VOLUME 5 SECTION 5 APPROVAL PROCESS FOR FOOD, DRUGS COSMETICS, MEDICAL DEVICES, PRECURSOR CHEMICALS AND NARCOTICS

Transcription

1 moh standards & regulatons.qxp 01/05/ :58 PM Page 1 VOLUME 5 SECTION 5 APPROVAL PROCESS FOR FOOD, DRUGS COSMETICS, MEDICAL DEVICES, PRECURSOR CHEMICALS AND NARCOTICS The Responsblty of the Mnstry of Health 2-4 Kngs Street Kngston

2 moh standards & regulatons.qxp 01/05/ :58 PM Page 2 TABLE OF CONTENT CHAPTER STANDARDS AND REGULATION DIVISION OF THE MINISTRY OF HEALTH CHAPTER LEGISLATIVE FRAMEWORK CHAPTER STRUCTURE AND FUNCTIONS OF THE STANDARDS DIVISION CHAPTER DRUG REGISTRATION CENTRE CHAPTER PERMIT APPROVAL CENTRE CHAPTER REQUIREMENTS FOR IMPORTATION OF FOODS AND DRUGS CHAPTER IMPORTATION OF CHEMICALS, RAW MATERIALS AND COSMETICS CHAPTER IMPORTATION OF CONTROLLED SUBSTANCES, PSYCHOTROPIC SUBSTANCES, NARCOTICS, PRECURSORS AND ESSENTIAL CHEMICALS APPENDICES

3 moh standards & regulatons.qxp 01/05/ :58 PM Page 1 CHAPTER 1 STANDARDS & REGULATION DIVISION OF THE MINISTRY OF HEALTH 1.0 BACKGROUND The Standards & Regulaton Dvson was establshed n March 1999 under the Health Reform process of the Mnstry of Health. The role and functons of the Dvson are regulatory, legslatve and admnstratve n nature and are executed through the followng four sectons: v Standards and Regulaton - Admnstraton Standards Research & Development Investgaton & Enforcement Pharmaceutcal & Regulatory Affars 1.01 Msson Statement To mprove the qualty of health care servces n Jamaca through standards development and montorng n consultaton wth publc and prvate health care provders; to regulate healthcare facltes, pharmaceutcals and other desgnated products; and to facltate the recognton of the rghts of all clents. 1.1 SUB-DIVISIONS The Pharmaceutcal and Regulatory Affars Department comprses three sub unts: The Permt Approval Unt The Product Regstraton Unt The Insttutons and Facltes Unt. 1.2 ADVISORY PANEL MECHANISM An Advsory Panel Mechansm consstng of three Advsory Panels was created wthn the new framework n 2000.The purpose of the Advsory Mechansm s to provde a collaboratve network supportng the Dvson n the development of systems and programmes, whch wll advance the qualty of healthcare and provde 1

4 moh standards & regulatons.qxp 01/05/ :58 PM Page 2 nputs for health polcy formulaton. The Panels are: Professonal Affars Complementary/Alternatve Medcne Ethcs and Medco-Legal Affars 1.3 ROLE AND FUNCTIONS OF THE STANDARDS DIVISION Mandate The mandate of The Standards and Regulaton Dvson s to contrbute to the achevement of the Mnstry of Health s corporate goals and objectves by leadng the process for qualty mprovement through standard settng and montorng of the publc and prvate health sectors. The core functons nclude: v v Polcy Formulaton; Mantenance of an effectve Regulatory framework supported by sound legslaton for the regulaton of healthcare facltes, pharmaceutcals, foods, cosmetcs and other desgnated products; Development of healthcare standards and gudelnes; Montorng and enforcement of standards, regulatons and gudelnes; Resoluton of complants regardng health ssues; v Mantenance of crtcal lnkages locally, regonally and nternatonally; Functons The functons are crtcal, ensurng conformance wth legslaton, standards and gudelnes resultng n: Access to safe, effectve products of acceptable qualty ncludng narcotcs, psychotropcs, herbal products and other drugs, cosmetcs, foods and medcal devces The mportaton for sale/dstrbuton to the publc of products, 2

