Professional Documents
Culture Documents
The are 5 types of Malaysian Pharmacy Legislations. It consist of 5 Main Acts and several regulation made under each Act. Each Act stand by itself and are specific in its own way and control. Certain requirement can be different or overlapping between the Acts but the public have to satisfy and abide to the requirement of every Act.
ORDINANCE
Laws before Merdeka Day For Federal they are called
ORDINANCE
For State they are known as
ENACTMENT
ACT (AKTA)
Laws after Merdeka Day Written Laws
REGULATION
Subsidiary Legislation Form a subsidiary to the Act with the criteria of supervisional Regulation only need to be approved by the Minister who will be empowered by the Parent Act. Do not go to Parliament for approval
GUIDELINES
More for the purpose of Administrative Mostly no legal standing May have legal implication when the Parent Act or the regulations have provision for certain bodies to issues guidelines ***eg. The DCA who are promulgated under the Control of Drug and Cosmetic Regulations is given power under Regulations 20(1), 22.
AKTA UBAT (IKLAN DAN PENJUALAN) 1956 MEDICINE (ADVETISMENT & SALE) ACT 1956
SECTION 2
Advertisment
Definition; *advertisment includes any notice, circular, report, comentary, pemphlet, label, wrapper or other document or any announcement made orally or by any means of producing or transmitting light or sound; * the inclusive definition of advertisment means that it take into consideration the traditional meaning (as in the dictionaries) of and advertisment and it include..............
PRODUCT
TREATMENT
SECTION 3
Prohibition of advertisment relating to certain diseases. Paragraph 3(1)(a) prohibition of advertisment relating to diseases in Schedule Paragraph 3(1)(b) prohibition of advertisment relating to contraception among human beings Paragraph 3(1)(c) prohibition of advertisment relating to improving condition or function of human kidney, heart, sexual function or sexual performance of human Paragraph 3(1)(d) prohibition of advertisment relating to diagnosis of disease as specified in schedule
Subsection 3(1A); give power to the minister to amend the schedule Subsection 3(2) give examption for such prohibited advertisment ion the manner so far as was reasonably necessary to bring to the notice of person of the following classes; * - public or local authorities * public hospital governing bodies * registered medical practitioners * registered dentist * registered nurses and midwives * registered Pharmacist, Chemist or * poison licence holder * person undergoing training
SECTION 4
Prohibition of advertisment relating to abortion this section relates to advertisment for article used for procuring the miscarriage of woman
SECTION 4A
This section prohibit advertisment relating to skill or service Paragraph 4A(a) refer to skill or service relating to treatment, prevention or diagnosis of disease, injury, infirmity or condition effecting the human body Paragraph 4A(b) added that the advertisment which is capable of inducing, contain an invitation to any person to seek the advive of the advertiser or any person referred to in the advertisment Paragraph 4A(aa) is an examption for advertisment of such nature by pfofessional body Paragraph 4A(bb) approval from MAB needed for such advertisment for private hosp., clinic, radiology or lab.
SECTION 4B
Avertisment of medicines to be approved by the Medicines Advertisment Board (MAB) established by the Minister This approval given by the MAB do not include the advertisment of medicine for the treatment and prevention the diseases listed under the Schedule (because those in the schedule are totaly prohibited for layman advertisment) Subsection 4 (2) stated that the advertisment to be publish have to be submitted to MAB in the manner as regulated
Subsection 5(3) provide a defence for the person charge to prove; * - paragraph 5(3)(a) to prove that he do * not know and had no reason to * believe that he was taking part in the * publication * paragraph 5(3)(b) to prove that the * advertisment was publish only in a * publication of technical character * intended for professional circulation
SECTIONS 6
Disclosure of composition of medicines Such information have to be written in English or national language and clearly legible Information includes ingredient, quantity, poison (as in the Poison Act 1952 and its regulations), ..........
SECTION 6B
Power of Officer to investigate offences under the Act Power of officer with the cooperation of the court to secure attendance of witness for the purpose of investigation
SECTION 6C
Examination of witness Recording statement of who ever is acquainted with the fact and circumstances of the case Proviso for caution and the right of the person investigated upon
SECTION 6D
Power of officer to enter, search and examine premises related with the offence under the Act power of officer to inspect, remove, detain any related item with the offence under the Act.
SECTION 6E
Penalty for obstructing or impeding an authorised officer
SECTION 6F
Sanction by the Public Prosecutor before a case under this Act can be taken to court Authorised Officer to conduct prosecution
SEC. 7:
Regulation to establish MAB Manner of submitting advertisment for approval under Sec. 4A and 4B Procedure to be followed by the MAB Manner of appeal against the dicision of MAB
ANY QUESTION?
