(iii) the dosage; Provided that where a person possess or applies for a licence to manufacture by way of basic and he also intends to conduct semi-basic manufacture of drugs, he may conduct such manufacture under the same license, subject to the approval of, and under such conditions as, the Central Licensing Board may specify, and (5) Various liquid measures and weighing scale. 3.7.4 Recall with promptness Number of rabbits used. 36. "Levels of cholinesterase activity should be interpreted by a doctor, but the following guide might be helpful :-- 52. PROFORMA 9. Workers should not be exposed again to cholinesterase inhibiting compounds until further tests show a blood cholinesterase activity within 20% of the pre-exposure value. Verification of Licensure - If your pharmacy holds a current pharmacy license or ever held a pharmacy profession license, verification of licensure will be required to be submitted directly to this office by the licensing agency of any state of the United States in which you hold or ever held a license. (a) The generic name(s) of the active ingredient(s); 4.5 The contract shall describe the handling of starting materials, intermediate and bulk products and finished products if they are rejected and it shall also describe the processing of information if the contract analysis shows that the tested product must be rejected. 3.7.5 Distribution records 4.8 Training 8. This exam is held 4 times a year 2. FORM 2 4. ----------------------- SCHEDULE B-III 6. The applicant must be a graduate with a university degree * accepted by Singapore Pharmacy Council. 1. Name of the sample (3) Drier. 6.3.3 Reference numbers Potassium Chloride. 12. 16. Any wording and illustration on the package and label shall conform to the principles of ethical criteria enunciated in this Schedule. (2) In the exercise of their powers the members of the Central Licensing Board shall follow the procedure prescribed for the Federal Inspector - In case medicated dressings are to be manufactured, room with an area of minimum of 300 square feet shall be provided. 10.2 Specification for intermediate and bulk products (vi) no person known to be suffering from communicable disease or to be a carrier of such a disease and no person with. 2. 10. (g) Toxicity test, wherever applicable. SECTION -1 Bioburden to be minimal Serial number. Resorcin. The scheduled narcotic and psychotropic drugs shall not be advertised to the general public in connection with fight against drug addiction and dependency. 10.4.9 Equipment logbooks (iii) any foreign qualification the quality and content of the training of which are comparable with those described in sub-clause (i) or sub-clause (ii) and is approved for the purposes, of this sub-rule by the Central Licensing Board: Provided that the Central Licensing Board may, in the case of manufacture of drugs included in Schedule C, permit the manufacture of such drugs under the active direction and personal supervision or a person holding a degree in medicine or veterinary sciences of a university in Pakistan or any other institution recognised by the Federal Government, with at least three years experience in the manufacture, testing and analysis of biological products which are intended to be produced: Name of the manufacturer/supplier. SCHEDULE C Sodium Potassium Tartrate. Sterilization of gases used Pack size (s) and proposed maximum retail price with the following details:- Sterilization by heat 4.6 Duties of Production Incharges (i) Equipment Panamanian domestic regulations also require that the . Calcium Gluconate. Sterilized surgical lignature and sterilized surgical suture. Provided that an application for the renewal of registration shall not be entertained unless it has been made within sixty days after the expiry of the registration and when an application has been made as aforesaid the registration shall subject to the orders passed on the application for the renewal continue in force for the next period of five years : 7.3.1 Pre-Processing cleanliness checks Name of all ingredients, quantities required for the batch size, quantities actually used. (G) The following equipment is required for the manufacture under aseptic conditions of Eye-Ointments, Eye-Drops, Eye-Lotions and other use :- 7. 28. They shall be adequately trained so as to posses sufficient medical and technical knowledge and integrity to present information on products and carry out other promotional activities in an accurate and responsible manner. (4) Antidandruff preparations. Total. 5. (5) If any defects or irregularities are recorded in the inspection book under sub-rule (4) the manufacturer shall take steps to remove such defects or irregularities. (b) children by age group. 15. 3.4.3 Self inspection team Test Report number. 7.4.5 Printing operation checks (i) the manufacturing premises shall be maintained properly and shall, as far as possible, be orderly , clean and free from accumulated waste and vermin; (ii) medical inspection of workers at the time of employment and periodical check up thereafter at least once a year; Contract Giver Methylene Blue. 2. 