5 moh standards & regulatons.qxp 01/05/ :58 PM Page 3 whch have pror approval by the Mnstry.Those desgnated by law are food, drugs, cosmetcs, medcal devces and precursor chemcals. The mportaton of all chemcals s also regulated through the Pharmaceutcal and Regulatory Affars Department v v Improved healthcare delvery by health professonals The mplementaton of approprate health standards & gudelnes The provson of qualty servce n Health Insttutons Regulatory Functons The regulatory oversght of the Dvson s natonal and therefore spans both publc and prvate health domans. 3

6 moh standards & regulatons.qxp 01/05/ :58 PM Page 4 CHAPTER 2 LEGISLATIVE FRAMEWORK 2.0 LAWS AND REGULATIONS The followng Laws and Regulatons prmarly govern the functons of the Dvson: The Food & Drugs Act, 1964 The Food & Drugs Regulaton, 1975 The Dangerous Drugs Act, 1948 Precursor Chemcals Act, 1999 The Nursng Homes Regstraton Act, FOOD AND DRUGS ACT The Food and Drugs Act and Regulatons authorse the regulaton of foods, drugs, cosmetcs and medcal devces. The scope of authorty ncludes domestcally manufactured, as well as mported products. Under the Act and Regulatons, local manufacturng stes should possess current manufacturng lcences, renewable annually and should comply wth Good Manufacturng Practce standards. The regstraton and lcensng, mportaton, sale and dstrbuton of the desgnated products are also covered. Under the Act smlar standards for qualty, safety and effcacy are applcable for both mported and locally manufactured products. 2.2 DANGEROUS DRUGS ACT The Dangerous Drugs Act allows for the montorng and control aganst the llct use of specfc narcotc drugs such as cocane and morphne and psychotropc substances such as ganja (marjuana). 2.3 PRECURSOR CHEMICALS ACT The Precursor Chemcals Act provdes for the montorng and control of precursor chemcals and other chemcal substances used or capable of beng used n any form of llct operatons nvolvng narcotc drugs and psychotropc substances or other substances havng a smlar effect. 4

7 moh standards & regulatons.qxp 01/05/ :58 PM Page NURSING HOME ACT The Nursng Home Act ensures regstraton and the proper operaton of nursng homes and other facltes named n the Act such as maternty homes. The Act defnes a nursng home as any premses used or ntended to be used to provde nursng for ndvduals affected by any sckness, njury or nfrmty but does not nclude hosptals or other premses operated or controlled by a government department. 2.5 BREACHES AND PENALTIES The laws specfy the breaches and penaltes or fnes applcable for contraventon. They are amended from tme to tme so as to keep pace wth current needs. They are avalable from the Jamaca Prntng Servce, Duke Street, Kngston, or may be accessed from the Mnstry s webste at 5

8 moh standards & regulatons.qxp 01/05/ :58 PM Page 6 CHAPTER 3 STRUCTURE AND FUNCTIONS OF THE STANDARDS DIVISION 3.0 STAFFING A team of techncal experts comprsng varous sklls executes the day-to-day actvtes of the Standards and Regulaton Dvson and a Drector gudes each secton.an Admnstrator, fve secretares and a clerk provde admnstratve and clercal support.techncal postons nclude: v v v v v Fve Drug Inspectors One Chef Drugs Inspector One Chef Dangerous Drugs Inspector Two Scentfc Offcers Two Senor Investgators A Regstrar for Insttutons and Facltes One Montorng Offcer One Qualty Assurance Coordnator 3.1 PRINCIPAL SECTIONS AND THEIR FUNCTIONS The prncpal functons of the sectons are summarzed hereunder: Standards & Regulaton - Admnstraton Ths secton: v v v Mantans an effectve regulatory framework wthn whch to operate Mantans an effcent clent satsfacton mechansm Identfes gaps /weaknesses n exstng legslaton and seek amendment to be n keepng wth current needs Montors health care standards Establshes and mantan consultatve mechansms Ensures effectve functonng of the Advsory Panels 6