An act to regulate the importation, possession, manufacture, compounding, storage, transport, sale and use of poisons. This Act apply throught Malaysia
PREAMBLE
Generally
For over 40 years this Act and its regulations provided the chief source of law relating to the sale and supply of medicines and other chemicals. A Poison Board was created under the Act, to advice the Health Minister on substances to be controlled and various restriction to be imposed upon. The expression Poison was defined as any substance specified by name in the first column of the poison list order under the Act.
The Health Minister after consultation with the Poison Board has power to amend or vary the Poison List. However some of the substances listed as poison were not really toxic but were included in the List because there were no other means of controlling their distribution and use. The poison Act only allow a licensed Pharmacist to deal in all the substances listed in the poison list where this include importation, possession for sale, manufacture, compounding and retailing. A registered Medical Practitioner, registered Dentist are allowed to use the substances in the poison list for their own particular patient treatment only.
A veterinary Doctor is allow to use the same substances for animal treatment. There are several Regulations being made under this Act to supervise matters pertaining to Poison.
The Poison Regulation 1952, regulate the matters pertaining to importation, storage, supply, transport, labelling, recording, colouring of poison and provide a special provisions relating to manufacture, import, sale and possession of Lead Tetra Ethyl. The Poison (Sodium Hydroxide) Regulations 1952 regulate the purchase, store and use of NaOH. The Poison (Exemption) Regulation 1980 allow the Minister to issue an exemption to persons who in the course of his work use Part II Poisons in substantial quantity. An authorization may be granted subject to restrictions and conditions as may be specified.
Regulations
The Poisons (Psychotropic Substances) Regulation 1989 is an outcome of the signing of the Single Convention on Psychotropic Substances 1971. After becoming a signatory to the said convention there seem to be a need to regulate a more standardise control tuned towards the convention. This Regulation regulate the possession, import and export, sale and supply, purchase and use, administration, dispensing, compounding mixing and manufacturing, storage, disposal and labelling of Psychotropic Substances.
Part I Poisons are Group A, B, C, D, E and F Poison as specified in the Poison List Order Part II Poison are those substances listed under the Part II column of the Poison List Order. dispensed medicine means a medicine supplied by a registered medical practitioner, registered dentist or veterinary surgeon under and in accordance with sec. 19 or supplied, for the purpose of medical, dental or animal treatment, of a particular individual by a licensed pharmacist on the premises specified in his licence;
The Act define the term possession for sale as to also include having in possession knowing that the article possessed is likely to be sold or expose for sale. Sell or Sale, include barter, offering or attempting to sell in the traditional meaning as sell or sale. definition of supply include the supply of commercial sample and dispense med. but it does not include the direct administration by or under the immediate supervision of a reg. med. practitioner or reg. dentist to his patient in the course of that patient treatment.
Wholesale, the meaning of wholesale in this Act is, a sale to a person who intent to sell again and any sale by a wholesaler authorised under this Act.
Section 3 laid out the establishment of the poisons Board, appointment of member of the Board, who to be appointed and from which office. Section provide that the Board may regulate its own procedure and action. The Board must advice the Minister on matter concerning poisons and this is also provided under section 6 where the Minister have to consult the Board before amending or varying the Poison List Order and section 7 where the Minister can exempt any substance or preparation and put them in the Second schedule after consultation with the Poisons Board
All members other than the ex-officio member shall hold office for a period of three years and the can be reappointed by the Minister. The Minister may also appoint a similar qualified person to be a temporary member during illness or absence from Malaysia of any member other than the Ex-officio member. Four members including the Chairman or member presiding shall form a quorum. Section 5(2) provides the procedure of the Board cannot be question on the ground of vacancy in membership, constitution of the Board or omission, defect or irregularities in procedure not effecting the merits of the case.
The Minister may from time to time amend by adding, removing, reinstating, transferring or including in any column of the Poisons List. The Minister have to consult the Poison Board Before amending this List and all the amendment have to be gazetted by notification in an Order. Amendment also include the exemption of any preparation or amendment of any definition of any poison in the Poisons List. (Sec.6)
Section 9 prohibit the sale, supply, keeping or having in possession or having under control or store any poison, not in accordance with any regulation made relating to the possession, containers, packaging, labelling or storing. This section in general make it an offence for infringing any of the regulations pertaining to packaging, labelling and storing as set out in the Poison Regulation 1952. This regulation regulates these matter as follows;
*Poison shall be stored in container impervious to the poison and sufficiently stout to prevent leakage (r. 5) *Regulation 6 further regulate the manner that poisons have to be stored where it have to separated from non poison, distinguishable from other preparation interm of container and kept under lock and key. There is also a proviso under regulation 6 where it allows the storage of poisons in dispensary, retail shop or premises to be kept in a part of the premises which partition or separated from the remainder of the premises and to which customer are not permitted access. * Regulation 9 regulate that the poison have to be labelled with the accepted name of the poison as in the Poisons List or as specify by British Pharmacopoeia or British Pharmaceutical Codex and have to also be labelled with the word "Poison" in red or red background. Exemption is give for smaller packing such as ampoule or cachet if the next larger packing have been labelled as such (r. 9(4). Labelling requirement will be more specific for specific types of Poison (Part I or
Transportation of Poison
Poisons have to be transported in accordance with regulation made under this Act (s. 10). The Poison Regulation set that the poison which are to be transported have to be;
* pack in such a way to avoid leakage (r.8(1)) * to be labelled with the name of the poison and to follow all the labelling requirement as being mention in any of the regulation made under this Act (r. *(2)) * to be transported on a vehicle separately from food to avoid contamination (r. 8(3))
This section also set out that any person doing Compounding, Dispensing or Mixing have to do them in accordance to the regulations made under this Act.
