c Maldives Food and Drug Authority Ministry of Health Male’, Republic of Maldives Approved Drug List Number: MTG/RE-AL/Li 0009/2018-0001 Acronym Expansion Remarks R Registered product These are pharmaceutical products registered and approved with full dossier submission. Product safety, quality and efficacy has been evaluated based on the submitted documents and certificates of the manufacture and the product Once registered and approved, it is the Re Registered product which has responsibility of the marketing authorization holder to been given exclusivity under set provide all necessary information required and if there is any condition. change in the product/packaging etc., and to ensure that the product is available in the market. EA Exemption Approvals These are special approvals for importing pharmaceutical products based on minimum evaluation of safety and quality of the product with information of the imports and availability in the market of the same. This approval is a temporary approval granted for a period of 1 year. For further import after 1 year, it has to be registered by full dossier submission under the registration criteria. Once registered by submitting full dossier then it will be added to the registered product list. TA Temporary Approvals These are the Products approved based on physicians requisition forms submitted by clinicians, and these products are in generic name and Pre Authorization has to be taken prior to import.These products will be kept as approved products for a period of 1 year , and as pre authorization required products. If needed for further import it has to be registered by full dossier submission under the registeration criteria. PP Primordial Products These are the products that has been in Approved Drug List from the beginning as approved products but not registered with full dossier submission. This has been kept in the Approved Drug List due to the unavailability of any alternative, plus that these products are kept on the fact that it has been in the market for a long time. Pre Authorization For all those products highlighted These are in generics and it is mentioned that Pre required products (PA) in Green Authorization has to be taken prior to import. Pre- authorization is an approval taken to import these products and it has to be taken for each product and for every shipment for import. Rec. Name: Approved Drug List Rec. No.: MTG/RE-AL/Li 0009 Issue No.: 02 Issued Date: 12/02/2018 MTG Division, MFDA Rev. No.: 00 Rev.Date:00 Authorized By: DDG, Pharmaceuticals Section: Regulation 1 Restricted for Hospital Medicines restricted to special These are the medicines that can only be imported by and institutional use only expertise and Health facilties and designated parties.These products cannot be kept for sale in (HI) clinics with registered medical pharmacies. practitioners Restricted for Hospital use Medicine restricted to special These are the medicines that can only be imported by only (HO) expertise for hospitals only designated parties.These products cannot be kept for sale in pharmacies. Restricted for the National Restricted to Use for the National These medicines can only be imported to be used by the programs only (NP) programes only (eg. Filaria, National Programes based on a valid request by the Leprosy, Malaria, TB,HIV,EPI, concerned agency Reproductive Health Programs etc) CONTROLLED ( C ) Controlled Drugs which include These are medicines which are controlled and can only be Narcotics and Psychotropics imported by designated parties.From these medicines (Internationally and Nationally Narcotics cannot be kept in pharmacies for sale Controlled). OTC Over the counter medicine (OTC) These are the medicines that can be sold without prescriptions POM Prescription only medicine (POM) These are medicines that can be sold to a valid prescription only. E Essential medicine These are medicines that are essential and is in the most recent National Essential medicine list Updated on: 12th February 2018 Color codes Category Text/Highlighted Colour Explanation Prescription Only Black All the "POM" drugs are in black text Medicine (POM) Over the Counter (OTC) Blue All the "OTC" drugs are in blue text CONTROLLED Purple All the "Controlled" medicine are in purple text Restricted for Hospital Dark Blue All the "Restricted for Hospital Use Only" medicines use only are in dark blue text Restricted and to be Dark Red All the "Restricted and to be used for the National used for the National programme only" medicines are in dark red text programme only Pre-Authorization required before import All the "Pre-Authorization required before import" items are highlighted in light green Products proposed to be removed after evaluation "Products proposed to be removed after evaluation" are highlighted in red colour 1. For the Products in this list where the formulation is mentioned, that specific formulation only can be imported 2. For those products in which the fomulation is not mentioned, the product imported should be of export quality and not specified for a specific