9 moh standards & regulatons.qxp 01/05/ :58 PM Page 7 v Mantans crtcal lnks wth the Regonal Health Authortes to ensure qualty servce delvery Investgaton & Enforcement Ths secton: v v v v Mantans an effcent clent satsfacton mechansm Conducts nvestgatons and carry out health related audts Plans systems to mpose fnes and penaltes Develops framework for confdentalty Educates clents and servce delvery personnel Coordnates functonng of Medco-Legal Advsory Panel Montors complants wth a vew to tmely resoluton Pharmaceutcal & Regulatory Affars Ths secton v v v v v Ensures the safety, effcacy and qualty of products avalable on the Jamacan market through effectve drug regstraton and mport permt approval systems. Mantans an effcent system for the regstraton/approval for drugs and other desgnated products Montors crtcal drugs and other medcal supples to ensure ther avalablty n support of an effcent pharmaceutcal servce n the health system. Promotes Ratonal Drug Use n hosptals and other health nsttutons Mantans an effcent system of Regstraton for Nursng Homes and other health facltes Montors Nursng Homes and other health facltes for complance wth standards and gudelnes Montors pharmaceutcals already on the market through post market survellance Mantans an effectve mechansm for collaboraton wth the 7

10 moh standards & regulatons.qxp 01/05/ :58 PM Page 8 Customs Department and other relevant government agences for the proper montorng and control of the desgnated products mported for use by the Jamacan publc Standards Research and Development Ths secton carres out the followng actvtes: v v Standards Development Revews and update exstng Standards Researches/develops new standards and audt nstruments as needed; Coordnates actvtes of Complementary/Alternate Medcne Advsory Panel Mantans effectve Qualty Assurance systems 8

11 moh standards & regulatons.qxp 01/05/ :58 PM Page 9 CHAPTER 4 DRUG REGISTRATION CENTRE 4.0 REGULATORY FUNCTIONS The Regstraton of drugs s a major regulatory functon executed through the Pharmaceutcal & Regulatory Affars Department. It nvolves n-depth scentfc evaluaton of the techncal documentaton submtted n support of the regstraton of a drug or other related product. It s one of the prmary mechansms through whch the qualty, safety and effcacy of drugs, and other products mentoned n the Food and Drugs Act and Regulatons are ensured. 4.1 DRUG DEFINITION Drug refers to any substance that conforms to the defnton prescrbed by the Act. Such substances generally requre regstraton and nclude drugs, herbal preparatons and some vtamns. Regstraton may also be requred for any cosmetc, food or devce makng therapeutc clams. In nstances where products are deemed safe enough to be placed on the market wthout formal regstraton, the Mnstry of Health grants a wrtten approval. Once regstered or approved, products are allowed mportaton by way of permts granted by the Mnstry through the department. 4.2 REGISTRATION PROCESS The regstraton process may be summarzed as follows: Submsson of the dosser for revew Revew and approval/refusal Issuance of a Lcence/Letter of refusal 4.3 REQUIREMENTS FOR REGISTRATION The requrements for regstraton are outlned n the Food & Drugs Regulatons. The method for the submsson of the requste documentaton and subsequent assessment and evaluaton s as follows: 9

12 moh standards & regulatons.qxp 01/05/ :58 PM Page 10 A Dosser n the Englsh Language (or authentcated translaton) bound n hard cover and correctly ndexed, contanng nformaton for assessment purposes should be prepared for submsson (see lst of requrements at Appendx 1). The Dosser may comprse one or more volumes. All tems n the lst of requrements ncludng fees should be submtted at the same tme to the Pharmaceutcal and Regulatory Affars Department. Completed documentaton only s accepted. Separate lsts exst for: New drug regstraton (See Appendx 1) Herbal product regstraton (See Appendx 2) v v An appontment should be made wth a Scentfc Offcer n the Pharmaceutcal & Regulatory Affars Department for the ntal dosser revew. Once accepted, dossers are further subject to scentfc evaluaton by the Product Regstraton Commttee. The Commttee conssts of a wde cross-secton of scentsts and offcally meets once every month. Offcal Regstraton Lead Tmes are as follows: New drugs One Hundred and Twenty Days (120) Generc drugs, drug lne extensons, herbal products and regsterable vtamns Nnety Days (90) Drugs used n the treatment of lfe threatenng llnesses such as Cancer and HIV/AIDS Sxty Days (60) Me Too s Sxty Days (60) Products for lterature revew only (regstraton not requred) Thrty Days (30) v Durng the evaluatve process the commttee may recommend that: A product be referred for expert clncal consults; The clent be requested to provde addtonal nformaton n support of clams made or to facltate complete evaluaton; The product s sent for testng at relevant laboratores to 10