All Poison sold, supplied or administered by the these professional man have to be done by them or under their immediate supervision.
(d) to an estate manager or person on his behalf, where this sale is for the purpose of estate hospital where it become the responsible of the estate manager (e) to a professional person or tradesman for their own use and not for resale, for example the sale of Theophylline to a tradesman for the use in the industry dealing with polishing (f) to a registered medical practitioner, registered dentist and registered veterinary surgeon for treatment of their own patient only (g) to licensed Pharmacist for wholesale or for retail (h) to a Government Department, Local Authorities or Public Body (i) to any treatment institution run by government, public fund or a charity body (j) to any institute concern with scientific education and research such as the Universities
Section 15(3) goes further into identifying the requirement on documentation and recording for wholesale sale.
A Wholesaler should keep a wholesale record book where he should enter the particular such as name and address of the purchaser, date of sale, name and quantity of the poison sold and the purpose A wholesaler can only deliver any poison after receiving a sign order (SO) from the purchaser, the SO have to be retain by the seller and a reference of the fail in which the SO is retained is entered in the earlier mention record book in place of the purchaser signature. If a poison is needed urgently and its SO cant be procured the seller can deliver the poison after entry in the record book stating the reason along with all the other particulars mention earlier. In such cases the poison Act required the SO in respect of such sale to be obtain by the seller within 7 days after the date of the delivery (15(3)).
The format of the poison wholesale sale record book is prescribed in Form A of the First Schedule in the Poison Regulations 1952 (r. 26(1).
Priscibtion book (s. 24) is kept for the sale of poison by filling up priscribtion (s. 21) or for recording the dispensing of any poison as a "dispense medicine" or an ingredient in a dispensed medicine (r. 12), (s. 22). Poison book is kept for recording those poison which are Group D poison and not a dispense medicine or any ingredient in a dispensed medicines (s 23(2)). The format for the poison book is being prescribed in the First Schedule, Form A. (r. 26(2)) .
Section 20 of the Act stated that Group A Poisons shall be sold or supply by wholesale or retail by a licensed wholesaler to a licensed Pharmacist or another licensed Wholesaler or to be exported to a purchaser outside Malaysia. The retail of Group A Poison is allowed for other purpose except for medical treatment where the medical practitioners, the dentist or the veterinary surgeon are not allowed to prescribed Group A Poison for the purpose of treatment.
The Act also allows licensed Pharmacist to supply Group B Poisons as a "dispensed medicine" and in accordance with a priscribtion Subsection 21(6) allow the supply of Group B Poison by a licensed Pharmacist without a priscibtion for urgent treatment upon request from a medical practitioner who is personally known to him by verble or telephone. He can dispense it by first recording in the priscribtion book and the priscribtion have follow within one day of the sale or supply. This Act regulate that both the medical practitoner and the Pharmacist are responsible to ensure that this requirement is followed.
If in this case the purchaser are not present to sign on the poison book the he has to send a written sign order before the delivery can be made. The Written sign order have to be kept in a file and the reference to it shall be use to replace the purchaser signiture. If a Group D poison is needed urgenly and and it is impossible to obtain the signature or its sign order can be procured the seller can deliver the poison after entery in the poison book stating the reason of his action. In such cases the poison Act required the sign order in respect of such sale to be obtain by the saler within seven days after the date of the delivery (s. 23(3))
Part II Poison might be dangerous if their handling such as storage, transport and labelling are not control. So those tradesman who handle such poisons have to be licensed so that the requirement of this Act and its Regulation are being followed and can be enforce on them. Any one who want to sell or supply a Part II poisons have to be licensed (s. 25) under these Act. These applicant can apply for either Type D License (to store and sell) where the name of poison they can dealt with will stated in this license or a Type E Licensed which is more specific for importation, storing and use Sodium Hydroxide.
