L.S. 458.55 Regoli dwar Prodotti Mediċinali li jiġu Provduti mill-Klinika ĠenitoUrinarja fis-Servizzi tas-Saħħa tal-Gvern

PROVISION OF MEDICINAL PRODUCTS THROUGH THE GENITO URINARY CLINIC WITHIN THE GOVERNMENT HEALTH SERVICES [ S.L.458.55 1 SUBSIDIARY LEGISLATION 458.55 PROVISION OF MEDICINAL PRODUCTS THROUGH THE GENITO URINARY CLINIC WITHIN THE GOVERNMENT HEALTH SERVICES RULES 12th June, 2009 LEGAL NOTICE 188 of 2009, as amended by Legal Notice 366 of 2013. 1. The title of these rules is the Provision of Medicinal Products through the GenitoUrinary Clinic within the Government Health Services Rules. Citation. 2. For the purpose of these rules and unless the context otherwise requires - Interpretation. "the Act" means the Medicines Act; Cap. 458. "the Authority" means the licensing authority established under the Act; "consultant" means the person who acts and is responsible for the clinic; "designated premises" means the premises of the Genito Urinary Clinic from which the medicinal products listed in the Schedule shall be dispensed; "the GenitoUrinary clinic" means any place designated as such by the Superintendent of Public Health and the term "clinic" shall be construed accordingly. 3. The medicinal products listed in the Schedule shall only be provided by the consultant to patients attending or who have been referred to the clinic. 4. The consultant shall: (

1. a)provide the medicinal products referred to in the Schedule, directly to patients attending the clinic, and he shall keep a record thereof; (
2. b)dispense only those amounts which are needed for the period specified therein; (
3. c)immediately notify the Authority of any amendment needed in the Schedule; (
4. d)inform the Authority of the address of the clinic and of any changes in such an address; (
5. e)be responsible for all duties and obligations relating to the provision of medicinal products to patients under the Act and any regulations or rules made thereunder, and for standards and conditions issued by the Authority from time to time in relation to dispensing; (
6. f)keep such amount of medicinal products as per internal Provision of medicinal products by the consultant. Duty of consultant. 2 [ S.L.458.55 PROVISION OF MEDICINAL PRODUCTS THROUGH THE GENITO URINARY CLINIC WITHIN THE GOVERNMENT HEALTH SERVICES arrangements with the hospital pharmacy in order to ensure continuation of service at the clinic; (
7. g)take all reasonable precautions to ensure appropriate storage and dispensing of medicinal products; (
8. h)keep an updated, written and agreed procedure with the hospital pharmacy supplying the medicinal products. Rights pertaining to the Authority. 5. The Authority shall have the right to amend, suspend or revoke the authorization if any of the provisions of the authorization granted under these rules or provisions related to any other legislation have been breached by the consultant. PROVISION OF MEDICINAL PRODUCTS THROUGH THE GENITO URINARY CLINIC WITHIN THE GOVERNMENT HEALTH SERVICES [ S.L.458.55 SCHEDULE (Rule 3) 3 Amended by: L.N. 366 of 2013. List of medicinal products authorized for the purpose of these rules 1. Doxycycline 100mg bd for 7 days. (Occasionally for 14 days in epididymitis and rarely for 28 days in LGV and Latent Syphilis) 2. Erythromycin 250mg - two tablets daily for 7 days 3. Metronidazole 200mg tablets - 2 tablets daily for 7 days 4. Ceftriaxone 500mg im injections and 1% lignocaine injection for dilution to be given as stat dose 5. Spectinomycin 2grams im stat 6. Benzathine Penicillin 1.2 million units im injections and 1% lignocaine injection for dilution to be given as stat dose of 2.4 million units. 7. Clotrimazole 100mg pessaries 8. Podophyllotoxin 0.15% cream 9. Podophyllotoxin 0.5% topical solution 10. Aciclovir 200mg to be given as 400mg tds for 7 days for acute episodes 11. Prednisolone 5mg to be given as 20mg tds for 3 days 12. Amoxicillin 250mg to be given as 500mg tds for 5 days 13. Azithromicin 250mg and 500mg