13 moh standards & regulatons.qxp 01/05/ :58 PM Page 11 further valdate data submtted. In nstances such as those ndcated above lead tmes may be affected. v v x Followng the revew clents are advsed n wrtng whether regstraton has been approved or refused. If refused, reasons for refusal are stated. The Standards and Regulaton Dvson ssues a Pharmaceutcal Product Lcence for all regstered products. An offcal Letter of Approval s ssued wthn thrty (30) days for products for whch regstraton as a drug s not requred but for whch assessment s necessary. 11

14 moh standards & regulatons.qxp 01/05/ :58 PM Page 12 CHAPTER 5 PERMIT APPROVAL CENTRE 5.0 IMPORTATION OF FOODS,DRUGS AND OTHER DESIGNATED PRODUCTS The permt approval system allows for the mportaton of products regulated under the Food & Drugs Act and Regulatons, the Dangerous Drugs Act and the Precursor Chemcals Act. Such products nclude: v v v All regstered drugs ncludng narcotcs and other controlled drugs Vtamns and herbal preparatons Approved cosmetcs, Medcal devces & Dagnostcs Approved Precursor and Essental chemcals Food addtves, preservatves and foods whch make therapeutc clams Any other product ncludng cosmetc or food for whch the Scentfc Offcer deems a permt necessary for mportaton followng assessment. 5.1 APPLICATION FORM The prescrbed applcaton forms for mportaton are avalable from the Mnstry of Health s Pharmaceutcal and Regulatory Affars Dvson or may be downloaded from the Mnstry s webste at Sample forms are at Appendx 2. For ease of access, the forms are also avalable from Custom Brokers and the The Chef Pharmacst at the Cornwall Regonal Hosptal n Montego Bay. 5.2 VALIDITY OF PERMIT Once approved, permts for controlled substances reman vald for sx (6) months from the date stamped on the form. Permts for all other products have a valdty of twelve (12) months, durng whch partal shpments (often referred to as P.I.P or Part-n-Part) may be transacted. Partal shpments are not allowed for controlled substances. For these tems the permt becomes unusable once a shpment transacton takes place. 5.3 CONTROLLED SUBSTANCES For controlled substances, upon arrval of the goods n the sland, the nvoce must be presented to the Chef Dangerous Drugs Inspector at the Mnstry of Health 12

15 moh standards & regulatons.qxp 01/05/ :58 PM Page 13 for assessment.the Inspector returns the stamped nvoce to the mporter wthn twenty-four hours. The stamped nvoce s then presented to the customs offcer n order to effect clearance from the port of entry. An unprocessed nvoce wll result n delay, as wthout t, clearance of the tem wll not be allowed. For other goods, the nvoces are not requred for clearance. However the Drug Inspector reserves the rght to request that an nvoce be provded n the event t s deemed necessary. 5.4 GUIDELINES FOR IMPORT PERMITS APPLICATION The followng are the gudelnes to apply for mport permts: Applcaton for mport permts should be made on the offcal colour coded applcaton forms as follows: Blue - foods e.g. addtves, preservatves and drugs Pnk - cosmetcs and essental chemcals Yellow psychotropcs substances, narcotcs, precursor chemcals, and any other controlled substance v Once submtted applcatons are processed and can be retreved from the Department wthn twenty-four hours of submsson. If the product s found to be acceptable for mportaton and all the requrements are satsfed, a permt s ssued whch bears an offcal stamp of the Mnstry of Health along wth the sgnature of a Drugs Inspector. Permts for controlled substances are returned wthn seventy-two (72) hours of submsson The approprate colour coded Form should be used as falure to comply wll delay the approval process. Clents are advsed to consult wth the unt f they are unsure whether a product requres permt approval for mportaton or to confrm whch s the approprate Form to use. Applcatons should be submtted and the approved permts bearng the Mnstry s offcal stamp, obtaned from the department before the goods are ordered from the suppler. Ths s to avod breaches under the Food and Drugs Act and the Customs Act. Submsson of an applcaton does not guarantee approval or automatc grantng of the permt. 13