Acethylating Substances are also listed under the custom prohibition list and their importation need to be authorised by the Ministry of Health through the issuence of Authorisation Permit (AP). The penalty for infringing the control of acethylating substances under this Act is very severe. An offender shall be liable to be imprisoned for a term not exceeding fourteen years and not less than three years, and shall also be punished with whipping of not less than six strokes (s. 14(3)). Any person charged for this offence concerning acethylating substances shall not be granted bail (s. 14(4)).
Regulation 19 restrict the import, sale or have in possession of ethyl petrol containing more than 1/150 in proportion of lead tetraethyl with the following conditions;
for the used in aircraft or any other purpose authorised by the Director of Medical services; such ethyl petrol have to be distinctively coloured inaccodance with a British Standard (r. 19); all container and appliances use in dealing with such ethyl petrol have to be conspicously and distinctively labelled or marked with the words "This spirit contains LEAD to be used for aircraft or motor fuel only" in English, Malay, Chinese and Tamil.
Regulation 16 to 22 of the Poison Regulation 1952 is very specific for lead tetraethyl and regulation 22 exempt all other requirement (other than regulation 16 to 22) of the Act or Regulation relating to import, possession, sale, supply, packing, storage, transport, colouring or labelling of poisons to be applicable on lead tetraethyl.
This Licence is only issued to registered Pharmacist. It allows the Pharmacist to deal in all poisons. In general it allows poisons to be imported, stored and sold. In term of sale this licence can be specific for wholesale only, retail only or for both wholesale or retail depending on the application made by the pharmacist to the licensing officer.
Type A Licence
Type B Licence
This licence is issued to any person the Licensing Officer may consider to be fit and proper person to hold such licence, or issued to a responsible officer of a company incorperated under the Companies Act 1965. This type B licence allows a person to import, store and sell by wholesale only such poison as may be specified in the licence. This licence is restricted only in dealing on specific poisons excluding the Group A poison. The Poison Act also have proviso which do not allow this type B licence to be issued to any person or officer who is engaged or concern in selling goods by retail.
Type C Licence
The Licensing Officer is issued to listed seller a Type C Licence when there is no pharmacist in within a local authority licensed to carry on a business in such area. This license will allow the listed seller to sell by retail and store Group F poisons. As the number of licensed pharmacist increase tremendously the Poison Board view that they should up grade all Group F poisons. Untill 1989 there is no more Group F poison in the Poison List so there is no more Type C licence issued by the Licensing Officer.
Type D Licence
This licence is issued to any person whom the licensing may consider to be fit and proper to hold such license to store and sell by retail such Part II Poisons as may be specified(ususlly after an inspection of the applicant premise by the enforcement officer to acertain that the applicant and their premises are fit to handler such poison in term of storage and safety)
Type E Licence
This licence is for any person who uses Sodium Hydroxide in the course of his business in a substantial quantity where this licence allows the holder to import, store and use. The enforcement unit of the state will have to ensure that the person and the premises is fit and proper for such activity before this licence can be considered by the Licensing Officer.
General: on license
All the format of licences are prescribed by the Act Licensing Officer have freedom to instate terms and condition in every licence where he deem it is fit, proper and which are not inconsistent with this Act or its Regulations. If the terms and condition stated in the licence is not aggreable by the applicant, the applicant can appeal to the minister (s. 26(3) and 26(4)). All licence is personal to the licensee named in the licence and are not tranferable. The person named in the licence have to be responsible for authorising any sale of the poison and any dealing in such poison have to be personally supervised by him.
Each licence is specific to the premise where the addresses are stated in the lic. Any change of add. have to be made by application to the Licensing Officer and he will amend the address as he see fit (s. 26(6). Section 26(5) give powers to the Licensing Officer to refuse issuance any such licence or he may may cancel a licence that had been issued. Anybody aggrieved by such action may appeal to the Minister. The Minister decision on the appeal shall be final All licensed shall be numbered by the State consecutively in respect of each type and of year in which it was issued and commencing each year with the number one. A Register recording all the particular of each lic. and records any event on cancellation or amendment have to be kept for all licence issued by the Licensing Officer of every State. This register shall be accepted in any court case as a prima facie evidence (s. 27). The Director General of Health shall publish the name of all licence holder in a Gazette annually in about the month of February each year. This Government Gazette shall also be prima facie evidence in any court proceeding (s. 28).
Power to investigate
A DEO is given the power to investigate under section 31(2). Power in oral examination of any body acquinted with the fact and circumstances of the case is also given (s. 31(3)) where it means that they are given the power to record statement of witnesses and the acused. Section 31(4), (5), and (6) laid the the caution involve in taking the statement.