market Rec. Name: Approved Drug List Rec. No.: MTG/RE-AL/Li 0009 Issue No.: 02 Issued Date: 12/02/2018 MTG Division, MFDA Rev. No.: 00 Rev.Date:00 Authorized By: DDG, Pharmaceuticals Section: Regulation 2 List 1: Registered Product List These are pharmaceutical products registered and approved with full dossier submission. Product safety, quality and efficacy has been evaluated based on the submitted documents and certificates of the manufacture and the product Once registered and approved, it is the responsibility of the marketing authorization holder to provide all necessary information required and if there is any change in the product/packaging etc., and to ensure that the product is available in the market. Serial Product Generic name Product name Manufacturer / Dosage form Strength Catergory Status Essent Registered Remarks No. No Company name iality Date 1 P2123 ACARBOSE BP Glucar - 50 Glenmark Tablet 50 mg POM R E Pharmaceuticals Ltd., India 2 P2423 ACECLOFENAC Aceclo Aristo India Tablet 100 mg POM R 25.10.2010 Registered by ADK Company Pvt Ltd 3 P3678 ACECLOFENAC BP Acelodon 100 Swiss Garnier Life Tablet 100 mg POM Re 01.03.2016- Market Exclusivity Sciences, No. 21-23, 28.02.2021 given to AMDC Pvt Ltd Industrial Area, Only Mehatpur, Dist: UNA, (H.P.)- 174 315, India 4 P2716 ACECLOFENAC BP Acedol Torrent Tablet 100 mg POM R 19.02.2013 Registered by Life Pharmaceuticals, India Support Pvt Ltd 5 P2275 ACECLOFENAC BP Acenac Medley Tablet 100 mg POM R Registered by ADK Pharmaceuticals Ltd, Company Pvt Ltd India. 6 P3140 ACECLOFENAC BP Aeronac Cassel Research Tablet 100 mg POM R 19.08.2014 My Chemist Laboratories, India 7 P3508 ACECLOFENAC BP Acenac-SR Medley Sustained Release 200 mg POM Re 19.05.2015- Market Exclusivity Pharmaceuticals Ltd, Tablet 18.05.2020 given to ADK Company India. Pvt Ltd only 8 P3267 ACECLOFENAC BP + LINSEED OIL BP + Stednac Stedman Gel 1.5% w/w + 3.0% + 10% + 5% POM R 06.01.2015 Registered by AMDC METHYL SALICYLATE BP + MENTHOL GEL Pharmaceuticals Pvt. Pvt Ltd USP Ltd., India 9 P2427 ACETYL SALICYLIC ACID Delisprin 75 Aristo India Tablet (Delayed 75 mg POM R E 25.10.2010 Registered by ADK Release) Company Pvt Ltd Rec. Name: Approved Drug List Rec. No.: MTG/RE-AL/Li 0009 Issue No.: 02 Issued Date: 12/02/2018 MTG Division, MFDA Rev. No.: 00 Rev.Date:00 Authorized By: DDG, Pharmaceuticals Section: Regulation 1 10 P3932 ACETYL SALICYLIC ACID (ASPIRIN) Casprin Y.S.P. Industries (M) Enteric Micro- 100 mg POM Re E 01.11.2016 - Market Exclusivity Sdn. Bhd. Lot 3, 5 & 7, encaptulated 31.10.2021 given to Treetop Jalan P/7, Section 13, Capsule Health Pvt Ltd only Kawasan Perindustrian Bandar Baru bangi, 43000 Kajang, Selangor Darul Ehsan, Malaysia 11 P2611 ACICLOVIR/ ACYCLOVIR Virest Hovid Bhd, Malaysia Cream 5% POM R E 10.07.2012 Registered by GKT Pharmacy 12 P2185 ACICLOVIR/ ACYCLOVIR Herperax 200 Micro Labs ltd., India Tablet 200 mg POM R E Registered by ADK Company Pvt Ltd 13 P2607 ACICLOVIR/ ACYCLOVIR Virest Hovid Bhd, Malaysia Tablet 400 mg POM R E 10.07.2012 Registered by GKT Pharmacy 14 P2608 ACICLOVIR/ ACYCLOVIR Virest Hovid Bhd, Malaysia Tablet 200 mg POM R E 10.07.2012 Registered by GKT Pharmacy 15 P2804 ACICLOVIR/ ACYCLOVIR Zovirax GlaxoSmithKline , Spain Tablet 200 mg POM R E 26.08.2013 Registered by ADK Company Pvt Ltd 16 P2805 ACICLOVIR/ ACYCLOVIR Zovirax GlaxoSmithKline , Spain Tablet 800 mg POM R E 26.08.2013 Registered by ADK Company Pvt Ltd 17 P2203 ACICLOVIR/ ACYCLOVIR Herperax Micro Labs ltd Ointment 5% POM R E Registered by ADK Company Pvt Ltd 18 P3214 ACICLOVIR/ ACYCLOVIR Zovirax Glaxo Operations, UK Cream 5% w/w POM R E 06.11.2014 State Trading Organization 19 P606 ACICLOVIR/ ACYCLOVIR Zovirax GlaxoSmithKline Injection 250mg/vial POM R E 06.11.2014 State Trading Manufacturing S.p.A, Organization Italy 20 P1832 ACICLOVIR/ ACYCLOVIR Declovir cream HOE Pharmaceutical Cream 5.00% POM R E Manufacturing (M) Sdn. Bhd., Malaysia 21 P1974 ACICLOVIR/ ACYCLOVIR Virux Square Tablet 200 mg POM R E Pharmaceuticals, Bangladesh Rec. Name: Approved Drug List Rec. No.: MTG/RE-AL/Li 0009 Issue No.: 02 Issued Date: 12/02/2018 MTG Division, MFDA Rev. No.: 00 Rev.Date:00 Authorized By: DDG, Pharmaceuticals Section: Regulation 2 22 P3939 ACICLOVIR/ ACYCLOVIR Axcel Acyclovir Kotra Pharma (M) Sdn. Cream 5% w/w (5g tube) POM Re E 01.11.2016 - Market Exclusivity Bhd., 1, 2, & 3 Jalan TTC 31.10.2021 given to State Trade 12, Cheng Industrial Organization Plc only Estate, 75250 Melaka, Malaysia 23 P1822 ACICLOVIR/ ACYCLOVIR IP Ocuvir 800 DT FDC Limited, India Dispersible Tablet 800 mg POM R E 24 P2184 ACICLOVIR/ ACYCLOVIR USP Herperax 800 Micro Labs ltd., India Tablet 800 mg POM R E Registered by ADK Company Pvt Ltd 25 P1336 ACTIVATED DIMETHICONE IP + Colimex Wallace Oral Drops 10mg + 40mg OTC R 06.01.2015 Registered by AMDC DICYCLOMINE IP Pharmaceuticals, India Pvt Ltd 26 P4070 ACYCLOVIR / ACICLOVIR Lovir Remington Ophthalmic 30mg (3.0%) POM Re 03.10.2017 - Market Exclusivity Pharmaceutical Ointment 02.10.2022 given to ADK Industries (Pvt) Ltd, Pharmaceutical 18km Multan Road, Company Pvt Ltd.