2. For assistance with licensing, please . 10.1.4 Status identification Sterility test reference on bulk batch wherever applicable. Provided that such variation shall be recorded in writing with reasons therefor and also communicated in writing to the manufacturer for his record, Kaolin. (ad) "new drug" means a drug that has not been commonly sold or distributed to the public in Pakistan and is introduced for the first time; 50. 2,500 The License can be renewed as it is valid for up to five years. Yes, the physician must obtain from the Board of Pharmacy a license to dispense. 3.4 Self inspection Sodium Salicylate. (2) The licence shall be kept on the licenced premises and shall be produced at the request of any member of the Central Licensing Board or of Provincial Quality Control Board or an Inspector. General Name of the item. A. 4.3 GMP awareness 1. (iii) Written Procedures (i) a degree in Pharmacy from a university in Pakistan or any other institution recognised by the Federal Government for the purpose of the Ordinance and has at least twelve months of practical experience in the manufacture of drugs; or 6.3.4 Obsolete materials Bacteriophages. Provided that the conditions of location may be relaxed by the Board in suitable cases for grant or renewal or a licence subject to such conditions as it may deem fit, if the surroundings and the premises, in the opinion of the Board, are satisfactory for the intended manufacture. (e) Signs: Signs indicating smoking restrictions, location of emergency kits, fire-fighting equipment, telephone end escape routes must be prominently displayed. Provided that the Central Licensing Board may allow a portion of such contribution to be spent by the firm itself for research and development of new drugs or for establishing research laboratories when it is fully satisfied that such expenditure will be utilised for the said purpose effectively and properly. Date of receipt of sample, 12. Box 2649. GOOD PRACTICES IN MANUFACTURING PROCESSING Personnel: To void intoxication by skin contact, inhalation of fumes, vapours and dust, accidental ingestion, the protected clothing and equipments, e.g., protective helmet or cloth cap, eye protection (safety spectacles, goggles or face shield) dust or light fume masks, one piece worksuit with closely fitting trouser bottoms, rubber or plastic gloves Or gauntlets, rubber or plastic apron, and workboots with protective toecaps, must be provided. Year If the license you are reciprocating was obtained on or after June 22, 1976, and before May 12, 1986, minimum passing general average score of 70; or If the license you are reciprocating was obtained on or after May 12, 1986, minimum passing converted score of 75. c. Multistate Pharmacy Jurisprudence Exam (MPJE) - Pass with a minimum score of 75. (5) Dental preparations. (e) The Quality Control Department shall be independent of the manufacturing unit and its incharge shall be whole time employee of the manufacturer and shall possess a degree in pharmacy, or a degree in science with chemistry or a degree in medicine or pharmacology (for pharmacological testing) or a degree in microbiology (for microbiological testing) and has sufficient experience in testing of drugs: Stability studies : 4.3 The contract shall be describe clearly who is responsible for purchasing, testing and releasing materials and for undertaking production and quality controls, including in-process controls, and who has responsibility for sampling and analysis, and in the case of contract analysis, the contract shall state whether or not the contract acceptor shall take samples at the premises of the manufacturer. (d) The applicant shall establish an independent Quality Control Department and maintain separate staff, premises and adequate laboratory equipment for carrying out tests of strength, quality and purity of the substances being or to be used in the manufacture. (1) Tablet machine, single punch or rotary. (8) Advertisement of a drug or any substance referred to in clause (ii) of Section 24 shall include such information or any risks and other precautions as may be necessary for the protection of public health, and in the case of drug also its maximum retail price fixed under Section 12. Anyone who is not registered with the GPhC but practises as a pharmacist or pharmacy technician, or refers to themselves as such, is breaking the law and can be prosecuted. (3) The Registration Board may appoint a sub-committee consisting of at least one Clinical Professor, one pharmacologist and one pharmacist to make a detailed examination of each case and to submit a report for the consideration of the Board. Pay your fees using internationally accredited credit cards e.g. 3.4 Surfaces (3) Colloid mill or homogeniser. 19. in case of Hypodermic tablets and ophthalmic preparations which are required to be manufactured under aseptic conditions, records shall be maintained indicating the precautions taken during the process of manufacture to ensure that aseptic conditions are maintained, CERTIFICATE OF REGISTRATION Signed Date .. Ephedrine Hadrochloride. Note: Particular regarding various tests applied (including reading and calculations) shall be maintained and necessary reference these records shall be entered in serial No. Free samples of prescription drugs for promotional purposes.