Power to inspect, detain, remove any item reasonably related to the case. A DEO may search, inspect, detain and remove any
substance reasonably believed to be a poison, book, document, equipment, instrument, material or any other article found in any premises in his opinion may furnish evidence (s. 31(8)). Under this section the DEO is also given the power to detain any person foun in such premises untill the DEO finishes his search. Section 31(10) provide that it is an offence for any person to obstruct or impedes a DOE in the performance of his duties under this Act
Section 32 goes further into specifiying the liability of body corporate, its officers and directors to be charge jointly under this Act and the officer or directors are deem to be guilty the same untill they can prove to the court that they have no knowledge what so ever or they have taken precaution to stop the offence from being commited (s. 32(3)(4)). Section 32(5) any poison related to the case in which an offence under this Act has been committed shall be forfieted and delivered to the Director General of Health for disposal. Section 33 provide that the Sessions Court or a First Class Mejistrate Court in West Malaysia or a Sessions Court in the East Malaysia Shall have full jurisdiction over offences against this Act. Prosecution instituted under this Act or its regulations shall need to be sanction by the Public Prosecutor and the prosecutor can be a registered Pharmacist in the public service authorised in writting by the Public Prosecutor (s. 34).
Regulations
Section 35 gives power to the Minister to make regulations to carry out the purpose of this Act and these regulations may be in respect or for the purpose related to poisons such as importation, manufacturing, sale, storage, transport, labelling, containers, compounding, dispensing, record, qualification of poison guardian, providing exemption, prescribing form of licences and register, the act of dealing in specific poison such as lead tetraethyl, presccribing penalties for offence againts the regulations and regulate the control of Psychotropics substance.
Third Schedule
This Act define Psychotropic Substances as those listed in Third Schedule of the Act (s. 30(1). The third Schedule listed out all the Psichotropic Substances under the control of this Act. not all psychotropic drugs as classified by way of their Pharmacological action are listed under this Schedule. Those listed are those Psychotropic which have abuse tendencies. The Minister from time to time can vary the Third Schedule by way of Gazzett. Section 30(3) provide that all dealing in Psy. Subst. have to be in accordence with the regulations made under this Act.
Regulation 3 of the Poisons (Psychotropic Substances) Regulation 1989 prohibit any person from possessing Psychotropic Substances unsless such possession is authorised and such Psychotropic Substances is for alawful purpose and is obtained in accordance with this Regulation and Reg. 4(2) listed the person or class of person who shall be authorised to possess Psychotropic Substances and the are as follows;
(a) a licensed Pharmacist (b) a registered Medical Practitioner
(c) a registered Dentist Division 1 (d) a veterinary surgeon (e) a permit holder issued under reg. 15 of this regulation, to purchase and use Psy. Subst. such person can be a game warden or any tradesman who use Psy. Subst. in his trade. (f) a person incharge of any ward, operating theatre or section to posseess Psychtropic Substance for the use of such places. (g) a person who is concern with scintific reaseach or chemical analysis in Uni. or any inst., own by Govt or approve by the Director General of Health (h) a pharmacist in the public service
(i) Custom, police or postal officer in the course of their duty (j) a Drug Enforcement Officer (k) a perso engaged in the delivery of Psychotropic Substances (l) a person whose Psy. Sub. is lawfully supplied by person in (b),(c), or (d) (m) a person acting on behalf of any class of authorised person who lawfully possess (n) a peson possessing psychotropic substsnces to be administered to a patient as directed by person in (b), (c), or (d).
These regulation priscribed the format for import authorization as Form B in the regulations and export authorization as Form C. The fee for import and export Authorization is ahundred ringgit (r.7) Due to the agreement in the Convention, certain pychotropic substances such as the amphetamine, methaqualone, secobarbital and etc. is compulsory to be to followed with an export authorization if they are imported or in transit so reg. 9 was promulgated so that this requirement is followed and a list of such psychotropic substance is listed in Second Schedule of these regulations. All psychotropic substances in transit shall not be tempered with and the packing shall not be change without a written consent of the Licensing Officer.
all pschotripic's priscribtion can only be valid for 90 days. Any Pharmacist dispensing this priscribtion have to endose upon the face of the priscibtion above the prisciber signiture, his full name and address and the date of dispensing. For urgent cases or an emegency upon the request of a medical practitioner, a Dvision 1 dentist or a veterinary surgeon the pharmacist can dispense a one day supply of psychotropic substance to a patient after he have made a record in the psychotropic register and a priscribtion have to follow up immediately the next day. All priscibtion pertaining to psychotropic substances have to be kept for a period of not less than two years.