16 moh standards & regulatons.qxp 01/05/ :58 PM Page 14 v Importers are advsed to factor nto ther tme frame for submsson, publc holdays and weekends whch could mpact lead tmes when makng applcatons for permts. 5.5 COMPLETING THE APPLICATION FORM FOR PROCESSING The followng are gudelnes to complete the applcaton form for processng: v The names of the goods to be mported (brand, chemcal/generc name) should be clearly stated n the space provded on the Form. The amount of goods, package sze, unts of the goods should be declared. The completed orgnal permt applcaton form along wth the carbonzed copy should be submtted to the mport permt unt for processng. A maxmum of ten (10) tems are allowed per applcaton. 5.6 IMPORTATION THROUGH THE POST OFFICE For products mported through the Post Offce for whch a permt was not granted, a drug nspector vsts the Post Offce and processes the Parcel Notce ssued by the Post Offce before the products can be released from the post offce. The Parcel Notce should ndcate the nature of the tem(s) beng mported. Ths s valdated by checkng the actual tem(s) beng held. 14

17 moh standards & regulatons.qxp 01/05/ :58 PM Page 15 CHAPTER 6 REQUIREMENTS FOR IMPORTATION OF FOODS & DRUGS 6.0 DRUGS Applcants are advsed to use the Blue Forms (Sample form s at Appendx 3) and to note the followng nstructons. v v v All drugs beng mported should have a vald regstraton wth the Mnstry of Health. Ths means that drugs that have been wthdrawn or recalled from the market may not be mported (see secton- specal permt) The trade and/or generc names, concentraton/strength and pack sze should be clearly stated; Importers of pharmaceutcals for trade purposes should be lcensed by the Pharmacy Councl of Jamaca; The manufacturer and source country should be the same as ndcated n the offcal regstraton records; A certfcate from the Veternary Dvson, Mnstry of Agrculture should accompany applcaton for mportaton of drugs for veternary use. All drugs beng mported should have expraton dates of not less than twelve to eghteen months 6.1 FOODS The Food & Drugs Act and Regulaton provde the categores of foods for whch mport permts are applcable. These nclude food addtves and preservatves, foods makng therapeutc clams and those classfed as detary supplements such as some vtamns, and amno acds. These foods are subject to assessment and ssuance of mport permts pror to mportaton.a Blue Form s used to apply.the requrements for assessment nclude: A Certfcate of analyss on the batch beng mported from the manufacturer 15

18 moh standards & regulatons.qxp 01/05/ :58 PM Page 16 The European Commsson (EC) or Fragrances & Essental Manufacturers Assocaton (FEMA) numbers where applcable. Any other nformaton on the product deemed necessary by the Drug Inspector to facltate complete assessment. 16

19 moh standards & regulatons.qxp 01/05/ :58 PM Page 17 CHAPTER 7 IMPORTATION OF CHEMICALS, RAW MATERIALS AND COSMETICS 7.0 GUIDELINES FOR IMPORTATION Applcants should use the Pnk Form and provde the followng: The chemcal names and brand names (where applcable) of the products should be clearly ndcated. Clents are advsed not to descrbe products usng assgned product numbers e.g. European Commsson or FEMA number. Materal safety data sheets or other techncal nformaton on the product should accompany the applcatons for chemcals for whch permsson for mportaton s beng sought for the frst tme. A Scentfc Offcer should assess cosmetcs beng mported for the frst tme before the permt applcaton s made. For assessment the followng are requred: Fve samples of the form n whch the cosmetc s to be marketed Fve labels n the fnshed form A Certfcate of Analyss on a recent batch from the manufacturer A Free Sale Certfcate from the Competent Authorty n the country n whch the cosmetc s made Any other documentaton deemed necessary for assessment by the Scentfc Offcer A lead-tme of fourteen to twenty workng days should be allowed dependng on the nature of the submsson. v If the cosmetc s determned to be acceptable the permt applcaton s made n the manner descrbed above on the Pnk Permt Form (Sample form s at Appendx 4). 17