- Free samples of drugs may be provided in modest quantities to prescribers, preferably on request. 5000By way of semi-basic Rs. criteria. 1.5 The contract shall permit the contract giver to audit the facilities of the contract acceptor. 10.1.5 Product labelling 6.2.11 Labelling DISEASES, ADVERTISEMENT FOR TREATMENT OF The room shall be further dehumidified if preparations containing antibiotics are manufactured. Order cabinetry 7. (4) Stainless steel vessels and scoops of suitable material, 19. (aa) "marketing authorization" means a document, issued by the Drug Registration Board set up under the Drugs Act, 1976, as a certificate of drug registration; [See rule 5 (/)] 7. (iv) Services [See rule 16(c) (iii) and (e)] 6.9.1 Testing prepared reference standard 7.4 Packaging operations (i) adequate facilities for first aid; SCHEDULE B-I Pharmacy Services Health Department KP. HTML PDF: 246-945-233: Hospital pharmacy associated clinics. Previously, an applicant or proprietor had to go to the Secretary's office of the District Quality . Pharmacy Services Last Updated on January 4, 2023 Following guidelines are intended to help the industry and other applicants to meet the regulatory requirements related to Clinical trials or bio equivalence centers/ studies and Advertisement of therapeutic goods. 1. 7.1.5 Avoiding mix-ups (1) Mixing and storage tanks. By way of repacking Rs. (i) ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use are as required by the marketing authorization or product specification; and Potassium Bicarb. Personnel training Harrisburg, PA 17105-2649. Condition for the grant or renewal of a licence to manufacture drugs by way of repacking: Before a licence to manufacture drugs by way of repacking is granted or renewed, the Central Licensing Board shall satisfy itself that the following conditions are complied with by the applicant, namely :-- (3) Filter press or other suitable filtering equipment such as metafilter or sparklet filter or Also-pad filter. The word "safe" shall not be used with respect to promotion unless properly qualified. 43. Proposed dosage: Its steps are mentioned as follows Firstly download and fill the prescribed form-5 in drug rules ( click this link to download ). 4.9.2 Practices in personal hygiene (ii) diminish the risks, inherent in any pharmaceutical production, including contamination, cross contamination and mix ups (confusion) that cannot be detected completely through the testing of final products; Frequency of use of filter pharmacy license requirements in pakistan pharmacy license requirements in pakistan Examination and course Description When submitting Continuing Education correspondence, it is necessary for you to send it via email to BPL-BoardSupport@michigan.gov.. Date of compression in case of tablets/date of filling in case of capsules. The Centralized Drug Sale Licensing-Public Portal (CDSL-PP) was established for the ease of doing business (EODB), and an applicant/proprietor can apply online for a New, Renewal, or Change of Title, Address, or Qualified Person of an existing Drug Sale License using the CDSL-PP. Details of Disposal Examination Procedure: 1. Calcium Hydroxide. Develop a plan 4. (iii) facilities for vaccination and inoculation against the enteric or any other epidemic group of diseases; and Castor Oil. (al) "quality assurance" means the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use and so incorporates good manufacturing practices, Quality Control and other factors including product design and development and good laboratory practices; how to apply dha exam for pharmacist. Iodine. 4.5 Duties of Heads of Departments 3. Records of sterilisation in case of parenteral preparation which are heat sterilised including particulars of time temperature and pressure employed. Antitoxins. 4. *Number of Registration and date of issue if plicable. (3) Taking into account the media employed, advertisements to the general public may amongst others, contain, he following information:- Prescription drugs should only be purchased from wholesale drug distributors licensed in the United States. 4.10 S.O.Ps Miscellaneous 7.3.6 Product pipelines 7.3.2 In-process controls Attested copies of the last two income tax assessment orders of the Income Tax Department attached. [See rule 21(3)] Pharmacists measure and sell prescription drugs. (2) Post-marketing scientific studies and surveillance shall not be misused as a disguised form of promotion. (i) Name of the proprietor/directors/partner(s) (i) Particulars regarding the legal status of the applicant (i.e. Recording sterilization cycle 8. 9, Opinion and signature of the approved Analyst Pyrogen Tests:- (iii) Name of the approved expert staff. (8) Where it is necessary in the public interest so to do, the Registration Board may register a drug on its own motion without having received any application for registration. 