Regulation 12 provides that a licensed pharmacist or a pharmacist in public services can sell or supply psychotropic substance other than to medical practitioner, dentist or veterinary surgeon for the purpose of treatment. Such sale and supply can be to;
another licensed pharmacist or pharmacist in public service; a person concern with scientific reasearch a person holding a permit under regulation 15, where reading together regulation 14 and 15 we will understant that a permit for purchase and use of pys.subs.may be issued by the Licensing Officer to a profesional person or tradesman for their profession or trade only (for example ) or to an authorised game warden for the use on animals only. to be legally exported to a puchaser outside Malaysia following the procedure in regulation 4.
Giving of Commercial sample are not allowed under regulation 12(2)(a) where there are only allowence for clinical trial sample and the issuence of this clinical trial sample have to be authorised by an import license under The Control Drug and Cosmetic Regulation 1984 Any authorised person under the poison Act or this regulation to purchase psychotropic substances, purchasing an unusually large amount acting in his ordinary course of duty shall be required to give an attestation to the seller before the sale and supply can be made (12(2)(b)).
Regulation 16 provide that only registered medical practitioner, Division 1 dentist or veterinary surgeon or any person directed by them. Regulation 17 stated that only licensed pharmacist or a pharmacist in the public service are allowed to dispense, compound and mix. Reg. 18 provides that only licensed pharmacist and pharmacist in the public service are allowed to manufacture psy. Subst. or any preparation containing psy. Subst. and this manufacturing can be assisted by any other person who are immediately supervise by them.
Register of Psychotropic
The recording of psychotropic provided in regulations 19, 20, 21, 22 and 23 and can be simplified as follows; i) Records of sale and supply for the purpose of treatment (r.19);
a) to keep a register containing
- name strength and quantity sold or supplied - name and address of patient, name and address of reciepient for veterinary
b) a separate register with respect to every types (can be in separate part of the same register or in a separate book) of psy. Subst., for the purpose ofrecording quantity recieved, date, total current stock, name and address of supplier,
ii) Recs of sale & supp other than for the purpose of treat. (r.20);
a) to keep a supply register for Psychotropic, containing
name and address of purchaser date of sale or supply name, strength and quantity of Psychotropic substance intended use of the psychotropic substances by the purchaser.
More on register
Any register of Psychotropic Substances should only be corrected with a marginal note or footnote specifying the date and the correction (r.22(c)). All entery have to be made in cronological order (r.22(d)) register have to be in a bound book (r.23) or any other form approved by the Licensing Officer registers to be preserved for not less than 2 years from the date of last entry.
Reg. 30 laid out the procedure for making the prohibitory order, where;
The Minister shall serve on the person;
a) the term of the proposed order b) the ground on which the order is to be made c) the person right to make a representation in writting within30days
The Minister shall refer any representation made before the aforesaid period to anadvisory committee established under reg.31, where the Fourth Shedule under regulation 31 listed out all the possible member of the advisory committe depending on the profession of the person whom the prohibitory order is to be made. Eg. in the case of a registered Pharmacist the advisory committe shall consist of the Director General of Health, the Director of Pharmaceutical Services, and two registered pharmacist in the public services appointed by the Minister.
Since the tendency of abuse for dangerous drug is very high the dealing of such drug have to be control stringently. As stipulated in the preamble of this Act that it regulate the control of importation , exportation, manufacture, sale and use of dangerous drug, these responsibility lies upon Ministry of Health and form part of the duties, jurisdiction and ministerial power of Minister of Health. The Police and the Custom Department shall focus more on the smuggling, illegal possession, illegal use of dangerous drug in the illegal market.
All importation, exportation and statistic of use on dangerous drug have to be reported to INCB and INCB will study the trend of usage and will sometimes request the competent authority of the member country to comment if they detected an unusual trend in the use of any dangerous drug. The Convention also issued out classification for dangerous drug and how are they dealt with following the agreement in the convention. The member countries can adopt the basic classification in to their regulation to facilitate global harmonised control
The first schedule under the act was further divided into five parts.
Part I of the first schedule consist of raw opium, coca leaves, poppy straw and cannabis. It is very clear that Part I control the raw unprocessed drugs which are not at all use in therapeutic treatment. Possibility of the Ministry of health having jurisdiction for this part is their used in research institution or in the primary pharmaceutical active manufacturing , if not the possession is more of criminal in nature and the police or custom are the enforcement authority.
Part I
Part II
Part II consist of prepared Opium and cannabis resin. These are processed drug but are still in the raw extract state. The control are still the same as those in Part I.
Part III
Part III are made up of the longest list of dangerous drug in the form of chemical active or in the form of content in any dosage form. Most of the Pharmaceutical dosage forms are control under this Part.
Part IV
Part IV listed out ethylmorphin, propoxyphene and most of the morphine derivatives in the codiene groups. The dangerous drugs under this part are also very common in the pharmaceutical preparation or dosage form.