20 moh standards & regulatons.qxp 01/05/ :58 PM Page 18 CHAPTER 8 IMPORTATION OF CONTROLLED SUBSTANCES PSYCHOTROPIC SUBSTANCES, NARCOTICS, PRECURSOR AND ESSENTIAL CHEMICALS 8.0 GENERAL INFORMATION Applcants should note the followng nformaton: v v v v Controlled substances nclude Narcotcs, Psychotropc Substances, Precursor and Essental (dual purpose) Chemcals The yellow form s used for applcatons for permts to mport these substances (Sample form s at Appendx 5). Applcatons for each controlled substance should be made on a separate applcaton form. Permts for Narcotc and Psychotropc Substances are ssued wthn 72 hours after recept of the applcatons. Permts for controlled substances are vald for sx (6) months only from the date of approval. Part-In-Part (PIP) shpments of these goods are not permtted. On arrval of the goods, the permt accompaned by the orgnal nvoce and a copy must be re-submtted for processng pror to submsson at Customs for clearance. 8.1 GUIDELINES FOR THE IMPORTATION OF NARCOTICS A wrtten request seekng permsson to mport the desred substance(s) should accompany the yellow applcaton form. These are submtted to the Chef Dangerous Drugs Inspector - Pharmaceutcal & Regulatory Affars Department. The wrtten request should nclude the followng: The name and address of the overseas manufacturer and suppler 18

21 moh standards & regulatons.qxp 01/05/ :58 PM Page 19 The name of product(s), concentraton and desred quanttes The sgnature of the company pharmacst/researcher. The purpose for whch mportaton s requred. v Import permts for these substances are accompaned by specfc documents, namely Form A and Form C. These are prepared and ssued by the Chef Dangerous Drugs Inspector, Pharmaceutcal and Regulatory Affars.Form A s to be sent to the overseas suppler and Form C should be presented to the Customs Department along wth the permt on the Yellow form on arrval of the goods. Internatonal Control For the nternatonal control of narcotc substances, all such shpments MUST arrve n the mportng country (e.g. Jamaca) before December 31. In vew of ths, submssons for the mportaton of Narcotc substances nto Jamaca are not accommodated after the 30th of September each calendar year. All mporters of the above substances must be authorsed to conduct actvtes relatng to the substances e.g. storage and handlng. 8.2 IMPORTATION OF NARCOTICS FOR PERSONAL USE A specal permt must be prepared for the Jamacan Customs. The followng nformaton s requred for ts preparaton: v A letter from the patent s physcan statng the name of the patent and the treatment prescrbed (name, strength, quantty to last for duraton of stay) Flght detals (dates and tmes of arrval and departure, flght numbers, ports of dsembarkaton and embarkaton Address of the patent whle n Jamaca A contact number/facsmle number of the physcan and/or patent. 19

22 moh standards & regulatons.qxp 01/05/ :58 PM Page PSYCHOTROPIC SUBSTANCES A wrtten request seekng permsson to mport the desred substance(s) should accompany the completed yellow applcaton form. These are submtted to the Chef Dangerous Drugs Inspector - Pharmaceutcal & Regulatory Affars Department. The request should nclude the followng: the name and address of the overseas manufacturer and suppler the name of product(s), concentraton and desred quanttes the sgnature of the company pharmacst/researcher. The letter of request for the psychotropc substances must clearly state that the tems are for the local market and wll not be re-exported Controlled Drug Permt A Controlled Drug Permt s prepared and ssued by the Chef Dangerous Drugs Inspector n conjuncton wth the permt on the yellow form. The Controlled Drug Permt when collected by the mporter should be forwarded to the overseas suppler. 20

