilace 10 Ramipril Capsules Each capsule contains Ramipril 10 mg 08/7.1.3/ /6/08 83 Adcock Ingram Ltd Tramgesic Flashtabs Tramadol Each tablet contains Tramadol 50,0 mg 08/2.9/ /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/ /6/08

10 10 Government Gazette 18 August 2008 No MINISTRY OF HEALTH AND SOCIAL SERVICES No 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;

11 No Government Gazette 18 August (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 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 12 Government Gazette 18 August 2008 No 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.

MEDICINES CONTROL COUNCIL

Notification of of Medicines MEDICINES CONTROL COUNCIL NOTIFICATION OF REGISTRATION OF MEDICINES BY THE REGISTRAR IN TERMS OF SECTION 17 OF THE MEDICINES AND RELATED SUBSTANCES ACT, 1965 (ACT 101 OF 1965)