Part IV
Part IV is considered to be the lowest control dangerous. The drug listed in this Part are pharmaceutical preparations. The Act regulates that the items in this part do not need an export authorisation on exportation (more explanation will be given on import and export of dangerous drugs in the coming chapter) .
The following chart depicted below in general explain the guidance and control on importation of Dangerous Drugs
EXPORTING COMPANY
Import Authorization
To release consign -ment upon arrival & declara -tion To export the Drug only after all requirem ent of their competent authority have been fullfilled
The following chart depicted below in general explain the guidance and control on exportation of Dangerous Drugs
COMPETENT AUTHORITY OF THE IMPORTING COUNTRY Issuance of import authorization or/and approval of import authorization
MINISTER (Pharmacy Division as the Competent Authority) Receive a copy of import authorization or approval of import authorization from importing country competent authority
Receive import authorization or/and approval of import authorization from the related Competent Aothority
Receive import authorization or approval of import authorization from the importing company
Both types of manufacturing can only be done with a valid manufacturing license issued by the minister by virtue of Section 16 of the Dangerous Drugs Act 1952and regulation 4, of the Dangerous Drugs Regulations 1952. Reg. 9 - manufacturing in the daily course of retail business
The manufacturing of active Dangerous Drugs as a form of pharmaceutical actives raw material is further regulated by the INCB where Malaysia being the signatory to the Single Narcotic Convention need to send quarterly report to this board on the amount of Dangerous Drug manufactured. Until today Malaysia do not manufacture its own active Dangerous Drugs in the form of pharmaceutical actives raw material. All Malaysian Dangerous Drug raw material are imported.
Reg. 13 - supply by authorised retailer to authorised persons 13(1), conditions to be followed 13(2), In urgent case, SO have to delivered within 24 hrs - an offence punishable ...
Storage, Records of DD
Reg. 9 (2),- dengerous drug to be under lock and key and the authorised person as guardian. Reg. 15(1) & (2)
15(1)(a) - DD Register, in chronological order for every DD for receive and supply (day book) 15(1)(b) - Separate book for every DD - purpose of audit 15(1) c - entry on supply to be made on the same day 15(1)(d) - format for cancellation of record 15(1)(e) - call for information by the DG of Health or the authority
15(2)(a) & (b) - exemption of day book if there is already in existance of prescription book under the Poison Act, Reg. 16 - all records to be kept for 2 years
Form of DD prescription
Reg. 11(2) - set the format for prescription Format for Psy. Subst. Is an improved format from DD prescription.
Dispensing of DD
Reg. 12(1) - validity of prescription
Reg. 12(1)(a) - prescription should comply to format Reg. 12(1)(b) - to ascertain that the prescription is genuine
Reg. 12(2) - Offence section for dispensing of faulty prescription Reg. 12(3) - interval of lapse for supplies Reg. 12(4) - date of dispensing to be noted and completed dispensed prescription to be retained Reg. 12(5) - offence section
DD Licenses
Reg. 18 - Wholesale license Reg. 4 - Manufacturing License
25
sale or sell includes barter and exchange and include offering or attempting to sell or allowing to be sold or exposing for sale or recieving or sending or delivering for sale or having in possession any drug knowingly that the same is likely to be sold or offered or exposed for sale, and refer only for sale for human consumption or use.
SELAIN DARI PENGUATKUASAAN KE ATAS UBAT-UBAT TIDAK BERDAFTAR DAN PELESENAN PERATURAN-PERATURAN KAWALAN DADAH DAN KOSMETIK BOLEH DIKUATKUASAKAN KE ATAS KEHENDAK-KEHENDAK
GMP QA
GMP
QA
GMP
REG. 19; PERSONEL REG. 20; PREMISE REG. 21; EQUIPMENT REG. 22; MANUFACTURING OPERATION REG. 23; QUALITY CONTROL REG. 24; SELF INSPECTIONS REG. 25; RECORDS
PREAMBLE
An Act relating to the establishment of a Pharmacy Board and the registration of Pharmacist It set up Pharmacy Board Registration of Pharmacist as a person Registration of Bodies Corporate
Board means the Pharmacy Board established under sec. 3 of the Act; person does not include abody corporate registered pharmacist means a peson whose name appears for the time being in the register kept under this Act (Section 5)
DEFINITIONS
therapeutic substance means any substance which may be prescribed by the Board for the purpose of this Act, provided that there is written law on therapeutic substance, meaning in such writtern law will be taken;
3(3) the Minister have power to terminate or appoint a replacement for member of the Board who is unable to act or absent for 3 consecutive meetings except ex-officio members (proviso of replacent to follow 3(1) 3(4) safeguard the Action of by the Board when there are defect in the appointment or vacancy
Chairman shall have an original vote and a casting vote The Board shall meet at place and time decided by the President 5 member of the Board will form a quorum
6(2) the Board may also register person holding any other appropriate Pharm. qualification approve by the Minister after consulting the Board or any person practising Pharmacist who applies before 31 Dec 1954 and have been practising for the past 5 years 6(3) no qualification will be entered into the register untill the Registra is satisfied that such qualification is entitled thereto 6(4) person to be registered nedd to attained the age 21
7(1) person not registered under this Act shall no t use the titles Phamaceutical Chemist, Pharmaceutist, Chemist, Druggist, Pharmacist or any thing to implies that the outlet having somebody registered under this Act.