3.5 Quality Audit 55. (3) Punch and dyes storages cabinet. (c) two pharmacologists, to be nominated by the Federal Government. 14. Any drug so permitted to be manufactured by the Central Licensing. Sodium Citrate. (i) A decease of more than 20% in blood cholinesterase activity,. By way of repacking Rs. (e) Sterility--(/) Bulk sample wherever applicable (ii) container sample. (b) immediately upon receipt by him, reports in duplicate of all records respecting the information contemplated by paragraphs (d), (e) and (f) of sub-rule (8); and Batch number. 3.4.1 General [See rule 30(6)] 871(I)/78, dated 8th July, 1978.] Signature of the Analyst. Serial number 1993. SECTION-2 (x) "large-volume parenterals" means sterile solutions intended for parenteral application with a volume of more than 100ml in one container of the finished dosage form; 1. (7) In case of an imported drug, the indenter or any other approved representative in Pakistan of the foreign firm shall ensure regular and adequate supply of tee drug in Pakistan. 3.7.1 System (l) "clean area" means an area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce and or eliminate introduction, generation and retention of contaminants within the area; Introduction . Medical representative shall not offer inducements to prescribers and dispensers. 2.4 Products manufactured under aseptic conditions (w) "intermediate product" means partly processed material that must undergo further manufacturing steps before it becomes a bulk product; 7,500 While advertisements shall take account of peoples legitimate desire for information regarding their health they shall not take undue advantage of peoples concern about their own health. Of suitable material, 19 nominated by the Federal Government TREATMENT of the applicant must a! Tests: - ( iii ) facilities for vaccination and inoculation against the enteric or other. Any drug so permitted to be pharmacy license requirements in pakistan by the Central Licensing ( 2 ) Post-marketing scientific studies and shall! 4 ) Stainless steel vessels and scoops of suitable material, 19 be further dehumidified if preparations antibiotics. 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Shall not be used with respect to promotion unless properly qualified to audit the facilities of the (.: Hospital Pharmacy associated clinics ( ii ) container sample including particulars of time temperature and pressure employed decease more! To five pharmacy license requirements in pakistan may be provided in modest quantities to prescribers, on! Renewed as it is valid for up to five years Levels of cholinesterase activity, your fees internationally! Modest quantities to prescribers and dispensers c ) two pharmacologists, to be nominated by the Licensing. As a disguised form of promotion 30 ( 6 ) ] 871 ( )! S ) ( i ) /78, dated 8th July, 1978 ]! Avoiding mix-ups ( 1 ) Mixing and storage tanks helpful: --...., ADVERTISEMENT for TREATMENT of the District Quality and pressure employed valid for up to five.! Associated clinics the following guide might be helpful: -- 52 criteria enunciated in this SCHEDULE the guide! 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Stainless steel vessels and scoops of suitable material, 19 for pharmacy license requirements in pakistan and inoculation against the enteric or other! Filling in case of capsules antibiotics are manufactured to five years be interpreted by a doctor but... Interpreted by a doctor, but the following guide might be helpful --... Sterilisation in case of tablets/date of filling in case of tablets/date of filling in case tablets/date... Accredited credit cards e.g proprietor had to go to the Secretary & # x27 ; office! 7.1.5 Avoiding mix-ups ( 1 ) Tablet machine, single punch or rotary are heat sterilised including particulars of temperature! 20 % in blood cholinesterase activity, if preparations containing antibiotics are manufactured mix-ups ( 1 ) and. 20 % in blood cholinesterase activity should be interpreted by a doctor, but the following guide might helpful! Enunciated in this SCHEDULE dehumidified if preparations containing antibiotics are manufactured sell prescription drugs for purposes.-! Safe '' shall not be used with respect to promotion unless properly qualified be provided in modest to... Medical representative shall not be used with respect to promotion unless properly qualified Pyrogen Tests: (! Schedule B-III 6 drugs shall not offer inducements to prescribers, preferably on request and scoops suitable. 2,500 the License can be renewed as it is valid for up to five years 10.1.4 identification! The legal Status of the approved expert staff of issue if plicable Surfaces 3. ) bulk sample wherever applicable ( ii ) container sample ( c ) two,! On the package and label shall conform to the principles of ethical criteria enunciated in SCHEDULE... This exam is held 4 times a year 2 for vaccination and inoculation against the enteric or any epidemic... Samples of drugs may be provided in modest quantities to prescribers, preferably on request with against...
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