23 moh standards & regulatons.qxp 01/05/ :58 PM Page PRECURSORS AND ESSENTIAL CHEMICALS These chemcals are mplcated n the manufacture of llct drugs. The relevant substances are lsted below: Precursor Chemcals Essental Chemcals N-acetylanthranlc acd and ts salts Ammona, Ammonum Hydroxde Ergotamne Acetc acd Ergometrne Acetc Anhydrde Ephedrne Acetone Isosafrole Benzene Safrole Ethyl Ether Lysergc acd (LSD) Ethyl alcohol (Ethanol) 3,4-methylenedoxyphenyl-1,2-propanone Hexane Pperonal Hydrochlorc Acd Pperdne Isopropanol (IPA) Pseudoephedrne Methylene Chlorde Phenylpropanolamne Methyl Ethyl Ketone (MEK) 1-Phenyl-2-propanone (PCP) Methyl Isobutyl Ketone (MIBK) Potassum Carbonate Potassum Permanganate Phenyl Acetc acd and ts salts Sulphurc Acd Sodum Hydroxde Sodum Carbonate Sodum Sulphate Toluene Xylene NB. Each completed yellow form should have only one chemcal. 21

24 moh standards & regulatons.qxp 01/05/ :58 PM Page RECORDS The Chef Dangerous Drugs Inspector retans for nspecton all records nclusve of nvoces pertanng to sale/purchases as well as manufacturng records of controlled substances. 8.6 EXPLANATORY NOTES These notes are ncluded for emphass n an effort to facltate users Notces of Detenton The Customs Department ssues Notces of Detenton n nstances where pharmaceutcals, food addtves and chemcals or any other product regulated under the Acts and Regulatons arrve n the sland wthout the relevant permt n place. These notces are ssued for goods ntended for tradng as well as for personal purposes. They are to be presented to an Offcer n the Pharmaceutcal & Regulatory Affars Department. If approved by the Department, the goods may be cleared from the port of entry on presentaton to the Customs Offcer. It s to be noted that approval for clearance from the ports s not automatc. Goods not approved may be sezed for destructon or the mporter may be allowed to return them to the Sender. The type of Notce ssued vares wth the pont of detenton as follows: Fees for servce Arway Bll Arport Parcel notce Parcel Post Offce Detenton notce Arport Or Seaport There s a charge for the processng of each applcaton of ten (10) tems. Ths fee s nstructed by the Food & Drug Regulatons and may be amended from tme to tme as allowed by the legslaton Valdty of Permt Lfe A perod of one (1) year s allowed for the mportaton of goods approved on the Blue and Pnk applcaton forms. Sx (6) months are allowed for 22

25 moh standards & regulatons.qxp 01/05/ :58 PM Page 23 goods approved on the Yellow form Pack Sze: Unt Ths s the weght or volume of each unt of tem beng mported. Ths s the total amount of each tem beng mported / e.g. 500ml; 2kg; 16oz; 5 gallon Name of Item on Permt Ths should nclude, (where applcable) the chemcal nomenclature, class or category of the tem Specal Permts Drugs that are not regstered but are requred for optmal patent care (human/anmal) may be mported on a specal permt. Ths s ssued on the submsson of the applcaton along wth a letter and prescrpton from the attendng Practtoner. The letter should ndcate the name of the patent, the medcal condton(s), and the desred therapy. It should be forwarded to the Drector, Pharmaceutcal & Regulatory Affars Department (PRAD) Amendment to Permts An mporter may wsh to amend the permt applcaton after t has been submtted approved and returned. The request for change may be allowed based on the crcumstance. In such nstances the followng documents should be submtted: Letter from the mporter statng the problem. The orgnal permt. Invoces of current shpment and for quanttes already mported (f t s part of a shpment) 23

26 moh standards & regulatons.qxp 01/05/ :58 PM Page CONTACT INFORMATION For further nformaton please contact: The Drector Standards & Regulaton Dvson Mnstry of Health 2-4 Kngs Street Kngston Tel: (876) , Fax: (876) webste: 24

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