7(2) noting should be use or affix at a premise any title or descibtion to suggest that he or any one employed in the premise possess any qualification on selling, dispensing, or compoundong of drugs or poisons
7(4) contravention of this sec. is an offence 7(3) the use of the words pharmacy or dispensary shall deemed the premise to have aperson registered under this Act. The re is a proviso to allow the use of such terms by a registered medical practitioner or a vet. surg.
Application for registration To be made in such a manner and to be accopanied with such documens, photograph and particulars as may be prescribed for the purpose of satisfactory proof of identity
SEC. 8:
SEC.9:
Power to refuse registration If a person is being guilty of infamous conduct after due inquiry by the Board, admission to the register may be refused.
SEC.10:
Entry of higher education into register Every registered person have the entitlement to insert, add or substitute in the register a higher qualification with prove of achievement.
Issue of certificate of registration After admission to the register the Board may issue a certificate of regitration with a photograph affixed. If the is any condition as mention in Sec 6(2)(c), such condition or restriction will be specified in the certificate.
SEC.11:
13(2) for this purpose the Board have to be satisfied that the bussiness is under the control and management of asuperintendent who is a registered Pharmacist and who does not act at that time in the same capacity for another company 13(3) a certificate of registration will be issued upon registration
13(4) A body coporate registered under this section carrying bussiness as mention in S.13(1) shall; (a) have a superintendent who is a registered pharmacist and who does not act at the same time in a similar capacity for another company to manage and control the body corporate; (b) the business have to be bona fide conducted by the body corporate or by a manager who is also a registered pharmacist under the directive of the superintendent;
(c) his certificate have to be conspicuously exhibited in those premises; (d) the certificate of registration for body coporate or copies shall be conspicuously exhibited in each set of premises. 13(5) a registered body corporate who have complied with S.13(4) under this Act may use the name or title as mention in S.7
13(7) the Board may inquire into a case and may refuse to register or remove from the register a body coporate if; (a) a body corporate is convicted of an offence under this Act or any written law relating to poisons, dangerous drugs or therapiutic substances; or
(b) any officer, director or any person employed by such body corporate is convicted the same or guilty of any misconduct. the body corporate have to satisfies the Board that the act in question was not instigated the body coporate (superintendent, director or manager) and the person guilty is no longer employed.
13(8) the Board can remove the name of the body corporate from the register; (a) when incorrect staetment was given to obtain the registration or it was obtained by fraudulent; (b) when the body corporate cease to carry out the bussiness of keeping, retailing, dispensing,and compounding poisons, dangerous drugs or therapiutic substances
13(9) offence section on contravening this section. 13(10) power of the Board on restoration of registration after its action of removal.
14(1) If a registered Pharmacist dies while carrying a bussiness, any executor, administrator or trustee shall carry on the bussiness and shall entitle to use the tittle in connection to the bussinesss, use by the deceased
14(2) for 14(1) to be applicable, the bussiness must be conducted by a registered pharmacist and his certificate be exhibited in the premises 14(3) If any of the representative have conviction, the Board may inquire into the case and may ceased him from using te title used by the deceased pahrmacist
15(2),(3),(4) are presumption as to prove of registration by the Gazette and the cetificate with the registra and these form conclusive evidence
application have to befollowed by a fee and acertificate will be issued which will last untill the end of such year late renewal of retention certificate will be charge with an extra fee non renewal of retention certificate will cause the name to be removed from the register
17(1) Board may cancel or remove any registered pharmacist from the register if proven that;
(a) there is a fraud in obtaining the registration; (b)there is conviction which render him unfit; (c)guilty of infamous or disgraceful conduct; (d)is deceased; (e)permanently left Malaysia; (f)unsound mind, infirmity which render him unfit.
17(2) Board have jurisdiction in restoring name in the register. 17(3) Board can remove name in the register if there is a breach of restriction or condition.
SEC.22: Board have power to make regulation with the approval of the Minister
pupilage and training examination to be eligible for registration meeting procedure matter required under this Act to be priscribed
registration of body corporate exaemption fron any operation of this Act appointment and payment of legal advisers payment to members of the Board any matter which will be expediet by regulation